NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

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These tips were gathered by NIGMS staff members Suggestions for additions to the list are welcome and should be sent to ruizbrannigmsnihgov

First Steps

1 Find out about the institutional support that is available to you (such as a startup package)

2 Broaden your vision beyond that which you had as a student

3 Seek mentoring

4 Instead of feedback try feed forward (This approach put forth by Dr Keith Yamamoto of the University of California San Francisco involves asking three senior colleagues to act as your grant committee and discussing your ideas for the application with them before starting the writing process Next write one page of three to five specific aims and discuss these with the committee before beginning to write the body of the application Thus by the time you tackle the bulk of the writing the organization and content of your proposal have received fairly detailed scrutiny and critical consideration)

Start Work

5 Have a good idea

6 Establish your independence as an investigator

7 Generate preliminary data

8 Enlist collaborators and include letters that clearly spell out the collaborations in your proposal

9 Look at successful proposals of colleagues in your field

10 Contact NIH by Web and by phone to reach people who want to help you

l NIH--httpwwwnihgov

l Center for Scientific Review--httpwwwcsrnihgov

l National Institute of General Medical Sciences --httpwwwnigmsnihgov

l Computer Retrieval of Information on Scientific Projects (CRISP a searchable database of federally funded biomedical research projects)--httpcrispcitnihgov

Start Writing

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11 Prepare your proposal early--well before the deadline Do not rush

12 Make your first proposal your best proposal Convey your confidence and enthusiasm for the project

13 Do your homework and know the literature and issues questions and controversies in your area

14 Place your work in perspective Cite others If there are two camps make sure you cite both sides

15 Make your priorities clear Provide a timeline

16 Be focused

17 Discuss potential problems and pitfalls Describe alternate strategies

18 Carefully consider your funding needs Start with personnel--you will need to explain fully the role of each person on the grant Review the NIH modular grant rules which specify that you must request funds in $25000 modules and which do not permit increments for inflation in the out -years In order to arrive at an appropriate bottom-line figure you will have to treat the budget as a 4- or 5-year budget you should get expert assistance in this preparation Although you will not have to detail budgetary needs keep in mind that the reviewers will judge your competence in part by how well your funding request matches the scope of the project

19 Use a clear and concise writing style

20 Proofread Have zero tolerance for typographical errors misspellings or sloppy formatting

21 Critique your own proposal

22 Have others read your final draft as well

After Review

23 Remember that reviewers and the NIH program directors who influence funding decisions usually try to give new investigators a break

24 If you are not funded the first time around revise your application carefully Consult your program director for advice

25 If you are funded be sure to talk with your program director at least once a year to discuss your progress

National Institute of General Medical Sciences National Institutes of Health Bethesda Maryland 20892-6200

Last updated November 1 1999 Last reviewed February 13 2001

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A SHORT GUIDE TO THE PREPARATION OF NIH GRANT APPLICATIONS

TABLE OF CONTENTS

INTRODUCTION ABSTRACT RESEARCH PLAN (overview)

A SPECIFIC AIMS B BACKGROUND AND SIGNIFICANCE C PRELIMINARY RESULTSPROGRESS REPORT D RESEARCH DESIGN AND METHODS

BUDGET AND JUSTIFICATION ASSURANCES

iexcl HUMAN iexcl ANIMAL

RESOURCES AND ENVIRONMENT OVERALL CONSIDERATIONS

INTRODUCTION This information is based very closely on NIH Publication No 93-3606 Quick Guide for the Preparation of Grant Applications written and distributed by the Hispanic Cancer Control Research Network (HCCRN) Hispanic Cancer Control Program Special Populations Studies Branch National Cancer Institute NIH The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992 It contains information and suggestions especially pertinent to cancer control research along with more generic information This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects

The guide is organized according to the major sections of the PHS-398 Grant Application Instructions Each section is described and a checklist is provided detailing what that section should cover In addition suggestions are included to enhance an applications success The checklists are not exhaustive but rather are designed to job ther application writers memory and ensure completeness This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH

PLANNING YOUR APPLICATION Several key issues should be considered before during and after your application is written

1 The usual deadlines for new NIH grant applications are February 1 June 1 and October 1

2 The usual deadlines for amended applications and competing renewal applications are March 1 July 1 and November 1

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3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

7 Reread your application Have someone else read it Proofread it again

8 If several people are contributing to the writing decide who will do the final editing

9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

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Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

Content The abstract should include

iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

Recommended Length The maximum length of the research plan is 25 pages

Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

do iexcl How will the research be accomplished Who What When Where Why

Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

2 Show knowledge of recent literature and explain how the proposed research will further what is already known

3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

4 Establish credibility of the proposed principal investigator and the collaborating researchers

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RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

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Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST

    11 Prepare your proposal early--well before the deadline Do not rush

    12 Make your first proposal your best proposal Convey your confidence and enthusiasm for the project

    13 Do your homework and know the literature and issues questions and controversies in your area

    14 Place your work in perspective Cite others If there are two camps make sure you cite both sides

    15 Make your priorities clear Provide a timeline

    16 Be focused

    17 Discuss potential problems and pitfalls Describe alternate strategies

    18 Carefully consider your funding needs Start with personnel--you will need to explain fully the role of each person on the grant Review the NIH modular grant rules which specify that you must request funds in $25000 modules and which do not permit increments for inflation in the out -years In order to arrive at an appropriate bottom-line figure you will have to treat the budget as a 4- or 5-year budget you should get expert assistance in this preparation Although you will not have to detail budgetary needs keep in mind that the reviewers will judge your competence in part by how well your funding request matches the scope of the project

    19 Use a clear and concise writing style

    20 Proofread Have zero tolerance for typographical errors misspellings or sloppy formatting

    21 Critique your own proposal

    22 Have others read your final draft as well

    After Review

    23 Remember that reviewers and the NIH program directors who influence funding decisions usually try to give new investigators a break

    24 If you are not funded the first time around revise your application carefully Consult your program director for advice

    25 If you are funded be sure to talk with your program director at least once a year to discuss your progress

    National Institute of General Medical Sciences National Institutes of Health Bethesda Maryland 20892-6200

    Last updated November 1 1999 Last reviewed February 13 2001

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    A SHORT GUIDE TO THE PREPARATION OF NIH GRANT APPLICATIONS

    TABLE OF CONTENTS

    INTRODUCTION ABSTRACT RESEARCH PLAN (overview)

    A SPECIFIC AIMS B BACKGROUND AND SIGNIFICANCE C PRELIMINARY RESULTSPROGRESS REPORT D RESEARCH DESIGN AND METHODS

    BUDGET AND JUSTIFICATION ASSURANCES

    iexcl HUMAN iexcl ANIMAL

    RESOURCES AND ENVIRONMENT OVERALL CONSIDERATIONS

    INTRODUCTION This information is based very closely on NIH Publication No 93-3606 Quick Guide for the Preparation of Grant Applications written and distributed by the Hispanic Cancer Control Research Network (HCCRN) Hispanic Cancer Control Program Special Populations Studies Branch National Cancer Institute NIH The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992 It contains information and suggestions especially pertinent to cancer control research along with more generic information This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects

    The guide is organized according to the major sections of the PHS-398 Grant Application Instructions Each section is described and a checklist is provided detailing what that section should cover In addition suggestions are included to enhance an applications success The checklists are not exhaustive but rather are designed to job ther application writers memory and ensure completeness This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH

    PLANNING YOUR APPLICATION Several key issues should be considered before during and after your application is written

    1 The usual deadlines for new NIH grant applications are February 1 June 1 and October 1

    2 The usual deadlines for amended applications and competing renewal applications are March 1 July 1 and November 1

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    3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

    4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

    5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

    6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

    7 Reread your application Have someone else read it Proofread it again

    8 If several people are contributing to the writing decide who will do the final editing

    9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

    10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

    11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

    12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

    13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

    ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

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    Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

    Content The abstract should include

    iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

    Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

    for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

    RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

    Recommended Length The maximum length of the research plan is 25 pages

    Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

    appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

    do iexcl How will the research be accomplished Who What When Where Why

    Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

    consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

    2 Show knowledge of recent literature and explain how the proposed research will further what is already known

    3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

    4 Establish credibility of the proposed principal investigator and the collaborating researchers

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    RESEARCH PLAN PART A

    SPECIFIC AIMS

    Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

    Recommended Length The recommended length of the specific aims is one page

    Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

    Suggestions

    1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

    2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

    3 Show that the objectives are attainable within the stated time frame

    4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

    5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

    6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

    7 Focus on aims where you have good supporting preliminary data and scientific expertise

    RESEARCH PLAN PART B

    BACKGROUND AND SIGNIFICENCE

    Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

    Recommended Length Approximately 3 pages

    Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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    Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

    are the specific research questions important How are the researchers qualified to address these

    2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

    3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

    4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

    5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

    RESEARCH PLAN PART C

    PRELIMINARY RESULTSPROGRESS REPORT

    Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

    Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

    Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

    feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

    background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

    are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

    Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

    this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

    2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

    3 Do not dwell on results already published Summarize the critical findings in the text and include

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    reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

    RESEARCH PLAN PART D

    RESEARCH DESIGN AND METHODS

    Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

    Recommended Length The maximum recommended length of the research design and methods section is 20 pages

    Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

    existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

    hazardous to personnel or human subjects

    Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

    1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

    2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

    3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

    4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

    5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

    BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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    budget for each subcontractor or consortium member

    Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

    Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

    Suggestions

    1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

    2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

    3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

    4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

    5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

    6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

    7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

    8 Check indirect costs Some institutions have on-campus and off -campus rates

    9 Be complete but concise There are no page limits in this section

    10 Provide adequate justification for the need to use outside consultants if applicable

    11 The budget must be approved by the grantee institution business office before they can sign the application

    12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

    13 Prorate service contracts to percentage of time equipment is used for this project

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    ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

    Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

    Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

    Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

    regulations

    2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

    3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

    HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

    Recommended Length There is no specified length but be succinct

    Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

    All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

    The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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    Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

    contact OPRR as soon as possible to obtain a single project assurance

    2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

    3 You must provide information on the inclusion of women and minorities in the study population

    VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

    Recommended Length There is no specified length but be succinct

    Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

    The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

    Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

    contact OPRR as soon as possible to obtain a single project assurance

    2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

    3 Be sure the number of animals proposed is realistic

    4 Justify all animal expenses

    RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

    Recommended Length A special form is provided for the resources and environment section

    Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

    research plan

    2 Justify any reliance on resources external to the research

    3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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    4 Make certain your resources and budget requests are consistent

    OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

    2 Use basic English and avoid jargon

    3 Make sure all acronyms are spelled out when used initially

    4 Type single-spaced and stay within the margins

    5 Observe the type size and page limitations strictly do not use a small font

    6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

    7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

    8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

    9 List all citations (six pages maximum) at the end of the research plan

    10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

    11 Have an outside reader review the proposal for clarity and consistency

    12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

    13 Be consistent with terms references and forrn writing style

    14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

    15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

    16 Make sure all the check-box items on page II of the PHS 398 application are completed

    17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

    DEA Home

    created 27sep95 Lorrie Smith revised 02apr98

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    Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

    The following slides were presented at the University of Louisville on September 23 and 24 1999

    Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

    Slides Table of Contents

    l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

    NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

    Page 1 of 1How to Apply for NIH Funding (slides)

    3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

    Third Edition amended August 30 2001

    The Original How to Write a Research Grant Application

    Contents

    Strategy for Getting an NIH Grant 2

    Writing an Application for a Research Project Grant 3

    I Before You Begin 4

    II Application Contents 5

    III Developing Your Research Plan 6

    IV Application Contents Other Than the Research Plan 15

    V Writing and Formatting 18

    VI Submitting Your Grant Application 20

    VII Problems and Concerns Commonly Cited by Reviewers 21

    VIII Referral and Assignment of the Application 23

    IX Review of Research Project Applications 24

    X How Funding Is Decided 27

    XI When You Have Not Obtained Funding 29

    XII When Your Application Is Approved for Funding 32

    Checklists 35

    Strategy for Getting an NIH Grant

    1 Assess competition in the field

    2 Know the level of resources needed to compete

    - do an organizational assessment

    - look for opportunities to build research with support from various sources

    - get a mentor

    3 Be willing to change yourself your projects your career

    4 Know the opportunities in the field for

    - collaboration with a known laboratory or mentor

    - carving out a niche

    5 Find out which NIH institutes supporting research in your area are seeking applications

    - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

    - discuss your ideas with Institute program staff See NIAIDs program and staff listing

    6 Make sure you and your collaborators are properly trained for the research

    7 Closely examine grant applications from successful grantees

    8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

    9 Have several experienced grantees critique your application

    10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

    Writing an Application for a Research Project Grant

    There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

    This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

    Eight Basic Questions Reviewers Ask

    1 How high are the intellectual quality and merit of the study

    2 What is its potential impact

    3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

    4 Is the hypothesis valid and have you presented evidence supporting it

    5 Are the aims logical

    6 Are the procedures appropriate adequate and feasible for the research

    7 Are the investigators qualified Have they shown competence credentials and experience

    8 Are the facilities adequate and the environment conducive to the research

    Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

    A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

    Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

    I Before You Begin

    Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

    Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

    To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

    Developing the Hypothesis

    Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

    Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

    State your hypothesis in both the specific aims section of the research plan and the abstract

    II Application Contents

    Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

    The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

    Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

    Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

    Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

    III Developing Your Research Plan

    A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

    - Your application should be based on a strong hypothesis

    - Be sure your project has a coherent direction

    - Keep the sections of the plan well coordinated and clearly related to the central focus

    - Emphasize mechanism A good grant application asks questions about biological mechanisms

    - Dont be overly ambitious your plan should be based on a feasible timetable

    - Specific aims and experiments should relate directly to the hypothesis to be tested

    A Specific Aims

    Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

    Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

    State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

    B Background and Significance

    Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

    Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

    Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

    Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

    Identify the next logical stage of research beyond your current application

    C Preliminary StudiesProgress Report

    By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

    Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

    Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

    Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

    Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

    D Research Design and Methods

    Describe the experimental design and procedures in detail and give a rationale for their use

    Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

    Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

    advantageous to the research you propose to do

    More and more applicants are including colored charts graphs and photographs in their applications

    Approach

    State why you chose your approach or approaches as opposed to others

    If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

    Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

    Consider the limitations of each approach and how it may affect your results and the data generated

    Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

    Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

    Results

    Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

    Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

    Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

    Describe your proposed statistical methods for analyzing the data you plan to collect

    Define the criteria for evaluating the success or failure of a specific test

    Other pointers

    Read the PHS 398 carefully for specific requirements especially those involving human subjects

    Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

    Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

    Describe any procedures situations or materials that may be hazardous and precautions you will take

    Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

    E Human Subjects

    Is it human subject research

    Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

    A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

    If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

    If the answer is yes

    If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

    This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

    The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

    bull Description of how you will protect subjects from research risks bull Plans to include

    Women Children Minorities Analyses capable of showing intervention differences between men and

    women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

    Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

    Protection

    Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

    bull Identify the characteristics of the study population or sources of research materials

    bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

    bull Describe potential benefits to the subjects and mankind

    bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

    In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

    Inclusion

    Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

    This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

    After your human subjects section start new pages for the following plans

    Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

    Put your plans on separate pages they are not included in the page limit

    In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

    Monitoring

    The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

    NIAID must also approve your monitoring plan see our Terms of award

    Reporting

    Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

    For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

    Also pay attention to the minority subgroups required for clinical trial reporting

    Training

    Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

    Certifications and assurances

    If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

    Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

    NIAID Special Terms of Award

    NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

    Review of Clinical Applications

    In addition to the regular review criteria clinical research applications will also be reviewed for

    bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

    bull Reasonableness of the proposed budget and duration in relation to the proposed research

    bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

    bull Adequacy of the proposed plan to share data if appropriate

    Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

    More Human Subjects Links

    In addition to the 398 see these sites for more information

    Glossary of human subject-related terms including a definition of what constitutes human subject research

    Human subjects feature of March 2001 Council News

    NIH human subjects reviewer guidance

    Also see our Terms of award for NIAID-specific requirements

    F Vertebrate Animals

    As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

    Your application should include

    - A detailed description of the proposed use of the animals

    - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

    - Information on the veterinary care of the animals

    - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

    - Justification for any euthanasia method to be used

    If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

    G Literature Cited

    Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

    Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

    Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

    H ConsortiumContractual Arrangements

    This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

    The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

    I Consultants

    Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

    IV Application Contents Other Than the Research Plan

    Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

    Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

    Abstract (Form BB)

    Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

    Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

    Title

    Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

    Biographical Sketches (Form FF)

    This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

    With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

    - Name and title

    - Education -- institutions location degree(s) year conferred and field(s) of study

    - Roles in other relevant current or past research

    - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

    - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

    Budget

    Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

    Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

    Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

    Modular grants

    NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

    Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

    NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

    Resources

    The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

    research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

    V Writing and Formatting

    Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

    Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

    Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

    Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

    Page Limitations

    Type (font) Size and Spacing

    Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

    Font size in figures and tables may be smaller but must be readily legible

    Writing Tips

    Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

    Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

    Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

    Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

    tables

    Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

    VI Submitting Your Grant Application

    Receipt Date

    NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

    Cover Letter

    Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

    Requesting an SRG and InstituteCenter

    Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

    You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

    Modular Grants and Applications and Just in Time

    The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

    The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

    For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

    VII Problems and Concerns Commonly Cited by Reviewers

    Below is a list of the most common reasons cited by reviewers for an applications lack of success

    Lack of significance to the scientific issue being addressed

    Lack of original or new ideas

    Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

    Project too diffuse or superficial or lacks focus

    Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

    Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

    Rationale for experiments not provided (why important or how relevant to the hypothesis)

    Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

    Lack of alternative methodological approaches in case the primary approach does not work out

    Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

    The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

    The proposed experiments do not include all relevant controls

    Proposal innovative but lacking enough preliminary data

    Preliminary data do not support the feasibility of the project or the hypothesis

    Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

    The proposal lacks critical literature references causing reviewers to think that the

    applicant either does not know the literature or has purposely neglected critical published material

    Not clear which data were obtained by the investigator and which have been reported by others

    VIII Referral and Assignment of the Application

    When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

    Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

    Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

    To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

    You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

    If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

    IX Review of Research Project Applications

    This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

    Scientific Review Groups

    Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

    Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

    Review Criteria

    In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

    Significance Approach Innovation Investigator Environment

    To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

    Cover Letter

    Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

    State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

    Administrative Review

    Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

    If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

    At the Peer Review Meeting

    Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

    Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

    How Priority Scores Are Determined

    If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

    Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

    Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

    1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

    2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

    3 Deferred In some instances the scientific review group is unable to make an

    adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

    Summary Statements

    Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

    Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

    Appeal

    You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

    X How Funding Is Decided

    Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

    Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

    How Paylines Work

    Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

    Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

    Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

    You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

    For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

    Second Level Peer Review

    In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

    They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

    Possible Outcomes of Secondary Review

    Following Council review NIAID takes one of four actions for an application

    1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

    Why Applications Are Kept on Hold

    ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

    Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

    XI When You Have Not Obtained Funding

    What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

    Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

    Most Common Reasons for a Low Score (in priority order)

    - Lack of new or original ideas

    - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

    - Methods unsuitable or defective and not likely to yield results

    - Data collection confused in design inappropriate instrumentation poor timing or conditions

    - Data management and analysis vague unsophisticated

    - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

    - Poor resources or facilities limited access to appropriate patient population

    From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

    When to Revise

    How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

    If the problems are repairable revise the application and resubmit it to the same study section

    Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

    - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

    Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

    vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

    If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

    For fatal flaws and weaknesses rethink your idea and start over

    Revising Your Application

    Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

    Respond to reviewersrsquo comments

    The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

    Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

    Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

    additions deletions and changes in the revised application and address the main criticisms in the summary statement

    Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

    Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

    If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

    XII When Your Application Is Approved for Funding

    If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

    Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

    If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

    There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

    For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

    Documentation

    Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

    Human subjects

    For more information concerning the human subjects assurance contact OHRP at

    Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

    And find a wealth of guidance documents on the Web

    Animals in Research

    For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

    Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

    Or see the Web site at Office of Laboratory Animal Welfare

    What You Can and Cannot Pay for on a Grant

    In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

    OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

    For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

    Terms and Conditions of Award

    Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

    Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

    NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

    Reporting Requirements

    Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

    Address and phone number are

    NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

    For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

    Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

    Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

    Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

    Checklists

    BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

    HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

    RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

    RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

    rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

    SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

    BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

    PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

    DESIGN AND METHODS CHECKLIST

    General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

    Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

    Does the PIs salary exceed the government cap of $141300

    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

    • howtopdf
      • Third Edition amended August 30 2001
      • The Original How to Write a Research Grant Application
        • I Before You Begin
            • If the answer is yes
            • Protection
            • Inclusion
            • Monitoring
            • Reporting
            • Training
            • Certifications and assurances
              • Most Common Reasons for a Low Score (in priority order)
              • BEGINNING CHECKLIST
              • HYPOTHESIS CHECKLIST
              • RESEARCH PLAN - PLANNING CHECKLIST
              • RESEARCH PLAN - PROCESS CHECKLIST
              • SPECIFIC AIMS CHECKLIST
              • BACKGROUND AND SIGNIFICANCE CHECKLIST
              • PRELIMINARY DATA CHECKLIST
              • DESIGN AND METHODS CHECKLIST
              • General
              • Approach
              • ABSTRACT CHECKLIST
              • BIOSKETCHES CHECKLIST
              • BUDGET CHECKLIST
              • RESOURCES CHECKLIST
              • REVISING CHECKLIST

      A SHORT GUIDE TO THE PREPARATION OF NIH GRANT APPLICATIONS

      TABLE OF CONTENTS

      INTRODUCTION ABSTRACT RESEARCH PLAN (overview)

      A SPECIFIC AIMS B BACKGROUND AND SIGNIFICANCE C PRELIMINARY RESULTSPROGRESS REPORT D RESEARCH DESIGN AND METHODS

      BUDGET AND JUSTIFICATION ASSURANCES

      iexcl HUMAN iexcl ANIMAL

      RESOURCES AND ENVIRONMENT OVERALL CONSIDERATIONS

      INTRODUCTION This information is based very closely on NIH Publication No 93-3606 Quick Guide for the Preparation of Grant Applications written and distributed by the Hispanic Cancer Control Research Network (HCCRN) Hispanic Cancer Control Program Special Populations Studies Branch National Cancer Institute NIH The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992 It contains information and suggestions especially pertinent to cancer control research along with more generic information This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects

      The guide is organized according to the major sections of the PHS-398 Grant Application Instructions Each section is described and a checklist is provided detailing what that section should cover In addition suggestions are included to enhance an applications success The checklists are not exhaustive but rather are designed to job ther application writers memory and ensure completeness This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH

      PLANNING YOUR APPLICATION Several key issues should be considered before during and after your application is written

      1 The usual deadlines for new NIH grant applications are February 1 June 1 and October 1

      2 The usual deadlines for amended applications and competing renewal applications are March 1 July 1 and November 1

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      3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

      4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

      5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

      6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

      7 Reread your application Have someone else read it Proofread it again

      8 If several people are contributing to the writing decide who will do the final editing

      9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

      10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

      11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

      12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

      13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

      ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

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      Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

      Content The abstract should include

      iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

      Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

      for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

      RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

      Recommended Length The maximum length of the research plan is 25 pages

      Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

      appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

      do iexcl How will the research be accomplished Who What When Where Why

      Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

      consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

      2 Show knowledge of recent literature and explain how the proposed research will further what is already known

      3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

      4 Establish credibility of the proposed principal investigator and the collaborating researchers

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      RESEARCH PLAN PART A

      SPECIFIC AIMS

      Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

      Recommended Length The recommended length of the specific aims is one page

      Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

      Suggestions

      1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

      2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

      3 Show that the objectives are attainable within the stated time frame

      4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

      5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

      6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

      7 Focus on aims where you have good supporting preliminary data and scientific expertise

      RESEARCH PLAN PART B

      BACKGROUND AND SIGNIFICENCE

      Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

      Recommended Length Approximately 3 pages

      Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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      Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

      are the specific research questions important How are the researchers qualified to address these

      2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

      3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

      4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

      5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

      RESEARCH PLAN PART C

      PRELIMINARY RESULTSPROGRESS REPORT

      Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

      Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

      Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

      feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

      background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

      are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

      Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

      this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

      2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

      3 Do not dwell on results already published Summarize the critical findings in the text and include

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      reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

      RESEARCH PLAN PART D

      RESEARCH DESIGN AND METHODS

      Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

      Recommended Length The maximum recommended length of the research design and methods section is 20 pages

      Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

      existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

      hazardous to personnel or human subjects

      Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

      1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

      2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

      3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

      4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

      5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

      BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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      budget for each subcontractor or consortium member

      Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

      Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

      Suggestions

      1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

      2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

      3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

      4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

      5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

      6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

      7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

      8 Check indirect costs Some institutions have on-campus and off -campus rates

      9 Be complete but concise There are no page limits in this section

      10 Provide adequate justification for the need to use outside consultants if applicable

      11 The budget must be approved by the grantee institution business office before they can sign the application

      12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

      13 Prorate service contracts to percentage of time equipment is used for this project

      Page 7 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

      3202002httpdeainfoncinihgovextraextdocsgntapphtm

      ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

      Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

      Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

      Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

      regulations

      2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

      3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

      HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

      Recommended Length There is no specified length but be succinct

      Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

      All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

      The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

      Page 8 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

      3202002httpdeainfoncinihgovextraextdocsgntapphtm

      Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

      contact OPRR as soon as possible to obtain a single project assurance

      2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

      3 You must provide information on the inclusion of women and minorities in the study population

      VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

      Recommended Length There is no specified length but be succinct

      Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

      The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

      Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

      contact OPRR as soon as possible to obtain a single project assurance

      2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

      3 Be sure the number of animals proposed is realistic

      4 Justify all animal expenses

      RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

      Recommended Length A special form is provided for the resources and environment section

      Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

      research plan

      2 Justify any reliance on resources external to the research

      3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

      Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

      3202002httpdeainfoncinihgovextraextdocsgntapphtm

      4 Make certain your resources and budget requests are consistent

      OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

      2 Use basic English and avoid jargon

      3 Make sure all acronyms are spelled out when used initially

      4 Type single-spaced and stay within the margins

      5 Observe the type size and page limitations strictly do not use a small font

      6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

      7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

      8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

      9 List all citations (six pages maximum) at the end of the research plan

      10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

      11 Have an outside reader review the proposal for clarity and consistency

      12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

      13 Be consistent with terms references and forrn writing style

      14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

      15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

      16 Make sure all the check-box items on page II of the PHS 398 application are completed

      17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

      DEA Home

      created 27sep95 Lorrie Smith revised 02apr98

      Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

      3202002httpdeainfoncinihgovextraextdocsgntapphtm

      Home | Search | Sitemap | Contact

      About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

      Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

      The following slides were presented at the University of Louisville on September 23 and 24 1999

      Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

      Slides Table of Contents

      l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

      NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

      Page 1 of 1How to Apply for NIH Funding (slides)

      3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

      Third Edition amended August 30 2001

      The Original How to Write a Research Grant Application

      Contents

      Strategy for Getting an NIH Grant 2

      Writing an Application for a Research Project Grant 3

      I Before You Begin 4

      II Application Contents 5

      III Developing Your Research Plan 6

      IV Application Contents Other Than the Research Plan 15

      V Writing and Formatting 18

      VI Submitting Your Grant Application 20

      VII Problems and Concerns Commonly Cited by Reviewers 21

      VIII Referral and Assignment of the Application 23

      IX Review of Research Project Applications 24

      X How Funding Is Decided 27

      XI When You Have Not Obtained Funding 29

      XII When Your Application Is Approved for Funding 32

      Checklists 35

      Strategy for Getting an NIH Grant

      1 Assess competition in the field

      2 Know the level of resources needed to compete

      - do an organizational assessment

      - look for opportunities to build research with support from various sources

      - get a mentor

      3 Be willing to change yourself your projects your career

      4 Know the opportunities in the field for

      - collaboration with a known laboratory or mentor

      - carving out a niche

      5 Find out which NIH institutes supporting research in your area are seeking applications

      - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

      - discuss your ideas with Institute program staff See NIAIDs program and staff listing

      6 Make sure you and your collaborators are properly trained for the research

      7 Closely examine grant applications from successful grantees

      8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

      9 Have several experienced grantees critique your application

      10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

      Writing an Application for a Research Project Grant

      There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

      This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

      Eight Basic Questions Reviewers Ask

      1 How high are the intellectual quality and merit of the study

      2 What is its potential impact

      3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

      4 Is the hypothesis valid and have you presented evidence supporting it

      5 Are the aims logical

      6 Are the procedures appropriate adequate and feasible for the research

      7 Are the investigators qualified Have they shown competence credentials and experience

      8 Are the facilities adequate and the environment conducive to the research

      Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

      A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

      Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

      I Before You Begin

      Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

      Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

      To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

      Developing the Hypothesis

      Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

      Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

      State your hypothesis in both the specific aims section of the research plan and the abstract

      II Application Contents

      Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

      The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

      Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

      Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

      Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

      III Developing Your Research Plan

      A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

      - Your application should be based on a strong hypothesis

      - Be sure your project has a coherent direction

      - Keep the sections of the plan well coordinated and clearly related to the central focus

      - Emphasize mechanism A good grant application asks questions about biological mechanisms

      - Dont be overly ambitious your plan should be based on a feasible timetable

      - Specific aims and experiments should relate directly to the hypothesis to be tested

      A Specific Aims

      Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

      Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

      State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

      B Background and Significance

      Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

      Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

      Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

      Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

      Identify the next logical stage of research beyond your current application

      C Preliminary StudiesProgress Report

      By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

      Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

      Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

      Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

      Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

      D Research Design and Methods

      Describe the experimental design and procedures in detail and give a rationale for their use

      Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

      Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

      advantageous to the research you propose to do

      More and more applicants are including colored charts graphs and photographs in their applications

      Approach

      State why you chose your approach or approaches as opposed to others

      If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

      Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

      Consider the limitations of each approach and how it may affect your results and the data generated

      Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

      Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

      Results

      Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

      Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

      Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

      Describe your proposed statistical methods for analyzing the data you plan to collect

      Define the criteria for evaluating the success or failure of a specific test

      Other pointers

      Read the PHS 398 carefully for specific requirements especially those involving human subjects

      Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

      Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

      Describe any procedures situations or materials that may be hazardous and precautions you will take

      Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

      E Human Subjects

      Is it human subject research

      Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

      A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

      If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

      If the answer is yes

      If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

      This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

      The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

      bull Description of how you will protect subjects from research risks bull Plans to include

      Women Children Minorities Analyses capable of showing intervention differences between men and

      women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

      Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

      Protection

      Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

      bull Identify the characteristics of the study population or sources of research materials

      bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

      bull Describe potential benefits to the subjects and mankind

      bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

      In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

      Inclusion

      Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

      This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

      After your human subjects section start new pages for the following plans

      Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

      Put your plans on separate pages they are not included in the page limit

      In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

      Monitoring

      The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

      NIAID must also approve your monitoring plan see our Terms of award

      Reporting

      Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

      For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

      Also pay attention to the minority subgroups required for clinical trial reporting

      Training

      Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

      Certifications and assurances

      If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

      Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

      NIAID Special Terms of Award

      NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

      Review of Clinical Applications

      In addition to the regular review criteria clinical research applications will also be reviewed for

      bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

      bull Reasonableness of the proposed budget and duration in relation to the proposed research

      bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

      bull Adequacy of the proposed plan to share data if appropriate

      Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

      More Human Subjects Links

      In addition to the 398 see these sites for more information

      Glossary of human subject-related terms including a definition of what constitutes human subject research

      Human subjects feature of March 2001 Council News

      NIH human subjects reviewer guidance

      Also see our Terms of award for NIAID-specific requirements

      F Vertebrate Animals

      As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

      Your application should include

      - A detailed description of the proposed use of the animals

      - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

      - Information on the veterinary care of the animals

      - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

      - Justification for any euthanasia method to be used

      If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

      G Literature Cited

      Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

      Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

      Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

      H ConsortiumContractual Arrangements

      This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

      The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

      I Consultants

      Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

      IV Application Contents Other Than the Research Plan

      Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

      Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

      Abstract (Form BB)

      Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

      Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

      Title

      Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

      Biographical Sketches (Form FF)

      This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

      With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

      - Name and title

      - Education -- institutions location degree(s) year conferred and field(s) of study

      - Roles in other relevant current or past research

      - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

      - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

      Budget

      Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

      Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

      Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

      Modular grants

      NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

      Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

      NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

      Resources

      The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

      research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

      V Writing and Formatting

      Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

      Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

      Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

      Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

      Page Limitations

      Type (font) Size and Spacing

      Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

      Font size in figures and tables may be smaller but must be readily legible

      Writing Tips

      Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

      Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

      Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

      Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

      tables

      Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

      VI Submitting Your Grant Application

      Receipt Date

      NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

      Cover Letter

      Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

      Requesting an SRG and InstituteCenter

      Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

      You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

      Modular Grants and Applications and Just in Time

      The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

      The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

      For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

      VII Problems and Concerns Commonly Cited by Reviewers

      Below is a list of the most common reasons cited by reviewers for an applications lack of success

      Lack of significance to the scientific issue being addressed

      Lack of original or new ideas

      Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

      Project too diffuse or superficial or lacks focus

      Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

      Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

      Rationale for experiments not provided (why important or how relevant to the hypothesis)

      Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

      Lack of alternative methodological approaches in case the primary approach does not work out

      Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

      The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

      The proposed experiments do not include all relevant controls

      Proposal innovative but lacking enough preliminary data

      Preliminary data do not support the feasibility of the project or the hypothesis

      Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

      The proposal lacks critical literature references causing reviewers to think that the

      applicant either does not know the literature or has purposely neglected critical published material

      Not clear which data were obtained by the investigator and which have been reported by others

      VIII Referral and Assignment of the Application

      When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

      Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

      Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

      To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

      You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

      If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

      IX Review of Research Project Applications

      This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

      Scientific Review Groups

      Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

      Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

      Review Criteria

      In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

      Significance Approach Innovation Investigator Environment

      To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

      Cover Letter

      Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

      State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

      Administrative Review

      Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

      If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

      At the Peer Review Meeting

      Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

      Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

      How Priority Scores Are Determined

      If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

      Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

      Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

      1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

      2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

      3 Deferred In some instances the scientific review group is unable to make an

      adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

      Summary Statements

      Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

      Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

      Appeal

      You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

      X How Funding Is Decided

      Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

      Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

      How Paylines Work

      Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

      Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

      Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

      You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

      For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

      Second Level Peer Review

      In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

      They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

      Possible Outcomes of Secondary Review

      Following Council review NIAID takes one of four actions for an application

      1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

      Why Applications Are Kept on Hold

      ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

      Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

      XI When You Have Not Obtained Funding

      What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

      Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

      Most Common Reasons for a Low Score (in priority order)

      - Lack of new or original ideas

      - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

      - Methods unsuitable or defective and not likely to yield results

      - Data collection confused in design inappropriate instrumentation poor timing or conditions

      - Data management and analysis vague unsophisticated

      - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

      - Poor resources or facilities limited access to appropriate patient population

      From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

      When to Revise

      How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

      If the problems are repairable revise the application and resubmit it to the same study section

      Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

      - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

      Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

      vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

      If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

      For fatal flaws and weaknesses rethink your idea and start over

      Revising Your Application

      Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

      Respond to reviewersrsquo comments

      The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

      Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

      Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

      additions deletions and changes in the revised application and address the main criticisms in the summary statement

      Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

      Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

      If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

      XII When Your Application Is Approved for Funding

      If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

      Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

      If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

      There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

      For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

      Documentation

      Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

      Human subjects

      For more information concerning the human subjects assurance contact OHRP at

      Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

      And find a wealth of guidance documents on the Web

      Animals in Research

      For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

      Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

      Or see the Web site at Office of Laboratory Animal Welfare

      What You Can and Cannot Pay for on a Grant

      In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

      OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

      For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

      Terms and Conditions of Award

      Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

      Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

      NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

      Reporting Requirements

      Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

      Address and phone number are

      NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

      For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

      Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

      Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

      Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

      Checklists

      BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

      HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

      RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

      RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

      rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

      SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

      BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

      PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

      DESIGN AND METHODS CHECKLIST

      General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

      Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

      Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

      Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

      ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

      BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

      BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

      Does the PIs salary exceed the government cap of $141300

      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

      • howtopdf
        • Third Edition amended August 30 2001
        • The Original How to Write a Research Grant Application
          • I Before You Begin
              • If the answer is yes
              • Protection
              • Inclusion
              • Monitoring
              • Reporting
              • Training
              • Certifications and assurances
                • Most Common Reasons for a Low Score (in priority order)
                • BEGINNING CHECKLIST
                • HYPOTHESIS CHECKLIST
                • RESEARCH PLAN - PLANNING CHECKLIST
                • RESEARCH PLAN - PROCESS CHECKLIST
                • SPECIFIC AIMS CHECKLIST
                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                • PRELIMINARY DATA CHECKLIST
                • DESIGN AND METHODS CHECKLIST
                • General
                • Approach
                • ABSTRACT CHECKLIST
                • BIOSKETCHES CHECKLIST
                • BUDGET CHECKLIST
                • RESOURCES CHECKLIST
                • REVISING CHECKLIST

        3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

        4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

        5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

        6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

        7 Reread your application Have someone else read it Proofread it again

        8 If several people are contributing to the writing decide who will do the final editing

        9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

        10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

        11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

        12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

        13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

        ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

        Page 2 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

        3202002httpdeainfoncinihgovextraextdocsgntapphtm

        Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

        Content The abstract should include

        iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

        Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

        for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

        RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

        Recommended Length The maximum length of the research plan is 25 pages

        Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

        appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

        do iexcl How will the research be accomplished Who What When Where Why

        Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

        consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

        2 Show knowledge of recent literature and explain how the proposed research will further what is already known

        3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

        4 Establish credibility of the proposed principal investigator and the collaborating researchers

        Page 3 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

        3202002httpdeainfoncinihgovextraextdocsgntapphtm

        RESEARCH PLAN PART A

        SPECIFIC AIMS

        Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

        Recommended Length The recommended length of the specific aims is one page

        Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

        Suggestions

        1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

        2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

        3 Show that the objectives are attainable within the stated time frame

        4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

        5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

        6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

        7 Focus on aims where you have good supporting preliminary data and scientific expertise

        RESEARCH PLAN PART B

        BACKGROUND AND SIGNIFICENCE

        Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

        Recommended Length Approximately 3 pages

        Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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        Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

        are the specific research questions important How are the researchers qualified to address these

        2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

        3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

        4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

        5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

        RESEARCH PLAN PART C

        PRELIMINARY RESULTSPROGRESS REPORT

        Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

        Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

        Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

        feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

        background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

        are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

        Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

        this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

        2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

        3 Do not dwell on results already published Summarize the critical findings in the text and include

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        reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

        RESEARCH PLAN PART D

        RESEARCH DESIGN AND METHODS

        Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

        Recommended Length The maximum recommended length of the research design and methods section is 20 pages

        Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

        existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

        hazardous to personnel or human subjects

        Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

        1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

        2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

        3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

        4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

        5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

        BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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        budget for each subcontractor or consortium member

        Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

        Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

        Suggestions

        1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

        2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

        3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

        4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

        5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

        6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

        7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

        8 Check indirect costs Some institutions have on-campus and off -campus rates

        9 Be complete but concise There are no page limits in this section

        10 Provide adequate justification for the need to use outside consultants if applicable

        11 The budget must be approved by the grantee institution business office before they can sign the application

        12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

        13 Prorate service contracts to percentage of time equipment is used for this project

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        ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

        Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

        Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

        Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

        regulations

        2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

        3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

        HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

        Recommended Length There is no specified length but be succinct

        Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

        All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

        The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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        Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

        contact OPRR as soon as possible to obtain a single project assurance

        2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

        3 You must provide information on the inclusion of women and minorities in the study population

        VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

        Recommended Length There is no specified length but be succinct

        Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

        The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

        Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

        contact OPRR as soon as possible to obtain a single project assurance

        2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

        3 Be sure the number of animals proposed is realistic

        4 Justify all animal expenses

        RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

        Recommended Length A special form is provided for the resources and environment section

        Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

        research plan

        2 Justify any reliance on resources external to the research

        3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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        4 Make certain your resources and budget requests are consistent

        OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

        2 Use basic English and avoid jargon

        3 Make sure all acronyms are spelled out when used initially

        4 Type single-spaced and stay within the margins

        5 Observe the type size and page limitations strictly do not use a small font

        6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

        7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

        8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

        9 List all citations (six pages maximum) at the end of the research plan

        10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

        11 Have an outside reader review the proposal for clarity and consistency

        12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

        13 Be consistent with terms references and forrn writing style

        14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

        15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

        16 Make sure all the check-box items on page II of the PHS 398 application are completed

        17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

        DEA Home

        created 27sep95 Lorrie Smith revised 02apr98

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        Home | Search | Sitemap | Contact

        About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

        Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

        The following slides were presented at the University of Louisville on September 23 and 24 1999

        Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

        Slides Table of Contents

        l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

        NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

        Page 1 of 1How to Apply for NIH Funding (slides)

        3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

        Third Edition amended August 30 2001

        The Original How to Write a Research Grant Application

        Contents

        Strategy for Getting an NIH Grant 2

        Writing an Application for a Research Project Grant 3

        I Before You Begin 4

        II Application Contents 5

        III Developing Your Research Plan 6

        IV Application Contents Other Than the Research Plan 15

        V Writing and Formatting 18

        VI Submitting Your Grant Application 20

        VII Problems and Concerns Commonly Cited by Reviewers 21

        VIII Referral and Assignment of the Application 23

        IX Review of Research Project Applications 24

        X How Funding Is Decided 27

        XI When You Have Not Obtained Funding 29

        XII When Your Application Is Approved for Funding 32

        Checklists 35

        Strategy for Getting an NIH Grant

        1 Assess competition in the field

        2 Know the level of resources needed to compete

        - do an organizational assessment

        - look for opportunities to build research with support from various sources

        - get a mentor

        3 Be willing to change yourself your projects your career

        4 Know the opportunities in the field for

        - collaboration with a known laboratory or mentor

        - carving out a niche

        5 Find out which NIH institutes supporting research in your area are seeking applications

        - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

        - discuss your ideas with Institute program staff See NIAIDs program and staff listing

        6 Make sure you and your collaborators are properly trained for the research

        7 Closely examine grant applications from successful grantees

        8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

        9 Have several experienced grantees critique your application

        10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

        Writing an Application for a Research Project Grant

        There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

        This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

        Eight Basic Questions Reviewers Ask

        1 How high are the intellectual quality and merit of the study

        2 What is its potential impact

        3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

        4 Is the hypothesis valid and have you presented evidence supporting it

        5 Are the aims logical

        6 Are the procedures appropriate adequate and feasible for the research

        7 Are the investigators qualified Have they shown competence credentials and experience

        8 Are the facilities adequate and the environment conducive to the research

        Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

        A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

        Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

        I Before You Begin

        Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

        Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

        To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

        Developing the Hypothesis

        Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

        Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

        State your hypothesis in both the specific aims section of the research plan and the abstract

        II Application Contents

        Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

        The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

        Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

        Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

        Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

        III Developing Your Research Plan

        A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

        - Your application should be based on a strong hypothesis

        - Be sure your project has a coherent direction

        - Keep the sections of the plan well coordinated and clearly related to the central focus

        - Emphasize mechanism A good grant application asks questions about biological mechanisms

        - Dont be overly ambitious your plan should be based on a feasible timetable

        - Specific aims and experiments should relate directly to the hypothesis to be tested

        A Specific Aims

        Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

        Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

        State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

        B Background and Significance

        Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

        Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

        Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

        Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

        Identify the next logical stage of research beyond your current application

        C Preliminary StudiesProgress Report

        By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

        Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

        Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

        Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

        Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

        D Research Design and Methods

        Describe the experimental design and procedures in detail and give a rationale for their use

        Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

        Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

        advantageous to the research you propose to do

        More and more applicants are including colored charts graphs and photographs in their applications

        Approach

        State why you chose your approach or approaches as opposed to others

        If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

        Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

        Consider the limitations of each approach and how it may affect your results and the data generated

        Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

        Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

        Results

        Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

        Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

        Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

        Describe your proposed statistical methods for analyzing the data you plan to collect

        Define the criteria for evaluating the success or failure of a specific test

        Other pointers

        Read the PHS 398 carefully for specific requirements especially those involving human subjects

        Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

        Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

        Describe any procedures situations or materials that may be hazardous and precautions you will take

        Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

        E Human Subjects

        Is it human subject research

        Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

        A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

        If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

        If the answer is yes

        If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

        This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

        The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

        bull Description of how you will protect subjects from research risks bull Plans to include

        Women Children Minorities Analyses capable of showing intervention differences between men and

        women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

        Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

        Protection

        Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

        bull Identify the characteristics of the study population or sources of research materials

        bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

        bull Describe potential benefits to the subjects and mankind

        bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

        In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

        Inclusion

        Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

        This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

        After your human subjects section start new pages for the following plans

        Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

        Put your plans on separate pages they are not included in the page limit

        In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

        Monitoring

        The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

        NIAID must also approve your monitoring plan see our Terms of award

        Reporting

        Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

        For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

        Also pay attention to the minority subgroups required for clinical trial reporting

        Training

        Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

        Certifications and assurances

        If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

        Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

        NIAID Special Terms of Award

        NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

        Review of Clinical Applications

        In addition to the regular review criteria clinical research applications will also be reviewed for

        bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

        bull Reasonableness of the proposed budget and duration in relation to the proposed research

        bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

        bull Adequacy of the proposed plan to share data if appropriate

        Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

        More Human Subjects Links

        In addition to the 398 see these sites for more information

        Glossary of human subject-related terms including a definition of what constitutes human subject research

        Human subjects feature of March 2001 Council News

        NIH human subjects reviewer guidance

        Also see our Terms of award for NIAID-specific requirements

        F Vertebrate Animals

        As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

        Your application should include

        - A detailed description of the proposed use of the animals

        - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

        - Information on the veterinary care of the animals

        - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

        - Justification for any euthanasia method to be used

        If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

        G Literature Cited

        Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

        Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

        Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

        H ConsortiumContractual Arrangements

        This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

        The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

        I Consultants

        Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

        IV Application Contents Other Than the Research Plan

        Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

        Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

        Abstract (Form BB)

        Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

        Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

        Title

        Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

        Biographical Sketches (Form FF)

        This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

        With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

        - Name and title

        - Education -- institutions location degree(s) year conferred and field(s) of study

        - Roles in other relevant current or past research

        - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

        - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

        Budget

        Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

        Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

        Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

        Modular grants

        NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

        Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

        NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

        Resources

        The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

        research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

        V Writing and Formatting

        Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

        Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

        Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

        Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

        Page Limitations

        Type (font) Size and Spacing

        Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

        Font size in figures and tables may be smaller but must be readily legible

        Writing Tips

        Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

        Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

        Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

        Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

        tables

        Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

        VI Submitting Your Grant Application

        Receipt Date

        NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

        Cover Letter

        Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

        Requesting an SRG and InstituteCenter

        Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

        You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

        Modular Grants and Applications and Just in Time

        The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

        The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

        For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

        VII Problems and Concerns Commonly Cited by Reviewers

        Below is a list of the most common reasons cited by reviewers for an applications lack of success

        Lack of significance to the scientific issue being addressed

        Lack of original or new ideas

        Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

        Project too diffuse or superficial or lacks focus

        Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

        Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

        Rationale for experiments not provided (why important or how relevant to the hypothesis)

        Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

        Lack of alternative methodological approaches in case the primary approach does not work out

        Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

        The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

        The proposed experiments do not include all relevant controls

        Proposal innovative but lacking enough preliminary data

        Preliminary data do not support the feasibility of the project or the hypothesis

        Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

        The proposal lacks critical literature references causing reviewers to think that the

        applicant either does not know the literature or has purposely neglected critical published material

        Not clear which data were obtained by the investigator and which have been reported by others

        VIII Referral and Assignment of the Application

        When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

        Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

        Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

        To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

        You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

        If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

        IX Review of Research Project Applications

        This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

        Scientific Review Groups

        Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

        Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

        Review Criteria

        In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

        Significance Approach Innovation Investigator Environment

        To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

        Cover Letter

        Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

        State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

        Administrative Review

        Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

        If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

        At the Peer Review Meeting

        Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

        Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

        How Priority Scores Are Determined

        If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

        Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

        Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

        1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

        2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

        3 Deferred In some instances the scientific review group is unable to make an

        adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

        Summary Statements

        Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

        Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

        Appeal

        You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

        X How Funding Is Decided

        Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

        Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

        How Paylines Work

        Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

        Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

        Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

        You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

        For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

        Second Level Peer Review

        In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

        They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

        Possible Outcomes of Secondary Review

        Following Council review NIAID takes one of four actions for an application

        1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

        Why Applications Are Kept on Hold

        ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

        Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

        XI When You Have Not Obtained Funding

        What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

        Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

        Most Common Reasons for a Low Score (in priority order)

        - Lack of new or original ideas

        - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

        - Methods unsuitable or defective and not likely to yield results

        - Data collection confused in design inappropriate instrumentation poor timing or conditions

        - Data management and analysis vague unsophisticated

        - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

        - Poor resources or facilities limited access to appropriate patient population

        From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

        When to Revise

        How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

        If the problems are repairable revise the application and resubmit it to the same study section

        Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

        - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

        Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

        vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

        If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

        For fatal flaws and weaknesses rethink your idea and start over

        Revising Your Application

        Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

        Respond to reviewersrsquo comments

        The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

        Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

        Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

        additions deletions and changes in the revised application and address the main criticisms in the summary statement

        Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

        Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

        If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

        XII When Your Application Is Approved for Funding

        If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

        Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

        If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

        There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

        For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

        Documentation

        Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

        Human subjects

        For more information concerning the human subjects assurance contact OHRP at

        Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

        And find a wealth of guidance documents on the Web

        Animals in Research

        For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

        Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

        Or see the Web site at Office of Laboratory Animal Welfare

        What You Can and Cannot Pay for on a Grant

        In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

        OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

        For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

        Terms and Conditions of Award

        Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

        Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

        NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

        Reporting Requirements

        Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

        Address and phone number are

        NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

        For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

        Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

        Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

        Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

        Checklists

        BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

        HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

        RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

        RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

        rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

        SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

        BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

        PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

        DESIGN AND METHODS CHECKLIST

        General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

        Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

        Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

        Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

        ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

        BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

        BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

        Does the PIs salary exceed the government cap of $141300

        RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

        WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

        REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

        • howtopdf
          • Third Edition amended August 30 2001
          • The Original How to Write a Research Grant Application
            • I Before You Begin
                • If the answer is yes
                • Protection
                • Inclusion
                • Monitoring
                • Reporting
                • Training
                • Certifications and assurances
                  • Most Common Reasons for a Low Score (in priority order)
                  • BEGINNING CHECKLIST
                  • HYPOTHESIS CHECKLIST
                  • RESEARCH PLAN - PLANNING CHECKLIST
                  • RESEARCH PLAN - PROCESS CHECKLIST
                  • SPECIFIC AIMS CHECKLIST
                  • BACKGROUND AND SIGNIFICANCE CHECKLIST
                  • PRELIMINARY DATA CHECKLIST
                  • DESIGN AND METHODS CHECKLIST
                  • General
                  • Approach
                  • ABSTRACT CHECKLIST
                  • BIOSKETCHES CHECKLIST
                  • BUDGET CHECKLIST
                  • RESOURCES CHECKLIST
                  • REVISING CHECKLIST

          Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

          Content The abstract should include

          iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

          Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

          for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

          RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

          Recommended Length The maximum length of the research plan is 25 pages

          Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

          appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

          do iexcl How will the research be accomplished Who What When Where Why

          Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

          consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

          2 Show knowledge of recent literature and explain how the proposed research will further what is already known

          3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

          4 Establish credibility of the proposed principal investigator and the collaborating researchers

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          RESEARCH PLAN PART A

          SPECIFIC AIMS

          Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

          Recommended Length The recommended length of the specific aims is one page

          Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

          Suggestions

          1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

          2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

          3 Show that the objectives are attainable within the stated time frame

          4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

          5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

          6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

          7 Focus on aims where you have good supporting preliminary data and scientific expertise

          RESEARCH PLAN PART B

          BACKGROUND AND SIGNIFICENCE

          Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

          Recommended Length Approximately 3 pages

          Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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          Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

          are the specific research questions important How are the researchers qualified to address these

          2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

          3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

          4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

          5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

          RESEARCH PLAN PART C

          PRELIMINARY RESULTSPROGRESS REPORT

          Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

          Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

          Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

          feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

          background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

          are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

          Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

          this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

          2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

          3 Do not dwell on results already published Summarize the critical findings in the text and include

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          reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

          RESEARCH PLAN PART D

          RESEARCH DESIGN AND METHODS

          Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

          Recommended Length The maximum recommended length of the research design and methods section is 20 pages

          Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

          existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

          hazardous to personnel or human subjects

          Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

          1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

          2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

          3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

          4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

          5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

          BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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          budget for each subcontractor or consortium member

          Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

          Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

          Suggestions

          1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

          2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

          3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

          4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

          5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

          6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

          7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

          8 Check indirect costs Some institutions have on-campus and off -campus rates

          9 Be complete but concise There are no page limits in this section

          10 Provide adequate justification for the need to use outside consultants if applicable

          11 The budget must be approved by the grantee institution business office before they can sign the application

          12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

          13 Prorate service contracts to percentage of time equipment is used for this project

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          ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

          Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

          Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

          Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

          regulations

          2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

          3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

          HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

          Recommended Length There is no specified length but be succinct

          Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

          All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

          The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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          Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

          contact OPRR as soon as possible to obtain a single project assurance

          2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

          3 You must provide information on the inclusion of women and minorities in the study population

          VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

          Recommended Length There is no specified length but be succinct

          Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

          The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

          Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

          contact OPRR as soon as possible to obtain a single project assurance

          2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

          3 Be sure the number of animals proposed is realistic

          4 Justify all animal expenses

          RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

          Recommended Length A special form is provided for the resources and environment section

          Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

          research plan

          2 Justify any reliance on resources external to the research

          3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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          4 Make certain your resources and budget requests are consistent

          OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

          2 Use basic English and avoid jargon

          3 Make sure all acronyms are spelled out when used initially

          4 Type single-spaced and stay within the margins

          5 Observe the type size and page limitations strictly do not use a small font

          6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

          7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

          8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

          9 List all citations (six pages maximum) at the end of the research plan

          10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

          11 Have an outside reader review the proposal for clarity and consistency

          12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

          13 Be consistent with terms references and forrn writing style

          14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

          15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

          16 Make sure all the check-box items on page II of the PHS 398 application are completed

          17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

          DEA Home

          created 27sep95 Lorrie Smith revised 02apr98

          Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

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          Home | Search | Sitemap | Contact

          About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

          Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

          The following slides were presented at the University of Louisville on September 23 and 24 1999

          Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

          Slides Table of Contents

          l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

          NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

          Page 1 of 1How to Apply for NIH Funding (slides)

          3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

          Third Edition amended August 30 2001

          The Original How to Write a Research Grant Application

          Contents

          Strategy for Getting an NIH Grant 2

          Writing an Application for a Research Project Grant 3

          I Before You Begin 4

          II Application Contents 5

          III Developing Your Research Plan 6

          IV Application Contents Other Than the Research Plan 15

          V Writing and Formatting 18

          VI Submitting Your Grant Application 20

          VII Problems and Concerns Commonly Cited by Reviewers 21

          VIII Referral and Assignment of the Application 23

          IX Review of Research Project Applications 24

          X How Funding Is Decided 27

          XI When You Have Not Obtained Funding 29

          XII When Your Application Is Approved for Funding 32

          Checklists 35

          Strategy for Getting an NIH Grant

          1 Assess competition in the field

          2 Know the level of resources needed to compete

          - do an organizational assessment

          - look for opportunities to build research with support from various sources

          - get a mentor

          3 Be willing to change yourself your projects your career

          4 Know the opportunities in the field for

          - collaboration with a known laboratory or mentor

          - carving out a niche

          5 Find out which NIH institutes supporting research in your area are seeking applications

          - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

          - discuss your ideas with Institute program staff See NIAIDs program and staff listing

          6 Make sure you and your collaborators are properly trained for the research

          7 Closely examine grant applications from successful grantees

          8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

          9 Have several experienced grantees critique your application

          10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

          Writing an Application for a Research Project Grant

          There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

          This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

          Eight Basic Questions Reviewers Ask

          1 How high are the intellectual quality and merit of the study

          2 What is its potential impact

          3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

          4 Is the hypothesis valid and have you presented evidence supporting it

          5 Are the aims logical

          6 Are the procedures appropriate adequate and feasible for the research

          7 Are the investigators qualified Have they shown competence credentials and experience

          8 Are the facilities adequate and the environment conducive to the research

          Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

          A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

          Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

          I Before You Begin

          Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

          Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

          To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

          Developing the Hypothesis

          Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

          Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

          State your hypothesis in both the specific aims section of the research plan and the abstract

          II Application Contents

          Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

          The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

          Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

          Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

          Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

          III Developing Your Research Plan

          A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

          - Your application should be based on a strong hypothesis

          - Be sure your project has a coherent direction

          - Keep the sections of the plan well coordinated and clearly related to the central focus

          - Emphasize mechanism A good grant application asks questions about biological mechanisms

          - Dont be overly ambitious your plan should be based on a feasible timetable

          - Specific aims and experiments should relate directly to the hypothesis to be tested

          A Specific Aims

          Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

          Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

          State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

          B Background and Significance

          Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

          Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

          Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

          Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

          Identify the next logical stage of research beyond your current application

          C Preliminary StudiesProgress Report

          By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

          Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

          Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

          Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

          Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

          D Research Design and Methods

          Describe the experimental design and procedures in detail and give a rationale for their use

          Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

          Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

          advantageous to the research you propose to do

          More and more applicants are including colored charts graphs and photographs in their applications

          Approach

          State why you chose your approach or approaches as opposed to others

          If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

          Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

          Consider the limitations of each approach and how it may affect your results and the data generated

          Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

          Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

          Results

          Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

          Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

          Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

          Describe your proposed statistical methods for analyzing the data you plan to collect

          Define the criteria for evaluating the success or failure of a specific test

          Other pointers

          Read the PHS 398 carefully for specific requirements especially those involving human subjects

          Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

          Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

          Describe any procedures situations or materials that may be hazardous and precautions you will take

          Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

          E Human Subjects

          Is it human subject research

          Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

          A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

          If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

          If the answer is yes

          If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

          This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

          The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

          bull Description of how you will protect subjects from research risks bull Plans to include

          Women Children Minorities Analyses capable of showing intervention differences between men and

          women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

          Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

          Protection

          Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

          bull Identify the characteristics of the study population or sources of research materials

          bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

          bull Describe potential benefits to the subjects and mankind

          bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

          In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

          Inclusion

          Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

          This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

          After your human subjects section start new pages for the following plans

          Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

          Put your plans on separate pages they are not included in the page limit

          In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

          Monitoring

          The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

          NIAID must also approve your monitoring plan see our Terms of award

          Reporting

          Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

          For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

          Also pay attention to the minority subgroups required for clinical trial reporting

          Training

          Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

          Certifications and assurances

          If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

          Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

          NIAID Special Terms of Award

          NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

          Review of Clinical Applications

          In addition to the regular review criteria clinical research applications will also be reviewed for

          bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

          bull Reasonableness of the proposed budget and duration in relation to the proposed research

          bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

          bull Adequacy of the proposed plan to share data if appropriate

          Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

          More Human Subjects Links

          In addition to the 398 see these sites for more information

          Glossary of human subject-related terms including a definition of what constitutes human subject research

          Human subjects feature of March 2001 Council News

          NIH human subjects reviewer guidance

          Also see our Terms of award for NIAID-specific requirements

          F Vertebrate Animals

          As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

          Your application should include

          - A detailed description of the proposed use of the animals

          - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

          - Information on the veterinary care of the animals

          - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

          - Justification for any euthanasia method to be used

          If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

          G Literature Cited

          Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

          Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

          Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

          H ConsortiumContractual Arrangements

          This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

          The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

          I Consultants

          Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

          IV Application Contents Other Than the Research Plan

          Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

          Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

          Abstract (Form BB)

          Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

          Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

          Title

          Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

          Biographical Sketches (Form FF)

          This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

          With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

          - Name and title

          - Education -- institutions location degree(s) year conferred and field(s) of study

          - Roles in other relevant current or past research

          - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

          - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

          Budget

          Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

          Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

          Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

          Modular grants

          NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

          Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

          NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

          Resources

          The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

          research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

          V Writing and Formatting

          Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

          Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

          Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

          Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

          Page Limitations

          Type (font) Size and Spacing

          Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

          Font size in figures and tables may be smaller but must be readily legible

          Writing Tips

          Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

          Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

          Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

          Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

          tables

          Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

          VI Submitting Your Grant Application

          Receipt Date

          NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

          Cover Letter

          Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

          Requesting an SRG and InstituteCenter

          Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

          You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

          Modular Grants and Applications and Just in Time

          The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

          The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

          For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

          VII Problems and Concerns Commonly Cited by Reviewers

          Below is a list of the most common reasons cited by reviewers for an applications lack of success

          Lack of significance to the scientific issue being addressed

          Lack of original or new ideas

          Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

          Project too diffuse or superficial or lacks focus

          Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

          Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

          Rationale for experiments not provided (why important or how relevant to the hypothesis)

          Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

          Lack of alternative methodological approaches in case the primary approach does not work out

          Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

          The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

          The proposed experiments do not include all relevant controls

          Proposal innovative but lacking enough preliminary data

          Preliminary data do not support the feasibility of the project or the hypothesis

          Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

          The proposal lacks critical literature references causing reviewers to think that the

          applicant either does not know the literature or has purposely neglected critical published material

          Not clear which data were obtained by the investigator and which have been reported by others

          VIII Referral and Assignment of the Application

          When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

          Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

          Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

          To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

          You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

          If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

          IX Review of Research Project Applications

          This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

          Scientific Review Groups

          Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

          Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

          Review Criteria

          In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

          Significance Approach Innovation Investigator Environment

          To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

          Cover Letter

          Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

          State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

          Administrative Review

          Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

          If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

          At the Peer Review Meeting

          Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

          Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

          How Priority Scores Are Determined

          If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

          Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

          Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

          1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

          2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

          3 Deferred In some instances the scientific review group is unable to make an

          adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

          Summary Statements

          Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

          Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

          Appeal

          You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

          X How Funding Is Decided

          Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

          Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

          How Paylines Work

          Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

          Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

          Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

          You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

          For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

          Second Level Peer Review

          In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

          They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

          Possible Outcomes of Secondary Review

          Following Council review NIAID takes one of four actions for an application

          1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

          Why Applications Are Kept on Hold

          ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

          Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

          XI When You Have Not Obtained Funding

          What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

          Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

          Most Common Reasons for a Low Score (in priority order)

          - Lack of new or original ideas

          - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

          - Methods unsuitable or defective and not likely to yield results

          - Data collection confused in design inappropriate instrumentation poor timing or conditions

          - Data management and analysis vague unsophisticated

          - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

          - Poor resources or facilities limited access to appropriate patient population

          From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

          When to Revise

          How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

          If the problems are repairable revise the application and resubmit it to the same study section

          Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

          - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

          Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

          vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

          If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

          For fatal flaws and weaknesses rethink your idea and start over

          Revising Your Application

          Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

          Respond to reviewersrsquo comments

          The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

          Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

          Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

          additions deletions and changes in the revised application and address the main criticisms in the summary statement

          Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

          Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

          If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

          XII When Your Application Is Approved for Funding

          If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

          Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

          If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

          There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

          For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

          Documentation

          Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

          Human subjects

          For more information concerning the human subjects assurance contact OHRP at

          Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

          And find a wealth of guidance documents on the Web

          Animals in Research

          For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

          Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

          Or see the Web site at Office of Laboratory Animal Welfare

          What You Can and Cannot Pay for on a Grant

          In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

          OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

          For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

          Terms and Conditions of Award

          Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

          Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

          NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

          Reporting Requirements

          Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

          Address and phone number are

          NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

          For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

          Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

          Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

          Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

          Checklists

          BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

          HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

          RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

          RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

          rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

          SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

          BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

          PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

          DESIGN AND METHODS CHECKLIST

          General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

          Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

          Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

          Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

          ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

          BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

          BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

          Does the PIs salary exceed the government cap of $141300

          RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

          WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

          REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

          • howtopdf
            • Third Edition amended August 30 2001
            • The Original How to Write a Research Grant Application
              • I Before You Begin
                  • If the answer is yes
                  • Protection
                  • Inclusion
                  • Monitoring
                  • Reporting
                  • Training
                  • Certifications and assurances
                    • Most Common Reasons for a Low Score (in priority order)
                    • BEGINNING CHECKLIST
                    • HYPOTHESIS CHECKLIST
                    • RESEARCH PLAN - PLANNING CHECKLIST
                    • RESEARCH PLAN - PROCESS CHECKLIST
                    • SPECIFIC AIMS CHECKLIST
                    • BACKGROUND AND SIGNIFICANCE CHECKLIST
                    • PRELIMINARY DATA CHECKLIST
                    • DESIGN AND METHODS CHECKLIST
                    • General
                    • Approach
                    • ABSTRACT CHECKLIST
                    • BIOSKETCHES CHECKLIST
                    • BUDGET CHECKLIST
                    • RESOURCES CHECKLIST
                    • REVISING CHECKLIST

            RESEARCH PLAN PART A

            SPECIFIC AIMS

            Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

            Recommended Length The recommended length of the specific aims is one page

            Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

            Suggestions

            1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

            2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

            3 Show that the objectives are attainable within the stated time frame

            4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

            5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

            6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

            7 Focus on aims where you have good supporting preliminary data and scientific expertise

            RESEARCH PLAN PART B

            BACKGROUND AND SIGNIFICENCE

            Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

            Recommended Length Approximately 3 pages

            Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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            Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

            are the specific research questions important How are the researchers qualified to address these

            2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

            3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

            4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

            5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

            RESEARCH PLAN PART C

            PRELIMINARY RESULTSPROGRESS REPORT

            Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

            Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

            Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

            feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

            background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

            are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

            Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

            this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

            2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

            3 Do not dwell on results already published Summarize the critical findings in the text and include

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            reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

            RESEARCH PLAN PART D

            RESEARCH DESIGN AND METHODS

            Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

            Recommended Length The maximum recommended length of the research design and methods section is 20 pages

            Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

            existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

            hazardous to personnel or human subjects

            Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

            1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

            2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

            3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

            4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

            5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

            BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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            budget for each subcontractor or consortium member

            Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

            Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

            Suggestions

            1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

            2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

            3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

            4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

            5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

            6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

            7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

            8 Check indirect costs Some institutions have on-campus and off -campus rates

            9 Be complete but concise There are no page limits in this section

            10 Provide adequate justification for the need to use outside consultants if applicable

            11 The budget must be approved by the grantee institution business office before they can sign the application

            12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

            13 Prorate service contracts to percentage of time equipment is used for this project

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            ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

            Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

            Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

            Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

            regulations

            2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

            3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

            HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

            Recommended Length There is no specified length but be succinct

            Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

            All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

            The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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            Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

            contact OPRR as soon as possible to obtain a single project assurance

            2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

            3 You must provide information on the inclusion of women and minorities in the study population

            VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

            Recommended Length There is no specified length but be succinct

            Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

            The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

            Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

            contact OPRR as soon as possible to obtain a single project assurance

            2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

            3 Be sure the number of animals proposed is realistic

            4 Justify all animal expenses

            RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

            Recommended Length A special form is provided for the resources and environment section

            Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

            research plan

            2 Justify any reliance on resources external to the research

            3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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            4 Make certain your resources and budget requests are consistent

            OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

            2 Use basic English and avoid jargon

            3 Make sure all acronyms are spelled out when used initially

            4 Type single-spaced and stay within the margins

            5 Observe the type size and page limitations strictly do not use a small font

            6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

            7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

            8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

            9 List all citations (six pages maximum) at the end of the research plan

            10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

            11 Have an outside reader review the proposal for clarity and consistency

            12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

            13 Be consistent with terms references and forrn writing style

            14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

            15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

            16 Make sure all the check-box items on page II of the PHS 398 application are completed

            17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

            DEA Home

            created 27sep95 Lorrie Smith revised 02apr98

            Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

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            Home | Search | Sitemap | Contact

            About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

            Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

            The following slides were presented at the University of Louisville on September 23 and 24 1999

            Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

            Slides Table of Contents

            l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

            NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

            Page 1 of 1How to Apply for NIH Funding (slides)

            3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

            Third Edition amended August 30 2001

            The Original How to Write a Research Grant Application

            Contents

            Strategy for Getting an NIH Grant 2

            Writing an Application for a Research Project Grant 3

            I Before You Begin 4

            II Application Contents 5

            III Developing Your Research Plan 6

            IV Application Contents Other Than the Research Plan 15

            V Writing and Formatting 18

            VI Submitting Your Grant Application 20

            VII Problems and Concerns Commonly Cited by Reviewers 21

            VIII Referral and Assignment of the Application 23

            IX Review of Research Project Applications 24

            X How Funding Is Decided 27

            XI When You Have Not Obtained Funding 29

            XII When Your Application Is Approved for Funding 32

            Checklists 35

            Strategy for Getting an NIH Grant

            1 Assess competition in the field

            2 Know the level of resources needed to compete

            - do an organizational assessment

            - look for opportunities to build research with support from various sources

            - get a mentor

            3 Be willing to change yourself your projects your career

            4 Know the opportunities in the field for

            - collaboration with a known laboratory or mentor

            - carving out a niche

            5 Find out which NIH institutes supporting research in your area are seeking applications

            - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

            - discuss your ideas with Institute program staff See NIAIDs program and staff listing

            6 Make sure you and your collaborators are properly trained for the research

            7 Closely examine grant applications from successful grantees

            8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

            9 Have several experienced grantees critique your application

            10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

            Writing an Application for a Research Project Grant

            There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

            This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

            Eight Basic Questions Reviewers Ask

            1 How high are the intellectual quality and merit of the study

            2 What is its potential impact

            3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

            4 Is the hypothesis valid and have you presented evidence supporting it

            5 Are the aims logical

            6 Are the procedures appropriate adequate and feasible for the research

            7 Are the investigators qualified Have they shown competence credentials and experience

            8 Are the facilities adequate and the environment conducive to the research

            Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

            A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

            Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

            I Before You Begin

            Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

            Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

            To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

            Developing the Hypothesis

            Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

            Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

            State your hypothesis in both the specific aims section of the research plan and the abstract

            II Application Contents

            Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

            The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

            Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

            Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

            Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

            III Developing Your Research Plan

            A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

            - Your application should be based on a strong hypothesis

            - Be sure your project has a coherent direction

            - Keep the sections of the plan well coordinated and clearly related to the central focus

            - Emphasize mechanism A good grant application asks questions about biological mechanisms

            - Dont be overly ambitious your plan should be based on a feasible timetable

            - Specific aims and experiments should relate directly to the hypothesis to be tested

            A Specific Aims

            Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

            Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

            State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

            B Background and Significance

            Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

            Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

            Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

            Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

            Identify the next logical stage of research beyond your current application

            C Preliminary StudiesProgress Report

            By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

            Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

            Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

            Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

            Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

            D Research Design and Methods

            Describe the experimental design and procedures in detail and give a rationale for their use

            Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

            Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

            advantageous to the research you propose to do

            More and more applicants are including colored charts graphs and photographs in their applications

            Approach

            State why you chose your approach or approaches as opposed to others

            If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

            Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

            Consider the limitations of each approach and how it may affect your results and the data generated

            Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

            Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

            Results

            Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

            Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

            Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

            Describe your proposed statistical methods for analyzing the data you plan to collect

            Define the criteria for evaluating the success or failure of a specific test

            Other pointers

            Read the PHS 398 carefully for specific requirements especially those involving human subjects

            Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

            Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

            Describe any procedures situations or materials that may be hazardous and precautions you will take

            Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

            E Human Subjects

            Is it human subject research

            Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

            A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

            If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

            If the answer is yes

            If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

            This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

            The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

            bull Description of how you will protect subjects from research risks bull Plans to include

            Women Children Minorities Analyses capable of showing intervention differences between men and

            women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

            Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

            Protection

            Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

            bull Identify the characteristics of the study population or sources of research materials

            bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

            bull Describe potential benefits to the subjects and mankind

            bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

            In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

            Inclusion

            Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

            This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

            After your human subjects section start new pages for the following plans

            Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

            Put your plans on separate pages they are not included in the page limit

            In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

            Monitoring

            The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

            NIAID must also approve your monitoring plan see our Terms of award

            Reporting

            Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

            For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

            Also pay attention to the minority subgroups required for clinical trial reporting

            Training

            Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

            Certifications and assurances

            If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

            Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

            NIAID Special Terms of Award

            NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

            Review of Clinical Applications

            In addition to the regular review criteria clinical research applications will also be reviewed for

            bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

            bull Reasonableness of the proposed budget and duration in relation to the proposed research

            bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

            bull Adequacy of the proposed plan to share data if appropriate

            Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

            More Human Subjects Links

            In addition to the 398 see these sites for more information

            Glossary of human subject-related terms including a definition of what constitutes human subject research

            Human subjects feature of March 2001 Council News

            NIH human subjects reviewer guidance

            Also see our Terms of award for NIAID-specific requirements

            F Vertebrate Animals

            As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

            Your application should include

            - A detailed description of the proposed use of the animals

            - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

            - Information on the veterinary care of the animals

            - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

            - Justification for any euthanasia method to be used

            If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

            G Literature Cited

            Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

            Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

            Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

            H ConsortiumContractual Arrangements

            This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

            The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

            I Consultants

            Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

            IV Application Contents Other Than the Research Plan

            Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

            Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

            Abstract (Form BB)

            Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

            Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

            Title

            Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

            Biographical Sketches (Form FF)

            This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

            With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

            - Name and title

            - Education -- institutions location degree(s) year conferred and field(s) of study

            - Roles in other relevant current or past research

            - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

            - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

            Budget

            Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

            Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

            Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

            Modular grants

            NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

            Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

            NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

            Resources

            The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

            research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

            V Writing and Formatting

            Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

            Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

            Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

            Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

            Page Limitations

            Type (font) Size and Spacing

            Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

            Font size in figures and tables may be smaller but must be readily legible

            Writing Tips

            Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

            Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

            Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

            Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

            tables

            Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

            VI Submitting Your Grant Application

            Receipt Date

            NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

            Cover Letter

            Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

            Requesting an SRG and InstituteCenter

            Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

            You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

            Modular Grants and Applications and Just in Time

            The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

            The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

            For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

            VII Problems and Concerns Commonly Cited by Reviewers

            Below is a list of the most common reasons cited by reviewers for an applications lack of success

            Lack of significance to the scientific issue being addressed

            Lack of original or new ideas

            Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

            Project too diffuse or superficial or lacks focus

            Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

            Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

            Rationale for experiments not provided (why important or how relevant to the hypothesis)

            Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

            Lack of alternative methodological approaches in case the primary approach does not work out

            Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

            The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

            The proposed experiments do not include all relevant controls

            Proposal innovative but lacking enough preliminary data

            Preliminary data do not support the feasibility of the project or the hypothesis

            Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

            The proposal lacks critical literature references causing reviewers to think that the

            applicant either does not know the literature or has purposely neglected critical published material

            Not clear which data were obtained by the investigator and which have been reported by others

            VIII Referral and Assignment of the Application

            When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

            Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

            Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

            To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

            You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

            If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

            IX Review of Research Project Applications

            This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

            Scientific Review Groups

            Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

            Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

            Review Criteria

            In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

            Significance Approach Innovation Investigator Environment

            To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

            Cover Letter

            Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

            State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

            Administrative Review

            Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

            If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

            At the Peer Review Meeting

            Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

            Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

            How Priority Scores Are Determined

            If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

            Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

            Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

            1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

            2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

            3 Deferred In some instances the scientific review group is unable to make an

            adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

            Summary Statements

            Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

            Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

            Appeal

            You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

            X How Funding Is Decided

            Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

            Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

            How Paylines Work

            Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

            Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

            Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

            You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

            For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

            Second Level Peer Review

            In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

            They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

            Possible Outcomes of Secondary Review

            Following Council review NIAID takes one of four actions for an application

            1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

            Why Applications Are Kept on Hold

            ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

            Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

            XI When You Have Not Obtained Funding

            What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

            Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

            Most Common Reasons for a Low Score (in priority order)

            - Lack of new or original ideas

            - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

            - Methods unsuitable or defective and not likely to yield results

            - Data collection confused in design inappropriate instrumentation poor timing or conditions

            - Data management and analysis vague unsophisticated

            - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

            - Poor resources or facilities limited access to appropriate patient population

            From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

            When to Revise

            How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

            If the problems are repairable revise the application and resubmit it to the same study section

            Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

            - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

            Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

            vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

            If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

            For fatal flaws and weaknesses rethink your idea and start over

            Revising Your Application

            Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

            Respond to reviewersrsquo comments

            The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

            Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

            Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

            additions deletions and changes in the revised application and address the main criticisms in the summary statement

            Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

            Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

            If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

            XII When Your Application Is Approved for Funding

            If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

            Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

            If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

            There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

            For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

            Documentation

            Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

            Human subjects

            For more information concerning the human subjects assurance contact OHRP at

            Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

            And find a wealth of guidance documents on the Web

            Animals in Research

            For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

            Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

            Or see the Web site at Office of Laboratory Animal Welfare

            What You Can and Cannot Pay for on a Grant

            In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

            OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

            For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

            Terms and Conditions of Award

            Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

            Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

            NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

            Reporting Requirements

            Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

            Address and phone number are

            NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

            For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

            Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

            Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

            Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

            Checklists

            BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

            HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

            RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

            RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

            rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

            SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

            BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

            PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

            DESIGN AND METHODS CHECKLIST

            General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

            Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

            Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

            Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

            ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

            BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

            BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

            Does the PIs salary exceed the government cap of $141300

            RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

            WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

            REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

            • howtopdf
              • Third Edition amended August 30 2001
              • The Original How to Write a Research Grant Application
                • I Before You Begin
                    • If the answer is yes
                    • Protection
                    • Inclusion
                    • Monitoring
                    • Reporting
                    • Training
                    • Certifications and assurances
                      • Most Common Reasons for a Low Score (in priority order)
                      • BEGINNING CHECKLIST
                      • HYPOTHESIS CHECKLIST
                      • RESEARCH PLAN - PLANNING CHECKLIST
                      • RESEARCH PLAN - PROCESS CHECKLIST
                      • SPECIFIC AIMS CHECKLIST
                      • BACKGROUND AND SIGNIFICANCE CHECKLIST
                      • PRELIMINARY DATA CHECKLIST
                      • DESIGN AND METHODS CHECKLIST
                      • General
                      • Approach
                      • ABSTRACT CHECKLIST
                      • BIOSKETCHES CHECKLIST
                      • BUDGET CHECKLIST
                      • RESOURCES CHECKLIST
                      • REVISING CHECKLIST

              Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

              are the specific research questions important How are the researchers qualified to address these

              2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

              3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

              4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

              5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

              RESEARCH PLAN PART C

              PRELIMINARY RESULTSPROGRESS REPORT

              Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

              Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

              Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

              feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

              background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

              are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

              Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

              this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

              2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

              3 Do not dwell on results already published Summarize the critical findings in the text and include

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              reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

              RESEARCH PLAN PART D

              RESEARCH DESIGN AND METHODS

              Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

              Recommended Length The maximum recommended length of the research design and methods section is 20 pages

              Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

              existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

              hazardous to personnel or human subjects

              Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

              1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

              2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

              3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

              4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

              5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

              BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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              budget for each subcontractor or consortium member

              Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

              Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

              Suggestions

              1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

              2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

              3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

              4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

              5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

              6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

              7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

              8 Check indirect costs Some institutions have on-campus and off -campus rates

              9 Be complete but concise There are no page limits in this section

              10 Provide adequate justification for the need to use outside consultants if applicable

              11 The budget must be approved by the grantee institution business office before they can sign the application

              12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

              13 Prorate service contracts to percentage of time equipment is used for this project

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              3202002httpdeainfoncinihgovextraextdocsgntapphtm

              ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

              Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

              Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

              Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

              regulations

              2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

              3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

              HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

              Recommended Length There is no specified length but be succinct

              Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

              All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

              The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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              3202002httpdeainfoncinihgovextraextdocsgntapphtm

              Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

              contact OPRR as soon as possible to obtain a single project assurance

              2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

              3 You must provide information on the inclusion of women and minorities in the study population

              VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

              Recommended Length There is no specified length but be succinct

              Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

              The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

              Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

              contact OPRR as soon as possible to obtain a single project assurance

              2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

              3 Be sure the number of animals proposed is realistic

              4 Justify all animal expenses

              RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

              Recommended Length A special form is provided for the resources and environment section

              Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

              research plan

              2 Justify any reliance on resources external to the research

              3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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              4 Make certain your resources and budget requests are consistent

              OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

              2 Use basic English and avoid jargon

              3 Make sure all acronyms are spelled out when used initially

              4 Type single-spaced and stay within the margins

              5 Observe the type size and page limitations strictly do not use a small font

              6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

              7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

              8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

              9 List all citations (six pages maximum) at the end of the research plan

              10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

              11 Have an outside reader review the proposal for clarity and consistency

              12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

              13 Be consistent with terms references and forrn writing style

              14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

              15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

              16 Make sure all the check-box items on page II of the PHS 398 application are completed

              17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

              DEA Home

              created 27sep95 Lorrie Smith revised 02apr98

              Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

              3202002httpdeainfoncinihgovextraextdocsgntapphtm

              Home | Search | Sitemap | Contact

              About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

              Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

              The following slides were presented at the University of Louisville on September 23 and 24 1999

              Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

              Slides Table of Contents

              l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

              NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

              Page 1 of 1How to Apply for NIH Funding (slides)

              3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

              Third Edition amended August 30 2001

              The Original How to Write a Research Grant Application

              Contents

              Strategy for Getting an NIH Grant 2

              Writing an Application for a Research Project Grant 3

              I Before You Begin 4

              II Application Contents 5

              III Developing Your Research Plan 6

              IV Application Contents Other Than the Research Plan 15

              V Writing and Formatting 18

              VI Submitting Your Grant Application 20

              VII Problems and Concerns Commonly Cited by Reviewers 21

              VIII Referral and Assignment of the Application 23

              IX Review of Research Project Applications 24

              X How Funding Is Decided 27

              XI When You Have Not Obtained Funding 29

              XII When Your Application Is Approved for Funding 32

              Checklists 35

              Strategy for Getting an NIH Grant

              1 Assess competition in the field

              2 Know the level of resources needed to compete

              - do an organizational assessment

              - look for opportunities to build research with support from various sources

              - get a mentor

              3 Be willing to change yourself your projects your career

              4 Know the opportunities in the field for

              - collaboration with a known laboratory or mentor

              - carving out a niche

              5 Find out which NIH institutes supporting research in your area are seeking applications

              - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

              - discuss your ideas with Institute program staff See NIAIDs program and staff listing

              6 Make sure you and your collaborators are properly trained for the research

              7 Closely examine grant applications from successful grantees

              8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

              9 Have several experienced grantees critique your application

              10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

              Writing an Application for a Research Project Grant

              There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

              This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

              Eight Basic Questions Reviewers Ask

              1 How high are the intellectual quality and merit of the study

              2 What is its potential impact

              3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

              4 Is the hypothesis valid and have you presented evidence supporting it

              5 Are the aims logical

              6 Are the procedures appropriate adequate and feasible for the research

              7 Are the investigators qualified Have they shown competence credentials and experience

              8 Are the facilities adequate and the environment conducive to the research

              Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

              A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

              Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

              I Before You Begin

              Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

              Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

              To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

              Developing the Hypothesis

              Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

              Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

              State your hypothesis in both the specific aims section of the research plan and the abstract

              II Application Contents

              Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

              The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

              Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

              Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

              Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

              III Developing Your Research Plan

              A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

              - Your application should be based on a strong hypothesis

              - Be sure your project has a coherent direction

              - Keep the sections of the plan well coordinated and clearly related to the central focus

              - Emphasize mechanism A good grant application asks questions about biological mechanisms

              - Dont be overly ambitious your plan should be based on a feasible timetable

              - Specific aims and experiments should relate directly to the hypothesis to be tested

              A Specific Aims

              Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

              Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

              State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

              B Background and Significance

              Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

              Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

              Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

              Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

              Identify the next logical stage of research beyond your current application

              C Preliminary StudiesProgress Report

              By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

              Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

              Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

              Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

              Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

              D Research Design and Methods

              Describe the experimental design and procedures in detail and give a rationale for their use

              Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

              Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

              advantageous to the research you propose to do

              More and more applicants are including colored charts graphs and photographs in their applications

              Approach

              State why you chose your approach or approaches as opposed to others

              If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

              Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

              Consider the limitations of each approach and how it may affect your results and the data generated

              Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

              Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

              Results

              Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

              Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

              Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

              Describe your proposed statistical methods for analyzing the data you plan to collect

              Define the criteria for evaluating the success or failure of a specific test

              Other pointers

              Read the PHS 398 carefully for specific requirements especially those involving human subjects

              Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

              Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

              Describe any procedures situations or materials that may be hazardous and precautions you will take

              Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

              E Human Subjects

              Is it human subject research

              Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

              A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

              If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

              If the answer is yes

              If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

              This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

              The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

              bull Description of how you will protect subjects from research risks bull Plans to include

              Women Children Minorities Analyses capable of showing intervention differences between men and

              women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

              Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

              Protection

              Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

              bull Identify the characteristics of the study population or sources of research materials

              bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

              bull Describe potential benefits to the subjects and mankind

              bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

              In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

              Inclusion

              Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

              This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

              After your human subjects section start new pages for the following plans

              Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

              Put your plans on separate pages they are not included in the page limit

              In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

              Monitoring

              The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

              NIAID must also approve your monitoring plan see our Terms of award

              Reporting

              Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

              For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

              Also pay attention to the minority subgroups required for clinical trial reporting

              Training

              Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

              Certifications and assurances

              If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

              Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

              NIAID Special Terms of Award

              NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

              Review of Clinical Applications

              In addition to the regular review criteria clinical research applications will also be reviewed for

              bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

              bull Reasonableness of the proposed budget and duration in relation to the proposed research

              bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

              bull Adequacy of the proposed plan to share data if appropriate

              Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

              More Human Subjects Links

              In addition to the 398 see these sites for more information

              Glossary of human subject-related terms including a definition of what constitutes human subject research

              Human subjects feature of March 2001 Council News

              NIH human subjects reviewer guidance

              Also see our Terms of award for NIAID-specific requirements

              F Vertebrate Animals

              As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

              Your application should include

              - A detailed description of the proposed use of the animals

              - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

              - Information on the veterinary care of the animals

              - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

              - Justification for any euthanasia method to be used

              If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

              G Literature Cited

              Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

              Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

              Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

              H ConsortiumContractual Arrangements

              This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

              The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

              I Consultants

              Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

              IV Application Contents Other Than the Research Plan

              Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

              Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

              Abstract (Form BB)

              Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

              Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

              Title

              Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

              Biographical Sketches (Form FF)

              This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

              With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

              - Name and title

              - Education -- institutions location degree(s) year conferred and field(s) of study

              - Roles in other relevant current or past research

              - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

              - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

              Budget

              Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

              Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

              Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

              Modular grants

              NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

              Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

              NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

              Resources

              The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

              research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

              V Writing and Formatting

              Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

              Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

              Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

              Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

              Page Limitations

              Type (font) Size and Spacing

              Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

              Font size in figures and tables may be smaller but must be readily legible

              Writing Tips

              Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

              Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

              Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

              Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

              tables

              Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

              VI Submitting Your Grant Application

              Receipt Date

              NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

              Cover Letter

              Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

              Requesting an SRG and InstituteCenter

              Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

              You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

              Modular Grants and Applications and Just in Time

              The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

              The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

              For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

              VII Problems and Concerns Commonly Cited by Reviewers

              Below is a list of the most common reasons cited by reviewers for an applications lack of success

              Lack of significance to the scientific issue being addressed

              Lack of original or new ideas

              Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

              Project too diffuse or superficial or lacks focus

              Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

              Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

              Rationale for experiments not provided (why important or how relevant to the hypothesis)

              Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

              Lack of alternative methodological approaches in case the primary approach does not work out

              Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

              The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

              The proposed experiments do not include all relevant controls

              Proposal innovative but lacking enough preliminary data

              Preliminary data do not support the feasibility of the project or the hypothesis

              Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

              The proposal lacks critical literature references causing reviewers to think that the

              applicant either does not know the literature or has purposely neglected critical published material

              Not clear which data were obtained by the investigator and which have been reported by others

              VIII Referral and Assignment of the Application

              When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

              Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

              Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

              To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

              You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

              If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

              IX Review of Research Project Applications

              This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

              Scientific Review Groups

              Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

              Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

              Review Criteria

              In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

              Significance Approach Innovation Investigator Environment

              To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

              Cover Letter

              Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

              State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

              Administrative Review

              Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

              If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

              At the Peer Review Meeting

              Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

              Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

              How Priority Scores Are Determined

              If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

              Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

              Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

              1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

              2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

              3 Deferred In some instances the scientific review group is unable to make an

              adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

              Summary Statements

              Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

              Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

              Appeal

              You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

              X How Funding Is Decided

              Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

              Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

              How Paylines Work

              Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

              Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

              Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

              You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

              For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

              Second Level Peer Review

              In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

              They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

              Possible Outcomes of Secondary Review

              Following Council review NIAID takes one of four actions for an application

              1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

              Why Applications Are Kept on Hold

              ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

              Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

              XI When You Have Not Obtained Funding

              What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

              Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

              Most Common Reasons for a Low Score (in priority order)

              - Lack of new or original ideas

              - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

              - Methods unsuitable or defective and not likely to yield results

              - Data collection confused in design inappropriate instrumentation poor timing or conditions

              - Data management and analysis vague unsophisticated

              - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

              - Poor resources or facilities limited access to appropriate patient population

              From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

              When to Revise

              How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

              If the problems are repairable revise the application and resubmit it to the same study section

              Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

              - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

              Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

              vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

              If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

              For fatal flaws and weaknesses rethink your idea and start over

              Revising Your Application

              Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

              Respond to reviewersrsquo comments

              The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

              Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

              Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

              additions deletions and changes in the revised application and address the main criticisms in the summary statement

              Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

              Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

              If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

              XII When Your Application Is Approved for Funding

              If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

              Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

              If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

              There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

              For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

              Documentation

              Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

              Human subjects

              For more information concerning the human subjects assurance contact OHRP at

              Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

              And find a wealth of guidance documents on the Web

              Animals in Research

              For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

              Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

              Or see the Web site at Office of Laboratory Animal Welfare

              What You Can and Cannot Pay for on a Grant

              In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

              OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

              For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

              Terms and Conditions of Award

              Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

              Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

              NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

              Reporting Requirements

              Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

              Address and phone number are

              NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

              For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

              Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

              Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

              Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

              Checklists

              BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

              HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

              RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

              RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

              rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

              SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

              BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

              PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

              DESIGN AND METHODS CHECKLIST

              General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

              Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

              Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

              Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

              ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

              BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

              BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

              Does the PIs salary exceed the government cap of $141300

              RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

              WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

              REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

              • howtopdf
                • Third Edition amended August 30 2001
                • The Original How to Write a Research Grant Application
                  • I Before You Begin
                      • If the answer is yes
                      • Protection
                      • Inclusion
                      • Monitoring
                      • Reporting
                      • Training
                      • Certifications and assurances
                        • Most Common Reasons for a Low Score (in priority order)
                        • BEGINNING CHECKLIST
                        • HYPOTHESIS CHECKLIST
                        • RESEARCH PLAN - PLANNING CHECKLIST
                        • RESEARCH PLAN - PROCESS CHECKLIST
                        • SPECIFIC AIMS CHECKLIST
                        • BACKGROUND AND SIGNIFICANCE CHECKLIST
                        • PRELIMINARY DATA CHECKLIST
                        • DESIGN AND METHODS CHECKLIST
                        • General
                        • Approach
                        • ABSTRACT CHECKLIST
                        • BIOSKETCHES CHECKLIST
                        • BUDGET CHECKLIST
                        • RESOURCES CHECKLIST
                        • REVISING CHECKLIST

                reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

                RESEARCH PLAN PART D

                RESEARCH DESIGN AND METHODS

                Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

                Recommended Length The maximum recommended length of the research design and methods section is 20 pages

                Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

                existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

                hazardous to personnel or human subjects

                Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

                1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

                2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

                3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

                4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

                5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

                BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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                budget for each subcontractor or consortium member

                Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

                Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

                Suggestions

                1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

                2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

                3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

                4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

                5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

                6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

                7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

                8 Check indirect costs Some institutions have on-campus and off -campus rates

                9 Be complete but concise There are no page limits in this section

                10 Provide adequate justification for the need to use outside consultants if applicable

                11 The budget must be approved by the grantee institution business office before they can sign the application

                12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

                13 Prorate service contracts to percentage of time equipment is used for this project

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                ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

                Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

                Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

                Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

                regulations

                2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

                3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

                HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

                Recommended Length There is no specified length but be succinct

                Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

                All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

                The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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                3202002httpdeainfoncinihgovextraextdocsgntapphtm

                Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                contact OPRR as soon as possible to obtain a single project assurance

                2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

                3 You must provide information on the inclusion of women and minorities in the study population

                VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

                Recommended Length There is no specified length but be succinct

                Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

                The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

                Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                contact OPRR as soon as possible to obtain a single project assurance

                2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

                3 Be sure the number of animals proposed is realistic

                4 Justify all animal expenses

                RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

                Recommended Length A special form is provided for the resources and environment section

                Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

                research plan

                2 Justify any reliance on resources external to the research

                3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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                3202002httpdeainfoncinihgovextraextdocsgntapphtm

                4 Make certain your resources and budget requests are consistent

                OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

                2 Use basic English and avoid jargon

                3 Make sure all acronyms are spelled out when used initially

                4 Type single-spaced and stay within the margins

                5 Observe the type size and page limitations strictly do not use a small font

                6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

                7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

                8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

                9 List all citations (six pages maximum) at the end of the research plan

                10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

                11 Have an outside reader review the proposal for clarity and consistency

                12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

                13 Be consistent with terms references and forrn writing style

                14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

                15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

                16 Make sure all the check-box items on page II of the PHS 398 application are completed

                17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

                DEA Home

                created 27sep95 Lorrie Smith revised 02apr98

                Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                3202002httpdeainfoncinihgovextraextdocsgntapphtm

                Home | Search | Sitemap | Contact

                About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

                Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

                The following slides were presented at the University of Louisville on September 23 and 24 1999

                Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

                Slides Table of Contents

                l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

                NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

                Page 1 of 1How to Apply for NIH Funding (slides)

                3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

                Third Edition amended August 30 2001

                The Original How to Write a Research Grant Application

                Contents

                Strategy for Getting an NIH Grant 2

                Writing an Application for a Research Project Grant 3

                I Before You Begin 4

                II Application Contents 5

                III Developing Your Research Plan 6

                IV Application Contents Other Than the Research Plan 15

                V Writing and Formatting 18

                VI Submitting Your Grant Application 20

                VII Problems and Concerns Commonly Cited by Reviewers 21

                VIII Referral and Assignment of the Application 23

                IX Review of Research Project Applications 24

                X How Funding Is Decided 27

                XI When You Have Not Obtained Funding 29

                XII When Your Application Is Approved for Funding 32

                Checklists 35

                Strategy for Getting an NIH Grant

                1 Assess competition in the field

                2 Know the level of resources needed to compete

                - do an organizational assessment

                - look for opportunities to build research with support from various sources

                - get a mentor

                3 Be willing to change yourself your projects your career

                4 Know the opportunities in the field for

                - collaboration with a known laboratory or mentor

                - carving out a niche

                5 Find out which NIH institutes supporting research in your area are seeking applications

                - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                6 Make sure you and your collaborators are properly trained for the research

                7 Closely examine grant applications from successful grantees

                8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                9 Have several experienced grantees critique your application

                10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                Writing an Application for a Research Project Grant

                There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                Eight Basic Questions Reviewers Ask

                1 How high are the intellectual quality and merit of the study

                2 What is its potential impact

                3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                4 Is the hypothesis valid and have you presented evidence supporting it

                5 Are the aims logical

                6 Are the procedures appropriate adequate and feasible for the research

                7 Are the investigators qualified Have they shown competence credentials and experience

                8 Are the facilities adequate and the environment conducive to the research

                Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                I Before You Begin

                Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                Developing the Hypothesis

                Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                State your hypothesis in both the specific aims section of the research plan and the abstract

                II Application Contents

                Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                III Developing Your Research Plan

                A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                - Your application should be based on a strong hypothesis

                - Be sure your project has a coherent direction

                - Keep the sections of the plan well coordinated and clearly related to the central focus

                - Emphasize mechanism A good grant application asks questions about biological mechanisms

                - Dont be overly ambitious your plan should be based on a feasible timetable

                - Specific aims and experiments should relate directly to the hypothesis to be tested

                A Specific Aims

                Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                B Background and Significance

                Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                Identify the next logical stage of research beyond your current application

                C Preliminary StudiesProgress Report

                By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                D Research Design and Methods

                Describe the experimental design and procedures in detail and give a rationale for their use

                Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                advantageous to the research you propose to do

                More and more applicants are including colored charts graphs and photographs in their applications

                Approach

                State why you chose your approach or approaches as opposed to others

                If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                Consider the limitations of each approach and how it may affect your results and the data generated

                Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                Results

                Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                Describe your proposed statistical methods for analyzing the data you plan to collect

                Define the criteria for evaluating the success or failure of a specific test

                Other pointers

                Read the PHS 398 carefully for specific requirements especially those involving human subjects

                Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                Describe any procedures situations or materials that may be hazardous and precautions you will take

                Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                E Human Subjects

                Is it human subject research

                Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                If the answer is yes

                If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                bull Description of how you will protect subjects from research risks bull Plans to include

                Women Children Minorities Analyses capable of showing intervention differences between men and

                women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                Protection

                Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                bull Identify the characteristics of the study population or sources of research materials

                bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                bull Describe potential benefits to the subjects and mankind

                bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                Inclusion

                Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                After your human subjects section start new pages for the following plans

                Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                Put your plans on separate pages they are not included in the page limit

                In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                Monitoring

                The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                NIAID must also approve your monitoring plan see our Terms of award

                Reporting

                Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                Also pay attention to the minority subgroups required for clinical trial reporting

                Training

                Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                Certifications and assurances

                If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                NIAID Special Terms of Award

                NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                Review of Clinical Applications

                In addition to the regular review criteria clinical research applications will also be reviewed for

                bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                bull Reasonableness of the proposed budget and duration in relation to the proposed research

                bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                bull Adequacy of the proposed plan to share data if appropriate

                Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                More Human Subjects Links

                In addition to the 398 see these sites for more information

                Glossary of human subject-related terms including a definition of what constitutes human subject research

                Human subjects feature of March 2001 Council News

                NIH human subjects reviewer guidance

                Also see our Terms of award for NIAID-specific requirements

                F Vertebrate Animals

                As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                Your application should include

                - A detailed description of the proposed use of the animals

                - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                - Information on the veterinary care of the animals

                - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                - Justification for any euthanasia method to be used

                If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                G Literature Cited

                Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                H ConsortiumContractual Arrangements

                This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                I Consultants

                Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                IV Application Contents Other Than the Research Plan

                Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                Abstract (Form BB)

                Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                Title

                Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                Biographical Sketches (Form FF)

                This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                - Name and title

                - Education -- institutions location degree(s) year conferred and field(s) of study

                - Roles in other relevant current or past research

                - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                Budget

                Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                Modular grants

                NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                Resources

                The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                V Writing and Formatting

                Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                Page Limitations

                Type (font) Size and Spacing

                Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                Font size in figures and tables may be smaller but must be readily legible

                Writing Tips

                Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                tables

                Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                VI Submitting Your Grant Application

                Receipt Date

                NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                Cover Letter

                Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                Requesting an SRG and InstituteCenter

                Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                Modular Grants and Applications and Just in Time

                The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                VII Problems and Concerns Commonly Cited by Reviewers

                Below is a list of the most common reasons cited by reviewers for an applications lack of success

                Lack of significance to the scientific issue being addressed

                Lack of original or new ideas

                Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                Project too diffuse or superficial or lacks focus

                Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                Rationale for experiments not provided (why important or how relevant to the hypothesis)

                Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                Lack of alternative methodological approaches in case the primary approach does not work out

                Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                The proposed experiments do not include all relevant controls

                Proposal innovative but lacking enough preliminary data

                Preliminary data do not support the feasibility of the project or the hypothesis

                Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                The proposal lacks critical literature references causing reviewers to think that the

                applicant either does not know the literature or has purposely neglected critical published material

                Not clear which data were obtained by the investigator and which have been reported by others

                VIII Referral and Assignment of the Application

                When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                IX Review of Research Project Applications

                This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                Scientific Review Groups

                Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                Review Criteria

                In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                Significance Approach Innovation Investigator Environment

                To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                Cover Letter

                Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                Administrative Review

                Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                At the Peer Review Meeting

                Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                How Priority Scores Are Determined

                If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                3 Deferred In some instances the scientific review group is unable to make an

                adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                Summary Statements

                Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                Appeal

                You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                X How Funding Is Decided

                Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                How Paylines Work

                Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                Second Level Peer Review

                In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                Possible Outcomes of Secondary Review

                Following Council review NIAID takes one of four actions for an application

                1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                Why Applications Are Kept on Hold

                ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                XI When You Have Not Obtained Funding

                What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                Most Common Reasons for a Low Score (in priority order)

                - Lack of new or original ideas

                - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                - Methods unsuitable or defective and not likely to yield results

                - Data collection confused in design inappropriate instrumentation poor timing or conditions

                - Data management and analysis vague unsophisticated

                - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                - Poor resources or facilities limited access to appropriate patient population

                From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                When to Revise

                How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                If the problems are repairable revise the application and resubmit it to the same study section

                Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                For fatal flaws and weaknesses rethink your idea and start over

                Revising Your Application

                Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                Respond to reviewersrsquo comments

                The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                additions deletions and changes in the revised application and address the main criticisms in the summary statement

                Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                XII When Your Application Is Approved for Funding

                If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                Documentation

                Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                Human subjects

                For more information concerning the human subjects assurance contact OHRP at

                Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                And find a wealth of guidance documents on the Web

                Animals in Research

                For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                Or see the Web site at Office of Laboratory Animal Welfare

                What You Can and Cannot Pay for on a Grant

                In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                Terms and Conditions of Award

                Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                Reporting Requirements

                Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                Address and phone number are

                NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                Checklists

                BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                DESIGN AND METHODS CHECKLIST

                General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                Does the PIs salary exceed the government cap of $141300

                RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                • howtopdf
                  • Third Edition amended August 30 2001
                  • The Original How to Write a Research Grant Application
                    • I Before You Begin
                        • If the answer is yes
                        • Protection
                        • Inclusion
                        • Monitoring
                        • Reporting
                        • Training
                        • Certifications and assurances
                          • Most Common Reasons for a Low Score (in priority order)
                          • BEGINNING CHECKLIST
                          • HYPOTHESIS CHECKLIST
                          • RESEARCH PLAN - PLANNING CHECKLIST
                          • RESEARCH PLAN - PROCESS CHECKLIST
                          • SPECIFIC AIMS CHECKLIST
                          • BACKGROUND AND SIGNIFICANCE CHECKLIST
                          • PRELIMINARY DATA CHECKLIST
                          • DESIGN AND METHODS CHECKLIST
                          • General
                          • Approach
                          • ABSTRACT CHECKLIST
                          • BIOSKETCHES CHECKLIST
                          • BUDGET CHECKLIST
                          • RESOURCES CHECKLIST
                          • REVISING CHECKLIST

                  budget for each subcontractor or consortium member

                  Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

                  Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

                  Suggestions

                  1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

                  2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

                  3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

                  4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

                  5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

                  6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

                  7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

                  8 Check indirect costs Some institutions have on-campus and off -campus rates

                  9 Be complete but concise There are no page limits in this section

                  10 Provide adequate justification for the need to use outside consultants if applicable

                  11 The budget must be approved by the grantee institution business office before they can sign the application

                  12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

                  13 Prorate service contracts to percentage of time equipment is used for this project

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                  ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

                  Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

                  Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

                  Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

                  regulations

                  2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

                  3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

                  HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

                  Recommended Length There is no specified length but be succinct

                  Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

                  All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

                  The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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                  3202002httpdeainfoncinihgovextraextdocsgntapphtm

                  Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                  contact OPRR as soon as possible to obtain a single project assurance

                  2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

                  3 You must provide information on the inclusion of women and minorities in the study population

                  VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

                  Recommended Length There is no specified length but be succinct

                  Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

                  The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

                  Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                  contact OPRR as soon as possible to obtain a single project assurance

                  2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

                  3 Be sure the number of animals proposed is realistic

                  4 Justify all animal expenses

                  RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

                  Recommended Length A special form is provided for the resources and environment section

                  Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

                  research plan

                  2 Justify any reliance on resources external to the research

                  3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

                  Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                  3202002httpdeainfoncinihgovextraextdocsgntapphtm

                  4 Make certain your resources and budget requests are consistent

                  OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

                  2 Use basic English and avoid jargon

                  3 Make sure all acronyms are spelled out when used initially

                  4 Type single-spaced and stay within the margins

                  5 Observe the type size and page limitations strictly do not use a small font

                  6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

                  7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

                  8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

                  9 List all citations (six pages maximum) at the end of the research plan

                  10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

                  11 Have an outside reader review the proposal for clarity and consistency

                  12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

                  13 Be consistent with terms references and forrn writing style

                  14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

                  15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

                  16 Make sure all the check-box items on page II of the PHS 398 application are completed

                  17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

                  DEA Home

                  created 27sep95 Lorrie Smith revised 02apr98

                  Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                  3202002httpdeainfoncinihgovextraextdocsgntapphtm

                  Home | Search | Sitemap | Contact

                  About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

                  Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

                  The following slides were presented at the University of Louisville on September 23 and 24 1999

                  Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

                  Slides Table of Contents

                  l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

                  NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

                  Page 1 of 1How to Apply for NIH Funding (slides)

                  3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

                  Third Edition amended August 30 2001

                  The Original How to Write a Research Grant Application

                  Contents

                  Strategy for Getting an NIH Grant 2

                  Writing an Application for a Research Project Grant 3

                  I Before You Begin 4

                  II Application Contents 5

                  III Developing Your Research Plan 6

                  IV Application Contents Other Than the Research Plan 15

                  V Writing and Formatting 18

                  VI Submitting Your Grant Application 20

                  VII Problems and Concerns Commonly Cited by Reviewers 21

                  VIII Referral and Assignment of the Application 23

                  IX Review of Research Project Applications 24

                  X How Funding Is Decided 27

                  XI When You Have Not Obtained Funding 29

                  XII When Your Application Is Approved for Funding 32

                  Checklists 35

                  Strategy for Getting an NIH Grant

                  1 Assess competition in the field

                  2 Know the level of resources needed to compete

                  - do an organizational assessment

                  - look for opportunities to build research with support from various sources

                  - get a mentor

                  3 Be willing to change yourself your projects your career

                  4 Know the opportunities in the field for

                  - collaboration with a known laboratory or mentor

                  - carving out a niche

                  5 Find out which NIH institutes supporting research in your area are seeking applications

                  - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                  - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                  6 Make sure you and your collaborators are properly trained for the research

                  7 Closely examine grant applications from successful grantees

                  8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                  9 Have several experienced grantees critique your application

                  10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                  Writing an Application for a Research Project Grant

                  There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                  This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                  Eight Basic Questions Reviewers Ask

                  1 How high are the intellectual quality and merit of the study

                  2 What is its potential impact

                  3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                  4 Is the hypothesis valid and have you presented evidence supporting it

                  5 Are the aims logical

                  6 Are the procedures appropriate adequate and feasible for the research

                  7 Are the investigators qualified Have they shown competence credentials and experience

                  8 Are the facilities adequate and the environment conducive to the research

                  Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                  A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                  Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                  I Before You Begin

                  Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                  Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                  To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                  Developing the Hypothesis

                  Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                  Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                  State your hypothesis in both the specific aims section of the research plan and the abstract

                  II Application Contents

                  Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                  The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                  Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                  Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                  Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                  III Developing Your Research Plan

                  A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                  - Your application should be based on a strong hypothesis

                  - Be sure your project has a coherent direction

                  - Keep the sections of the plan well coordinated and clearly related to the central focus

                  - Emphasize mechanism A good grant application asks questions about biological mechanisms

                  - Dont be overly ambitious your plan should be based on a feasible timetable

                  - Specific aims and experiments should relate directly to the hypothesis to be tested

                  A Specific Aims

                  Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                  Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                  State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                  B Background and Significance

                  Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                  Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                  Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                  Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                  Identify the next logical stage of research beyond your current application

                  C Preliminary StudiesProgress Report

                  By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                  Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                  Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                  Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                  Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                  D Research Design and Methods

                  Describe the experimental design and procedures in detail and give a rationale for their use

                  Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                  Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                  advantageous to the research you propose to do

                  More and more applicants are including colored charts graphs and photographs in their applications

                  Approach

                  State why you chose your approach or approaches as opposed to others

                  If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                  Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                  Consider the limitations of each approach and how it may affect your results and the data generated

                  Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                  Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                  Results

                  Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                  Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                  Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                  Describe your proposed statistical methods for analyzing the data you plan to collect

                  Define the criteria for evaluating the success or failure of a specific test

                  Other pointers

                  Read the PHS 398 carefully for specific requirements especially those involving human subjects

                  Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                  Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                  Describe any procedures situations or materials that may be hazardous and precautions you will take

                  Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                  E Human Subjects

                  Is it human subject research

                  Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                  A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                  If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                  If the answer is yes

                  If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                  This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                  The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                  bull Description of how you will protect subjects from research risks bull Plans to include

                  Women Children Minorities Analyses capable of showing intervention differences between men and

                  women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                  Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                  Protection

                  Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                  bull Identify the characteristics of the study population or sources of research materials

                  bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                  bull Describe potential benefits to the subjects and mankind

                  bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                  In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                  Inclusion

                  Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                  This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                  After your human subjects section start new pages for the following plans

                  Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                  Put your plans on separate pages they are not included in the page limit

                  In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                  Monitoring

                  The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                  NIAID must also approve your monitoring plan see our Terms of award

                  Reporting

                  Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                  For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                  Also pay attention to the minority subgroups required for clinical trial reporting

                  Training

                  Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                  Certifications and assurances

                  If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                  Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                  NIAID Special Terms of Award

                  NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                  Review of Clinical Applications

                  In addition to the regular review criteria clinical research applications will also be reviewed for

                  bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                  bull Reasonableness of the proposed budget and duration in relation to the proposed research

                  bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                  bull Adequacy of the proposed plan to share data if appropriate

                  Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                  More Human Subjects Links

                  In addition to the 398 see these sites for more information

                  Glossary of human subject-related terms including a definition of what constitutes human subject research

                  Human subjects feature of March 2001 Council News

                  NIH human subjects reviewer guidance

                  Also see our Terms of award for NIAID-specific requirements

                  F Vertebrate Animals

                  As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                  Your application should include

                  - A detailed description of the proposed use of the animals

                  - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                  - Information on the veterinary care of the animals

                  - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                  - Justification for any euthanasia method to be used

                  If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                  G Literature Cited

                  Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                  Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                  Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                  H ConsortiumContractual Arrangements

                  This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                  The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                  I Consultants

                  Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                  IV Application Contents Other Than the Research Plan

                  Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                  Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                  Abstract (Form BB)

                  Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                  Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                  Title

                  Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                  Biographical Sketches (Form FF)

                  This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                  With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                  - Name and title

                  - Education -- institutions location degree(s) year conferred and field(s) of study

                  - Roles in other relevant current or past research

                  - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                  - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                  Budget

                  Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                  Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                  Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                  Modular grants

                  NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                  Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                  NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                  Resources

                  The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                  research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                  V Writing and Formatting

                  Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                  Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                  Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                  Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                  Page Limitations

                  Type (font) Size and Spacing

                  Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                  Font size in figures and tables may be smaller but must be readily legible

                  Writing Tips

                  Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                  Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                  Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                  Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                  tables

                  Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                  VI Submitting Your Grant Application

                  Receipt Date

                  NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                  Cover Letter

                  Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                  Requesting an SRG and InstituteCenter

                  Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                  You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                  Modular Grants and Applications and Just in Time

                  The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                  The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                  For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                  VII Problems and Concerns Commonly Cited by Reviewers

                  Below is a list of the most common reasons cited by reviewers for an applications lack of success

                  Lack of significance to the scientific issue being addressed

                  Lack of original or new ideas

                  Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                  Project too diffuse or superficial or lacks focus

                  Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                  Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                  Rationale for experiments not provided (why important or how relevant to the hypothesis)

                  Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                  Lack of alternative methodological approaches in case the primary approach does not work out

                  Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                  The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                  The proposed experiments do not include all relevant controls

                  Proposal innovative but lacking enough preliminary data

                  Preliminary data do not support the feasibility of the project or the hypothesis

                  Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                  The proposal lacks critical literature references causing reviewers to think that the

                  applicant either does not know the literature or has purposely neglected critical published material

                  Not clear which data were obtained by the investigator and which have been reported by others

                  VIII Referral and Assignment of the Application

                  When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                  Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                  Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                  To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                  You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                  If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                  IX Review of Research Project Applications

                  This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                  Scientific Review Groups

                  Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                  Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                  Review Criteria

                  In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                  Significance Approach Innovation Investigator Environment

                  To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                  Cover Letter

                  Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                  State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                  Administrative Review

                  Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                  If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                  At the Peer Review Meeting

                  Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                  Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                  How Priority Scores Are Determined

                  If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                  Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                  Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                  1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                  2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                  3 Deferred In some instances the scientific review group is unable to make an

                  adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                  Summary Statements

                  Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                  Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                  Appeal

                  You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                  X How Funding Is Decided

                  Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                  Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                  How Paylines Work

                  Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                  Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                  Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                  You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                  For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                  Second Level Peer Review

                  In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                  They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                  Possible Outcomes of Secondary Review

                  Following Council review NIAID takes one of four actions for an application

                  1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                  Why Applications Are Kept on Hold

                  ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                  Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                  XI When You Have Not Obtained Funding

                  What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                  Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                  Most Common Reasons for a Low Score (in priority order)

                  - Lack of new or original ideas

                  - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                  - Methods unsuitable or defective and not likely to yield results

                  - Data collection confused in design inappropriate instrumentation poor timing or conditions

                  - Data management and analysis vague unsophisticated

                  - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                  - Poor resources or facilities limited access to appropriate patient population

                  From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                  When to Revise

                  How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                  If the problems are repairable revise the application and resubmit it to the same study section

                  Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                  - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                  Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                  vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                  If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                  For fatal flaws and weaknesses rethink your idea and start over

                  Revising Your Application

                  Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                  Respond to reviewersrsquo comments

                  The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                  Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                  Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                  additions deletions and changes in the revised application and address the main criticisms in the summary statement

                  Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                  Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                  If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                  XII When Your Application Is Approved for Funding

                  If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                  Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                  If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                  There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                  For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                  Documentation

                  Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                  Human subjects

                  For more information concerning the human subjects assurance contact OHRP at

                  Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                  And find a wealth of guidance documents on the Web

                  Animals in Research

                  For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                  Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                  Or see the Web site at Office of Laboratory Animal Welfare

                  What You Can and Cannot Pay for on a Grant

                  In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                  OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                  For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                  Terms and Conditions of Award

                  Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                  Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                  NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                  Reporting Requirements

                  Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                  Address and phone number are

                  NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                  For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                  Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                  Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                  Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                  Checklists

                  BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                  HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                  RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                  RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                  rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                  SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                  BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                  PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                  DESIGN AND METHODS CHECKLIST

                  General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                  Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                  Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                  Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                  ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                  BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                  BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                  Does the PIs salary exceed the government cap of $141300

                  RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                  WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                  REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                  • howtopdf
                    • Third Edition amended August 30 2001
                    • The Original How to Write a Research Grant Application
                      • I Before You Begin
                          • If the answer is yes
                          • Protection
                          • Inclusion
                          • Monitoring
                          • Reporting
                          • Training
                          • Certifications and assurances
                            • Most Common Reasons for a Low Score (in priority order)
                            • BEGINNING CHECKLIST
                            • HYPOTHESIS CHECKLIST
                            • RESEARCH PLAN - PLANNING CHECKLIST
                            • RESEARCH PLAN - PROCESS CHECKLIST
                            • SPECIFIC AIMS CHECKLIST
                            • BACKGROUND AND SIGNIFICANCE CHECKLIST
                            • PRELIMINARY DATA CHECKLIST
                            • DESIGN AND METHODS CHECKLIST
                            • General
                            • Approach
                            • ABSTRACT CHECKLIST
                            • BIOSKETCHES CHECKLIST
                            • BUDGET CHECKLIST
                            • RESOURCES CHECKLIST
                            • REVISING CHECKLIST

                    ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

                    Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

                    Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

                    Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

                    regulations

                    2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

                    3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

                    HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

                    Recommended Length There is no specified length but be succinct

                    Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

                    All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

                    The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

                    Page 8 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                    3202002httpdeainfoncinihgovextraextdocsgntapphtm

                    Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                    contact OPRR as soon as possible to obtain a single project assurance

                    2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

                    3 You must provide information on the inclusion of women and minorities in the study population

                    VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

                    Recommended Length There is no specified length but be succinct

                    Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

                    The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

                    Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                    contact OPRR as soon as possible to obtain a single project assurance

                    2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

                    3 Be sure the number of animals proposed is realistic

                    4 Justify all animal expenses

                    RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

                    Recommended Length A special form is provided for the resources and environment section

                    Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

                    research plan

                    2 Justify any reliance on resources external to the research

                    3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

                    Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                    3202002httpdeainfoncinihgovextraextdocsgntapphtm

                    4 Make certain your resources and budget requests are consistent

                    OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

                    2 Use basic English and avoid jargon

                    3 Make sure all acronyms are spelled out when used initially

                    4 Type single-spaced and stay within the margins

                    5 Observe the type size and page limitations strictly do not use a small font

                    6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

                    7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

                    8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

                    9 List all citations (six pages maximum) at the end of the research plan

                    10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

                    11 Have an outside reader review the proposal for clarity and consistency

                    12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

                    13 Be consistent with terms references and forrn writing style

                    14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

                    15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

                    16 Make sure all the check-box items on page II of the PHS 398 application are completed

                    17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

                    DEA Home

                    created 27sep95 Lorrie Smith revised 02apr98

                    Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                    3202002httpdeainfoncinihgovextraextdocsgntapphtm

                    Home | Search | Sitemap | Contact

                    About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

                    Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

                    The following slides were presented at the University of Louisville on September 23 and 24 1999

                    Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

                    Slides Table of Contents

                    l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

                    NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

                    Page 1 of 1How to Apply for NIH Funding (slides)

                    3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

                    Third Edition amended August 30 2001

                    The Original How to Write a Research Grant Application

                    Contents

                    Strategy for Getting an NIH Grant 2

                    Writing an Application for a Research Project Grant 3

                    I Before You Begin 4

                    II Application Contents 5

                    III Developing Your Research Plan 6

                    IV Application Contents Other Than the Research Plan 15

                    V Writing and Formatting 18

                    VI Submitting Your Grant Application 20

                    VII Problems and Concerns Commonly Cited by Reviewers 21

                    VIII Referral and Assignment of the Application 23

                    IX Review of Research Project Applications 24

                    X How Funding Is Decided 27

                    XI When You Have Not Obtained Funding 29

                    XII When Your Application Is Approved for Funding 32

                    Checklists 35

                    Strategy for Getting an NIH Grant

                    1 Assess competition in the field

                    2 Know the level of resources needed to compete

                    - do an organizational assessment

                    - look for opportunities to build research with support from various sources

                    - get a mentor

                    3 Be willing to change yourself your projects your career

                    4 Know the opportunities in the field for

                    - collaboration with a known laboratory or mentor

                    - carving out a niche

                    5 Find out which NIH institutes supporting research in your area are seeking applications

                    - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                    - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                    6 Make sure you and your collaborators are properly trained for the research

                    7 Closely examine grant applications from successful grantees

                    8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                    9 Have several experienced grantees critique your application

                    10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                    Writing an Application for a Research Project Grant

                    There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                    This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                    Eight Basic Questions Reviewers Ask

                    1 How high are the intellectual quality and merit of the study

                    2 What is its potential impact

                    3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                    4 Is the hypothesis valid and have you presented evidence supporting it

                    5 Are the aims logical

                    6 Are the procedures appropriate adequate and feasible for the research

                    7 Are the investigators qualified Have they shown competence credentials and experience

                    8 Are the facilities adequate and the environment conducive to the research

                    Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                    A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                    Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                    I Before You Begin

                    Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                    Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                    To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                    Developing the Hypothesis

                    Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                    Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                    State your hypothesis in both the specific aims section of the research plan and the abstract

                    II Application Contents

                    Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                    The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                    Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                    Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                    Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                    III Developing Your Research Plan

                    A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                    - Your application should be based on a strong hypothesis

                    - Be sure your project has a coherent direction

                    - Keep the sections of the plan well coordinated and clearly related to the central focus

                    - Emphasize mechanism A good grant application asks questions about biological mechanisms

                    - Dont be overly ambitious your plan should be based on a feasible timetable

                    - Specific aims and experiments should relate directly to the hypothesis to be tested

                    A Specific Aims

                    Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                    Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                    State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                    B Background and Significance

                    Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                    Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                    Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                    Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                    Identify the next logical stage of research beyond your current application

                    C Preliminary StudiesProgress Report

                    By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                    Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                    Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                    Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                    Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                    D Research Design and Methods

                    Describe the experimental design and procedures in detail and give a rationale for their use

                    Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                    Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                    advantageous to the research you propose to do

                    More and more applicants are including colored charts graphs and photographs in their applications

                    Approach

                    State why you chose your approach or approaches as opposed to others

                    If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                    Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                    Consider the limitations of each approach and how it may affect your results and the data generated

                    Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                    Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                    Results

                    Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                    Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                    Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                    Describe your proposed statistical methods for analyzing the data you plan to collect

                    Define the criteria for evaluating the success or failure of a specific test

                    Other pointers

                    Read the PHS 398 carefully for specific requirements especially those involving human subjects

                    Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                    Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                    Describe any procedures situations or materials that may be hazardous and precautions you will take

                    Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                    E Human Subjects

                    Is it human subject research

                    Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                    A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                    If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                    If the answer is yes

                    If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                    This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                    The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                    bull Description of how you will protect subjects from research risks bull Plans to include

                    Women Children Minorities Analyses capable of showing intervention differences between men and

                    women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                    Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                    Protection

                    Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                    bull Identify the characteristics of the study population or sources of research materials

                    bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                    bull Describe potential benefits to the subjects and mankind

                    bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                    In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                    Inclusion

                    Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                    This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                    After your human subjects section start new pages for the following plans

                    Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                    Put your plans on separate pages they are not included in the page limit

                    In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                    Monitoring

                    The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                    NIAID must also approve your monitoring plan see our Terms of award

                    Reporting

                    Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                    For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                    Also pay attention to the minority subgroups required for clinical trial reporting

                    Training

                    Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                    Certifications and assurances

                    If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                    Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                    NIAID Special Terms of Award

                    NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                    Review of Clinical Applications

                    In addition to the regular review criteria clinical research applications will also be reviewed for

                    bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                    bull Reasonableness of the proposed budget and duration in relation to the proposed research

                    bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                    bull Adequacy of the proposed plan to share data if appropriate

                    Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                    More Human Subjects Links

                    In addition to the 398 see these sites for more information

                    Glossary of human subject-related terms including a definition of what constitutes human subject research

                    Human subjects feature of March 2001 Council News

                    NIH human subjects reviewer guidance

                    Also see our Terms of award for NIAID-specific requirements

                    F Vertebrate Animals

                    As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                    Your application should include

                    - A detailed description of the proposed use of the animals

                    - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                    - Information on the veterinary care of the animals

                    - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                    - Justification for any euthanasia method to be used

                    If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                    G Literature Cited

                    Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                    Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                    Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                    H ConsortiumContractual Arrangements

                    This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                    The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                    I Consultants

                    Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                    IV Application Contents Other Than the Research Plan

                    Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                    Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                    Abstract (Form BB)

                    Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                    Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                    Title

                    Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                    Biographical Sketches (Form FF)

                    This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                    With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                    - Name and title

                    - Education -- institutions location degree(s) year conferred and field(s) of study

                    - Roles in other relevant current or past research

                    - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                    - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                    Budget

                    Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                    Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                    Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                    Modular grants

                    NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                    Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                    NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                    Resources

                    The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                    research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                    V Writing and Formatting

                    Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                    Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                    Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                    Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                    Page Limitations

                    Type (font) Size and Spacing

                    Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                    Font size in figures and tables may be smaller but must be readily legible

                    Writing Tips

                    Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                    Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                    Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                    Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                    tables

                    Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                    VI Submitting Your Grant Application

                    Receipt Date

                    NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                    Cover Letter

                    Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                    Requesting an SRG and InstituteCenter

                    Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                    You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                    Modular Grants and Applications and Just in Time

                    The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                    The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                    For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                    VII Problems and Concerns Commonly Cited by Reviewers

                    Below is a list of the most common reasons cited by reviewers for an applications lack of success

                    Lack of significance to the scientific issue being addressed

                    Lack of original or new ideas

                    Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                    Project too diffuse or superficial or lacks focus

                    Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                    Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                    Rationale for experiments not provided (why important or how relevant to the hypothesis)

                    Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                    Lack of alternative methodological approaches in case the primary approach does not work out

                    Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                    The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                    The proposed experiments do not include all relevant controls

                    Proposal innovative but lacking enough preliminary data

                    Preliminary data do not support the feasibility of the project or the hypothesis

                    Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                    The proposal lacks critical literature references causing reviewers to think that the

                    applicant either does not know the literature or has purposely neglected critical published material

                    Not clear which data were obtained by the investigator and which have been reported by others

                    VIII Referral and Assignment of the Application

                    When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                    Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                    Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                    To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                    You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                    If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                    IX Review of Research Project Applications

                    This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                    Scientific Review Groups

                    Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                    Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                    Review Criteria

                    In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                    Significance Approach Innovation Investigator Environment

                    To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                    Cover Letter

                    Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                    State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                    Administrative Review

                    Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                    If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                    At the Peer Review Meeting

                    Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                    Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                    How Priority Scores Are Determined

                    If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                    Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                    Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                    1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                    2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                    3 Deferred In some instances the scientific review group is unable to make an

                    adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                    Summary Statements

                    Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                    Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                    Appeal

                    You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                    X How Funding Is Decided

                    Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                    Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                    How Paylines Work

                    Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                    Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                    Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                    You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                    For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                    Second Level Peer Review

                    In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                    They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                    Possible Outcomes of Secondary Review

                    Following Council review NIAID takes one of four actions for an application

                    1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                    Why Applications Are Kept on Hold

                    ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                    Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                    XI When You Have Not Obtained Funding

                    What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                    Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                    Most Common Reasons for a Low Score (in priority order)

                    - Lack of new or original ideas

                    - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                    - Methods unsuitable or defective and not likely to yield results

                    - Data collection confused in design inappropriate instrumentation poor timing or conditions

                    - Data management and analysis vague unsophisticated

                    - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                    - Poor resources or facilities limited access to appropriate patient population

                    From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                    When to Revise

                    How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                    If the problems are repairable revise the application and resubmit it to the same study section

                    Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                    - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                    Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                    vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                    If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                    For fatal flaws and weaknesses rethink your idea and start over

                    Revising Your Application

                    Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                    Respond to reviewersrsquo comments

                    The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                    Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                    Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                    additions deletions and changes in the revised application and address the main criticisms in the summary statement

                    Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                    Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                    If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                    XII When Your Application Is Approved for Funding

                    If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                    Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                    If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                    There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                    For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                    Documentation

                    Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                    Human subjects

                    For more information concerning the human subjects assurance contact OHRP at

                    Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                    And find a wealth of guidance documents on the Web

                    Animals in Research

                    For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                    Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                    Or see the Web site at Office of Laboratory Animal Welfare

                    What You Can and Cannot Pay for on a Grant

                    In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                    OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                    For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                    Terms and Conditions of Award

                    Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                    Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                    NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                    Reporting Requirements

                    Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                    Address and phone number are

                    NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                    For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                    Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                    Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                    Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                    Checklists

                    BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                    HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                    RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                    RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                    rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                    SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                    BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                    PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                    DESIGN AND METHODS CHECKLIST

                    General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                    Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                    Does the PIs salary exceed the government cap of $141300

                    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                    • howtopdf
                      • Third Edition amended August 30 2001
                      • The Original How to Write a Research Grant Application
                        • I Before You Begin
                            • If the answer is yes
                            • Protection
                            • Inclusion
                            • Monitoring
                            • Reporting
                            • Training
                            • Certifications and assurances
                              • Most Common Reasons for a Low Score (in priority order)
                              • BEGINNING CHECKLIST
                              • HYPOTHESIS CHECKLIST
                              • RESEARCH PLAN - PLANNING CHECKLIST
                              • RESEARCH PLAN - PROCESS CHECKLIST
                              • SPECIFIC AIMS CHECKLIST
                              • BACKGROUND AND SIGNIFICANCE CHECKLIST
                              • PRELIMINARY DATA CHECKLIST
                              • DESIGN AND METHODS CHECKLIST
                              • General
                              • Approach
                              • ABSTRACT CHECKLIST
                              • BIOSKETCHES CHECKLIST
                              • BUDGET CHECKLIST
                              • RESOURCES CHECKLIST
                              • REVISING CHECKLIST

                      Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                      contact OPRR as soon as possible to obtain a single project assurance

                      2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

                      3 You must provide information on the inclusion of women and minorities in the study population

                      VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

                      Recommended Length There is no specified length but be succinct

                      Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

                      The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

                      Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

                      contact OPRR as soon as possible to obtain a single project assurance

                      2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

                      3 Be sure the number of animals proposed is realistic

                      4 Justify all animal expenses

                      RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

                      Recommended Length A special form is provided for the resources and environment section

                      Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

                      research plan

                      2 Justify any reliance on resources external to the research

                      3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

                      Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                      3202002httpdeainfoncinihgovextraextdocsgntapphtm

                      4 Make certain your resources and budget requests are consistent

                      OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

                      2 Use basic English and avoid jargon

                      3 Make sure all acronyms are spelled out when used initially

                      4 Type single-spaced and stay within the margins

                      5 Observe the type size and page limitations strictly do not use a small font

                      6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

                      7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

                      8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

                      9 List all citations (six pages maximum) at the end of the research plan

                      10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

                      11 Have an outside reader review the proposal for clarity and consistency

                      12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

                      13 Be consistent with terms references and forrn writing style

                      14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

                      15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

                      16 Make sure all the check-box items on page II of the PHS 398 application are completed

                      17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

                      DEA Home

                      created 27sep95 Lorrie Smith revised 02apr98

                      Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                      3202002httpdeainfoncinihgovextraextdocsgntapphtm

                      Home | Search | Sitemap | Contact

                      About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

                      Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

                      The following slides were presented at the University of Louisville on September 23 and 24 1999

                      Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

                      Slides Table of Contents

                      l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

                      NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

                      Page 1 of 1How to Apply for NIH Funding (slides)

                      3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

                      Third Edition amended August 30 2001

                      The Original How to Write a Research Grant Application

                      Contents

                      Strategy for Getting an NIH Grant 2

                      Writing an Application for a Research Project Grant 3

                      I Before You Begin 4

                      II Application Contents 5

                      III Developing Your Research Plan 6

                      IV Application Contents Other Than the Research Plan 15

                      V Writing and Formatting 18

                      VI Submitting Your Grant Application 20

                      VII Problems and Concerns Commonly Cited by Reviewers 21

                      VIII Referral and Assignment of the Application 23

                      IX Review of Research Project Applications 24

                      X How Funding Is Decided 27

                      XI When You Have Not Obtained Funding 29

                      XII When Your Application Is Approved for Funding 32

                      Checklists 35

                      Strategy for Getting an NIH Grant

                      1 Assess competition in the field

                      2 Know the level of resources needed to compete

                      - do an organizational assessment

                      - look for opportunities to build research with support from various sources

                      - get a mentor

                      3 Be willing to change yourself your projects your career

                      4 Know the opportunities in the field for

                      - collaboration with a known laboratory or mentor

                      - carving out a niche

                      5 Find out which NIH institutes supporting research in your area are seeking applications

                      - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                      - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                      6 Make sure you and your collaborators are properly trained for the research

                      7 Closely examine grant applications from successful grantees

                      8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                      9 Have several experienced grantees critique your application

                      10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                      Writing an Application for a Research Project Grant

                      There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                      This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                      Eight Basic Questions Reviewers Ask

                      1 How high are the intellectual quality and merit of the study

                      2 What is its potential impact

                      3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                      4 Is the hypothesis valid and have you presented evidence supporting it

                      5 Are the aims logical

                      6 Are the procedures appropriate adequate and feasible for the research

                      7 Are the investigators qualified Have they shown competence credentials and experience

                      8 Are the facilities adequate and the environment conducive to the research

                      Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                      A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                      Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                      I Before You Begin

                      Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                      Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                      To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                      Developing the Hypothesis

                      Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                      Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                      State your hypothesis in both the specific aims section of the research plan and the abstract

                      II Application Contents

                      Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                      The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                      Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                      Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                      Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                      III Developing Your Research Plan

                      A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                      - Your application should be based on a strong hypothesis

                      - Be sure your project has a coherent direction

                      - Keep the sections of the plan well coordinated and clearly related to the central focus

                      - Emphasize mechanism A good grant application asks questions about biological mechanisms

                      - Dont be overly ambitious your plan should be based on a feasible timetable

                      - Specific aims and experiments should relate directly to the hypothesis to be tested

                      A Specific Aims

                      Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                      Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                      State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                      B Background and Significance

                      Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                      Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                      Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                      Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                      Identify the next logical stage of research beyond your current application

                      C Preliminary StudiesProgress Report

                      By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                      Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                      Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                      Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                      Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                      D Research Design and Methods

                      Describe the experimental design and procedures in detail and give a rationale for their use

                      Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                      Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                      advantageous to the research you propose to do

                      More and more applicants are including colored charts graphs and photographs in their applications

                      Approach

                      State why you chose your approach or approaches as opposed to others

                      If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                      Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                      Consider the limitations of each approach and how it may affect your results and the data generated

                      Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                      Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                      Results

                      Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                      Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                      Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                      Describe your proposed statistical methods for analyzing the data you plan to collect

                      Define the criteria for evaluating the success or failure of a specific test

                      Other pointers

                      Read the PHS 398 carefully for specific requirements especially those involving human subjects

                      Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                      Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                      Describe any procedures situations or materials that may be hazardous and precautions you will take

                      Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                      E Human Subjects

                      Is it human subject research

                      Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                      A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                      If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                      If the answer is yes

                      If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                      This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                      The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                      bull Description of how you will protect subjects from research risks bull Plans to include

                      Women Children Minorities Analyses capable of showing intervention differences between men and

                      women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                      Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                      Protection

                      Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                      bull Identify the characteristics of the study population or sources of research materials

                      bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                      bull Describe potential benefits to the subjects and mankind

                      bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                      In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                      Inclusion

                      Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                      This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                      After your human subjects section start new pages for the following plans

                      Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                      Put your plans on separate pages they are not included in the page limit

                      In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                      Monitoring

                      The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                      NIAID must also approve your monitoring plan see our Terms of award

                      Reporting

                      Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                      For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                      Also pay attention to the minority subgroups required for clinical trial reporting

                      Training

                      Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                      Certifications and assurances

                      If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                      Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                      NIAID Special Terms of Award

                      NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                      Review of Clinical Applications

                      In addition to the regular review criteria clinical research applications will also be reviewed for

                      bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                      bull Reasonableness of the proposed budget and duration in relation to the proposed research

                      bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                      bull Adequacy of the proposed plan to share data if appropriate

                      Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                      More Human Subjects Links

                      In addition to the 398 see these sites for more information

                      Glossary of human subject-related terms including a definition of what constitutes human subject research

                      Human subjects feature of March 2001 Council News

                      NIH human subjects reviewer guidance

                      Also see our Terms of award for NIAID-specific requirements

                      F Vertebrate Animals

                      As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                      Your application should include

                      - A detailed description of the proposed use of the animals

                      - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                      - Information on the veterinary care of the animals

                      - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                      - Justification for any euthanasia method to be used

                      If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                      G Literature Cited

                      Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                      Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                      Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                      H ConsortiumContractual Arrangements

                      This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                      The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                      I Consultants

                      Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                      IV Application Contents Other Than the Research Plan

                      Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                      Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                      Abstract (Form BB)

                      Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                      Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                      Title

                      Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                      Biographical Sketches (Form FF)

                      This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                      With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                      - Name and title

                      - Education -- institutions location degree(s) year conferred and field(s) of study

                      - Roles in other relevant current or past research

                      - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                      - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                      Budget

                      Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                      Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                      Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                      Modular grants

                      NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                      Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                      NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                      Resources

                      The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                      research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                      V Writing and Formatting

                      Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                      Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                      Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                      Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                      Page Limitations

                      Type (font) Size and Spacing

                      Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                      Font size in figures and tables may be smaller but must be readily legible

                      Writing Tips

                      Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                      Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                      Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                      Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                      tables

                      Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                      VI Submitting Your Grant Application

                      Receipt Date

                      NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                      Cover Letter

                      Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                      Requesting an SRG and InstituteCenter

                      Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                      You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                      Modular Grants and Applications and Just in Time

                      The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                      The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                      For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                      VII Problems and Concerns Commonly Cited by Reviewers

                      Below is a list of the most common reasons cited by reviewers for an applications lack of success

                      Lack of significance to the scientific issue being addressed

                      Lack of original or new ideas

                      Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                      Project too diffuse or superficial or lacks focus

                      Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                      Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                      Rationale for experiments not provided (why important or how relevant to the hypothesis)

                      Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                      Lack of alternative methodological approaches in case the primary approach does not work out

                      Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                      The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                      The proposed experiments do not include all relevant controls

                      Proposal innovative but lacking enough preliminary data

                      Preliminary data do not support the feasibility of the project or the hypothesis

                      Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                      The proposal lacks critical literature references causing reviewers to think that the

                      applicant either does not know the literature or has purposely neglected critical published material

                      Not clear which data were obtained by the investigator and which have been reported by others

                      VIII Referral and Assignment of the Application

                      When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                      Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                      Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                      To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                      You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                      If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                      IX Review of Research Project Applications

                      This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                      Scientific Review Groups

                      Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                      Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                      Review Criteria

                      In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                      Significance Approach Innovation Investigator Environment

                      To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                      Cover Letter

                      Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                      State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                      Administrative Review

                      Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                      If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                      At the Peer Review Meeting

                      Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                      Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                      How Priority Scores Are Determined

                      If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                      Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                      Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                      1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                      2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                      3 Deferred In some instances the scientific review group is unable to make an

                      adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                      Summary Statements

                      Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                      Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                      Appeal

                      You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                      X How Funding Is Decided

                      Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                      Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                      How Paylines Work

                      Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                      Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                      Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                      You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                      For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                      Second Level Peer Review

                      In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                      They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                      Possible Outcomes of Secondary Review

                      Following Council review NIAID takes one of four actions for an application

                      1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                      Why Applications Are Kept on Hold

                      ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                      Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                      XI When You Have Not Obtained Funding

                      What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                      Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                      Most Common Reasons for a Low Score (in priority order)

                      - Lack of new or original ideas

                      - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                      - Methods unsuitable or defective and not likely to yield results

                      - Data collection confused in design inappropriate instrumentation poor timing or conditions

                      - Data management and analysis vague unsophisticated

                      - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                      - Poor resources or facilities limited access to appropriate patient population

                      From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                      When to Revise

                      How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                      If the problems are repairable revise the application and resubmit it to the same study section

                      Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                      - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                      Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                      vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                      If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                      For fatal flaws and weaknesses rethink your idea and start over

                      Revising Your Application

                      Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                      Respond to reviewersrsquo comments

                      The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                      Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                      Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                      additions deletions and changes in the revised application and address the main criticisms in the summary statement

                      Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                      Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                      If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                      XII When Your Application Is Approved for Funding

                      If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                      Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                      If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                      There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                      For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                      Documentation

                      Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                      Human subjects

                      For more information concerning the human subjects assurance contact OHRP at

                      Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                      And find a wealth of guidance documents on the Web

                      Animals in Research

                      For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                      Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                      Or see the Web site at Office of Laboratory Animal Welfare

                      What You Can and Cannot Pay for on a Grant

                      In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                      OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                      For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                      Terms and Conditions of Award

                      Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                      Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                      NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                      Reporting Requirements

                      Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                      Address and phone number are

                      NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                      For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                      Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                      Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                      Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                      Checklists

                      BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                      HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                      RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                      RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                      rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                      SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                      BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                      PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                      DESIGN AND METHODS CHECKLIST

                      General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                      Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                      Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                      Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                      ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                      BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                      BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                      Does the PIs salary exceed the government cap of $141300

                      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                      • howtopdf
                        • Third Edition amended August 30 2001
                        • The Original How to Write a Research Grant Application
                          • I Before You Begin
                              • If the answer is yes
                              • Protection
                              • Inclusion
                              • Monitoring
                              • Reporting
                              • Training
                              • Certifications and assurances
                                • Most Common Reasons for a Low Score (in priority order)
                                • BEGINNING CHECKLIST
                                • HYPOTHESIS CHECKLIST
                                • RESEARCH PLAN - PLANNING CHECKLIST
                                • RESEARCH PLAN - PROCESS CHECKLIST
                                • SPECIFIC AIMS CHECKLIST
                                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                • PRELIMINARY DATA CHECKLIST
                                • DESIGN AND METHODS CHECKLIST
                                • General
                                • Approach
                                • ABSTRACT CHECKLIST
                                • BIOSKETCHES CHECKLIST
                                • BUDGET CHECKLIST
                                • RESOURCES CHECKLIST
                                • REVISING CHECKLIST

                        4 Make certain your resources and budget requests are consistent

                        OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

                        2 Use basic English and avoid jargon

                        3 Make sure all acronyms are spelled out when used initially

                        4 Type single-spaced and stay within the margins

                        5 Observe the type size and page limitations strictly do not use a small font

                        6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

                        7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

                        8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

                        9 List all citations (six pages maximum) at the end of the research plan

                        10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

                        11 Have an outside reader review the proposal for clarity and consistency

                        12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

                        13 Be consistent with terms references and forrn writing style

                        14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

                        15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

                        16 Make sure all the check-box items on page II of the PHS 398 application are completed

                        17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

                        DEA Home

                        created 27sep95 Lorrie Smith revised 02apr98

                        Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

                        3202002httpdeainfoncinihgovextraextdocsgntapphtm

                        Home | Search | Sitemap | Contact

                        About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

                        Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

                        The following slides were presented at the University of Louisville on September 23 and 24 1999

                        Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

                        Slides Table of Contents

                        l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

                        NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

                        Page 1 of 1How to Apply for NIH Funding (slides)

                        3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

                        Third Edition amended August 30 2001

                        The Original How to Write a Research Grant Application

                        Contents

                        Strategy for Getting an NIH Grant 2

                        Writing an Application for a Research Project Grant 3

                        I Before You Begin 4

                        II Application Contents 5

                        III Developing Your Research Plan 6

                        IV Application Contents Other Than the Research Plan 15

                        V Writing and Formatting 18

                        VI Submitting Your Grant Application 20

                        VII Problems and Concerns Commonly Cited by Reviewers 21

                        VIII Referral and Assignment of the Application 23

                        IX Review of Research Project Applications 24

                        X How Funding Is Decided 27

                        XI When You Have Not Obtained Funding 29

                        XII When Your Application Is Approved for Funding 32

                        Checklists 35

                        Strategy for Getting an NIH Grant

                        1 Assess competition in the field

                        2 Know the level of resources needed to compete

                        - do an organizational assessment

                        - look for opportunities to build research with support from various sources

                        - get a mentor

                        3 Be willing to change yourself your projects your career

                        4 Know the opportunities in the field for

                        - collaboration with a known laboratory or mentor

                        - carving out a niche

                        5 Find out which NIH institutes supporting research in your area are seeking applications

                        - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                        - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                        6 Make sure you and your collaborators are properly trained for the research

                        7 Closely examine grant applications from successful grantees

                        8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                        9 Have several experienced grantees critique your application

                        10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                        Writing an Application for a Research Project Grant

                        There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                        This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                        Eight Basic Questions Reviewers Ask

                        1 How high are the intellectual quality and merit of the study

                        2 What is its potential impact

                        3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                        4 Is the hypothesis valid and have you presented evidence supporting it

                        5 Are the aims logical

                        6 Are the procedures appropriate adequate and feasible for the research

                        7 Are the investigators qualified Have they shown competence credentials and experience

                        8 Are the facilities adequate and the environment conducive to the research

                        Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                        A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                        Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                        I Before You Begin

                        Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                        Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                        To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                        Developing the Hypothesis

                        Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                        Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                        State your hypothesis in both the specific aims section of the research plan and the abstract

                        II Application Contents

                        Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                        The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                        Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                        Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                        Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                        III Developing Your Research Plan

                        A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                        - Your application should be based on a strong hypothesis

                        - Be sure your project has a coherent direction

                        - Keep the sections of the plan well coordinated and clearly related to the central focus

                        - Emphasize mechanism A good grant application asks questions about biological mechanisms

                        - Dont be overly ambitious your plan should be based on a feasible timetable

                        - Specific aims and experiments should relate directly to the hypothesis to be tested

                        A Specific Aims

                        Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                        Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                        State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                        B Background and Significance

                        Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                        Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                        Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                        Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                        Identify the next logical stage of research beyond your current application

                        C Preliminary StudiesProgress Report

                        By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                        Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                        Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                        Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                        Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                        D Research Design and Methods

                        Describe the experimental design and procedures in detail and give a rationale for their use

                        Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                        Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                        advantageous to the research you propose to do

                        More and more applicants are including colored charts graphs and photographs in their applications

                        Approach

                        State why you chose your approach or approaches as opposed to others

                        If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                        Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                        Consider the limitations of each approach and how it may affect your results and the data generated

                        Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                        Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                        Results

                        Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                        Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                        Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                        Describe your proposed statistical methods for analyzing the data you plan to collect

                        Define the criteria for evaluating the success or failure of a specific test

                        Other pointers

                        Read the PHS 398 carefully for specific requirements especially those involving human subjects

                        Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                        Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                        Describe any procedures situations or materials that may be hazardous and precautions you will take

                        Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                        E Human Subjects

                        Is it human subject research

                        Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                        A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                        If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                        If the answer is yes

                        If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                        This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                        The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                        bull Description of how you will protect subjects from research risks bull Plans to include

                        Women Children Minorities Analyses capable of showing intervention differences between men and

                        women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                        Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                        Protection

                        Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                        bull Identify the characteristics of the study population or sources of research materials

                        bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                        bull Describe potential benefits to the subjects and mankind

                        bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                        In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                        Inclusion

                        Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                        This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                        After your human subjects section start new pages for the following plans

                        Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                        Put your plans on separate pages they are not included in the page limit

                        In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                        Monitoring

                        The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                        NIAID must also approve your monitoring plan see our Terms of award

                        Reporting

                        Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                        For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                        Also pay attention to the minority subgroups required for clinical trial reporting

                        Training

                        Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                        Certifications and assurances

                        If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                        Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                        NIAID Special Terms of Award

                        NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                        Review of Clinical Applications

                        In addition to the regular review criteria clinical research applications will also be reviewed for

                        bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                        bull Reasonableness of the proposed budget and duration in relation to the proposed research

                        bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                        bull Adequacy of the proposed plan to share data if appropriate

                        Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                        More Human Subjects Links

                        In addition to the 398 see these sites for more information

                        Glossary of human subject-related terms including a definition of what constitutes human subject research

                        Human subjects feature of March 2001 Council News

                        NIH human subjects reviewer guidance

                        Also see our Terms of award for NIAID-specific requirements

                        F Vertebrate Animals

                        As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                        Your application should include

                        - A detailed description of the proposed use of the animals

                        - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                        - Information on the veterinary care of the animals

                        - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                        - Justification for any euthanasia method to be used

                        If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                        G Literature Cited

                        Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                        Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                        Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                        H ConsortiumContractual Arrangements

                        This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                        The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                        I Consultants

                        Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                        IV Application Contents Other Than the Research Plan

                        Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                        Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                        Abstract (Form BB)

                        Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                        Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                        Title

                        Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                        Biographical Sketches (Form FF)

                        This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                        With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                        - Name and title

                        - Education -- institutions location degree(s) year conferred and field(s) of study

                        - Roles in other relevant current or past research

                        - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                        - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                        Budget

                        Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                        Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                        Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                        Modular grants

                        NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                        Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                        NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                        Resources

                        The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                        research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                        V Writing and Formatting

                        Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                        Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                        Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                        Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                        Page Limitations

                        Type (font) Size and Spacing

                        Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                        Font size in figures and tables may be smaller but must be readily legible

                        Writing Tips

                        Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                        Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                        Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                        Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                        tables

                        Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                        VI Submitting Your Grant Application

                        Receipt Date

                        NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                        Cover Letter

                        Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                        Requesting an SRG and InstituteCenter

                        Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                        You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                        Modular Grants and Applications and Just in Time

                        The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                        The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                        For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                        VII Problems and Concerns Commonly Cited by Reviewers

                        Below is a list of the most common reasons cited by reviewers for an applications lack of success

                        Lack of significance to the scientific issue being addressed

                        Lack of original or new ideas

                        Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                        Project too diffuse or superficial or lacks focus

                        Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                        Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                        Rationale for experiments not provided (why important or how relevant to the hypothesis)

                        Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                        Lack of alternative methodological approaches in case the primary approach does not work out

                        Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                        The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                        The proposed experiments do not include all relevant controls

                        Proposal innovative but lacking enough preliminary data

                        Preliminary data do not support the feasibility of the project or the hypothesis

                        Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                        The proposal lacks critical literature references causing reviewers to think that the

                        applicant either does not know the literature or has purposely neglected critical published material

                        Not clear which data were obtained by the investigator and which have been reported by others

                        VIII Referral and Assignment of the Application

                        When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                        Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                        Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                        To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                        You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                        If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                        IX Review of Research Project Applications

                        This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                        Scientific Review Groups

                        Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                        Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                        Review Criteria

                        In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                        Significance Approach Innovation Investigator Environment

                        To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                        Cover Letter

                        Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                        State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                        Administrative Review

                        Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                        If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                        At the Peer Review Meeting

                        Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                        Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                        How Priority Scores Are Determined

                        If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                        Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                        Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                        1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                        2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                        3 Deferred In some instances the scientific review group is unable to make an

                        adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                        Summary Statements

                        Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                        Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                        Appeal

                        You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                        X How Funding Is Decided

                        Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                        Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                        How Paylines Work

                        Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                        Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                        Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                        You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                        For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                        Second Level Peer Review

                        In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                        They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                        Possible Outcomes of Secondary Review

                        Following Council review NIAID takes one of four actions for an application

                        1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                        Why Applications Are Kept on Hold

                        ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                        Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                        XI When You Have Not Obtained Funding

                        What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                        Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                        Most Common Reasons for a Low Score (in priority order)

                        - Lack of new or original ideas

                        - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                        - Methods unsuitable or defective and not likely to yield results

                        - Data collection confused in design inappropriate instrumentation poor timing or conditions

                        - Data management and analysis vague unsophisticated

                        - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                        - Poor resources or facilities limited access to appropriate patient population

                        From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                        When to Revise

                        How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                        If the problems are repairable revise the application and resubmit it to the same study section

                        Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                        - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                        Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                        vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                        If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                        For fatal flaws and weaknesses rethink your idea and start over

                        Revising Your Application

                        Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                        Respond to reviewersrsquo comments

                        The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                        Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                        Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                        additions deletions and changes in the revised application and address the main criticisms in the summary statement

                        Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                        Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                        If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                        XII When Your Application Is Approved for Funding

                        If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                        Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                        If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                        There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                        For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                        Documentation

                        Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                        Human subjects

                        For more information concerning the human subjects assurance contact OHRP at

                        Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                        And find a wealth of guidance documents on the Web

                        Animals in Research

                        For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                        Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                        Or see the Web site at Office of Laboratory Animal Welfare

                        What You Can and Cannot Pay for on a Grant

                        In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                        OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                        For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                        Terms and Conditions of Award

                        Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                        Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                        NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                        Reporting Requirements

                        Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                        Address and phone number are

                        NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                        For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                        Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                        Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                        Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                        Checklists

                        BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                        HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                        RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                        RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                        rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                        SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                        BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                        PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                        DESIGN AND METHODS CHECKLIST

                        General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                        Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                        Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                        Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                        ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                        BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                        BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                        Does the PIs salary exceed the government cap of $141300

                        RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                        WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                        REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                        • howtopdf
                          • Third Edition amended August 30 2001
                          • The Original How to Write a Research Grant Application
                            • I Before You Begin
                                • If the answer is yes
                                • Protection
                                • Inclusion
                                • Monitoring
                                • Reporting
                                • Training
                                • Certifications and assurances
                                  • Most Common Reasons for a Low Score (in priority order)
                                  • BEGINNING CHECKLIST
                                  • HYPOTHESIS CHECKLIST
                                  • RESEARCH PLAN - PLANNING CHECKLIST
                                  • RESEARCH PLAN - PROCESS CHECKLIST
                                  • SPECIFIC AIMS CHECKLIST
                                  • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                  • PRELIMINARY DATA CHECKLIST
                                  • DESIGN AND METHODS CHECKLIST
                                  • General
                                  • Approach
                                  • ABSTRACT CHECKLIST
                                  • BIOSKETCHES CHECKLIST
                                  • BUDGET CHECKLIST
                                  • RESOURCES CHECKLIST
                                  • REVISING CHECKLIST

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                          Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

                          The following slides were presented at the University of Louisville on September 23 and 24 1999

                          Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

                          Slides Table of Contents

                          l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

                          NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

                          Page 1 of 1How to Apply for NIH Funding (slides)

                          3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

                          Third Edition amended August 30 2001

                          The Original How to Write a Research Grant Application

                          Contents

                          Strategy for Getting an NIH Grant 2

                          Writing an Application for a Research Project Grant 3

                          I Before You Begin 4

                          II Application Contents 5

                          III Developing Your Research Plan 6

                          IV Application Contents Other Than the Research Plan 15

                          V Writing and Formatting 18

                          VI Submitting Your Grant Application 20

                          VII Problems and Concerns Commonly Cited by Reviewers 21

                          VIII Referral and Assignment of the Application 23

                          IX Review of Research Project Applications 24

                          X How Funding Is Decided 27

                          XI When You Have Not Obtained Funding 29

                          XII When Your Application Is Approved for Funding 32

                          Checklists 35

                          Strategy for Getting an NIH Grant

                          1 Assess competition in the field

                          2 Know the level of resources needed to compete

                          - do an organizational assessment

                          - look for opportunities to build research with support from various sources

                          - get a mentor

                          3 Be willing to change yourself your projects your career

                          4 Know the opportunities in the field for

                          - collaboration with a known laboratory or mentor

                          - carving out a niche

                          5 Find out which NIH institutes supporting research in your area are seeking applications

                          - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                          - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                          6 Make sure you and your collaborators are properly trained for the research

                          7 Closely examine grant applications from successful grantees

                          8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                          9 Have several experienced grantees critique your application

                          10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                          Writing an Application for a Research Project Grant

                          There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                          This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                          Eight Basic Questions Reviewers Ask

                          1 How high are the intellectual quality and merit of the study

                          2 What is its potential impact

                          3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                          4 Is the hypothesis valid and have you presented evidence supporting it

                          5 Are the aims logical

                          6 Are the procedures appropriate adequate and feasible for the research

                          7 Are the investigators qualified Have they shown competence credentials and experience

                          8 Are the facilities adequate and the environment conducive to the research

                          Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                          A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                          Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                          I Before You Begin

                          Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                          Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                          To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                          Developing the Hypothesis

                          Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                          Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                          State your hypothesis in both the specific aims section of the research plan and the abstract

                          II Application Contents

                          Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                          The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                          Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                          Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                          Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                          III Developing Your Research Plan

                          A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                          - Your application should be based on a strong hypothesis

                          - Be sure your project has a coherent direction

                          - Keep the sections of the plan well coordinated and clearly related to the central focus

                          - Emphasize mechanism A good grant application asks questions about biological mechanisms

                          - Dont be overly ambitious your plan should be based on a feasible timetable

                          - Specific aims and experiments should relate directly to the hypothesis to be tested

                          A Specific Aims

                          Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                          Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                          State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                          B Background and Significance

                          Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                          Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                          Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                          Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                          Identify the next logical stage of research beyond your current application

                          C Preliminary StudiesProgress Report

                          By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                          Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                          Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                          Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                          Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                          D Research Design and Methods

                          Describe the experimental design and procedures in detail and give a rationale for their use

                          Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                          Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                          advantageous to the research you propose to do

                          More and more applicants are including colored charts graphs and photographs in their applications

                          Approach

                          State why you chose your approach or approaches as opposed to others

                          If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                          Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                          Consider the limitations of each approach and how it may affect your results and the data generated

                          Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                          Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                          Results

                          Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                          Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                          Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                          Describe your proposed statistical methods for analyzing the data you plan to collect

                          Define the criteria for evaluating the success or failure of a specific test

                          Other pointers

                          Read the PHS 398 carefully for specific requirements especially those involving human subjects

                          Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                          Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                          Describe any procedures situations or materials that may be hazardous and precautions you will take

                          Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                          E Human Subjects

                          Is it human subject research

                          Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                          A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                          If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                          If the answer is yes

                          If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                          This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                          The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                          bull Description of how you will protect subjects from research risks bull Plans to include

                          Women Children Minorities Analyses capable of showing intervention differences between men and

                          women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                          Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                          Protection

                          Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                          bull Identify the characteristics of the study population or sources of research materials

                          bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                          bull Describe potential benefits to the subjects and mankind

                          bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                          In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                          Inclusion

                          Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                          This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                          After your human subjects section start new pages for the following plans

                          Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                          Put your plans on separate pages they are not included in the page limit

                          In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                          Monitoring

                          The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                          NIAID must also approve your monitoring plan see our Terms of award

                          Reporting

                          Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                          For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                          Also pay attention to the minority subgroups required for clinical trial reporting

                          Training

                          Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                          Certifications and assurances

                          If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                          Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                          NIAID Special Terms of Award

                          NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                          Review of Clinical Applications

                          In addition to the regular review criteria clinical research applications will also be reviewed for

                          bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                          bull Reasonableness of the proposed budget and duration in relation to the proposed research

                          bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                          bull Adequacy of the proposed plan to share data if appropriate

                          Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                          More Human Subjects Links

                          In addition to the 398 see these sites for more information

                          Glossary of human subject-related terms including a definition of what constitutes human subject research

                          Human subjects feature of March 2001 Council News

                          NIH human subjects reviewer guidance

                          Also see our Terms of award for NIAID-specific requirements

                          F Vertebrate Animals

                          As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                          Your application should include

                          - A detailed description of the proposed use of the animals

                          - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                          - Information on the veterinary care of the animals

                          - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                          - Justification for any euthanasia method to be used

                          If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                          G Literature Cited

                          Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                          Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                          Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                          H ConsortiumContractual Arrangements

                          This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                          The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                          I Consultants

                          Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                          IV Application Contents Other Than the Research Plan

                          Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                          Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                          Abstract (Form BB)

                          Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                          Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                          Title

                          Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                          Biographical Sketches (Form FF)

                          This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                          With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                          - Name and title

                          - Education -- institutions location degree(s) year conferred and field(s) of study

                          - Roles in other relevant current or past research

                          - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                          - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                          Budget

                          Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                          Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                          Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                          Modular grants

                          NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                          Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                          NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                          Resources

                          The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                          research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                          V Writing and Formatting

                          Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                          Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                          Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                          Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                          Page Limitations

                          Type (font) Size and Spacing

                          Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                          Font size in figures and tables may be smaller but must be readily legible

                          Writing Tips

                          Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                          Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                          Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                          Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                          tables

                          Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                          VI Submitting Your Grant Application

                          Receipt Date

                          NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                          Cover Letter

                          Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                          Requesting an SRG and InstituteCenter

                          Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                          You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                          Modular Grants and Applications and Just in Time

                          The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                          The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                          For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                          VII Problems and Concerns Commonly Cited by Reviewers

                          Below is a list of the most common reasons cited by reviewers for an applications lack of success

                          Lack of significance to the scientific issue being addressed

                          Lack of original or new ideas

                          Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                          Project too diffuse or superficial or lacks focus

                          Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                          Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                          Rationale for experiments not provided (why important or how relevant to the hypothesis)

                          Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                          Lack of alternative methodological approaches in case the primary approach does not work out

                          Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                          The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                          The proposed experiments do not include all relevant controls

                          Proposal innovative but lacking enough preliminary data

                          Preliminary data do not support the feasibility of the project or the hypothesis

                          Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                          The proposal lacks critical literature references causing reviewers to think that the

                          applicant either does not know the literature or has purposely neglected critical published material

                          Not clear which data were obtained by the investigator and which have been reported by others

                          VIII Referral and Assignment of the Application

                          When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                          Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                          Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                          To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                          You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                          If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                          IX Review of Research Project Applications

                          This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                          Scientific Review Groups

                          Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                          Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                          Review Criteria

                          In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                          Significance Approach Innovation Investigator Environment

                          To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                          Cover Letter

                          Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                          State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                          Administrative Review

                          Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                          If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                          At the Peer Review Meeting

                          Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                          Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                          How Priority Scores Are Determined

                          If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                          Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                          Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                          1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                          2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                          3 Deferred In some instances the scientific review group is unable to make an

                          adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                          Summary Statements

                          Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                          Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                          Appeal

                          You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                          X How Funding Is Decided

                          Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                          Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                          How Paylines Work

                          Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                          Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                          Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                          You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                          For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                          Second Level Peer Review

                          In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                          They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                          Possible Outcomes of Secondary Review

                          Following Council review NIAID takes one of four actions for an application

                          1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                          Why Applications Are Kept on Hold

                          ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                          Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                          XI When You Have Not Obtained Funding

                          What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                          Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                          Most Common Reasons for a Low Score (in priority order)

                          - Lack of new or original ideas

                          - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                          - Methods unsuitable or defective and not likely to yield results

                          - Data collection confused in design inappropriate instrumentation poor timing or conditions

                          - Data management and analysis vague unsophisticated

                          - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                          - Poor resources or facilities limited access to appropriate patient population

                          From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                          When to Revise

                          How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                          If the problems are repairable revise the application and resubmit it to the same study section

                          Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                          - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                          Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                          vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                          If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                          For fatal flaws and weaknesses rethink your idea and start over

                          Revising Your Application

                          Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                          Respond to reviewersrsquo comments

                          The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                          Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                          Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                          additions deletions and changes in the revised application and address the main criticisms in the summary statement

                          Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                          Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                          If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                          XII When Your Application Is Approved for Funding

                          If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                          Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                          If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                          There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                          For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                          Documentation

                          Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                          Human subjects

                          For more information concerning the human subjects assurance contact OHRP at

                          Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                          And find a wealth of guidance documents on the Web

                          Animals in Research

                          For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                          Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                          Or see the Web site at Office of Laboratory Animal Welfare

                          What You Can and Cannot Pay for on a Grant

                          In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                          OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                          For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                          Terms and Conditions of Award

                          Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                          Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                          NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                          Reporting Requirements

                          Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                          Address and phone number are

                          NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                          For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                          Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                          Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                          Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                          Checklists

                          BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                          HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                          RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                          RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                          rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                          SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                          BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                          PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                          DESIGN AND METHODS CHECKLIST

                          General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                          Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                          Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                          Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                          ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                          BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                          BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                          Does the PIs salary exceed the government cap of $141300

                          RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                          WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                          REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                          • howtopdf
                            • Third Edition amended August 30 2001
                            • The Original How to Write a Research Grant Application
                              • I Before You Begin
                                  • If the answer is yes
                                  • Protection
                                  • Inclusion
                                  • Monitoring
                                  • Reporting
                                  • Training
                                  • Certifications and assurances
                                    • Most Common Reasons for a Low Score (in priority order)
                                    • BEGINNING CHECKLIST
                                    • HYPOTHESIS CHECKLIST
                                    • RESEARCH PLAN - PLANNING CHECKLIST
                                    • RESEARCH PLAN - PROCESS CHECKLIST
                                    • SPECIFIC AIMS CHECKLIST
                                    • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                    • PRELIMINARY DATA CHECKLIST
                                    • DESIGN AND METHODS CHECKLIST
                                    • General
                                    • Approach
                                    • ABSTRACT CHECKLIST
                                    • BIOSKETCHES CHECKLIST
                                    • BUDGET CHECKLIST
                                    • RESOURCES CHECKLIST
                                    • REVISING CHECKLIST

                            Third Edition amended August 30 2001

                            The Original How to Write a Research Grant Application

                            Contents

                            Strategy for Getting an NIH Grant 2

                            Writing an Application for a Research Project Grant 3

                            I Before You Begin 4

                            II Application Contents 5

                            III Developing Your Research Plan 6

                            IV Application Contents Other Than the Research Plan 15

                            V Writing and Formatting 18

                            VI Submitting Your Grant Application 20

                            VII Problems and Concerns Commonly Cited by Reviewers 21

                            VIII Referral and Assignment of the Application 23

                            IX Review of Research Project Applications 24

                            X How Funding Is Decided 27

                            XI When You Have Not Obtained Funding 29

                            XII When Your Application Is Approved for Funding 32

                            Checklists 35

                            Strategy for Getting an NIH Grant

                            1 Assess competition in the field

                            2 Know the level of resources needed to compete

                            - do an organizational assessment

                            - look for opportunities to build research with support from various sources

                            - get a mentor

                            3 Be willing to change yourself your projects your career

                            4 Know the opportunities in the field for

                            - collaboration with a known laboratory or mentor

                            - carving out a niche

                            5 Find out which NIH institutes supporting research in your area are seeking applications

                            - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                            - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                            6 Make sure you and your collaborators are properly trained for the research

                            7 Closely examine grant applications from successful grantees

                            8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                            9 Have several experienced grantees critique your application

                            10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                            Writing an Application for a Research Project Grant

                            There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                            This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                            Eight Basic Questions Reviewers Ask

                            1 How high are the intellectual quality and merit of the study

                            2 What is its potential impact

                            3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                            4 Is the hypothesis valid and have you presented evidence supporting it

                            5 Are the aims logical

                            6 Are the procedures appropriate adequate and feasible for the research

                            7 Are the investigators qualified Have they shown competence credentials and experience

                            8 Are the facilities adequate and the environment conducive to the research

                            Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                            A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                            Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                            I Before You Begin

                            Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                            Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                            To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                            Developing the Hypothesis

                            Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                            Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                            State your hypothesis in both the specific aims section of the research plan and the abstract

                            II Application Contents

                            Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                            The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                            Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                            Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                            Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                            III Developing Your Research Plan

                            A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                            - Your application should be based on a strong hypothesis

                            - Be sure your project has a coherent direction

                            - Keep the sections of the plan well coordinated and clearly related to the central focus

                            - Emphasize mechanism A good grant application asks questions about biological mechanisms

                            - Dont be overly ambitious your plan should be based on a feasible timetable

                            - Specific aims and experiments should relate directly to the hypothesis to be tested

                            A Specific Aims

                            Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                            Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                            State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                            B Background and Significance

                            Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                            Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                            Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                            Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                            Identify the next logical stage of research beyond your current application

                            C Preliminary StudiesProgress Report

                            By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                            Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                            Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                            Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                            Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                            D Research Design and Methods

                            Describe the experimental design and procedures in detail and give a rationale for their use

                            Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                            Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                            advantageous to the research you propose to do

                            More and more applicants are including colored charts graphs and photographs in their applications

                            Approach

                            State why you chose your approach or approaches as opposed to others

                            If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                            Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                            Consider the limitations of each approach and how it may affect your results and the data generated

                            Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                            Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                            Results

                            Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                            Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                            Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                            Describe your proposed statistical methods for analyzing the data you plan to collect

                            Define the criteria for evaluating the success or failure of a specific test

                            Other pointers

                            Read the PHS 398 carefully for specific requirements especially those involving human subjects

                            Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                            Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                            Describe any procedures situations or materials that may be hazardous and precautions you will take

                            Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                            E Human Subjects

                            Is it human subject research

                            Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                            A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                            If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                            If the answer is yes

                            If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                            This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                            The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                            bull Description of how you will protect subjects from research risks bull Plans to include

                            Women Children Minorities Analyses capable of showing intervention differences between men and

                            women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                            Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                            Protection

                            Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                            bull Identify the characteristics of the study population or sources of research materials

                            bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                            bull Describe potential benefits to the subjects and mankind

                            bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                            In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                            Inclusion

                            Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                            This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                            After your human subjects section start new pages for the following plans

                            Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                            Put your plans on separate pages they are not included in the page limit

                            In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                            Monitoring

                            The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                            NIAID must also approve your monitoring plan see our Terms of award

                            Reporting

                            Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                            For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                            Also pay attention to the minority subgroups required for clinical trial reporting

                            Training

                            Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                            Certifications and assurances

                            If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                            Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                            NIAID Special Terms of Award

                            NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                            Review of Clinical Applications

                            In addition to the regular review criteria clinical research applications will also be reviewed for

                            bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                            bull Reasonableness of the proposed budget and duration in relation to the proposed research

                            bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                            bull Adequacy of the proposed plan to share data if appropriate

                            Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                            More Human Subjects Links

                            In addition to the 398 see these sites for more information

                            Glossary of human subject-related terms including a definition of what constitutes human subject research

                            Human subjects feature of March 2001 Council News

                            NIH human subjects reviewer guidance

                            Also see our Terms of award for NIAID-specific requirements

                            F Vertebrate Animals

                            As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                            Your application should include

                            - A detailed description of the proposed use of the animals

                            - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                            - Information on the veterinary care of the animals

                            - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                            - Justification for any euthanasia method to be used

                            If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                            G Literature Cited

                            Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                            Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                            Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                            H ConsortiumContractual Arrangements

                            This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                            The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                            I Consultants

                            Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                            IV Application Contents Other Than the Research Plan

                            Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                            Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                            Abstract (Form BB)

                            Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                            Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                            Title

                            Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                            Biographical Sketches (Form FF)

                            This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                            With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                            - Name and title

                            - Education -- institutions location degree(s) year conferred and field(s) of study

                            - Roles in other relevant current or past research

                            - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                            - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                            Budget

                            Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                            Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                            Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                            Modular grants

                            NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                            Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                            NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                            Resources

                            The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                            research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                            V Writing and Formatting

                            Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                            Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                            Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                            Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                            Page Limitations

                            Type (font) Size and Spacing

                            Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                            Font size in figures and tables may be smaller but must be readily legible

                            Writing Tips

                            Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                            Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                            Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                            Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                            tables

                            Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                            VI Submitting Your Grant Application

                            Receipt Date

                            NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                            Cover Letter

                            Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                            Requesting an SRG and InstituteCenter

                            Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                            You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                            Modular Grants and Applications and Just in Time

                            The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                            The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                            For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                            VII Problems and Concerns Commonly Cited by Reviewers

                            Below is a list of the most common reasons cited by reviewers for an applications lack of success

                            Lack of significance to the scientific issue being addressed

                            Lack of original or new ideas

                            Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                            Project too diffuse or superficial or lacks focus

                            Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                            Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                            Rationale for experiments not provided (why important or how relevant to the hypothesis)

                            Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                            Lack of alternative methodological approaches in case the primary approach does not work out

                            Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                            The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                            The proposed experiments do not include all relevant controls

                            Proposal innovative but lacking enough preliminary data

                            Preliminary data do not support the feasibility of the project or the hypothesis

                            Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                            The proposal lacks critical literature references causing reviewers to think that the

                            applicant either does not know the literature or has purposely neglected critical published material

                            Not clear which data were obtained by the investigator and which have been reported by others

                            VIII Referral and Assignment of the Application

                            When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                            Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                            Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                            To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                            You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                            If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                            IX Review of Research Project Applications

                            This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                            Scientific Review Groups

                            Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                            Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                            Review Criteria

                            In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                            Significance Approach Innovation Investigator Environment

                            To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                            Cover Letter

                            Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                            State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                            Administrative Review

                            Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                            If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                            At the Peer Review Meeting

                            Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                            Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                            How Priority Scores Are Determined

                            If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                            Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                            Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                            1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                            2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                            3 Deferred In some instances the scientific review group is unable to make an

                            adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                            Summary Statements

                            Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                            Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                            Appeal

                            You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                            X How Funding Is Decided

                            Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                            Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                            How Paylines Work

                            Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                            Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                            Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                            You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                            For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                            Second Level Peer Review

                            In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                            They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                            Possible Outcomes of Secondary Review

                            Following Council review NIAID takes one of four actions for an application

                            1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                            Why Applications Are Kept on Hold

                            ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                            Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                            XI When You Have Not Obtained Funding

                            What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                            Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                            Most Common Reasons for a Low Score (in priority order)

                            - Lack of new or original ideas

                            - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                            - Methods unsuitable or defective and not likely to yield results

                            - Data collection confused in design inappropriate instrumentation poor timing or conditions

                            - Data management and analysis vague unsophisticated

                            - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                            - Poor resources or facilities limited access to appropriate patient population

                            From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                            When to Revise

                            How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                            If the problems are repairable revise the application and resubmit it to the same study section

                            Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                            - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                            Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                            vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                            If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                            For fatal flaws and weaknesses rethink your idea and start over

                            Revising Your Application

                            Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                            Respond to reviewersrsquo comments

                            The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                            Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                            Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                            additions deletions and changes in the revised application and address the main criticisms in the summary statement

                            Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                            Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                            If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                            XII When Your Application Is Approved for Funding

                            If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                            Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                            If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                            There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                            For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                            Documentation

                            Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                            Human subjects

                            For more information concerning the human subjects assurance contact OHRP at

                            Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                            And find a wealth of guidance documents on the Web

                            Animals in Research

                            For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                            Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                            Or see the Web site at Office of Laboratory Animal Welfare

                            What You Can and Cannot Pay for on a Grant

                            In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                            OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                            For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                            Terms and Conditions of Award

                            Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                            Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                            NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                            Reporting Requirements

                            Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                            Address and phone number are

                            NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                            For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                            Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                            Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                            Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                            Checklists

                            BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                            HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                            RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                            RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                            rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                            SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                            BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                            PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                            DESIGN AND METHODS CHECKLIST

                            General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                            Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                            Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                            Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                            ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                            BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                            BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                            Does the PIs salary exceed the government cap of $141300

                            RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                            WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                            REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                            • howtopdf
                              • Third Edition amended August 30 2001
                              • The Original How to Write a Research Grant Application
                                • I Before You Begin
                                    • If the answer is yes
                                    • Protection
                                    • Inclusion
                                    • Monitoring
                                    • Reporting
                                    • Training
                                    • Certifications and assurances
                                      • Most Common Reasons for a Low Score (in priority order)
                                      • BEGINNING CHECKLIST
                                      • HYPOTHESIS CHECKLIST
                                      • RESEARCH PLAN - PLANNING CHECKLIST
                                      • RESEARCH PLAN - PROCESS CHECKLIST
                                      • SPECIFIC AIMS CHECKLIST
                                      • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                      • PRELIMINARY DATA CHECKLIST
                                      • DESIGN AND METHODS CHECKLIST
                                      • General
                                      • Approach
                                      • ABSTRACT CHECKLIST
                                      • BIOSKETCHES CHECKLIST
                                      • BUDGET CHECKLIST
                                      • RESOURCES CHECKLIST
                                      • REVISING CHECKLIST

                              Strategy for Getting an NIH Grant

                              1 Assess competition in the field

                              2 Know the level of resources needed to compete

                              - do an organizational assessment

                              - look for opportunities to build research with support from various sources

                              - get a mentor

                              3 Be willing to change yourself your projects your career

                              4 Know the opportunities in the field for

                              - collaboration with a known laboratory or mentor

                              - carving out a niche

                              5 Find out which NIH institutes supporting research in your area are seeking applications

                              - go to our list of program announcements (PA) on the Web and requests for applications (RFA)

                              - discuss your ideas with Institute program staff See NIAIDs program and staff listing

                              6 Make sure you and your collaborators are properly trained for the research

                              7 Closely examine grant applications from successful grantees

                              8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

                              9 Have several experienced grantees critique your application

                              10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

                              Writing an Application for a Research Project Grant

                              There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                              This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                              Eight Basic Questions Reviewers Ask

                              1 How high are the intellectual quality and merit of the study

                              2 What is its potential impact

                              3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                              4 Is the hypothesis valid and have you presented evidence supporting it

                              5 Are the aims logical

                              6 Are the procedures appropriate adequate and feasible for the research

                              7 Are the investigators qualified Have they shown competence credentials and experience

                              8 Are the facilities adequate and the environment conducive to the research

                              Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                              A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                              Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                              I Before You Begin

                              Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                              Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                              To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                              Developing the Hypothesis

                              Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                              Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                              State your hypothesis in both the specific aims section of the research plan and the abstract

                              II Application Contents

                              Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                              The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                              Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                              Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                              Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                              III Developing Your Research Plan

                              A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                              - Your application should be based on a strong hypothesis

                              - Be sure your project has a coherent direction

                              - Keep the sections of the plan well coordinated and clearly related to the central focus

                              - Emphasize mechanism A good grant application asks questions about biological mechanisms

                              - Dont be overly ambitious your plan should be based on a feasible timetable

                              - Specific aims and experiments should relate directly to the hypothesis to be tested

                              A Specific Aims

                              Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                              Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                              State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                              B Background and Significance

                              Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                              Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                              Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                              Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                              Identify the next logical stage of research beyond your current application

                              C Preliminary StudiesProgress Report

                              By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                              Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                              Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                              Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                              Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                              D Research Design and Methods

                              Describe the experimental design and procedures in detail and give a rationale for their use

                              Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                              Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                              advantageous to the research you propose to do

                              More and more applicants are including colored charts graphs and photographs in their applications

                              Approach

                              State why you chose your approach or approaches as opposed to others

                              If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                              Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                              Consider the limitations of each approach and how it may affect your results and the data generated

                              Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                              Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                              Results

                              Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                              Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                              Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                              Describe your proposed statistical methods for analyzing the data you plan to collect

                              Define the criteria for evaluating the success or failure of a specific test

                              Other pointers

                              Read the PHS 398 carefully for specific requirements especially those involving human subjects

                              Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                              Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                              Describe any procedures situations or materials that may be hazardous and precautions you will take

                              Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                              E Human Subjects

                              Is it human subject research

                              Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                              A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                              If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                              If the answer is yes

                              If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                              This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                              The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                              bull Description of how you will protect subjects from research risks bull Plans to include

                              Women Children Minorities Analyses capable of showing intervention differences between men and

                              women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                              Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                              Protection

                              Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                              bull Identify the characteristics of the study population or sources of research materials

                              bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                              bull Describe potential benefits to the subjects and mankind

                              bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                              In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                              Inclusion

                              Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                              This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                              After your human subjects section start new pages for the following plans

                              Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                              Put your plans on separate pages they are not included in the page limit

                              In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                              Monitoring

                              The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                              NIAID must also approve your monitoring plan see our Terms of award

                              Reporting

                              Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                              For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                              Also pay attention to the minority subgroups required for clinical trial reporting

                              Training

                              Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                              Certifications and assurances

                              If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                              Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                              NIAID Special Terms of Award

                              NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                              Review of Clinical Applications

                              In addition to the regular review criteria clinical research applications will also be reviewed for

                              bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                              bull Reasonableness of the proposed budget and duration in relation to the proposed research

                              bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                              bull Adequacy of the proposed plan to share data if appropriate

                              Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                              More Human Subjects Links

                              In addition to the 398 see these sites for more information

                              Glossary of human subject-related terms including a definition of what constitutes human subject research

                              Human subjects feature of March 2001 Council News

                              NIH human subjects reviewer guidance

                              Also see our Terms of award for NIAID-specific requirements

                              F Vertebrate Animals

                              As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                              Your application should include

                              - A detailed description of the proposed use of the animals

                              - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                              - Information on the veterinary care of the animals

                              - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                              - Justification for any euthanasia method to be used

                              If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                              G Literature Cited

                              Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                              Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                              Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                              H ConsortiumContractual Arrangements

                              This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                              The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                              I Consultants

                              Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                              IV Application Contents Other Than the Research Plan

                              Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                              Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                              Abstract (Form BB)

                              Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                              Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                              Title

                              Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                              Biographical Sketches (Form FF)

                              This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                              With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                              - Name and title

                              - Education -- institutions location degree(s) year conferred and field(s) of study

                              - Roles in other relevant current or past research

                              - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                              - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                              Budget

                              Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                              Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                              Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                              Modular grants

                              NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                              Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                              NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                              Resources

                              The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                              research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                              V Writing and Formatting

                              Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                              Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                              Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                              Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                              Page Limitations

                              Type (font) Size and Spacing

                              Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                              Font size in figures and tables may be smaller but must be readily legible

                              Writing Tips

                              Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                              Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                              Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                              Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                              tables

                              Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                              VI Submitting Your Grant Application

                              Receipt Date

                              NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                              Cover Letter

                              Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                              Requesting an SRG and InstituteCenter

                              Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                              You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                              Modular Grants and Applications and Just in Time

                              The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                              The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                              For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                              VII Problems and Concerns Commonly Cited by Reviewers

                              Below is a list of the most common reasons cited by reviewers for an applications lack of success

                              Lack of significance to the scientific issue being addressed

                              Lack of original or new ideas

                              Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                              Project too diffuse or superficial or lacks focus

                              Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                              Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                              Rationale for experiments not provided (why important or how relevant to the hypothesis)

                              Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                              Lack of alternative methodological approaches in case the primary approach does not work out

                              Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                              The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                              The proposed experiments do not include all relevant controls

                              Proposal innovative but lacking enough preliminary data

                              Preliminary data do not support the feasibility of the project or the hypothesis

                              Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                              The proposal lacks critical literature references causing reviewers to think that the

                              applicant either does not know the literature or has purposely neglected critical published material

                              Not clear which data were obtained by the investigator and which have been reported by others

                              VIII Referral and Assignment of the Application

                              When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                              Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                              Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                              To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                              You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                              If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                              IX Review of Research Project Applications

                              This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                              Scientific Review Groups

                              Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                              Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                              Review Criteria

                              In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                              Significance Approach Innovation Investigator Environment

                              To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                              Cover Letter

                              Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                              State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                              Administrative Review

                              Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                              If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                              At the Peer Review Meeting

                              Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                              Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                              How Priority Scores Are Determined

                              If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                              Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                              Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                              1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                              2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                              3 Deferred In some instances the scientific review group is unable to make an

                              adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                              Summary Statements

                              Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                              Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                              Appeal

                              You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                              X How Funding Is Decided

                              Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                              Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                              How Paylines Work

                              Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                              Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                              Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                              You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                              For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                              Second Level Peer Review

                              In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                              They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                              Possible Outcomes of Secondary Review

                              Following Council review NIAID takes one of four actions for an application

                              1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                              Why Applications Are Kept on Hold

                              ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                              Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                              XI When You Have Not Obtained Funding

                              What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                              Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                              Most Common Reasons for a Low Score (in priority order)

                              - Lack of new or original ideas

                              - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                              - Methods unsuitable or defective and not likely to yield results

                              - Data collection confused in design inappropriate instrumentation poor timing or conditions

                              - Data management and analysis vague unsophisticated

                              - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                              - Poor resources or facilities limited access to appropriate patient population

                              From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                              When to Revise

                              How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                              If the problems are repairable revise the application and resubmit it to the same study section

                              Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                              - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                              Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                              vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                              If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                              For fatal flaws and weaknesses rethink your idea and start over

                              Revising Your Application

                              Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                              Respond to reviewersrsquo comments

                              The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                              Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                              Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                              additions deletions and changes in the revised application and address the main criticisms in the summary statement

                              Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                              Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                              If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                              XII When Your Application Is Approved for Funding

                              If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                              Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                              If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                              There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                              For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                              Documentation

                              Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                              Human subjects

                              For more information concerning the human subjects assurance contact OHRP at

                              Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                              And find a wealth of guidance documents on the Web

                              Animals in Research

                              For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                              Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                              Or see the Web site at Office of Laboratory Animal Welfare

                              What You Can and Cannot Pay for on a Grant

                              In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                              OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                              For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                              Terms and Conditions of Award

                              Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                              Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                              NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                              Reporting Requirements

                              Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                              Address and phone number are

                              NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                              For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                              Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                              Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                              Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                              Checklists

                              BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                              HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                              RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                              RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                              rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                              SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                              BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                              PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                              DESIGN AND METHODS CHECKLIST

                              General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                              Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                              Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                              Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                              ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                              BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                              BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                              Does the PIs salary exceed the government cap of $141300

                              RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                              WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                              REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                              • howtopdf
                                • Third Edition amended August 30 2001
                                • The Original How to Write a Research Grant Application
                                  • I Before You Begin
                                      • If the answer is yes
                                      • Protection
                                      • Inclusion
                                      • Monitoring
                                      • Reporting
                                      • Training
                                      • Certifications and assurances
                                        • Most Common Reasons for a Low Score (in priority order)
                                        • BEGINNING CHECKLIST
                                        • HYPOTHESIS CHECKLIST
                                        • RESEARCH PLAN - PLANNING CHECKLIST
                                        • RESEARCH PLAN - PROCESS CHECKLIST
                                        • SPECIFIC AIMS CHECKLIST
                                        • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                        • PRELIMINARY DATA CHECKLIST
                                        • DESIGN AND METHODS CHECKLIST
                                        • General
                                        • Approach
                                        • ABSTRACT CHECKLIST
                                        • BIOSKETCHES CHECKLIST
                                        • BUDGET CHECKLIST
                                        • RESOURCES CHECKLIST
                                        • REVISING CHECKLIST

                                Writing an Application for a Research Project Grant

                                There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

                                This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

                                Eight Basic Questions Reviewers Ask

                                1 How high are the intellectual quality and merit of the study

                                2 What is its potential impact

                                3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

                                4 Is the hypothesis valid and have you presented evidence supporting it

                                5 Are the aims logical

                                6 Are the procedures appropriate adequate and feasible for the research

                                7 Are the investigators qualified Have they shown competence credentials and experience

                                8 Are the facilities adequate and the environment conducive to the research

                                Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

                                A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

                                Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

                                I Before You Begin

                                Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                                Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                                To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                                Developing the Hypothesis

                                Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                                Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                                State your hypothesis in both the specific aims section of the research plan and the abstract

                                II Application Contents

                                Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                                The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                                Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                                Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                                Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                                III Developing Your Research Plan

                                A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                                - Your application should be based on a strong hypothesis

                                - Be sure your project has a coherent direction

                                - Keep the sections of the plan well coordinated and clearly related to the central focus

                                - Emphasize mechanism A good grant application asks questions about biological mechanisms

                                - Dont be overly ambitious your plan should be based on a feasible timetable

                                - Specific aims and experiments should relate directly to the hypothesis to be tested

                                A Specific Aims

                                Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                                Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                                State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                                B Background and Significance

                                Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                                Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                                Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                                Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                                Identify the next logical stage of research beyond your current application

                                C Preliminary StudiesProgress Report

                                By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                                Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                                Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                                Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                                Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                                D Research Design and Methods

                                Describe the experimental design and procedures in detail and give a rationale for their use

                                Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                                Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                                advantageous to the research you propose to do

                                More and more applicants are including colored charts graphs and photographs in their applications

                                Approach

                                State why you chose your approach or approaches as opposed to others

                                If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                                Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                                Consider the limitations of each approach and how it may affect your results and the data generated

                                Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                                Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                                Results

                                Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                                Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                                Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                                Describe your proposed statistical methods for analyzing the data you plan to collect

                                Define the criteria for evaluating the success or failure of a specific test

                                Other pointers

                                Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                Describe any procedures situations or materials that may be hazardous and precautions you will take

                                Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                E Human Subjects

                                Is it human subject research

                                Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                If the answer is yes

                                If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                bull Description of how you will protect subjects from research risks bull Plans to include

                                Women Children Minorities Analyses capable of showing intervention differences between men and

                                women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                Protection

                                Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                bull Identify the characteristics of the study population or sources of research materials

                                bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                bull Describe potential benefits to the subjects and mankind

                                bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                Inclusion

                                Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                After your human subjects section start new pages for the following plans

                                Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                Put your plans on separate pages they are not included in the page limit

                                In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                Monitoring

                                The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                NIAID must also approve your monitoring plan see our Terms of award

                                Reporting

                                Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                Also pay attention to the minority subgroups required for clinical trial reporting

                                Training

                                Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                Certifications and assurances

                                If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                NIAID Special Terms of Award

                                NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                Review of Clinical Applications

                                In addition to the regular review criteria clinical research applications will also be reviewed for

                                bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                bull Adequacy of the proposed plan to share data if appropriate

                                Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                More Human Subjects Links

                                In addition to the 398 see these sites for more information

                                Glossary of human subject-related terms including a definition of what constitutes human subject research

                                Human subjects feature of March 2001 Council News

                                NIH human subjects reviewer guidance

                                Also see our Terms of award for NIAID-specific requirements

                                F Vertebrate Animals

                                As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                Your application should include

                                - A detailed description of the proposed use of the animals

                                - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                - Information on the veterinary care of the animals

                                - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                - Justification for any euthanasia method to be used

                                If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                G Literature Cited

                                Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                H ConsortiumContractual Arrangements

                                This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                I Consultants

                                Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                IV Application Contents Other Than the Research Plan

                                Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                Abstract (Form BB)

                                Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                Title

                                Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                Biographical Sketches (Form FF)

                                This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                - Name and title

                                - Education -- institutions location degree(s) year conferred and field(s) of study

                                - Roles in other relevant current or past research

                                - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                Budget

                                Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                Modular grants

                                NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                Resources

                                The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                V Writing and Formatting

                                Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                Page Limitations

                                Type (font) Size and Spacing

                                Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                Font size in figures and tables may be smaller but must be readily legible

                                Writing Tips

                                Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                tables

                                Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                VI Submitting Your Grant Application

                                Receipt Date

                                NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                Cover Letter

                                Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                Requesting an SRG and InstituteCenter

                                Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                Modular Grants and Applications and Just in Time

                                The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                VII Problems and Concerns Commonly Cited by Reviewers

                                Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                Lack of significance to the scientific issue being addressed

                                Lack of original or new ideas

                                Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                Project too diffuse or superficial or lacks focus

                                Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                Lack of alternative methodological approaches in case the primary approach does not work out

                                Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                The proposed experiments do not include all relevant controls

                                Proposal innovative but lacking enough preliminary data

                                Preliminary data do not support the feasibility of the project or the hypothesis

                                Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                The proposal lacks critical literature references causing reviewers to think that the

                                applicant either does not know the literature or has purposely neglected critical published material

                                Not clear which data were obtained by the investigator and which have been reported by others

                                VIII Referral and Assignment of the Application

                                When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                IX Review of Research Project Applications

                                This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                Scientific Review Groups

                                Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                Review Criteria

                                In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                Significance Approach Innovation Investigator Environment

                                To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                Cover Letter

                                Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                Administrative Review

                                Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                At the Peer Review Meeting

                                Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                How Priority Scores Are Determined

                                If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                3 Deferred In some instances the scientific review group is unable to make an

                                adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                Summary Statements

                                Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                Appeal

                                You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                X How Funding Is Decided

                                Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                How Paylines Work

                                Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                Second Level Peer Review

                                In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                Possible Outcomes of Secondary Review

                                Following Council review NIAID takes one of four actions for an application

                                1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                Why Applications Are Kept on Hold

                                ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                XI When You Have Not Obtained Funding

                                What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                Most Common Reasons for a Low Score (in priority order)

                                - Lack of new or original ideas

                                - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                - Methods unsuitable or defective and not likely to yield results

                                - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                - Data management and analysis vague unsophisticated

                                - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                - Poor resources or facilities limited access to appropriate patient population

                                From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                When to Revise

                                How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                If the problems are repairable revise the application and resubmit it to the same study section

                                Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                For fatal flaws and weaknesses rethink your idea and start over

                                Revising Your Application

                                Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                Respond to reviewersrsquo comments

                                The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                XII When Your Application Is Approved for Funding

                                If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                Documentation

                                Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                Human subjects

                                For more information concerning the human subjects assurance contact OHRP at

                                Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                And find a wealth of guidance documents on the Web

                                Animals in Research

                                For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                Or see the Web site at Office of Laboratory Animal Welfare

                                What You Can and Cannot Pay for on a Grant

                                In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                Terms and Conditions of Award

                                Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                Reporting Requirements

                                Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                Address and phone number are

                                NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                Checklists

                                BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                DESIGN AND METHODS CHECKLIST

                                General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                Does the PIs salary exceed the government cap of $141300

                                RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                • howtopdf
                                  • Third Edition amended August 30 2001
                                  • The Original How to Write a Research Grant Application
                                    • I Before You Begin
                                        • If the answer is yes
                                        • Protection
                                        • Inclusion
                                        • Monitoring
                                        • Reporting
                                        • Training
                                        • Certifications and assurances
                                          • Most Common Reasons for a Low Score (in priority order)
                                          • BEGINNING CHECKLIST
                                          • HYPOTHESIS CHECKLIST
                                          • RESEARCH PLAN - PLANNING CHECKLIST
                                          • RESEARCH PLAN - PROCESS CHECKLIST
                                          • SPECIFIC AIMS CHECKLIST
                                          • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                          • PRELIMINARY DATA CHECKLIST
                                          • DESIGN AND METHODS CHECKLIST
                                          • General
                                          • Approach
                                          • ABSTRACT CHECKLIST
                                          • BIOSKETCHES CHECKLIST
                                          • BUDGET CHECKLIST
                                          • RESOURCES CHECKLIST
                                          • REVISING CHECKLIST

                                  I Before You Begin

                                  Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

                                  Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

                                  To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

                                  Developing the Hypothesis

                                  Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

                                  Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

                                  State your hypothesis in both the specific aims section of the research plan and the abstract

                                  II Application Contents

                                  Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                                  The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                                  Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                                  Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                                  Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                                  III Developing Your Research Plan

                                  A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                                  - Your application should be based on a strong hypothesis

                                  - Be sure your project has a coherent direction

                                  - Keep the sections of the plan well coordinated and clearly related to the central focus

                                  - Emphasize mechanism A good grant application asks questions about biological mechanisms

                                  - Dont be overly ambitious your plan should be based on a feasible timetable

                                  - Specific aims and experiments should relate directly to the hypothesis to be tested

                                  A Specific Aims

                                  Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                                  Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                                  State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                                  B Background and Significance

                                  Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                                  Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                                  Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                                  Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                                  Identify the next logical stage of research beyond your current application

                                  C Preliminary StudiesProgress Report

                                  By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                                  Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                                  Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                                  Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                                  Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                                  D Research Design and Methods

                                  Describe the experimental design and procedures in detail and give a rationale for their use

                                  Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                                  Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                                  advantageous to the research you propose to do

                                  More and more applicants are including colored charts graphs and photographs in their applications

                                  Approach

                                  State why you chose your approach or approaches as opposed to others

                                  If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                                  Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                                  Consider the limitations of each approach and how it may affect your results and the data generated

                                  Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                                  Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                                  Results

                                  Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                                  Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                                  Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                                  Describe your proposed statistical methods for analyzing the data you plan to collect

                                  Define the criteria for evaluating the success or failure of a specific test

                                  Other pointers

                                  Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                  Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                  Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                  Describe any procedures situations or materials that may be hazardous and precautions you will take

                                  Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                  E Human Subjects

                                  Is it human subject research

                                  Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                  A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                  If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                  If the answer is yes

                                  If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                  This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                  The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                  bull Description of how you will protect subjects from research risks bull Plans to include

                                  Women Children Minorities Analyses capable of showing intervention differences between men and

                                  women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                  Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                  Protection

                                  Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                  bull Identify the characteristics of the study population or sources of research materials

                                  bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                  bull Describe potential benefits to the subjects and mankind

                                  bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                  In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                  Inclusion

                                  Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                  This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                  After your human subjects section start new pages for the following plans

                                  Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                  Put your plans on separate pages they are not included in the page limit

                                  In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                  Monitoring

                                  The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                  NIAID must also approve your monitoring plan see our Terms of award

                                  Reporting

                                  Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                  For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                  Also pay attention to the minority subgroups required for clinical trial reporting

                                  Training

                                  Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                  Certifications and assurances

                                  If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                  Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                  NIAID Special Terms of Award

                                  NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                  Review of Clinical Applications

                                  In addition to the regular review criteria clinical research applications will also be reviewed for

                                  bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                  bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                  bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                  bull Adequacy of the proposed plan to share data if appropriate

                                  Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                  More Human Subjects Links

                                  In addition to the 398 see these sites for more information

                                  Glossary of human subject-related terms including a definition of what constitutes human subject research

                                  Human subjects feature of March 2001 Council News

                                  NIH human subjects reviewer guidance

                                  Also see our Terms of award for NIAID-specific requirements

                                  F Vertebrate Animals

                                  As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                  Your application should include

                                  - A detailed description of the proposed use of the animals

                                  - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                  - Information on the veterinary care of the animals

                                  - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                  - Justification for any euthanasia method to be used

                                  If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                  G Literature Cited

                                  Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                  Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                  Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                  H ConsortiumContractual Arrangements

                                  This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                  The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                  I Consultants

                                  Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                  IV Application Contents Other Than the Research Plan

                                  Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                  Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                  Abstract (Form BB)

                                  Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                  Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                  Title

                                  Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                  Biographical Sketches (Form FF)

                                  This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                  With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                  - Name and title

                                  - Education -- institutions location degree(s) year conferred and field(s) of study

                                  - Roles in other relevant current or past research

                                  - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                  - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                  Budget

                                  Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                  Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                  Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                  Modular grants

                                  NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                  Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                  NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                  Resources

                                  The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                  research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                  V Writing and Formatting

                                  Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                  Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                  Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                  Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                  Page Limitations

                                  Type (font) Size and Spacing

                                  Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                  Font size in figures and tables may be smaller but must be readily legible

                                  Writing Tips

                                  Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                  Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                  Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                  Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                  tables

                                  Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                  VI Submitting Your Grant Application

                                  Receipt Date

                                  NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                  Cover Letter

                                  Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                  Requesting an SRG and InstituteCenter

                                  Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                  You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                  Modular Grants and Applications and Just in Time

                                  The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                  The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                  For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                  VII Problems and Concerns Commonly Cited by Reviewers

                                  Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                  Lack of significance to the scientific issue being addressed

                                  Lack of original or new ideas

                                  Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                  Project too diffuse or superficial or lacks focus

                                  Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                  Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                  Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                  Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                  Lack of alternative methodological approaches in case the primary approach does not work out

                                  Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                  The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                  The proposed experiments do not include all relevant controls

                                  Proposal innovative but lacking enough preliminary data

                                  Preliminary data do not support the feasibility of the project or the hypothesis

                                  Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                  The proposal lacks critical literature references causing reviewers to think that the

                                  applicant either does not know the literature or has purposely neglected critical published material

                                  Not clear which data were obtained by the investigator and which have been reported by others

                                  VIII Referral and Assignment of the Application

                                  When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                  Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                  Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                  To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                  You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                  If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                  IX Review of Research Project Applications

                                  This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                  Scientific Review Groups

                                  Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                  Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                  Review Criteria

                                  In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                  Significance Approach Innovation Investigator Environment

                                  To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                  Cover Letter

                                  Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                  State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                  Administrative Review

                                  Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                  If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                  At the Peer Review Meeting

                                  Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                  Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                  How Priority Scores Are Determined

                                  If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                  Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                  Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                  1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                  2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                  3 Deferred In some instances the scientific review group is unable to make an

                                  adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                  Summary Statements

                                  Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                  Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                  Appeal

                                  You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                  X How Funding Is Decided

                                  Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                  Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                  How Paylines Work

                                  Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                  Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                  Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                  You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                  For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                  Second Level Peer Review

                                  In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                  They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                  Possible Outcomes of Secondary Review

                                  Following Council review NIAID takes one of four actions for an application

                                  1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                  Why Applications Are Kept on Hold

                                  ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                  Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                  XI When You Have Not Obtained Funding

                                  What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                  Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                  Most Common Reasons for a Low Score (in priority order)

                                  - Lack of new or original ideas

                                  - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                  - Methods unsuitable or defective and not likely to yield results

                                  - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                  - Data management and analysis vague unsophisticated

                                  - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                  - Poor resources or facilities limited access to appropriate patient population

                                  From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                  When to Revise

                                  How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                  If the problems are repairable revise the application and resubmit it to the same study section

                                  Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                  - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                  Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                  vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                  If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                  For fatal flaws and weaknesses rethink your idea and start over

                                  Revising Your Application

                                  Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                  Respond to reviewersrsquo comments

                                  The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                  Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                  Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                  additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                  Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                  Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                  If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                  XII When Your Application Is Approved for Funding

                                  If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                  Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                  If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                  There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                  For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                  Documentation

                                  Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                  Human subjects

                                  For more information concerning the human subjects assurance contact OHRP at

                                  Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                  And find a wealth of guidance documents on the Web

                                  Animals in Research

                                  For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                  Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                  Or see the Web site at Office of Laboratory Animal Welfare

                                  What You Can and Cannot Pay for on a Grant

                                  In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                  OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                  For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                  Terms and Conditions of Award

                                  Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                  Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                  NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                  Reporting Requirements

                                  Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                  Address and phone number are

                                  NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                  For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                  Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                  Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                  Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                  Checklists

                                  BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                  HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                  RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                  RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                  rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                  SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                  BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                  PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                  DESIGN AND METHODS CHECKLIST

                                  General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                  Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                  Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                  Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                  ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                  BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                  BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                  Does the PIs salary exceed the government cap of $141300

                                  RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                  WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                  REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                  • howtopdf
                                    • Third Edition amended August 30 2001
                                    • The Original How to Write a Research Grant Application
                                      • I Before You Begin
                                          • If the answer is yes
                                          • Protection
                                          • Inclusion
                                          • Monitoring
                                          • Reporting
                                          • Training
                                          • Certifications and assurances
                                            • Most Common Reasons for a Low Score (in priority order)
                                            • BEGINNING CHECKLIST
                                            • HYPOTHESIS CHECKLIST
                                            • RESEARCH PLAN - PLANNING CHECKLIST
                                            • RESEARCH PLAN - PROCESS CHECKLIST
                                            • SPECIFIC AIMS CHECKLIST
                                            • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                            • PRELIMINARY DATA CHECKLIST
                                            • DESIGN AND METHODS CHECKLIST
                                            • General
                                            • Approach
                                            • ABSTRACT CHECKLIST
                                            • BIOSKETCHES CHECKLIST
                                            • BUDGET CHECKLIST
                                            • RESOURCES CHECKLIST
                                            • REVISING CHECKLIST

                                    II Application Contents

                                    Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

                                    The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

                                    Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

                                    Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

                                    Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

                                    III Developing Your Research Plan

                                    A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                                    - Your application should be based on a strong hypothesis

                                    - Be sure your project has a coherent direction

                                    - Keep the sections of the plan well coordinated and clearly related to the central focus

                                    - Emphasize mechanism A good grant application asks questions about biological mechanisms

                                    - Dont be overly ambitious your plan should be based on a feasible timetable

                                    - Specific aims and experiments should relate directly to the hypothesis to be tested

                                    A Specific Aims

                                    Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                                    Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                                    State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                                    B Background and Significance

                                    Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                                    Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                                    Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                                    Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                                    Identify the next logical stage of research beyond your current application

                                    C Preliminary StudiesProgress Report

                                    By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                                    Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                                    Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                                    Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                                    Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                                    D Research Design and Methods

                                    Describe the experimental design and procedures in detail and give a rationale for their use

                                    Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                                    Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                                    advantageous to the research you propose to do

                                    More and more applicants are including colored charts graphs and photographs in their applications

                                    Approach

                                    State why you chose your approach or approaches as opposed to others

                                    If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                                    Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                                    Consider the limitations of each approach and how it may affect your results and the data generated

                                    Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                                    Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                                    Results

                                    Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                                    Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                                    Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                                    Describe your proposed statistical methods for analyzing the data you plan to collect

                                    Define the criteria for evaluating the success or failure of a specific test

                                    Other pointers

                                    Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                    Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                    Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                    Describe any procedures situations or materials that may be hazardous and precautions you will take

                                    Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                    E Human Subjects

                                    Is it human subject research

                                    Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                    A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                    If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                    If the answer is yes

                                    If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                    This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                    The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                    bull Description of how you will protect subjects from research risks bull Plans to include

                                    Women Children Minorities Analyses capable of showing intervention differences between men and

                                    women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                    Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                    Protection

                                    Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                    bull Identify the characteristics of the study population or sources of research materials

                                    bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                    bull Describe potential benefits to the subjects and mankind

                                    bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                    In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                    Inclusion

                                    Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                    This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                    After your human subjects section start new pages for the following plans

                                    Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                    Put your plans on separate pages they are not included in the page limit

                                    In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                    Monitoring

                                    The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                    NIAID must also approve your monitoring plan see our Terms of award

                                    Reporting

                                    Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                    For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                    Also pay attention to the minority subgroups required for clinical trial reporting

                                    Training

                                    Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                    Certifications and assurances

                                    If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                    Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                    NIAID Special Terms of Award

                                    NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                    Review of Clinical Applications

                                    In addition to the regular review criteria clinical research applications will also be reviewed for

                                    bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                    bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                    bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                    bull Adequacy of the proposed plan to share data if appropriate

                                    Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                    More Human Subjects Links

                                    In addition to the 398 see these sites for more information

                                    Glossary of human subject-related terms including a definition of what constitutes human subject research

                                    Human subjects feature of March 2001 Council News

                                    NIH human subjects reviewer guidance

                                    Also see our Terms of award for NIAID-specific requirements

                                    F Vertebrate Animals

                                    As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                    Your application should include

                                    - A detailed description of the proposed use of the animals

                                    - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                    - Information on the veterinary care of the animals

                                    - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                    - Justification for any euthanasia method to be used

                                    If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                    G Literature Cited

                                    Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                    Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                    Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                    H ConsortiumContractual Arrangements

                                    This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                    The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                    I Consultants

                                    Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                    IV Application Contents Other Than the Research Plan

                                    Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                    Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                    Abstract (Form BB)

                                    Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                    Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                    Title

                                    Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                    Biographical Sketches (Form FF)

                                    This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                    With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                    - Name and title

                                    - Education -- institutions location degree(s) year conferred and field(s) of study

                                    - Roles in other relevant current or past research

                                    - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                    - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                    Budget

                                    Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                    Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                    Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                    Modular grants

                                    NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                    Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                    NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                    Resources

                                    The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                    research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                    V Writing and Formatting

                                    Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                    Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                    Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                    Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                    Page Limitations

                                    Type (font) Size and Spacing

                                    Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                    Font size in figures and tables may be smaller but must be readily legible

                                    Writing Tips

                                    Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                    Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                    Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                    Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                    tables

                                    Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                    VI Submitting Your Grant Application

                                    Receipt Date

                                    NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                    Cover Letter

                                    Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                    Requesting an SRG and InstituteCenter

                                    Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                    You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                    Modular Grants and Applications and Just in Time

                                    The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                    The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                    For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                    VII Problems and Concerns Commonly Cited by Reviewers

                                    Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                    Lack of significance to the scientific issue being addressed

                                    Lack of original or new ideas

                                    Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                    Project too diffuse or superficial or lacks focus

                                    Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                    Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                    Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                    Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                    Lack of alternative methodological approaches in case the primary approach does not work out

                                    Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                    The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                    The proposed experiments do not include all relevant controls

                                    Proposal innovative but lacking enough preliminary data

                                    Preliminary data do not support the feasibility of the project or the hypothesis

                                    Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                    The proposal lacks critical literature references causing reviewers to think that the

                                    applicant either does not know the literature or has purposely neglected critical published material

                                    Not clear which data were obtained by the investigator and which have been reported by others

                                    VIII Referral and Assignment of the Application

                                    When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                    Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                    Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                    To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                    You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                    If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                    IX Review of Research Project Applications

                                    This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                    Scientific Review Groups

                                    Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                    Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                    Review Criteria

                                    In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                    Significance Approach Innovation Investigator Environment

                                    To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                    Cover Letter

                                    Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                    State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                    Administrative Review

                                    Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                    If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                    At the Peer Review Meeting

                                    Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                    Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                    How Priority Scores Are Determined

                                    If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                    Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                    Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                    1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                    2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                    3 Deferred In some instances the scientific review group is unable to make an

                                    adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                    Summary Statements

                                    Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                    Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                    Appeal

                                    You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                    X How Funding Is Decided

                                    Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                    Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                    How Paylines Work

                                    Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                    Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                    Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                    You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                    For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                    Second Level Peer Review

                                    In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                    They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                    Possible Outcomes of Secondary Review

                                    Following Council review NIAID takes one of four actions for an application

                                    1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                    Why Applications Are Kept on Hold

                                    ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                    Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                    XI When You Have Not Obtained Funding

                                    What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                    Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                    Most Common Reasons for a Low Score (in priority order)

                                    - Lack of new or original ideas

                                    - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                    - Methods unsuitable or defective and not likely to yield results

                                    - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                    - Data management and analysis vague unsophisticated

                                    - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                    - Poor resources or facilities limited access to appropriate patient population

                                    From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                    When to Revise

                                    How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                    If the problems are repairable revise the application and resubmit it to the same study section

                                    Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                    - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                    Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                    vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                    If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                    For fatal flaws and weaknesses rethink your idea and start over

                                    Revising Your Application

                                    Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                    Respond to reviewersrsquo comments

                                    The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                    Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                    Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                    additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                    Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                    Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                    If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                    XII When Your Application Is Approved for Funding

                                    If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                    Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                    If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                    There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                    For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                    Documentation

                                    Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                    Human subjects

                                    For more information concerning the human subjects assurance contact OHRP at

                                    Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                    And find a wealth of guidance documents on the Web

                                    Animals in Research

                                    For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                    Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                    Or see the Web site at Office of Laboratory Animal Welfare

                                    What You Can and Cannot Pay for on a Grant

                                    In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                    OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                    For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                    Terms and Conditions of Award

                                    Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                    Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                    NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                    Reporting Requirements

                                    Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                    Address and phone number are

                                    NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                    For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                    Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                    Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                    Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                    Checklists

                                    BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                    HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                    RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                    RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                    rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                    SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                    BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                    PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                    DESIGN AND METHODS CHECKLIST

                                    General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                    Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                    Does the PIs salary exceed the government cap of $141300

                                    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                    • howtopdf
                                      • Third Edition amended August 30 2001
                                      • The Original How to Write a Research Grant Application
                                        • I Before You Begin
                                            • If the answer is yes
                                            • Protection
                                            • Inclusion
                                            • Monitoring
                                            • Reporting
                                            • Training
                                            • Certifications and assurances
                                              • Most Common Reasons for a Low Score (in priority order)
                                              • BEGINNING CHECKLIST
                                              • HYPOTHESIS CHECKLIST
                                              • RESEARCH PLAN - PLANNING CHECKLIST
                                              • RESEARCH PLAN - PROCESS CHECKLIST
                                              • SPECIFIC AIMS CHECKLIST
                                              • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                              • PRELIMINARY DATA CHECKLIST
                                              • DESIGN AND METHODS CHECKLIST
                                              • General
                                              • Approach
                                              • ABSTRACT CHECKLIST
                                              • BIOSKETCHES CHECKLIST
                                              • BUDGET CHECKLIST
                                              • RESOURCES CHECKLIST
                                              • REVISING CHECKLIST

                                      III Developing Your Research Plan

                                      A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

                                      - Your application should be based on a strong hypothesis

                                      - Be sure your project has a coherent direction

                                      - Keep the sections of the plan well coordinated and clearly related to the central focus

                                      - Emphasize mechanism A good grant application asks questions about biological mechanisms

                                      - Dont be overly ambitious your plan should be based on a feasible timetable

                                      - Specific aims and experiments should relate directly to the hypothesis to be tested

                                      A Specific Aims

                                      Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

                                      Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

                                      State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

                                      B Background and Significance

                                      Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

                                      Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

                                      Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                                      Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                                      Identify the next logical stage of research beyond your current application

                                      C Preliminary StudiesProgress Report

                                      By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                                      Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                                      Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                                      Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                                      Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                                      D Research Design and Methods

                                      Describe the experimental design and procedures in detail and give a rationale for their use

                                      Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                                      Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                                      advantageous to the research you propose to do

                                      More and more applicants are including colored charts graphs and photographs in their applications

                                      Approach

                                      State why you chose your approach or approaches as opposed to others

                                      If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                                      Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                                      Consider the limitations of each approach and how it may affect your results and the data generated

                                      Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                                      Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                                      Results

                                      Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                                      Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                                      Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                                      Describe your proposed statistical methods for analyzing the data you plan to collect

                                      Define the criteria for evaluating the success or failure of a specific test

                                      Other pointers

                                      Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                      Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                      Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                      Describe any procedures situations or materials that may be hazardous and precautions you will take

                                      Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                      E Human Subjects

                                      Is it human subject research

                                      Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                      A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                      If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                      If the answer is yes

                                      If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                      This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                      The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                      bull Description of how you will protect subjects from research risks bull Plans to include

                                      Women Children Minorities Analyses capable of showing intervention differences between men and

                                      women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                      Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                      Protection

                                      Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                      bull Identify the characteristics of the study population or sources of research materials

                                      bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                      bull Describe potential benefits to the subjects and mankind

                                      bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                      In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                      Inclusion

                                      Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                      This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                      After your human subjects section start new pages for the following plans

                                      Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                      Put your plans on separate pages they are not included in the page limit

                                      In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                      Monitoring

                                      The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                      NIAID must also approve your monitoring plan see our Terms of award

                                      Reporting

                                      Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                      For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                      Also pay attention to the minority subgroups required for clinical trial reporting

                                      Training

                                      Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                      Certifications and assurances

                                      If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                      Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                      NIAID Special Terms of Award

                                      NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                      Review of Clinical Applications

                                      In addition to the regular review criteria clinical research applications will also be reviewed for

                                      bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                      bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                      bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                      bull Adequacy of the proposed plan to share data if appropriate

                                      Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                      More Human Subjects Links

                                      In addition to the 398 see these sites for more information

                                      Glossary of human subject-related terms including a definition of what constitutes human subject research

                                      Human subjects feature of March 2001 Council News

                                      NIH human subjects reviewer guidance

                                      Also see our Terms of award for NIAID-specific requirements

                                      F Vertebrate Animals

                                      As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                      Your application should include

                                      - A detailed description of the proposed use of the animals

                                      - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                      - Information on the veterinary care of the animals

                                      - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                      - Justification for any euthanasia method to be used

                                      If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                      G Literature Cited

                                      Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                      Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                      Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                      H ConsortiumContractual Arrangements

                                      This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                      The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                      I Consultants

                                      Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                      IV Application Contents Other Than the Research Plan

                                      Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                      Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                      Abstract (Form BB)

                                      Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                      Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                      Title

                                      Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                      Biographical Sketches (Form FF)

                                      This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                      With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                      - Name and title

                                      - Education -- institutions location degree(s) year conferred and field(s) of study

                                      - Roles in other relevant current or past research

                                      - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                      - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                      Budget

                                      Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                      Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                      Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                      Modular grants

                                      NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                      Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                      NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                      Resources

                                      The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                      research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                      V Writing and Formatting

                                      Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                      Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                      Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                      Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                      Page Limitations

                                      Type (font) Size and Spacing

                                      Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                      Font size in figures and tables may be smaller but must be readily legible

                                      Writing Tips

                                      Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                      Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                      Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                      Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                      tables

                                      Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                      VI Submitting Your Grant Application

                                      Receipt Date

                                      NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                      Cover Letter

                                      Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                      Requesting an SRG and InstituteCenter

                                      Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                      You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                      Modular Grants and Applications and Just in Time

                                      The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                      The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                      For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                      VII Problems and Concerns Commonly Cited by Reviewers

                                      Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                      Lack of significance to the scientific issue being addressed

                                      Lack of original or new ideas

                                      Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                      Project too diffuse or superficial or lacks focus

                                      Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                      Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                      Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                      Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                      Lack of alternative methodological approaches in case the primary approach does not work out

                                      Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                      The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                      The proposed experiments do not include all relevant controls

                                      Proposal innovative but lacking enough preliminary data

                                      Preliminary data do not support the feasibility of the project or the hypothesis

                                      Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                      The proposal lacks critical literature references causing reviewers to think that the

                                      applicant either does not know the literature or has purposely neglected critical published material

                                      Not clear which data were obtained by the investigator and which have been reported by others

                                      VIII Referral and Assignment of the Application

                                      When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                      Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                      Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                      To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                      You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                      If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                      IX Review of Research Project Applications

                                      This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                      Scientific Review Groups

                                      Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                      Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                      Review Criteria

                                      In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                      Significance Approach Innovation Investigator Environment

                                      To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                      Cover Letter

                                      Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                      State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                      Administrative Review

                                      Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                      If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                      At the Peer Review Meeting

                                      Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                      Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                      How Priority Scores Are Determined

                                      If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                      Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                      Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                      1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                      2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                      3 Deferred In some instances the scientific review group is unable to make an

                                      adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                      Summary Statements

                                      Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                      Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                      Appeal

                                      You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                      X How Funding Is Decided

                                      Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                      Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                      How Paylines Work

                                      Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                      Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                      Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                      You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                      For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                      Second Level Peer Review

                                      In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                      They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                      Possible Outcomes of Secondary Review

                                      Following Council review NIAID takes one of four actions for an application

                                      1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                      Why Applications Are Kept on Hold

                                      ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                      Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                      XI When You Have Not Obtained Funding

                                      What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                      Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                      Most Common Reasons for a Low Score (in priority order)

                                      - Lack of new or original ideas

                                      - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                      - Methods unsuitable or defective and not likely to yield results

                                      - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                      - Data management and analysis vague unsophisticated

                                      - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                      - Poor resources or facilities limited access to appropriate patient population

                                      From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                      When to Revise

                                      How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                      If the problems are repairable revise the application and resubmit it to the same study section

                                      Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                      - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                      Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                      vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                      If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                      For fatal flaws and weaknesses rethink your idea and start over

                                      Revising Your Application

                                      Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                      Respond to reviewersrsquo comments

                                      The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                      Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                      Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                      additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                      Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                      Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                      If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                      XII When Your Application Is Approved for Funding

                                      If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                      Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                      If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                      There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                      For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                      Documentation

                                      Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                      Human subjects

                                      For more information concerning the human subjects assurance contact OHRP at

                                      Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                      And find a wealth of guidance documents on the Web

                                      Animals in Research

                                      For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                      Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                      Or see the Web site at Office of Laboratory Animal Welfare

                                      What You Can and Cannot Pay for on a Grant

                                      In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                      OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                      For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                      Terms and Conditions of Award

                                      Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                      Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                      NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                      Reporting Requirements

                                      Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                      Address and phone number are

                                      NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                      For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                      Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                      Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                      Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                      Checklists

                                      BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                      HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                      RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                      RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                      rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                      SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                      BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                      PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                      DESIGN AND METHODS CHECKLIST

                                      General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                      Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                      Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                      Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                      ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                      BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                      BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                      Does the PIs salary exceed the government cap of $141300

                                      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                      • howtopdf
                                        • Third Edition amended August 30 2001
                                        • The Original How to Write a Research Grant Application
                                          • I Before You Begin
                                              • If the answer is yes
                                              • Protection
                                              • Inclusion
                                              • Monitoring
                                              • Reporting
                                              • Training
                                              • Certifications and assurances
                                                • Most Common Reasons for a Low Score (in priority order)
                                                • BEGINNING CHECKLIST
                                                • HYPOTHESIS CHECKLIST
                                                • RESEARCH PLAN - PLANNING CHECKLIST
                                                • RESEARCH PLAN - PROCESS CHECKLIST
                                                • SPECIFIC AIMS CHECKLIST
                                                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                • PRELIMINARY DATA CHECKLIST
                                                • DESIGN AND METHODS CHECKLIST
                                                • General
                                                • Approach
                                                • ABSTRACT CHECKLIST
                                                • BIOSKETCHES CHECKLIST
                                                • BUDGET CHECKLIST
                                                • RESOURCES CHECKLIST
                                                • REVISING CHECKLIST

                                        Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

                                        Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

                                        Identify the next logical stage of research beyond your current application

                                        C Preliminary StudiesProgress Report

                                        By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

                                        Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

                                        Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

                                        Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

                                        Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

                                        D Research Design and Methods

                                        Describe the experimental design and procedures in detail and give a rationale for their use

                                        Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

                                        Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

                                        advantageous to the research you propose to do

                                        More and more applicants are including colored charts graphs and photographs in their applications

                                        Approach

                                        State why you chose your approach or approaches as opposed to others

                                        If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                                        Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                                        Consider the limitations of each approach and how it may affect your results and the data generated

                                        Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                                        Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                                        Results

                                        Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                                        Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                                        Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                                        Describe your proposed statistical methods for analyzing the data you plan to collect

                                        Define the criteria for evaluating the success or failure of a specific test

                                        Other pointers

                                        Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                        Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                        Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                        Describe any procedures situations or materials that may be hazardous and precautions you will take

                                        Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                        E Human Subjects

                                        Is it human subject research

                                        Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                        A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                        If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                        If the answer is yes

                                        If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                        This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                        The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                        bull Description of how you will protect subjects from research risks bull Plans to include

                                        Women Children Minorities Analyses capable of showing intervention differences between men and

                                        women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                        Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                        Protection

                                        Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                        bull Identify the characteristics of the study population or sources of research materials

                                        bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                        bull Describe potential benefits to the subjects and mankind

                                        bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                        In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                        Inclusion

                                        Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                        This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                        After your human subjects section start new pages for the following plans

                                        Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                        Put your plans on separate pages they are not included in the page limit

                                        In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                        Monitoring

                                        The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                        NIAID must also approve your monitoring plan see our Terms of award

                                        Reporting

                                        Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                        For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                        Also pay attention to the minority subgroups required for clinical trial reporting

                                        Training

                                        Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                        Certifications and assurances

                                        If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                        Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                        NIAID Special Terms of Award

                                        NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                        Review of Clinical Applications

                                        In addition to the regular review criteria clinical research applications will also be reviewed for

                                        bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                        bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                        bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                        bull Adequacy of the proposed plan to share data if appropriate

                                        Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                        More Human Subjects Links

                                        In addition to the 398 see these sites for more information

                                        Glossary of human subject-related terms including a definition of what constitutes human subject research

                                        Human subjects feature of March 2001 Council News

                                        NIH human subjects reviewer guidance

                                        Also see our Terms of award for NIAID-specific requirements

                                        F Vertebrate Animals

                                        As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                        Your application should include

                                        - A detailed description of the proposed use of the animals

                                        - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                        - Information on the veterinary care of the animals

                                        - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                        - Justification for any euthanasia method to be used

                                        If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                        G Literature Cited

                                        Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                        Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                        Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                        H ConsortiumContractual Arrangements

                                        This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                        The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                        I Consultants

                                        Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                        IV Application Contents Other Than the Research Plan

                                        Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                        Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                        Abstract (Form BB)

                                        Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                        Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                        Title

                                        Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                        Biographical Sketches (Form FF)

                                        This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                        With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                        - Name and title

                                        - Education -- institutions location degree(s) year conferred and field(s) of study

                                        - Roles in other relevant current or past research

                                        - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                        - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                        Budget

                                        Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                        Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                        Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                        Modular grants

                                        NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                        Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                        NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                        Resources

                                        The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                        research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                        V Writing and Formatting

                                        Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                        Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                        Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                        Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                        Page Limitations

                                        Type (font) Size and Spacing

                                        Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                        Font size in figures and tables may be smaller but must be readily legible

                                        Writing Tips

                                        Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                        Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                        Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                        Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                        tables

                                        Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                        VI Submitting Your Grant Application

                                        Receipt Date

                                        NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                        Cover Letter

                                        Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                        Requesting an SRG and InstituteCenter

                                        Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                        You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                        Modular Grants and Applications and Just in Time

                                        The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                        The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                        For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                        VII Problems and Concerns Commonly Cited by Reviewers

                                        Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                        Lack of significance to the scientific issue being addressed

                                        Lack of original or new ideas

                                        Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                        Project too diffuse or superficial or lacks focus

                                        Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                        Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                        Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                        Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                        Lack of alternative methodological approaches in case the primary approach does not work out

                                        Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                        The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                        The proposed experiments do not include all relevant controls

                                        Proposal innovative but lacking enough preliminary data

                                        Preliminary data do not support the feasibility of the project or the hypothesis

                                        Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                        The proposal lacks critical literature references causing reviewers to think that the

                                        applicant either does not know the literature or has purposely neglected critical published material

                                        Not clear which data were obtained by the investigator and which have been reported by others

                                        VIII Referral and Assignment of the Application

                                        When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                        Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                        Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                        To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                        You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                        If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                        IX Review of Research Project Applications

                                        This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                        Scientific Review Groups

                                        Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                        Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                        Review Criteria

                                        In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                        Significance Approach Innovation Investigator Environment

                                        To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                        Cover Letter

                                        Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                        State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                        Administrative Review

                                        Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                        If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                        At the Peer Review Meeting

                                        Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                        Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                        How Priority Scores Are Determined

                                        If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                        Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                        Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                        1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                        2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                        3 Deferred In some instances the scientific review group is unable to make an

                                        adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                        Summary Statements

                                        Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                        Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                        Appeal

                                        You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                        X How Funding Is Decided

                                        Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                        Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                        How Paylines Work

                                        Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                        Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                        Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                        You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                        For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                        Second Level Peer Review

                                        In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                        They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                        Possible Outcomes of Secondary Review

                                        Following Council review NIAID takes one of four actions for an application

                                        1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                        Why Applications Are Kept on Hold

                                        ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                        Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                        XI When You Have Not Obtained Funding

                                        What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                        Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                        Most Common Reasons for a Low Score (in priority order)

                                        - Lack of new or original ideas

                                        - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                        - Methods unsuitable or defective and not likely to yield results

                                        - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                        - Data management and analysis vague unsophisticated

                                        - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                        - Poor resources or facilities limited access to appropriate patient population

                                        From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                        When to Revise

                                        How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                        If the problems are repairable revise the application and resubmit it to the same study section

                                        Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                        - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                        Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                        vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                        If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                        For fatal flaws and weaknesses rethink your idea and start over

                                        Revising Your Application

                                        Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                        Respond to reviewersrsquo comments

                                        The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                        Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                        Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                        additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                        Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                        Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                        If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                        XII When Your Application Is Approved for Funding

                                        If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                        Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                        If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                        There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                        For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                        Documentation

                                        Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                        Human subjects

                                        For more information concerning the human subjects assurance contact OHRP at

                                        Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                        And find a wealth of guidance documents on the Web

                                        Animals in Research

                                        For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                        Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                        Or see the Web site at Office of Laboratory Animal Welfare

                                        What You Can and Cannot Pay for on a Grant

                                        In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                        OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                        For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                        Terms and Conditions of Award

                                        Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                        Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                        NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                        Reporting Requirements

                                        Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                        Address and phone number are

                                        NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                        For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                        Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                        Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                        Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                        Checklists

                                        BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                        HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                        RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                        RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                        rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                        SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                        BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                        PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                        DESIGN AND METHODS CHECKLIST

                                        General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                        Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                        Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                        Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                        ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                        BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                        BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                        Does the PIs salary exceed the government cap of $141300

                                        RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                        WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                        REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                        • howtopdf
                                          • Third Edition amended August 30 2001
                                          • The Original How to Write a Research Grant Application
                                            • I Before You Begin
                                                • If the answer is yes
                                                • Protection
                                                • Inclusion
                                                • Monitoring
                                                • Reporting
                                                • Training
                                                • Certifications and assurances
                                                  • Most Common Reasons for a Low Score (in priority order)
                                                  • BEGINNING CHECKLIST
                                                  • HYPOTHESIS CHECKLIST
                                                  • RESEARCH PLAN - PLANNING CHECKLIST
                                                  • RESEARCH PLAN - PROCESS CHECKLIST
                                                  • SPECIFIC AIMS CHECKLIST
                                                  • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                  • PRELIMINARY DATA CHECKLIST
                                                  • DESIGN AND METHODS CHECKLIST
                                                  • General
                                                  • Approach
                                                  • ABSTRACT CHECKLIST
                                                  • BIOSKETCHES CHECKLIST
                                                  • BUDGET CHECKLIST
                                                  • RESOURCES CHECKLIST
                                                  • REVISING CHECKLIST

                                          advantageous to the research you propose to do

                                          More and more applicants are including colored charts graphs and photographs in their applications

                                          Approach

                                          State why you chose your approach or approaches as opposed to others

                                          If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

                                          Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

                                          Consider the limitations of each approach and how it may affect your results and the data generated

                                          Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

                                          Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

                                          Results

                                          Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

                                          Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

                                          Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

                                          Describe your proposed statistical methods for analyzing the data you plan to collect

                                          Define the criteria for evaluating the success or failure of a specific test

                                          Other pointers

                                          Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                          Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                          Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                          Describe any procedures situations or materials that may be hazardous and precautions you will take

                                          Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                          E Human Subjects

                                          Is it human subject research

                                          Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                          A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                          If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                          If the answer is yes

                                          If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                          This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                          The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                          bull Description of how you will protect subjects from research risks bull Plans to include

                                          Women Children Minorities Analyses capable of showing intervention differences between men and

                                          women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                          Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                          Protection

                                          Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                          bull Identify the characteristics of the study population or sources of research materials

                                          bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                          bull Describe potential benefits to the subjects and mankind

                                          bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                          In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                          Inclusion

                                          Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                          This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                          After your human subjects section start new pages for the following plans

                                          Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                          Put your plans on separate pages they are not included in the page limit

                                          In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                          Monitoring

                                          The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                          NIAID must also approve your monitoring plan see our Terms of award

                                          Reporting

                                          Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                          For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                          Also pay attention to the minority subgroups required for clinical trial reporting

                                          Training

                                          Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                          Certifications and assurances

                                          If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                          Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                          NIAID Special Terms of Award

                                          NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                          Review of Clinical Applications

                                          In addition to the regular review criteria clinical research applications will also be reviewed for

                                          bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                          bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                          bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                          bull Adequacy of the proposed plan to share data if appropriate

                                          Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                          More Human Subjects Links

                                          In addition to the 398 see these sites for more information

                                          Glossary of human subject-related terms including a definition of what constitutes human subject research

                                          Human subjects feature of March 2001 Council News

                                          NIH human subjects reviewer guidance

                                          Also see our Terms of award for NIAID-specific requirements

                                          F Vertebrate Animals

                                          As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                          Your application should include

                                          - A detailed description of the proposed use of the animals

                                          - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                          - Information on the veterinary care of the animals

                                          - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                          - Justification for any euthanasia method to be used

                                          If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                          G Literature Cited

                                          Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                          Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                          Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                          H ConsortiumContractual Arrangements

                                          This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                          The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                          I Consultants

                                          Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                          IV Application Contents Other Than the Research Plan

                                          Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                          Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                          Abstract (Form BB)

                                          Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                          Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                          Title

                                          Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                          Biographical Sketches (Form FF)

                                          This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                          With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                          - Name and title

                                          - Education -- institutions location degree(s) year conferred and field(s) of study

                                          - Roles in other relevant current or past research

                                          - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                          - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                          Budget

                                          Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                          Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                          Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                          Modular grants

                                          NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                          Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                          NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                          Resources

                                          The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                          research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                          V Writing and Formatting

                                          Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                          Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                          Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                          Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                          Page Limitations

                                          Type (font) Size and Spacing

                                          Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                          Font size in figures and tables may be smaller but must be readily legible

                                          Writing Tips

                                          Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                          Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                          Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                          Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                          tables

                                          Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                          VI Submitting Your Grant Application

                                          Receipt Date

                                          NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                          Cover Letter

                                          Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                          Requesting an SRG and InstituteCenter

                                          Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                          You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                          Modular Grants and Applications and Just in Time

                                          The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                          The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                          For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                          VII Problems and Concerns Commonly Cited by Reviewers

                                          Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                          Lack of significance to the scientific issue being addressed

                                          Lack of original or new ideas

                                          Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                          Project too diffuse or superficial or lacks focus

                                          Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                          Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                          Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                          Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                          Lack of alternative methodological approaches in case the primary approach does not work out

                                          Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                          The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                          The proposed experiments do not include all relevant controls

                                          Proposal innovative but lacking enough preliminary data

                                          Preliminary data do not support the feasibility of the project or the hypothesis

                                          Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                          The proposal lacks critical literature references causing reviewers to think that the

                                          applicant either does not know the literature or has purposely neglected critical published material

                                          Not clear which data were obtained by the investigator and which have been reported by others

                                          VIII Referral and Assignment of the Application

                                          When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                          Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                          Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                          To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                          You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                          If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                          IX Review of Research Project Applications

                                          This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                          Scientific Review Groups

                                          Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                          Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                          Review Criteria

                                          In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                          Significance Approach Innovation Investigator Environment

                                          To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                          Cover Letter

                                          Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                          State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                          Administrative Review

                                          Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                          If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                          At the Peer Review Meeting

                                          Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                          Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                          How Priority Scores Are Determined

                                          If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                          Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                          Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                          1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                          2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                          3 Deferred In some instances the scientific review group is unable to make an

                                          adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                          Summary Statements

                                          Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                          Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                          Appeal

                                          You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                          X How Funding Is Decided

                                          Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                          Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                          How Paylines Work

                                          Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                          Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                          Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                          You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                          For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                          Second Level Peer Review

                                          In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                          They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                          Possible Outcomes of Secondary Review

                                          Following Council review NIAID takes one of four actions for an application

                                          1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                          Why Applications Are Kept on Hold

                                          ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                          Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                          XI When You Have Not Obtained Funding

                                          What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                          Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                          Most Common Reasons for a Low Score (in priority order)

                                          - Lack of new or original ideas

                                          - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                          - Methods unsuitable or defective and not likely to yield results

                                          - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                          - Data management and analysis vague unsophisticated

                                          - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                          - Poor resources or facilities limited access to appropriate patient population

                                          From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                          When to Revise

                                          How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                          If the problems are repairable revise the application and resubmit it to the same study section

                                          Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                          - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                          Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                          vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                          If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                          For fatal flaws and weaknesses rethink your idea and start over

                                          Revising Your Application

                                          Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                          Respond to reviewersrsquo comments

                                          The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                          Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                          Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                          additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                          Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                          Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                          If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                          XII When Your Application Is Approved for Funding

                                          If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                          Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                          If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                          There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                          For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                          Documentation

                                          Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                          Human subjects

                                          For more information concerning the human subjects assurance contact OHRP at

                                          Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                          And find a wealth of guidance documents on the Web

                                          Animals in Research

                                          For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                          Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                          Or see the Web site at Office of Laboratory Animal Welfare

                                          What You Can and Cannot Pay for on a Grant

                                          In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                          OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                          For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                          Terms and Conditions of Award

                                          Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                          Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                          NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                          Reporting Requirements

                                          Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                          Address and phone number are

                                          NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                          For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                          Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                          Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                          Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                          Checklists

                                          BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                          HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                          RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                          RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                          rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                          SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                          BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                          PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                          DESIGN AND METHODS CHECKLIST

                                          General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                          Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                          Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                          Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                          ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                          BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                          BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                          Does the PIs salary exceed the government cap of $141300

                                          RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                          WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                          REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                          • howtopdf
                                            • Third Edition amended August 30 2001
                                            • The Original How to Write a Research Grant Application
                                              • I Before You Begin
                                                  • If the answer is yes
                                                  • Protection
                                                  • Inclusion
                                                  • Monitoring
                                                  • Reporting
                                                  • Training
                                                  • Certifications and assurances
                                                    • Most Common Reasons for a Low Score (in priority order)
                                                    • BEGINNING CHECKLIST
                                                    • HYPOTHESIS CHECKLIST
                                                    • RESEARCH PLAN - PLANNING CHECKLIST
                                                    • RESEARCH PLAN - PROCESS CHECKLIST
                                                    • SPECIFIC AIMS CHECKLIST
                                                    • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                    • PRELIMINARY DATA CHECKLIST
                                                    • DESIGN AND METHODS CHECKLIST
                                                    • General
                                                    • Approach
                                                    • ABSTRACT CHECKLIST
                                                    • BIOSKETCHES CHECKLIST
                                                    • BUDGET CHECKLIST
                                                    • RESOURCES CHECKLIST
                                                    • REVISING CHECKLIST

                                            Other pointers

                                            Read the PHS 398 carefully for specific requirements especially those involving human subjects

                                            Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

                                            Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

                                            Describe any procedures situations or materials that may be hazardous and precautions you will take

                                            Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

                                            E Human Subjects

                                            Is it human subject research

                                            Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

                                            A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

                                            If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

                                            If the answer is yes

                                            If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

                                            This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                            The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                            bull Description of how you will protect subjects from research risks bull Plans to include

                                            Women Children Minorities Analyses capable of showing intervention differences between men and

                                            women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                            Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                            Protection

                                            Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                            bull Identify the characteristics of the study population or sources of research materials

                                            bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                            bull Describe potential benefits to the subjects and mankind

                                            bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                            In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                            Inclusion

                                            Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                            This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                            After your human subjects section start new pages for the following plans

                                            Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                            Put your plans on separate pages they are not included in the page limit

                                            In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                            Monitoring

                                            The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                            NIAID must also approve your monitoring plan see our Terms of award

                                            Reporting

                                            Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                            For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                            Also pay attention to the minority subgroups required for clinical trial reporting

                                            Training

                                            Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                            Certifications and assurances

                                            If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                            Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                            NIAID Special Terms of Award

                                            NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                            Review of Clinical Applications

                                            In addition to the regular review criteria clinical research applications will also be reviewed for

                                            bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                            bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                            bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                            bull Adequacy of the proposed plan to share data if appropriate

                                            Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                            More Human Subjects Links

                                            In addition to the 398 see these sites for more information

                                            Glossary of human subject-related terms including a definition of what constitutes human subject research

                                            Human subjects feature of March 2001 Council News

                                            NIH human subjects reviewer guidance

                                            Also see our Terms of award for NIAID-specific requirements

                                            F Vertebrate Animals

                                            As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                            Your application should include

                                            - A detailed description of the proposed use of the animals

                                            - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                            - Information on the veterinary care of the animals

                                            - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                            - Justification for any euthanasia method to be used

                                            If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                            G Literature Cited

                                            Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                            Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                            Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                            H ConsortiumContractual Arrangements

                                            This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                            The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                            I Consultants

                                            Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                            IV Application Contents Other Than the Research Plan

                                            Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                            Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                            Abstract (Form BB)

                                            Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                            Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                            Title

                                            Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                            Biographical Sketches (Form FF)

                                            This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                            With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                            - Name and title

                                            - Education -- institutions location degree(s) year conferred and field(s) of study

                                            - Roles in other relevant current or past research

                                            - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                            - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                            Budget

                                            Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                            Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                            Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                            Modular grants

                                            NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                            Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                            NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                            Resources

                                            The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                            research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                            V Writing and Formatting

                                            Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                            Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                            Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                            Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                            Page Limitations

                                            Type (font) Size and Spacing

                                            Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                            Font size in figures and tables may be smaller but must be readily legible

                                            Writing Tips

                                            Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                            Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                            Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                            Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                            tables

                                            Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                            VI Submitting Your Grant Application

                                            Receipt Date

                                            NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                            Cover Letter

                                            Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                            Requesting an SRG and InstituteCenter

                                            Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                            You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                            Modular Grants and Applications and Just in Time

                                            The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                            The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                            For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                            VII Problems and Concerns Commonly Cited by Reviewers

                                            Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                            Lack of significance to the scientific issue being addressed

                                            Lack of original or new ideas

                                            Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                            Project too diffuse or superficial or lacks focus

                                            Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                            Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                            Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                            Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                            Lack of alternative methodological approaches in case the primary approach does not work out

                                            Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                            The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                            The proposed experiments do not include all relevant controls

                                            Proposal innovative but lacking enough preliminary data

                                            Preliminary data do not support the feasibility of the project or the hypothesis

                                            Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                            The proposal lacks critical literature references causing reviewers to think that the

                                            applicant either does not know the literature or has purposely neglected critical published material

                                            Not clear which data were obtained by the investigator and which have been reported by others

                                            VIII Referral and Assignment of the Application

                                            When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                            Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                            Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                            To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                            You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                            If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                            IX Review of Research Project Applications

                                            This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                            Scientific Review Groups

                                            Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                            Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                            Review Criteria

                                            In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                            Significance Approach Innovation Investigator Environment

                                            To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                            Cover Letter

                                            Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                            State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                            Administrative Review

                                            Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                            If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                            At the Peer Review Meeting

                                            Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                            Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                            How Priority Scores Are Determined

                                            If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                            Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                            Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                            1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                            2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                            3 Deferred In some instances the scientific review group is unable to make an

                                            adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                            Summary Statements

                                            Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                            Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                            Appeal

                                            You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                            X How Funding Is Decided

                                            Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                            Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                            How Paylines Work

                                            Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                            Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                            Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                            You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                            For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                            Second Level Peer Review

                                            In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                            They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                            Possible Outcomes of Secondary Review

                                            Following Council review NIAID takes one of four actions for an application

                                            1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                            Why Applications Are Kept on Hold

                                            ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                            Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                            XI When You Have Not Obtained Funding

                                            What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                            Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                            Most Common Reasons for a Low Score (in priority order)

                                            - Lack of new or original ideas

                                            - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                            - Methods unsuitable or defective and not likely to yield results

                                            - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                            - Data management and analysis vague unsophisticated

                                            - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                            - Poor resources or facilities limited access to appropriate patient population

                                            From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                            When to Revise

                                            How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                            If the problems are repairable revise the application and resubmit it to the same study section

                                            Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                            - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                            Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                            vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                            If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                            For fatal flaws and weaknesses rethink your idea and start over

                                            Revising Your Application

                                            Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                            Respond to reviewersrsquo comments

                                            The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                            Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                            Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                            additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                            Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                            Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                            If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                            XII When Your Application Is Approved for Funding

                                            If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                            Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                            If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                            There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                            For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                            Documentation

                                            Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                            Human subjects

                                            For more information concerning the human subjects assurance contact OHRP at

                                            Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                            And find a wealth of guidance documents on the Web

                                            Animals in Research

                                            For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                            Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                            Or see the Web site at Office of Laboratory Animal Welfare

                                            What You Can and Cannot Pay for on a Grant

                                            In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                            OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                            For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                            Terms and Conditions of Award

                                            Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                            Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                            NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                            Reporting Requirements

                                            Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                            Address and phone number are

                                            NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                            For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                            Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                            Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                            Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                            Checklists

                                            BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                            HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                            RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                            RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                            rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                            SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                            BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                            PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                            DESIGN AND METHODS CHECKLIST

                                            General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                            Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                            Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                            Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                            ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                            BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                            BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                            Does the PIs salary exceed the government cap of $141300

                                            RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                            WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                            REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                            • howtopdf
                                              • Third Edition amended August 30 2001
                                              • The Original How to Write a Research Grant Application
                                                • I Before You Begin
                                                    • If the answer is yes
                                                    • Protection
                                                    • Inclusion
                                                    • Monitoring
                                                    • Reporting
                                                    • Training
                                                    • Certifications and assurances
                                                      • Most Common Reasons for a Low Score (in priority order)
                                                      • BEGINNING CHECKLIST
                                                      • HYPOTHESIS CHECKLIST
                                                      • RESEARCH PLAN - PLANNING CHECKLIST
                                                      • RESEARCH PLAN - PROCESS CHECKLIST
                                                      • SPECIFIC AIMS CHECKLIST
                                                      • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                      • PRELIMINARY DATA CHECKLIST
                                                      • DESIGN AND METHODS CHECKLIST
                                                      • General
                                                      • Approach
                                                      • ABSTRACT CHECKLIST
                                                      • BIOSKETCHES CHECKLIST
                                                      • BUDGET CHECKLIST
                                                      • RESOURCES CHECKLIST
                                                      • REVISING CHECKLIST

                                              This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

                                              The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

                                              bull Description of how you will protect subjects from research risks bull Plans to include

                                              Women Children Minorities Analyses capable of showing intervention differences between men and

                                              women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

                                              Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

                                              Protection

                                              Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

                                              bull Identify the characteristics of the study population or sources of research materials

                                              bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

                                              bull Describe potential benefits to the subjects and mankind

                                              bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

                                              In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

                                              Inclusion

                                              Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

                                              This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                              After your human subjects section start new pages for the following plans

                                              Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                              Put your plans on separate pages they are not included in the page limit

                                              In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                              Monitoring

                                              The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                              NIAID must also approve your monitoring plan see our Terms of award

                                              Reporting

                                              Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                              For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                              Also pay attention to the minority subgroups required for clinical trial reporting

                                              Training

                                              Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                              Certifications and assurances

                                              If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                              Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                              NIAID Special Terms of Award

                                              NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                              Review of Clinical Applications

                                              In addition to the regular review criteria clinical research applications will also be reviewed for

                                              bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                              bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                              bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                              bull Adequacy of the proposed plan to share data if appropriate

                                              Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                              More Human Subjects Links

                                              In addition to the 398 see these sites for more information

                                              Glossary of human subject-related terms including a definition of what constitutes human subject research

                                              Human subjects feature of March 2001 Council News

                                              NIH human subjects reviewer guidance

                                              Also see our Terms of award for NIAID-specific requirements

                                              F Vertebrate Animals

                                              As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                              Your application should include

                                              - A detailed description of the proposed use of the animals

                                              - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                              - Information on the veterinary care of the animals

                                              - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                              - Justification for any euthanasia method to be used

                                              If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                              G Literature Cited

                                              Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                              Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                              Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                              H ConsortiumContractual Arrangements

                                              This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                              The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                              I Consultants

                                              Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                              IV Application Contents Other Than the Research Plan

                                              Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                              Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                              Abstract (Form BB)

                                              Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                              Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                              Title

                                              Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                              Biographical Sketches (Form FF)

                                              This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                              With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                              - Name and title

                                              - Education -- institutions location degree(s) year conferred and field(s) of study

                                              - Roles in other relevant current or past research

                                              - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                              - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                              Budget

                                              Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                              Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                              Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                              Modular grants

                                              NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                              Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                              NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                              Resources

                                              The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                              research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                              V Writing and Formatting

                                              Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                              Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                              Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                              Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                              Page Limitations

                                              Type (font) Size and Spacing

                                              Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                              Font size in figures and tables may be smaller but must be readily legible

                                              Writing Tips

                                              Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                              Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                              Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                              Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                              tables

                                              Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                              VI Submitting Your Grant Application

                                              Receipt Date

                                              NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                              Cover Letter

                                              Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                              Requesting an SRG and InstituteCenter

                                              Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                              You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                              Modular Grants and Applications and Just in Time

                                              The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                              The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                              For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                              VII Problems and Concerns Commonly Cited by Reviewers

                                              Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                              Lack of significance to the scientific issue being addressed

                                              Lack of original or new ideas

                                              Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                              Project too diffuse or superficial or lacks focus

                                              Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                              Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                              Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                              Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                              Lack of alternative methodological approaches in case the primary approach does not work out

                                              Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                              The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                              The proposed experiments do not include all relevant controls

                                              Proposal innovative but lacking enough preliminary data

                                              Preliminary data do not support the feasibility of the project or the hypothesis

                                              Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                              The proposal lacks critical literature references causing reviewers to think that the

                                              applicant either does not know the literature or has purposely neglected critical published material

                                              Not clear which data were obtained by the investigator and which have been reported by others

                                              VIII Referral and Assignment of the Application

                                              When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                              Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                              Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                              To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                              You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                              If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                              IX Review of Research Project Applications

                                              This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                              Scientific Review Groups

                                              Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                              Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                              Review Criteria

                                              In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                              Significance Approach Innovation Investigator Environment

                                              To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                              Cover Letter

                                              Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                              State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                              Administrative Review

                                              Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                              If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                              At the Peer Review Meeting

                                              Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                              Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                              How Priority Scores Are Determined

                                              If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                              Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                              Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                              1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                              2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                              3 Deferred In some instances the scientific review group is unable to make an

                                              adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                              Summary Statements

                                              Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                              Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                              Appeal

                                              You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                              X How Funding Is Decided

                                              Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                              Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                              How Paylines Work

                                              Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                              Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                              Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                              You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                              For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                              Second Level Peer Review

                                              In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                              They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                              Possible Outcomes of Secondary Review

                                              Following Council review NIAID takes one of four actions for an application

                                              1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                              Why Applications Are Kept on Hold

                                              ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                              Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                              XI When You Have Not Obtained Funding

                                              What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                              Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                              Most Common Reasons for a Low Score (in priority order)

                                              - Lack of new or original ideas

                                              - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                              - Methods unsuitable or defective and not likely to yield results

                                              - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                              - Data management and analysis vague unsophisticated

                                              - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                              - Poor resources or facilities limited access to appropriate patient population

                                              From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                              When to Revise

                                              How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                              If the problems are repairable revise the application and resubmit it to the same study section

                                              Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                              - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                              Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                              vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                              If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                              For fatal flaws and weaknesses rethink your idea and start over

                                              Revising Your Application

                                              Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                              Respond to reviewersrsquo comments

                                              The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                              Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                              Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                              additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                              Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                              Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                              If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                              XII When Your Application Is Approved for Funding

                                              If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                              Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                              If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                              There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                              For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                              Documentation

                                              Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                              Human subjects

                                              For more information concerning the human subjects assurance contact OHRP at

                                              Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                              And find a wealth of guidance documents on the Web

                                              Animals in Research

                                              For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                              Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                              Or see the Web site at Office of Laboratory Animal Welfare

                                              What You Can and Cannot Pay for on a Grant

                                              In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                              OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                              For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                              Terms and Conditions of Award

                                              Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                              Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                              NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                              Reporting Requirements

                                              Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                              Address and phone number are

                                              NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                              For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                              Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                              Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                              Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                              Checklists

                                              BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                              HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                              RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                              RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                              rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                              SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                              BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                              PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                              DESIGN AND METHODS CHECKLIST

                                              General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                              Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                              Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                              Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                              ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                              BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                              BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                              Does the PIs salary exceed the government cap of $141300

                                              RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                              WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                              REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                              • howtopdf
                                                • Third Edition amended August 30 2001
                                                • The Original How to Write a Research Grant Application
                                                  • I Before You Begin
                                                      • If the answer is yes
                                                      • Protection
                                                      • Inclusion
                                                      • Monitoring
                                                      • Reporting
                                                      • Training
                                                      • Certifications and assurances
                                                        • Most Common Reasons for a Low Score (in priority order)
                                                        • BEGINNING CHECKLIST
                                                        • HYPOTHESIS CHECKLIST
                                                        • RESEARCH PLAN - PLANNING CHECKLIST
                                                        • RESEARCH PLAN - PROCESS CHECKLIST
                                                        • SPECIFIC AIMS CHECKLIST
                                                        • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                        • PRELIMINARY DATA CHECKLIST
                                                        • DESIGN AND METHODS CHECKLIST
                                                        • General
                                                        • Approach
                                                        • ABSTRACT CHECKLIST
                                                        • BIOSKETCHES CHECKLIST
                                                        • BUDGET CHECKLIST
                                                        • RESOURCES CHECKLIST
                                                        • REVISING CHECKLIST

                                                This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

                                                After your human subjects section start new pages for the following plans

                                                Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

                                                Put your plans on separate pages they are not included in the page limit

                                                In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

                                                Monitoring

                                                The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

                                                NIAID must also approve your monitoring plan see our Terms of award

                                                Reporting

                                                Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

                                                For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

                                                Also pay attention to the minority subgroups required for clinical trial reporting

                                                Training

                                                Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

                                                Certifications and assurances

                                                If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                                Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                                NIAID Special Terms of Award

                                                NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                                Review of Clinical Applications

                                                In addition to the regular review criteria clinical research applications will also be reviewed for

                                                bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                                bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                                bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                                bull Adequacy of the proposed plan to share data if appropriate

                                                Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                                More Human Subjects Links

                                                In addition to the 398 see these sites for more information

                                                Glossary of human subject-related terms including a definition of what constitutes human subject research

                                                Human subjects feature of March 2001 Council News

                                                NIH human subjects reviewer guidance

                                                Also see our Terms of award for NIAID-specific requirements

                                                F Vertebrate Animals

                                                As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                                Your application should include

                                                - A detailed description of the proposed use of the animals

                                                - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                                - Information on the veterinary care of the animals

                                                - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                                - Justification for any euthanasia method to be used

                                                If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                                G Literature Cited

                                                Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                                Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                                Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                                H ConsortiumContractual Arrangements

                                                This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                                The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                                I Consultants

                                                Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                                IV Application Contents Other Than the Research Plan

                                                Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                                Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                                Abstract (Form BB)

                                                Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                                Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                                Title

                                                Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                                Biographical Sketches (Form FF)

                                                This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                                With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                                - Name and title

                                                - Education -- institutions location degree(s) year conferred and field(s) of study

                                                - Roles in other relevant current or past research

                                                - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                                - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                                Budget

                                                Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                                Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                                Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                                Modular grants

                                                NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                                Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                                NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                                Resources

                                                The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                                research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                V Writing and Formatting

                                                Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                Page Limitations

                                                Type (font) Size and Spacing

                                                Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                Font size in figures and tables may be smaller but must be readily legible

                                                Writing Tips

                                                Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                tables

                                                Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                VI Submitting Your Grant Application

                                                Receipt Date

                                                NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                Cover Letter

                                                Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                Requesting an SRG and InstituteCenter

                                                Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                Modular Grants and Applications and Just in Time

                                                The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                VII Problems and Concerns Commonly Cited by Reviewers

                                                Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                Lack of significance to the scientific issue being addressed

                                                Lack of original or new ideas

                                                Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                Project too diffuse or superficial or lacks focus

                                                Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                Lack of alternative methodological approaches in case the primary approach does not work out

                                                Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                The proposed experiments do not include all relevant controls

                                                Proposal innovative but lacking enough preliminary data

                                                Preliminary data do not support the feasibility of the project or the hypothesis

                                                Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                The proposal lacks critical literature references causing reviewers to think that the

                                                applicant either does not know the literature or has purposely neglected critical published material

                                                Not clear which data were obtained by the investigator and which have been reported by others

                                                VIII Referral and Assignment of the Application

                                                When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                IX Review of Research Project Applications

                                                This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                Scientific Review Groups

                                                Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                Review Criteria

                                                In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                Significance Approach Innovation Investigator Environment

                                                To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                Cover Letter

                                                Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                Administrative Review

                                                Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                At the Peer Review Meeting

                                                Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                How Priority Scores Are Determined

                                                If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                3 Deferred In some instances the scientific review group is unable to make an

                                                adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                Summary Statements

                                                Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                Appeal

                                                You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                X How Funding Is Decided

                                                Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                How Paylines Work

                                                Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                Second Level Peer Review

                                                In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                Possible Outcomes of Secondary Review

                                                Following Council review NIAID takes one of four actions for an application

                                                1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                Why Applications Are Kept on Hold

                                                ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                XI When You Have Not Obtained Funding

                                                What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                Most Common Reasons for a Low Score (in priority order)

                                                - Lack of new or original ideas

                                                - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                - Methods unsuitable or defective and not likely to yield results

                                                - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                - Data management and analysis vague unsophisticated

                                                - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                - Poor resources or facilities limited access to appropriate patient population

                                                From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                When to Revise

                                                How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                If the problems are repairable revise the application and resubmit it to the same study section

                                                Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                For fatal flaws and weaknesses rethink your idea and start over

                                                Revising Your Application

                                                Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                Respond to reviewersrsquo comments

                                                The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                XII When Your Application Is Approved for Funding

                                                If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                Documentation

                                                Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                Human subjects

                                                For more information concerning the human subjects assurance contact OHRP at

                                                Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                And find a wealth of guidance documents on the Web

                                                Animals in Research

                                                For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                Or see the Web site at Office of Laboratory Animal Welfare

                                                What You Can and Cannot Pay for on a Grant

                                                In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                Terms and Conditions of Award

                                                Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                Reporting Requirements

                                                Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                Address and phone number are

                                                NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                Checklists

                                                BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                DESIGN AND METHODS CHECKLIST

                                                General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                Does the PIs salary exceed the government cap of $141300

                                                RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                • howtopdf
                                                  • Third Edition amended August 30 2001
                                                  • The Original How to Write a Research Grant Application
                                                    • I Before You Begin
                                                        • If the answer is yes
                                                        • Protection
                                                        • Inclusion
                                                        • Monitoring
                                                        • Reporting
                                                        • Training
                                                        • Certifications and assurances
                                                          • Most Common Reasons for a Low Score (in priority order)
                                                          • BEGINNING CHECKLIST
                                                          • HYPOTHESIS CHECKLIST
                                                          • RESEARCH PLAN - PLANNING CHECKLIST
                                                          • RESEARCH PLAN - PROCESS CHECKLIST
                                                          • SPECIFIC AIMS CHECKLIST
                                                          • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                          • PRELIMINARY DATA CHECKLIST
                                                          • DESIGN AND METHODS CHECKLIST
                                                          • General
                                                          • Approach
                                                          • ABSTRACT CHECKLIST
                                                          • BIOSKETCHES CHECKLIST
                                                          • BUDGET CHECKLIST
                                                          • RESOURCES CHECKLIST
                                                          • REVISING CHECKLIST

                                                  Certifications and assurances

                                                  If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

                                                  Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

                                                  NIAID Special Terms of Award

                                                  NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

                                                  Review of Clinical Applications

                                                  In addition to the regular review criteria clinical research applications will also be reviewed for

                                                  bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

                                                  bull Reasonableness of the proposed budget and duration in relation to the proposed research

                                                  bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

                                                  bull Adequacy of the proposed plan to share data if appropriate

                                                  Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

                                                  More Human Subjects Links

                                                  In addition to the 398 see these sites for more information

                                                  Glossary of human subject-related terms including a definition of what constitutes human subject research

                                                  Human subjects feature of March 2001 Council News

                                                  NIH human subjects reviewer guidance

                                                  Also see our Terms of award for NIAID-specific requirements

                                                  F Vertebrate Animals

                                                  As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                                  Your application should include

                                                  - A detailed description of the proposed use of the animals

                                                  - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                                  - Information on the veterinary care of the animals

                                                  - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                                  - Justification for any euthanasia method to be used

                                                  If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                                  G Literature Cited

                                                  Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                                  Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                                  Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                                  H ConsortiumContractual Arrangements

                                                  This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                                  The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                                  I Consultants

                                                  Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                                  IV Application Contents Other Than the Research Plan

                                                  Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                                  Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                                  Abstract (Form BB)

                                                  Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                                  Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                                  Title

                                                  Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                                  Biographical Sketches (Form FF)

                                                  This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                                  With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                                  - Name and title

                                                  - Education -- institutions location degree(s) year conferred and field(s) of study

                                                  - Roles in other relevant current or past research

                                                  - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                                  - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                                  Budget

                                                  Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                                  Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                                  Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                                  Modular grants

                                                  NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                                  Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                                  NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                                  Resources

                                                  The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                                  research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                  V Writing and Formatting

                                                  Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                  Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                  Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                  Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                  Page Limitations

                                                  Type (font) Size and Spacing

                                                  Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                  Font size in figures and tables may be smaller but must be readily legible

                                                  Writing Tips

                                                  Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                  Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                  Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                  Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                  tables

                                                  Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                  VI Submitting Your Grant Application

                                                  Receipt Date

                                                  NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                  Cover Letter

                                                  Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                  Requesting an SRG and InstituteCenter

                                                  Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                  You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                  Modular Grants and Applications and Just in Time

                                                  The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                  The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                  For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                  VII Problems and Concerns Commonly Cited by Reviewers

                                                  Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                  Lack of significance to the scientific issue being addressed

                                                  Lack of original or new ideas

                                                  Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                  Project too diffuse or superficial or lacks focus

                                                  Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                  Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                  Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                  Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                  Lack of alternative methodological approaches in case the primary approach does not work out

                                                  Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                  The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                  The proposed experiments do not include all relevant controls

                                                  Proposal innovative but lacking enough preliminary data

                                                  Preliminary data do not support the feasibility of the project or the hypothesis

                                                  Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                  The proposal lacks critical literature references causing reviewers to think that the

                                                  applicant either does not know the literature or has purposely neglected critical published material

                                                  Not clear which data were obtained by the investigator and which have been reported by others

                                                  VIII Referral and Assignment of the Application

                                                  When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                  Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                  Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                  To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                  You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                  If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                  IX Review of Research Project Applications

                                                  This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                  Scientific Review Groups

                                                  Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                  Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                  Review Criteria

                                                  In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                  Significance Approach Innovation Investigator Environment

                                                  To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                  Cover Letter

                                                  Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                  State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                  Administrative Review

                                                  Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                  If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                  At the Peer Review Meeting

                                                  Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                  Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                  How Priority Scores Are Determined

                                                  If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                  Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                  Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                  1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                  2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                  3 Deferred In some instances the scientific review group is unable to make an

                                                  adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                  Summary Statements

                                                  Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                  Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                  Appeal

                                                  You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                  X How Funding Is Decided

                                                  Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                  Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                  How Paylines Work

                                                  Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                  Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                  Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                  You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                  For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                  Second Level Peer Review

                                                  In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                  They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                  Possible Outcomes of Secondary Review

                                                  Following Council review NIAID takes one of four actions for an application

                                                  1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                  Why Applications Are Kept on Hold

                                                  ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                  Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                  XI When You Have Not Obtained Funding

                                                  What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                  Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                  Most Common Reasons for a Low Score (in priority order)

                                                  - Lack of new or original ideas

                                                  - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                  - Methods unsuitable or defective and not likely to yield results

                                                  - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                  - Data management and analysis vague unsophisticated

                                                  - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                  - Poor resources or facilities limited access to appropriate patient population

                                                  From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                  When to Revise

                                                  How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                  If the problems are repairable revise the application and resubmit it to the same study section

                                                  Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                  - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                  Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                  vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                  If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                  For fatal flaws and weaknesses rethink your idea and start over

                                                  Revising Your Application

                                                  Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                  Respond to reviewersrsquo comments

                                                  The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                  Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                  Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                  additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                  Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                  Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                  If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                  XII When Your Application Is Approved for Funding

                                                  If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                  Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                  If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                  There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                  For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                  Documentation

                                                  Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                  Human subjects

                                                  For more information concerning the human subjects assurance contact OHRP at

                                                  Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                  And find a wealth of guidance documents on the Web

                                                  Animals in Research

                                                  For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                  Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                  Or see the Web site at Office of Laboratory Animal Welfare

                                                  What You Can and Cannot Pay for on a Grant

                                                  In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                  OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                  For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                  Terms and Conditions of Award

                                                  Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                  Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                  NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                  Reporting Requirements

                                                  Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                  Address and phone number are

                                                  NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                  For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                  Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                  Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                  Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                  Checklists

                                                  BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                  HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                  RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                  RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                  rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                  SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                  BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                  PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                  DESIGN AND METHODS CHECKLIST

                                                  General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                  Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                  Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                  Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                  ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                  BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                  BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                  Does the PIs salary exceed the government cap of $141300

                                                  RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                  WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                  REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                  • howtopdf
                                                    • Third Edition amended August 30 2001
                                                    • The Original How to Write a Research Grant Application
                                                      • I Before You Begin
                                                          • If the answer is yes
                                                          • Protection
                                                          • Inclusion
                                                          • Monitoring
                                                          • Reporting
                                                          • Training
                                                          • Certifications and assurances
                                                            • Most Common Reasons for a Low Score (in priority order)
                                                            • BEGINNING CHECKLIST
                                                            • HYPOTHESIS CHECKLIST
                                                            • RESEARCH PLAN - PLANNING CHECKLIST
                                                            • RESEARCH PLAN - PROCESS CHECKLIST
                                                            • SPECIFIC AIMS CHECKLIST
                                                            • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                            • PRELIMINARY DATA CHECKLIST
                                                            • DESIGN AND METHODS CHECKLIST
                                                            • General
                                                            • Approach
                                                            • ABSTRACT CHECKLIST
                                                            • BIOSKETCHES CHECKLIST
                                                            • BUDGET CHECKLIST
                                                            • RESOURCES CHECKLIST
                                                            • REVISING CHECKLIST

                                                    NIH human subjects reviewer guidance

                                                    Also see our Terms of award for NIAID-specific requirements

                                                    F Vertebrate Animals

                                                    As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

                                                    Your application should include

                                                    - A detailed description of the proposed use of the animals

                                                    - A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

                                                    - Information on the veterinary care of the animals

                                                    - An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

                                                    - Justification for any euthanasia method to be used

                                                    If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

                                                    G Literature Cited

                                                    Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

                                                    Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

                                                    Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

                                                    H ConsortiumContractual Arrangements

                                                    This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                                    The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                                    I Consultants

                                                    Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                                    IV Application Contents Other Than the Research Plan

                                                    Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                                    Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                                    Abstract (Form BB)

                                                    Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                                    Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                                    Title

                                                    Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                                    Biographical Sketches (Form FF)

                                                    This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                                    With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                                    - Name and title

                                                    - Education -- institutions location degree(s) year conferred and field(s) of study

                                                    - Roles in other relevant current or past research

                                                    - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                                    - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                                    Budget

                                                    Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                                    Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                                    Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                                    Modular grants

                                                    NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                                    Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                                    NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                                    Resources

                                                    The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                                    research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                    V Writing and Formatting

                                                    Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                    Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                    Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                    Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                    Page Limitations

                                                    Type (font) Size and Spacing

                                                    Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                    Font size in figures and tables may be smaller but must be readily legible

                                                    Writing Tips

                                                    Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                    Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                    Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                    Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                    tables

                                                    Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                    VI Submitting Your Grant Application

                                                    Receipt Date

                                                    NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                    Cover Letter

                                                    Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                    Requesting an SRG and InstituteCenter

                                                    Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                    You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                    Modular Grants and Applications and Just in Time

                                                    The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                    The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                    For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                    VII Problems and Concerns Commonly Cited by Reviewers

                                                    Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                    Lack of significance to the scientific issue being addressed

                                                    Lack of original or new ideas

                                                    Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                    Project too diffuse or superficial or lacks focus

                                                    Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                    Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                    Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                    Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                    Lack of alternative methodological approaches in case the primary approach does not work out

                                                    Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                    The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                    The proposed experiments do not include all relevant controls

                                                    Proposal innovative but lacking enough preliminary data

                                                    Preliminary data do not support the feasibility of the project or the hypothesis

                                                    Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                    The proposal lacks critical literature references causing reviewers to think that the

                                                    applicant either does not know the literature or has purposely neglected critical published material

                                                    Not clear which data were obtained by the investigator and which have been reported by others

                                                    VIII Referral and Assignment of the Application

                                                    When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                    Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                    Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                    To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                    You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                    If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                    IX Review of Research Project Applications

                                                    This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                    Scientific Review Groups

                                                    Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                    Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                    Review Criteria

                                                    In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                    Significance Approach Innovation Investigator Environment

                                                    To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                    Cover Letter

                                                    Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                    State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                    Administrative Review

                                                    Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                    If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                    At the Peer Review Meeting

                                                    Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                    Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                    How Priority Scores Are Determined

                                                    If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                    Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                    Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                    1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                    2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                    3 Deferred In some instances the scientific review group is unable to make an

                                                    adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                    Summary Statements

                                                    Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                    Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                    Appeal

                                                    You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                    X How Funding Is Decided

                                                    Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                    Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                    How Paylines Work

                                                    Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                    Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                    Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                    You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                    For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                    Second Level Peer Review

                                                    In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                    They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                    Possible Outcomes of Secondary Review

                                                    Following Council review NIAID takes one of four actions for an application

                                                    1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                    Why Applications Are Kept on Hold

                                                    ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                    Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                    XI When You Have Not Obtained Funding

                                                    What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                    Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                    Most Common Reasons for a Low Score (in priority order)

                                                    - Lack of new or original ideas

                                                    - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                    - Methods unsuitable or defective and not likely to yield results

                                                    - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                    - Data management and analysis vague unsophisticated

                                                    - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                    - Poor resources or facilities limited access to appropriate patient population

                                                    From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                    When to Revise

                                                    How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                    If the problems are repairable revise the application and resubmit it to the same study section

                                                    Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                    - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                    Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                    vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                    If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                    For fatal flaws and weaknesses rethink your idea and start over

                                                    Revising Your Application

                                                    Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                    Respond to reviewersrsquo comments

                                                    The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                    Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                    Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                    additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                    Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                    Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                    If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                    XII When Your Application Is Approved for Funding

                                                    If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                    Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                    If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                    There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                    For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                    Documentation

                                                    Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                    Human subjects

                                                    For more information concerning the human subjects assurance contact OHRP at

                                                    Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                    And find a wealth of guidance documents on the Web

                                                    Animals in Research

                                                    For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                    Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                    Or see the Web site at Office of Laboratory Animal Welfare

                                                    What You Can and Cannot Pay for on a Grant

                                                    In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                    OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                    For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                    Terms and Conditions of Award

                                                    Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                    Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                    NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                    Reporting Requirements

                                                    Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                    Address and phone number are

                                                    NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                    For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                    Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                    Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                    Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                    Checklists

                                                    BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                    HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                    RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                    RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                    rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                    SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                    BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                    PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                    DESIGN AND METHODS CHECKLIST

                                                    General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                    Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                    Does the PIs salary exceed the government cap of $141300

                                                    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                    • howtopdf
                                                      • Third Edition amended August 30 2001
                                                      • The Original How to Write a Research Grant Application
                                                        • I Before You Begin
                                                            • If the answer is yes
                                                            • Protection
                                                            • Inclusion
                                                            • Monitoring
                                                            • Reporting
                                                            • Training
                                                            • Certifications and assurances
                                                              • Most Common Reasons for a Low Score (in priority order)
                                                              • BEGINNING CHECKLIST
                                                              • HYPOTHESIS CHECKLIST
                                                              • RESEARCH PLAN - PLANNING CHECKLIST
                                                              • RESEARCH PLAN - PROCESS CHECKLIST
                                                              • SPECIFIC AIMS CHECKLIST
                                                              • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                              • PRELIMINARY DATA CHECKLIST
                                                              • DESIGN AND METHODS CHECKLIST
                                                              • General
                                                              • Approach
                                                              • ABSTRACT CHECKLIST
                                                              • BIOSKETCHES CHECKLIST
                                                              • BUDGET CHECKLIST
                                                              • RESOURCES CHECKLIST
                                                              • REVISING CHECKLIST

                                                      This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

                                                      The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

                                                      I Consultants

                                                      Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

                                                      IV Application Contents Other Than the Research Plan

                                                      Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                                      Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                                      Abstract (Form BB)

                                                      Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                                      Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                                      Title

                                                      Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                                      Biographical Sketches (Form FF)

                                                      This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                                      With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                                      - Name and title

                                                      - Education -- institutions location degree(s) year conferred and field(s) of study

                                                      - Roles in other relevant current or past research

                                                      - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                                      - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                                      Budget

                                                      Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                                      Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                                      Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                                      Modular grants

                                                      NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                                      Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                                      NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                                      Resources

                                                      The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                                      research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                      V Writing and Formatting

                                                      Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                      Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                      Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                      Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                      Page Limitations

                                                      Type (font) Size and Spacing

                                                      Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                      Font size in figures and tables may be smaller but must be readily legible

                                                      Writing Tips

                                                      Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                      Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                      Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                      Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                      tables

                                                      Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                      VI Submitting Your Grant Application

                                                      Receipt Date

                                                      NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                      Cover Letter

                                                      Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                      Requesting an SRG and InstituteCenter

                                                      Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                      You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                      Modular Grants and Applications and Just in Time

                                                      The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                      The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                      For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                      VII Problems and Concerns Commonly Cited by Reviewers

                                                      Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                      Lack of significance to the scientific issue being addressed

                                                      Lack of original or new ideas

                                                      Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                      Project too diffuse or superficial or lacks focus

                                                      Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                      Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                      Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                      Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                      Lack of alternative methodological approaches in case the primary approach does not work out

                                                      Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                      The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                      The proposed experiments do not include all relevant controls

                                                      Proposal innovative but lacking enough preliminary data

                                                      Preliminary data do not support the feasibility of the project or the hypothesis

                                                      Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                      The proposal lacks critical literature references causing reviewers to think that the

                                                      applicant either does not know the literature or has purposely neglected critical published material

                                                      Not clear which data were obtained by the investigator and which have been reported by others

                                                      VIII Referral and Assignment of the Application

                                                      When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                      Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                      Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                      To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                      You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                      If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                      IX Review of Research Project Applications

                                                      This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                      Scientific Review Groups

                                                      Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                      Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                      Review Criteria

                                                      In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                      Significance Approach Innovation Investigator Environment

                                                      To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                      Cover Letter

                                                      Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                      State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                      Administrative Review

                                                      Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                      If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                      At the Peer Review Meeting

                                                      Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                      Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                      How Priority Scores Are Determined

                                                      If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                      Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                      Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                      1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                      2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                      3 Deferred In some instances the scientific review group is unable to make an

                                                      adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                      Summary Statements

                                                      Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                      Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                      Appeal

                                                      You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                      X How Funding Is Decided

                                                      Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                      Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                      How Paylines Work

                                                      Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                      Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                      Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                      You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                      For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                      Second Level Peer Review

                                                      In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                      They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                      Possible Outcomes of Secondary Review

                                                      Following Council review NIAID takes one of four actions for an application

                                                      1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                      Why Applications Are Kept on Hold

                                                      ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                      Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                      XI When You Have Not Obtained Funding

                                                      What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                      Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                      Most Common Reasons for a Low Score (in priority order)

                                                      - Lack of new or original ideas

                                                      - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                      - Methods unsuitable or defective and not likely to yield results

                                                      - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                      - Data management and analysis vague unsophisticated

                                                      - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                      - Poor resources or facilities limited access to appropriate patient population

                                                      From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                      When to Revise

                                                      How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                      If the problems are repairable revise the application and resubmit it to the same study section

                                                      Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                      - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                      Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                      vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                      If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                      For fatal flaws and weaknesses rethink your idea and start over

                                                      Revising Your Application

                                                      Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                      Respond to reviewersrsquo comments

                                                      The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                      Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                      Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                      additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                      Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                      Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                      If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                      XII When Your Application Is Approved for Funding

                                                      If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                      Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                      If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                      There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                      For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                      Documentation

                                                      Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                      Human subjects

                                                      For more information concerning the human subjects assurance contact OHRP at

                                                      Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                      And find a wealth of guidance documents on the Web

                                                      Animals in Research

                                                      For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                      Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                      Or see the Web site at Office of Laboratory Animal Welfare

                                                      What You Can and Cannot Pay for on a Grant

                                                      In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                      OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                      For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                      Terms and Conditions of Award

                                                      Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                      Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                      NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                      Reporting Requirements

                                                      Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                      Address and phone number are

                                                      NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                      For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                      Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                      Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                      Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                      Checklists

                                                      BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                      HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                      RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                      RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                      rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                      SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                      BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                      PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                      DESIGN AND METHODS CHECKLIST

                                                      General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                      Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                      Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                      Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                      ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                      BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                      BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                      Does the PIs salary exceed the government cap of $141300

                                                      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                      • howtopdf
                                                        • Third Edition amended August 30 2001
                                                        • The Original How to Write a Research Grant Application
                                                          • I Before You Begin
                                                              • If the answer is yes
                                                              • Protection
                                                              • Inclusion
                                                              • Monitoring
                                                              • Reporting
                                                              • Training
                                                              • Certifications and assurances
                                                                • Most Common Reasons for a Low Score (in priority order)
                                                                • BEGINNING CHECKLIST
                                                                • HYPOTHESIS CHECKLIST
                                                                • RESEARCH PLAN - PLANNING CHECKLIST
                                                                • RESEARCH PLAN - PROCESS CHECKLIST
                                                                • SPECIFIC AIMS CHECKLIST
                                                                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                • PRELIMINARY DATA CHECKLIST
                                                                • DESIGN AND METHODS CHECKLIST
                                                                • General
                                                                • Approach
                                                                • ABSTRACT CHECKLIST
                                                                • BIOSKETCHES CHECKLIST
                                                                • BUDGET CHECKLIST
                                                                • RESOURCES CHECKLIST
                                                                • REVISING CHECKLIST

                                                        IV Application Contents Other Than the Research Plan

                                                        Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

                                                        Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

                                                        Abstract (Form BB)

                                                        Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

                                                        Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

                                                        Title

                                                        Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

                                                        Biographical Sketches (Form FF)

                                                        This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

                                                        With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

                                                        - Name and title

                                                        - Education -- institutions location degree(s) year conferred and field(s) of study

                                                        - Roles in other relevant current or past research

                                                        - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                                        - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                                        Budget

                                                        Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                                        Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                                        Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                                        Modular grants

                                                        NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                                        Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                                        NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                                        Resources

                                                        The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                                        research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                        V Writing and Formatting

                                                        Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                        Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                        Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                        Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                        Page Limitations

                                                        Type (font) Size and Spacing

                                                        Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                        Font size in figures and tables may be smaller but must be readily legible

                                                        Writing Tips

                                                        Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                        Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                        Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                        Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                        tables

                                                        Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                        VI Submitting Your Grant Application

                                                        Receipt Date

                                                        NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                        Cover Letter

                                                        Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                        Requesting an SRG and InstituteCenter

                                                        Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                        You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                        Modular Grants and Applications and Just in Time

                                                        The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                        The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                        For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                        VII Problems and Concerns Commonly Cited by Reviewers

                                                        Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                        Lack of significance to the scientific issue being addressed

                                                        Lack of original or new ideas

                                                        Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                        Project too diffuse or superficial or lacks focus

                                                        Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                        Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                        Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                        Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                        Lack of alternative methodological approaches in case the primary approach does not work out

                                                        Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                        The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                        The proposed experiments do not include all relevant controls

                                                        Proposal innovative but lacking enough preliminary data

                                                        Preliminary data do not support the feasibility of the project or the hypothesis

                                                        Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                        The proposal lacks critical literature references causing reviewers to think that the

                                                        applicant either does not know the literature or has purposely neglected critical published material

                                                        Not clear which data were obtained by the investigator and which have been reported by others

                                                        VIII Referral and Assignment of the Application

                                                        When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                        Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                        Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                        To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                        You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                        If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                        IX Review of Research Project Applications

                                                        This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                        Scientific Review Groups

                                                        Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                        Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                        Review Criteria

                                                        In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                        Significance Approach Innovation Investigator Environment

                                                        To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                        Cover Letter

                                                        Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                        State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                        Administrative Review

                                                        Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                        If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                        At the Peer Review Meeting

                                                        Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                        Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                        How Priority Scores Are Determined

                                                        If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                        Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                        Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                        1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                        2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                        3 Deferred In some instances the scientific review group is unable to make an

                                                        adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                        Summary Statements

                                                        Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                        Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                        Appeal

                                                        You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                        X How Funding Is Decided

                                                        Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                        Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                        How Paylines Work

                                                        Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                        Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                        Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                        You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                        For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                        Second Level Peer Review

                                                        In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                        They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                        Possible Outcomes of Secondary Review

                                                        Following Council review NIAID takes one of four actions for an application

                                                        1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                        Why Applications Are Kept on Hold

                                                        ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                        Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                        XI When You Have Not Obtained Funding

                                                        What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                        Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                        Most Common Reasons for a Low Score (in priority order)

                                                        - Lack of new or original ideas

                                                        - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                        - Methods unsuitable or defective and not likely to yield results

                                                        - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                        - Data management and analysis vague unsophisticated

                                                        - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                        - Poor resources or facilities limited access to appropriate patient population

                                                        From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                        When to Revise

                                                        How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                        If the problems are repairable revise the application and resubmit it to the same study section

                                                        Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                        - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                        Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                        vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                        If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                        For fatal flaws and weaknesses rethink your idea and start over

                                                        Revising Your Application

                                                        Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                        Respond to reviewersrsquo comments

                                                        The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                        Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                        Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                        additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                        Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                        Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                        If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                        XII When Your Application Is Approved for Funding

                                                        If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                        Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                        If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                        There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                        For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                        Documentation

                                                        Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                        Human subjects

                                                        For more information concerning the human subjects assurance contact OHRP at

                                                        Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                        And find a wealth of guidance documents on the Web

                                                        Animals in Research

                                                        For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                        Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                        Or see the Web site at Office of Laboratory Animal Welfare

                                                        What You Can and Cannot Pay for on a Grant

                                                        In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                        OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                        For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                        Terms and Conditions of Award

                                                        Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                        Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                        NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                        Reporting Requirements

                                                        Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                        Address and phone number are

                                                        NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                        For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                        Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                        Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                        Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                        Checklists

                                                        BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                        HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                        RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                        RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                        rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                        SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                        BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                        PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                        DESIGN AND METHODS CHECKLIST

                                                        General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                        Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                        Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                        Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                        ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                        BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                        BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                        Does the PIs salary exceed the government cap of $141300

                                                        RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                        WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                        REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                        • howtopdf
                                                          • Third Edition amended August 30 2001
                                                          • The Original How to Write a Research Grant Application
                                                            • I Before You Begin
                                                                • If the answer is yes
                                                                • Protection
                                                                • Inclusion
                                                                • Monitoring
                                                                • Reporting
                                                                • Training
                                                                • Certifications and assurances
                                                                  • Most Common Reasons for a Low Score (in priority order)
                                                                  • BEGINNING CHECKLIST
                                                                  • HYPOTHESIS CHECKLIST
                                                                  • RESEARCH PLAN - PLANNING CHECKLIST
                                                                  • RESEARCH PLAN - PROCESS CHECKLIST
                                                                  • SPECIFIC AIMS CHECKLIST
                                                                  • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                  • PRELIMINARY DATA CHECKLIST
                                                                  • DESIGN AND METHODS CHECKLIST
                                                                  • General
                                                                  • Approach
                                                                  • ABSTRACT CHECKLIST
                                                                  • BIOSKETCHES CHECKLIST
                                                                  • BUDGET CHECKLIST
                                                                  • RESOURCES CHECKLIST
                                                                  • REVISING CHECKLIST

                                                          - Roles in other relevant current or past research

                                                          - Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

                                                          - List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

                                                          Budget

                                                          Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

                                                          Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

                                                          Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

                                                          Modular grants

                                                          NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

                                                          Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

                                                          NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

                                                          Resources

                                                          The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

                                                          research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                          V Writing and Formatting

                                                          Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                          Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                          Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                          Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                          Page Limitations

                                                          Type (font) Size and Spacing

                                                          Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                          Font size in figures and tables may be smaller but must be readily legible

                                                          Writing Tips

                                                          Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                          Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                          Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                          Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                          tables

                                                          Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                          VI Submitting Your Grant Application

                                                          Receipt Date

                                                          NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                          Cover Letter

                                                          Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                          Requesting an SRG and InstituteCenter

                                                          Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                          You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                          Modular Grants and Applications and Just in Time

                                                          The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                          The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                          For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                          VII Problems and Concerns Commonly Cited by Reviewers

                                                          Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                          Lack of significance to the scientific issue being addressed

                                                          Lack of original or new ideas

                                                          Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                          Project too diffuse or superficial or lacks focus

                                                          Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                          Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                          Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                          Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                          Lack of alternative methodological approaches in case the primary approach does not work out

                                                          Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                          The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                          The proposed experiments do not include all relevant controls

                                                          Proposal innovative but lacking enough preliminary data

                                                          Preliminary data do not support the feasibility of the project or the hypothesis

                                                          Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                          The proposal lacks critical literature references causing reviewers to think that the

                                                          applicant either does not know the literature or has purposely neglected critical published material

                                                          Not clear which data were obtained by the investigator and which have been reported by others

                                                          VIII Referral and Assignment of the Application

                                                          When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                          Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                          Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                          To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                          You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                          If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                          IX Review of Research Project Applications

                                                          This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                          Scientific Review Groups

                                                          Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                          Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                          Review Criteria

                                                          In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                          Significance Approach Innovation Investigator Environment

                                                          To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                          Cover Letter

                                                          Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                          State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                          Administrative Review

                                                          Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                          If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                          At the Peer Review Meeting

                                                          Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                          Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                          How Priority Scores Are Determined

                                                          If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                          Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                          Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                          1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                          2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                          3 Deferred In some instances the scientific review group is unable to make an

                                                          adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                          Summary Statements

                                                          Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                          Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                          Appeal

                                                          You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                          X How Funding Is Decided

                                                          Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                          Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                          How Paylines Work

                                                          Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                          Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                          Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                          You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                          For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                          Second Level Peer Review

                                                          In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                          They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                          Possible Outcomes of Secondary Review

                                                          Following Council review NIAID takes one of four actions for an application

                                                          1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                          Why Applications Are Kept on Hold

                                                          ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                          Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                          XI When You Have Not Obtained Funding

                                                          What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                          Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                          Most Common Reasons for a Low Score (in priority order)

                                                          - Lack of new or original ideas

                                                          - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                          - Methods unsuitable or defective and not likely to yield results

                                                          - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                          - Data management and analysis vague unsophisticated

                                                          - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                          - Poor resources or facilities limited access to appropriate patient population

                                                          From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                          When to Revise

                                                          How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                          If the problems are repairable revise the application and resubmit it to the same study section

                                                          Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                          - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                          Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                          vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                          If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                          For fatal flaws and weaknesses rethink your idea and start over

                                                          Revising Your Application

                                                          Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                          Respond to reviewersrsquo comments

                                                          The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                          Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                          Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                          additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                          Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                          Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                          If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                          XII When Your Application Is Approved for Funding

                                                          If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                          Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                          If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                          There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                          For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                          Documentation

                                                          Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                          Human subjects

                                                          For more information concerning the human subjects assurance contact OHRP at

                                                          Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                          And find a wealth of guidance documents on the Web

                                                          Animals in Research

                                                          For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                          Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                          Or see the Web site at Office of Laboratory Animal Welfare

                                                          What You Can and Cannot Pay for on a Grant

                                                          In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                          OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                          For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                          Terms and Conditions of Award

                                                          Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                          Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                          NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                          Reporting Requirements

                                                          Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                          Address and phone number are

                                                          NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                          For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                          Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                          Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                          Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                          Checklists

                                                          BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                          HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                          RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                          RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                          rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                          SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                          BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                          PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                          DESIGN AND METHODS CHECKLIST

                                                          General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                          Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                          Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                          Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                          ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                          BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                          BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                          Does the PIs salary exceed the government cap of $141300

                                                          RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                          WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                          REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                          • howtopdf
                                                            • Third Edition amended August 30 2001
                                                            • The Original How to Write a Research Grant Application
                                                              • I Before You Begin
                                                                  • If the answer is yes
                                                                  • Protection
                                                                  • Inclusion
                                                                  • Monitoring
                                                                  • Reporting
                                                                  • Training
                                                                  • Certifications and assurances
                                                                    • Most Common Reasons for a Low Score (in priority order)
                                                                    • BEGINNING CHECKLIST
                                                                    • HYPOTHESIS CHECKLIST
                                                                    • RESEARCH PLAN - PLANNING CHECKLIST
                                                                    • RESEARCH PLAN - PROCESS CHECKLIST
                                                                    • SPECIFIC AIMS CHECKLIST
                                                                    • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                    • PRELIMINARY DATA CHECKLIST
                                                                    • DESIGN AND METHODS CHECKLIST
                                                                    • General
                                                                    • Approach
                                                                    • ABSTRACT CHECKLIST
                                                                    • BIOSKETCHES CHECKLIST
                                                                    • BUDGET CHECKLIST
                                                                    • RESOURCES CHECKLIST
                                                                    • REVISING CHECKLIST

                                                            research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

                                                            V Writing and Formatting

                                                            Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                            Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                            Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                            Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                            Page Limitations

                                                            Type (font) Size and Spacing

                                                            Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                            Font size in figures and tables may be smaller but must be readily legible

                                                            Writing Tips

                                                            Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                            Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                            Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                            Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                            tables

                                                            Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                            VI Submitting Your Grant Application

                                                            Receipt Date

                                                            NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                            Cover Letter

                                                            Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                            Requesting an SRG and InstituteCenter

                                                            Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                            You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                            Modular Grants and Applications and Just in Time

                                                            The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                            The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                            For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                            VII Problems and Concerns Commonly Cited by Reviewers

                                                            Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                            Lack of significance to the scientific issue being addressed

                                                            Lack of original or new ideas

                                                            Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                            Project too diffuse or superficial or lacks focus

                                                            Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                            Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                            Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                            Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                            Lack of alternative methodological approaches in case the primary approach does not work out

                                                            Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                            The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                            The proposed experiments do not include all relevant controls

                                                            Proposal innovative but lacking enough preliminary data

                                                            Preliminary data do not support the feasibility of the project or the hypothesis

                                                            Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                            The proposal lacks critical literature references causing reviewers to think that the

                                                            applicant either does not know the literature or has purposely neglected critical published material

                                                            Not clear which data were obtained by the investigator and which have been reported by others

                                                            VIII Referral and Assignment of the Application

                                                            When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                            Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                            Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                            To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                            You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                            If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                            IX Review of Research Project Applications

                                                            This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                            Scientific Review Groups

                                                            Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                            Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                            Review Criteria

                                                            In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                            Significance Approach Innovation Investigator Environment

                                                            To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                            Cover Letter

                                                            Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                            State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                            Administrative Review

                                                            Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                            If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                            At the Peer Review Meeting

                                                            Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                            Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                            How Priority Scores Are Determined

                                                            If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                            Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                            Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                            1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                            2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                            3 Deferred In some instances the scientific review group is unable to make an

                                                            adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                            Summary Statements

                                                            Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                            Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                            Appeal

                                                            You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                            X How Funding Is Decided

                                                            Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                            Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                            How Paylines Work

                                                            Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                            Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                            Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                            You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                            For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                            Second Level Peer Review

                                                            In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                            They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                            Possible Outcomes of Secondary Review

                                                            Following Council review NIAID takes one of four actions for an application

                                                            1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                            Why Applications Are Kept on Hold

                                                            ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                            Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                            XI When You Have Not Obtained Funding

                                                            What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                            Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                            Most Common Reasons for a Low Score (in priority order)

                                                            - Lack of new or original ideas

                                                            - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                            - Methods unsuitable or defective and not likely to yield results

                                                            - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                            - Data management and analysis vague unsophisticated

                                                            - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                            - Poor resources or facilities limited access to appropriate patient population

                                                            From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                            When to Revise

                                                            How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                            If the problems are repairable revise the application and resubmit it to the same study section

                                                            Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                            - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                            Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                            vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                            If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                            For fatal flaws and weaknesses rethink your idea and start over

                                                            Revising Your Application

                                                            Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                            Respond to reviewersrsquo comments

                                                            The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                            Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                            Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                            additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                            Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                            Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                            If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                            XII When Your Application Is Approved for Funding

                                                            If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                            Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                            If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                            There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                            For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                            Documentation

                                                            Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                            Human subjects

                                                            For more information concerning the human subjects assurance contact OHRP at

                                                            Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                            And find a wealth of guidance documents on the Web

                                                            Animals in Research

                                                            For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                            Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                            Or see the Web site at Office of Laboratory Animal Welfare

                                                            What You Can and Cannot Pay for on a Grant

                                                            In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                            OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                            For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                            Terms and Conditions of Award

                                                            Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                            Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                            NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                            Reporting Requirements

                                                            Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                            Address and phone number are

                                                            NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                            For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                            Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                            Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                            Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                            Checklists

                                                            BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                            HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                            RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                            RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                            rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                            SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                            BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                            PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                            DESIGN AND METHODS CHECKLIST

                                                            General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                            Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                            Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                            Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                            ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                            BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                            BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                            Does the PIs salary exceed the government cap of $141300

                                                            RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                            WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                            REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                            • howtopdf
                                                              • Third Edition amended August 30 2001
                                                              • The Original How to Write a Research Grant Application
                                                                • I Before You Begin
                                                                    • If the answer is yes
                                                                    • Protection
                                                                    • Inclusion
                                                                    • Monitoring
                                                                    • Reporting
                                                                    • Training
                                                                    • Certifications and assurances
                                                                      • Most Common Reasons for a Low Score (in priority order)
                                                                      • BEGINNING CHECKLIST
                                                                      • HYPOTHESIS CHECKLIST
                                                                      • RESEARCH PLAN - PLANNING CHECKLIST
                                                                      • RESEARCH PLAN - PROCESS CHECKLIST
                                                                      • SPECIFIC AIMS CHECKLIST
                                                                      • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                      • PRELIMINARY DATA CHECKLIST
                                                                      • DESIGN AND METHODS CHECKLIST
                                                                      • General
                                                                      • Approach
                                                                      • ABSTRACT CHECKLIST
                                                                      • BIOSKETCHES CHECKLIST
                                                                      • BUDGET CHECKLIST
                                                                      • RESOURCES CHECKLIST
                                                                      • REVISING CHECKLIST

                                                              V Writing and Formatting

                                                              Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

                                                              Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

                                                              Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

                                                              Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

                                                              Page Limitations

                                                              Type (font) Size and Spacing

                                                              Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

                                                              Font size in figures and tables may be smaller but must be readily legible

                                                              Writing Tips

                                                              Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

                                                              Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

                                                              Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

                                                              Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

                                                              tables

                                                              Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                              VI Submitting Your Grant Application

                                                              Receipt Date

                                                              NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                              Cover Letter

                                                              Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                              Requesting an SRG and InstituteCenter

                                                              Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                              You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                              Modular Grants and Applications and Just in Time

                                                              The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                              The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                              For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                              VII Problems and Concerns Commonly Cited by Reviewers

                                                              Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                              Lack of significance to the scientific issue being addressed

                                                              Lack of original or new ideas

                                                              Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                              Project too diffuse or superficial or lacks focus

                                                              Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                              Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                              Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                              Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                              Lack of alternative methodological approaches in case the primary approach does not work out

                                                              Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                              The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                              The proposed experiments do not include all relevant controls

                                                              Proposal innovative but lacking enough preliminary data

                                                              Preliminary data do not support the feasibility of the project or the hypothesis

                                                              Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                              The proposal lacks critical literature references causing reviewers to think that the

                                                              applicant either does not know the literature or has purposely neglected critical published material

                                                              Not clear which data were obtained by the investigator and which have been reported by others

                                                              VIII Referral and Assignment of the Application

                                                              When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                              Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                              Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                              To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                              You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                              If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                              IX Review of Research Project Applications

                                                              This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                              Scientific Review Groups

                                                              Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                              Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                              Review Criteria

                                                              In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                              Significance Approach Innovation Investigator Environment

                                                              To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                              Cover Letter

                                                              Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                              State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                              Administrative Review

                                                              Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                              If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                              At the Peer Review Meeting

                                                              Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                              Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                              How Priority Scores Are Determined

                                                              If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                              Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                              Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                              1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                              2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                              3 Deferred In some instances the scientific review group is unable to make an

                                                              adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                              Summary Statements

                                                              Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                              Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                              Appeal

                                                              You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                              X How Funding Is Decided

                                                              Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                              Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                              How Paylines Work

                                                              Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                              Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                              Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                              You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                              For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                              Second Level Peer Review

                                                              In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                              They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                              Possible Outcomes of Secondary Review

                                                              Following Council review NIAID takes one of four actions for an application

                                                              1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                              Why Applications Are Kept on Hold

                                                              ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                              Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                              XI When You Have Not Obtained Funding

                                                              What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                              Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                              Most Common Reasons for a Low Score (in priority order)

                                                              - Lack of new or original ideas

                                                              - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                              - Methods unsuitable or defective and not likely to yield results

                                                              - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                              - Data management and analysis vague unsophisticated

                                                              - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                              - Poor resources or facilities limited access to appropriate patient population

                                                              From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                              When to Revise

                                                              How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                              If the problems are repairable revise the application and resubmit it to the same study section

                                                              Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                              - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                              Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                              vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                              If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                              For fatal flaws and weaknesses rethink your idea and start over

                                                              Revising Your Application

                                                              Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                              Respond to reviewersrsquo comments

                                                              The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                              Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                              Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                              additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                              Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                              Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                              If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                              XII When Your Application Is Approved for Funding

                                                              If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                              Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                              If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                              There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                              For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                              Documentation

                                                              Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                              Human subjects

                                                              For more information concerning the human subjects assurance contact OHRP at

                                                              Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                              And find a wealth of guidance documents on the Web

                                                              Animals in Research

                                                              For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                              Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                              Or see the Web site at Office of Laboratory Animal Welfare

                                                              What You Can and Cannot Pay for on a Grant

                                                              In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                              OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                              For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                              Terms and Conditions of Award

                                                              Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                              Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                              NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                              Reporting Requirements

                                                              Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                              Address and phone number are

                                                              NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                              For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                              Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                              Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                              Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                              Checklists

                                                              BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                              HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                              RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                              RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                              rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                              SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                              BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                              PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                              DESIGN AND METHODS CHECKLIST

                                                              General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                              Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                              Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                              Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                              ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                              BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                              BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                              Does the PIs salary exceed the government cap of $141300

                                                              RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                              WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                              REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                              • howtopdf
                                                                • Third Edition amended August 30 2001
                                                                • The Original How to Write a Research Grant Application
                                                                  • I Before You Begin
                                                                      • If the answer is yes
                                                                      • Protection
                                                                      • Inclusion
                                                                      • Monitoring
                                                                      • Reporting
                                                                      • Training
                                                                      • Certifications and assurances
                                                                        • Most Common Reasons for a Low Score (in priority order)
                                                                        • BEGINNING CHECKLIST
                                                                        • HYPOTHESIS CHECKLIST
                                                                        • RESEARCH PLAN - PLANNING CHECKLIST
                                                                        • RESEARCH PLAN - PROCESS CHECKLIST
                                                                        • SPECIFIC AIMS CHECKLIST
                                                                        • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                        • PRELIMINARY DATA CHECKLIST
                                                                        • DESIGN AND METHODS CHECKLIST
                                                                        • General
                                                                        • Approach
                                                                        • ABSTRACT CHECKLIST
                                                                        • BIOSKETCHES CHECKLIST
                                                                        • BUDGET CHECKLIST
                                                                        • RESOURCES CHECKLIST
                                                                        • REVISING CHECKLIST

                                                                tables

                                                                Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

                                                                VI Submitting Your Grant Application

                                                                Receipt Date

                                                                NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                                Cover Letter

                                                                Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                                Requesting an SRG and InstituteCenter

                                                                Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                                You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                                Modular Grants and Applications and Just in Time

                                                                The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                                The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                                For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                                VII Problems and Concerns Commonly Cited by Reviewers

                                                                Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                                Lack of significance to the scientific issue being addressed

                                                                Lack of original or new ideas

                                                                Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                                Project too diffuse or superficial or lacks focus

                                                                Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                                Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                                Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                                Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                                Lack of alternative methodological approaches in case the primary approach does not work out

                                                                Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                                The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                                The proposed experiments do not include all relevant controls

                                                                Proposal innovative but lacking enough preliminary data

                                                                Preliminary data do not support the feasibility of the project or the hypothesis

                                                                Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                                The proposal lacks critical literature references causing reviewers to think that the

                                                                applicant either does not know the literature or has purposely neglected critical published material

                                                                Not clear which data were obtained by the investigator and which have been reported by others

                                                                VIII Referral and Assignment of the Application

                                                                When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                                Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                                Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                                To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                                You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                                If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                                IX Review of Research Project Applications

                                                                This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                                Scientific Review Groups

                                                                Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                                Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                                Review Criteria

                                                                In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                                Significance Approach Innovation Investigator Environment

                                                                To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                                Cover Letter

                                                                Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                                State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                                Administrative Review

                                                                Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                At the Peer Review Meeting

                                                                Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                How Priority Scores Are Determined

                                                                If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                3 Deferred In some instances the scientific review group is unable to make an

                                                                adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                Summary Statements

                                                                Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                Appeal

                                                                You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                X How Funding Is Decided

                                                                Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                How Paylines Work

                                                                Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                Second Level Peer Review

                                                                In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                Possible Outcomes of Secondary Review

                                                                Following Council review NIAID takes one of four actions for an application

                                                                1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                Why Applications Are Kept on Hold

                                                                ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                XI When You Have Not Obtained Funding

                                                                What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                Most Common Reasons for a Low Score (in priority order)

                                                                - Lack of new or original ideas

                                                                - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                - Methods unsuitable or defective and not likely to yield results

                                                                - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                - Data management and analysis vague unsophisticated

                                                                - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                - Poor resources or facilities limited access to appropriate patient population

                                                                From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                When to Revise

                                                                How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                If the problems are repairable revise the application and resubmit it to the same study section

                                                                Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                For fatal flaws and weaknesses rethink your idea and start over

                                                                Revising Your Application

                                                                Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                Respond to reviewersrsquo comments

                                                                The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                XII When Your Application Is Approved for Funding

                                                                If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                Documentation

                                                                Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                Human subjects

                                                                For more information concerning the human subjects assurance contact OHRP at

                                                                Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                And find a wealth of guidance documents on the Web

                                                                Animals in Research

                                                                For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                Or see the Web site at Office of Laboratory Animal Welfare

                                                                What You Can and Cannot Pay for on a Grant

                                                                In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                Terms and Conditions of Award

                                                                Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                Reporting Requirements

                                                                Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                Address and phone number are

                                                                NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                Checklists

                                                                BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                DESIGN AND METHODS CHECKLIST

                                                                General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                Does the PIs salary exceed the government cap of $141300

                                                                RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                • howtopdf
                                                                  • Third Edition amended August 30 2001
                                                                  • The Original How to Write a Research Grant Application
                                                                    • I Before You Begin
                                                                        • If the answer is yes
                                                                        • Protection
                                                                        • Inclusion
                                                                        • Monitoring
                                                                        • Reporting
                                                                        • Training
                                                                        • Certifications and assurances
                                                                          • Most Common Reasons for a Low Score (in priority order)
                                                                          • BEGINNING CHECKLIST
                                                                          • HYPOTHESIS CHECKLIST
                                                                          • RESEARCH PLAN - PLANNING CHECKLIST
                                                                          • RESEARCH PLAN - PROCESS CHECKLIST
                                                                          • SPECIFIC AIMS CHECKLIST
                                                                          • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                          • PRELIMINARY DATA CHECKLIST
                                                                          • DESIGN AND METHODS CHECKLIST
                                                                          • General
                                                                          • Approach
                                                                          • ABSTRACT CHECKLIST
                                                                          • BIOSKETCHES CHECKLIST
                                                                          • BUDGET CHECKLIST
                                                                          • RESOURCES CHECKLIST
                                                                          • REVISING CHECKLIST

                                                                  VI Submitting Your Grant Application

                                                                  Receipt Date

                                                                  NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

                                                                  Cover Letter

                                                                  Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

                                                                  Requesting an SRG and InstituteCenter

                                                                  Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

                                                                  You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

                                                                  Modular Grants and Applications and Just in Time

                                                                  The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

                                                                  The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

                                                                  For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

                                                                  VII Problems and Concerns Commonly Cited by Reviewers

                                                                  Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                                  Lack of significance to the scientific issue being addressed

                                                                  Lack of original or new ideas

                                                                  Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                                  Project too diffuse or superficial or lacks focus

                                                                  Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                                  Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                                  Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                                  Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                                  Lack of alternative methodological approaches in case the primary approach does not work out

                                                                  Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                                  The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                                  The proposed experiments do not include all relevant controls

                                                                  Proposal innovative but lacking enough preliminary data

                                                                  Preliminary data do not support the feasibility of the project or the hypothesis

                                                                  Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                                  The proposal lacks critical literature references causing reviewers to think that the

                                                                  applicant either does not know the literature or has purposely neglected critical published material

                                                                  Not clear which data were obtained by the investigator and which have been reported by others

                                                                  VIII Referral and Assignment of the Application

                                                                  When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                                  Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                                  Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                                  To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                                  You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                                  If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                                  IX Review of Research Project Applications

                                                                  This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                                  Scientific Review Groups

                                                                  Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                                  Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                                  Review Criteria

                                                                  In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                                  Significance Approach Innovation Investigator Environment

                                                                  To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                                  Cover Letter

                                                                  Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                                  State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                                  Administrative Review

                                                                  Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                  If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                  At the Peer Review Meeting

                                                                  Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                  Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                  How Priority Scores Are Determined

                                                                  If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                  Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                  Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                  1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                  2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                  3 Deferred In some instances the scientific review group is unable to make an

                                                                  adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                  Summary Statements

                                                                  Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                  Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                  Appeal

                                                                  You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                  X How Funding Is Decided

                                                                  Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                  Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                  How Paylines Work

                                                                  Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                  Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                  Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                  You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                  For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                  Second Level Peer Review

                                                                  In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                  They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                  Possible Outcomes of Secondary Review

                                                                  Following Council review NIAID takes one of four actions for an application

                                                                  1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                  Why Applications Are Kept on Hold

                                                                  ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                  Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                  XI When You Have Not Obtained Funding

                                                                  What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                  Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                  Most Common Reasons for a Low Score (in priority order)

                                                                  - Lack of new or original ideas

                                                                  - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                  - Methods unsuitable or defective and not likely to yield results

                                                                  - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                  - Data management and analysis vague unsophisticated

                                                                  - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                  - Poor resources or facilities limited access to appropriate patient population

                                                                  From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                  When to Revise

                                                                  How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                  If the problems are repairable revise the application and resubmit it to the same study section

                                                                  Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                  - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                  Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                  vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                  If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                  For fatal flaws and weaknesses rethink your idea and start over

                                                                  Revising Your Application

                                                                  Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                  Respond to reviewersrsquo comments

                                                                  The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                  Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                  Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                  additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                  Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                  Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                  If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                  XII When Your Application Is Approved for Funding

                                                                  If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                  Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                  If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                  There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                  For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                  Documentation

                                                                  Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                  Human subjects

                                                                  For more information concerning the human subjects assurance contact OHRP at

                                                                  Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                  And find a wealth of guidance documents on the Web

                                                                  Animals in Research

                                                                  For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                  Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                  Or see the Web site at Office of Laboratory Animal Welfare

                                                                  What You Can and Cannot Pay for on a Grant

                                                                  In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                  OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                  For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                  Terms and Conditions of Award

                                                                  Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                  Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                  NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                  Reporting Requirements

                                                                  Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                  Address and phone number are

                                                                  NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                  For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                  Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                  Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                  Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                  Checklists

                                                                  BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                  HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                  RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                  RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                  rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                  SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                  BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                  PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                  DESIGN AND METHODS CHECKLIST

                                                                  General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                  Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                  Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                  Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                  ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                  BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                  BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                  Does the PIs salary exceed the government cap of $141300

                                                                  RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                  WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                  REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                  • howtopdf
                                                                    • Third Edition amended August 30 2001
                                                                    • The Original How to Write a Research Grant Application
                                                                      • I Before You Begin
                                                                          • If the answer is yes
                                                                          • Protection
                                                                          • Inclusion
                                                                          • Monitoring
                                                                          • Reporting
                                                                          • Training
                                                                          • Certifications and assurances
                                                                            • Most Common Reasons for a Low Score (in priority order)
                                                                            • BEGINNING CHECKLIST
                                                                            • HYPOTHESIS CHECKLIST
                                                                            • RESEARCH PLAN - PLANNING CHECKLIST
                                                                            • RESEARCH PLAN - PROCESS CHECKLIST
                                                                            • SPECIFIC AIMS CHECKLIST
                                                                            • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                            • PRELIMINARY DATA CHECKLIST
                                                                            • DESIGN AND METHODS CHECKLIST
                                                                            • General
                                                                            • Approach
                                                                            • ABSTRACT CHECKLIST
                                                                            • BIOSKETCHES CHECKLIST
                                                                            • BUDGET CHECKLIST
                                                                            • RESOURCES CHECKLIST
                                                                            • REVISING CHECKLIST

                                                                    VII Problems and Concerns Commonly Cited by Reviewers

                                                                    Below is a list of the most common reasons cited by reviewers for an applications lack of success

                                                                    Lack of significance to the scientific issue being addressed

                                                                    Lack of original or new ideas

                                                                    Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

                                                                    Project too diffuse or superficial or lacks focus

                                                                    Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

                                                                    Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

                                                                    Rationale for experiments not provided (why important or how relevant to the hypothesis)

                                                                    Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

                                                                    Lack of alternative methodological approaches in case the primary approach does not work out

                                                                    Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

                                                                    The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

                                                                    The proposed experiments do not include all relevant controls

                                                                    Proposal innovative but lacking enough preliminary data

                                                                    Preliminary data do not support the feasibility of the project or the hypothesis

                                                                    Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

                                                                    The proposal lacks critical literature references causing reviewers to think that the

                                                                    applicant either does not know the literature or has purposely neglected critical published material

                                                                    Not clear which data were obtained by the investigator and which have been reported by others

                                                                    VIII Referral and Assignment of the Application

                                                                    When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                                    Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                                    Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                                    To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                                    You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                                    If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                                    IX Review of Research Project Applications

                                                                    This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                                    Scientific Review Groups

                                                                    Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                                    Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                                    Review Criteria

                                                                    In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                                    Significance Approach Innovation Investigator Environment

                                                                    To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                                    Cover Letter

                                                                    Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                                    State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                                    Administrative Review

                                                                    Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                    If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                    At the Peer Review Meeting

                                                                    Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                    Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                    How Priority Scores Are Determined

                                                                    If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                    Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                    Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                    1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                    2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                    3 Deferred In some instances the scientific review group is unable to make an

                                                                    adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                    Summary Statements

                                                                    Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                    Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                    Appeal

                                                                    You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                    X How Funding Is Decided

                                                                    Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                    Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                    How Paylines Work

                                                                    Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                    Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                    Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                    You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                    For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                    Second Level Peer Review

                                                                    In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                    They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                    Possible Outcomes of Secondary Review

                                                                    Following Council review NIAID takes one of four actions for an application

                                                                    1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                    Why Applications Are Kept on Hold

                                                                    ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                    Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                    XI When You Have Not Obtained Funding

                                                                    What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                    Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                    Most Common Reasons for a Low Score (in priority order)

                                                                    - Lack of new or original ideas

                                                                    - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                    - Methods unsuitable or defective and not likely to yield results

                                                                    - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                    - Data management and analysis vague unsophisticated

                                                                    - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                    - Poor resources or facilities limited access to appropriate patient population

                                                                    From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                    When to Revise

                                                                    How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                    If the problems are repairable revise the application and resubmit it to the same study section

                                                                    Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                    - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                    Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                    vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                    If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                    For fatal flaws and weaknesses rethink your idea and start over

                                                                    Revising Your Application

                                                                    Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                    Respond to reviewersrsquo comments

                                                                    The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                    Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                    Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                    additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                    Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                    Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                    If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                    XII When Your Application Is Approved for Funding

                                                                    If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                    Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                    If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                    There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                    For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                    Documentation

                                                                    Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                    Human subjects

                                                                    For more information concerning the human subjects assurance contact OHRP at

                                                                    Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                    And find a wealth of guidance documents on the Web

                                                                    Animals in Research

                                                                    For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                    Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                    Or see the Web site at Office of Laboratory Animal Welfare

                                                                    What You Can and Cannot Pay for on a Grant

                                                                    In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                    OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                    For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                    Terms and Conditions of Award

                                                                    Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                    Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                    NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                    Reporting Requirements

                                                                    Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                    Address and phone number are

                                                                    NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                    For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                    Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                    Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                    Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                    Checklists

                                                                    BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                    HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                    RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                    RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                    rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                    SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                    BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                    PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                    DESIGN AND METHODS CHECKLIST

                                                                    General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                    Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                    Does the PIs salary exceed the government cap of $141300

                                                                    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                    • howtopdf
                                                                      • Third Edition amended August 30 2001
                                                                      • The Original How to Write a Research Grant Application
                                                                        • I Before You Begin
                                                                            • If the answer is yes
                                                                            • Protection
                                                                            • Inclusion
                                                                            • Monitoring
                                                                            • Reporting
                                                                            • Training
                                                                            • Certifications and assurances
                                                                              • Most Common Reasons for a Low Score (in priority order)
                                                                              • BEGINNING CHECKLIST
                                                                              • HYPOTHESIS CHECKLIST
                                                                              • RESEARCH PLAN - PLANNING CHECKLIST
                                                                              • RESEARCH PLAN - PROCESS CHECKLIST
                                                                              • SPECIFIC AIMS CHECKLIST
                                                                              • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                              • PRELIMINARY DATA CHECKLIST
                                                                              • DESIGN AND METHODS CHECKLIST
                                                                              • General
                                                                              • Approach
                                                                              • ABSTRACT CHECKLIST
                                                                              • BIOSKETCHES CHECKLIST
                                                                              • BUDGET CHECKLIST
                                                                              • RESOURCES CHECKLIST
                                                                              • REVISING CHECKLIST

                                                                      applicant either does not know the literature or has purposely neglected critical published material

                                                                      Not clear which data were obtained by the investigator and which have been reported by others

                                                                      VIII Referral and Assignment of the Application

                                                                      When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                                      Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                                      Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                                      To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                                      You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                                      If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                                      IX Review of Research Project Applications

                                                                      This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                                      Scientific Review Groups

                                                                      Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                                      Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                                      Review Criteria

                                                                      In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                                      Significance Approach Innovation Investigator Environment

                                                                      To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                                      Cover Letter

                                                                      Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                                      State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                                      Administrative Review

                                                                      Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                      If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                      At the Peer Review Meeting

                                                                      Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                      Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                      How Priority Scores Are Determined

                                                                      If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                      Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                      Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                      1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                      2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                      3 Deferred In some instances the scientific review group is unable to make an

                                                                      adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                      Summary Statements

                                                                      Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                      Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                      Appeal

                                                                      You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                      X How Funding Is Decided

                                                                      Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                      Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                      How Paylines Work

                                                                      Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                      Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                      Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                      You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                      For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                      Second Level Peer Review

                                                                      In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                      They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                      Possible Outcomes of Secondary Review

                                                                      Following Council review NIAID takes one of four actions for an application

                                                                      1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                      Why Applications Are Kept on Hold

                                                                      ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                      Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                      XI When You Have Not Obtained Funding

                                                                      What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                      Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                      Most Common Reasons for a Low Score (in priority order)

                                                                      - Lack of new or original ideas

                                                                      - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                      - Methods unsuitable or defective and not likely to yield results

                                                                      - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                      - Data management and analysis vague unsophisticated

                                                                      - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                      - Poor resources or facilities limited access to appropriate patient population

                                                                      From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                      When to Revise

                                                                      How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                      If the problems are repairable revise the application and resubmit it to the same study section

                                                                      Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                      - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                      Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                      vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                      If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                      For fatal flaws and weaknesses rethink your idea and start over

                                                                      Revising Your Application

                                                                      Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                      Respond to reviewersrsquo comments

                                                                      The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                      Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                      Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                      additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                      Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                      Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                      If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                      XII When Your Application Is Approved for Funding

                                                                      If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                      Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                      If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                      There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                      For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                      Documentation

                                                                      Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                      Human subjects

                                                                      For more information concerning the human subjects assurance contact OHRP at

                                                                      Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                      And find a wealth of guidance documents on the Web

                                                                      Animals in Research

                                                                      For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                      Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                      Or see the Web site at Office of Laboratory Animal Welfare

                                                                      What You Can and Cannot Pay for on a Grant

                                                                      In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                      OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                      For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                      Terms and Conditions of Award

                                                                      Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                      Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                      NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                      Reporting Requirements

                                                                      Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                      Address and phone number are

                                                                      NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                      For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                      Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                      Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                      Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                      Checklists

                                                                      BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                      HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                      RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                      RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                      rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                      SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                      BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                      PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                      DESIGN AND METHODS CHECKLIST

                                                                      General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                      Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                      Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                      Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                      ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                      BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                      BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                      Does the PIs salary exceed the government cap of $141300

                                                                      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                      • howtopdf
                                                                        • Third Edition amended August 30 2001
                                                                        • The Original How to Write a Research Grant Application
                                                                          • I Before You Begin
                                                                              • If the answer is yes
                                                                              • Protection
                                                                              • Inclusion
                                                                              • Monitoring
                                                                              • Reporting
                                                                              • Training
                                                                              • Certifications and assurances
                                                                                • Most Common Reasons for a Low Score (in priority order)
                                                                                • BEGINNING CHECKLIST
                                                                                • HYPOTHESIS CHECKLIST
                                                                                • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                • SPECIFIC AIMS CHECKLIST
                                                                                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                • PRELIMINARY DATA CHECKLIST
                                                                                • DESIGN AND METHODS CHECKLIST
                                                                                • General
                                                                                • Approach
                                                                                • ABSTRACT CHECKLIST
                                                                                • BIOSKETCHES CHECKLIST
                                                                                • BUDGET CHECKLIST
                                                                                • RESOURCES CHECKLIST
                                                                                • REVISING CHECKLIST

                                                                        VIII Referral and Assignment of the Application

                                                                        When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

                                                                        Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

                                                                        Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

                                                                        To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

                                                                        You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

                                                                        If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

                                                                        IX Review of Research Project Applications

                                                                        This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                                        Scientific Review Groups

                                                                        Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                                        Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                                        Review Criteria

                                                                        In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                                        Significance Approach Innovation Investigator Environment

                                                                        To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                                        Cover Letter

                                                                        Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                                        State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                                        Administrative Review

                                                                        Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                        If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                        At the Peer Review Meeting

                                                                        Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                        Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                        How Priority Scores Are Determined

                                                                        If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                        Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                        Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                        1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                        2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                        3 Deferred In some instances the scientific review group is unable to make an

                                                                        adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                        Summary Statements

                                                                        Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                        Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                        Appeal

                                                                        You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                        X How Funding Is Decided

                                                                        Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                        Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                        How Paylines Work

                                                                        Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                        Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                        Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                        You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                        For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                        Second Level Peer Review

                                                                        In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                        They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                        Possible Outcomes of Secondary Review

                                                                        Following Council review NIAID takes one of four actions for an application

                                                                        1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                        Why Applications Are Kept on Hold

                                                                        ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                        Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                        XI When You Have Not Obtained Funding

                                                                        What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                        Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                        Most Common Reasons for a Low Score (in priority order)

                                                                        - Lack of new or original ideas

                                                                        - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                        - Methods unsuitable or defective and not likely to yield results

                                                                        - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                        - Data management and analysis vague unsophisticated

                                                                        - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                        - Poor resources or facilities limited access to appropriate patient population

                                                                        From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                        When to Revise

                                                                        How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                        If the problems are repairable revise the application and resubmit it to the same study section

                                                                        Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                        - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                        Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                        vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                        If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                        For fatal flaws and weaknesses rethink your idea and start over

                                                                        Revising Your Application

                                                                        Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                        Respond to reviewersrsquo comments

                                                                        The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                        Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                        Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                        additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                        Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                        Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                        If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                        XII When Your Application Is Approved for Funding

                                                                        If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                        Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                        If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                        There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                        For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                        Documentation

                                                                        Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                        Human subjects

                                                                        For more information concerning the human subjects assurance contact OHRP at

                                                                        Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                        And find a wealth of guidance documents on the Web

                                                                        Animals in Research

                                                                        For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                        Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                        Or see the Web site at Office of Laboratory Animal Welfare

                                                                        What You Can and Cannot Pay for on a Grant

                                                                        In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                        OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                        For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                        Terms and Conditions of Award

                                                                        Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                        Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                        NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                        Reporting Requirements

                                                                        Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                        Address and phone number are

                                                                        NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                        For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                        Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                        Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                        Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                        Checklists

                                                                        BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                        HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                        RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                        RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                        rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                        SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                        BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                        PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                        DESIGN AND METHODS CHECKLIST

                                                                        General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                        Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                        Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                        Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                        ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                        BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                        BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                        Does the PIs salary exceed the government cap of $141300

                                                                        RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                        WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                        REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                        • howtopdf
                                                                          • Third Edition amended August 30 2001
                                                                          • The Original How to Write a Research Grant Application
                                                                            • I Before You Begin
                                                                                • If the answer is yes
                                                                                • Protection
                                                                                • Inclusion
                                                                                • Monitoring
                                                                                • Reporting
                                                                                • Training
                                                                                • Certifications and assurances
                                                                                  • Most Common Reasons for a Low Score (in priority order)
                                                                                  • BEGINNING CHECKLIST
                                                                                  • HYPOTHESIS CHECKLIST
                                                                                  • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                  • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                  • SPECIFIC AIMS CHECKLIST
                                                                                  • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                  • PRELIMINARY DATA CHECKLIST
                                                                                  • DESIGN AND METHODS CHECKLIST
                                                                                  • General
                                                                                  • Approach
                                                                                  • ABSTRACT CHECKLIST
                                                                                  • BIOSKETCHES CHECKLIST
                                                                                  • BUDGET CHECKLIST
                                                                                  • RESOURCES CHECKLIST
                                                                                  • REVISING CHECKLIST

                                                                          IX Review of Research Project Applications

                                                                          This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

                                                                          Scientific Review Groups

                                                                          Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

                                                                          Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

                                                                          Review Criteria

                                                                          In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

                                                                          Significance Approach Innovation Investigator Environment

                                                                          To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

                                                                          Cover Letter

                                                                          Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

                                                                          State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

                                                                          Administrative Review

                                                                          Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                          If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                          At the Peer Review Meeting

                                                                          Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                          Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                          How Priority Scores Are Determined

                                                                          If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                          Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                          Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                          1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                          2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                          3 Deferred In some instances the scientific review group is unable to make an

                                                                          adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                          Summary Statements

                                                                          Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                          Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                          Appeal

                                                                          You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                          X How Funding Is Decided

                                                                          Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                          Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                          How Paylines Work

                                                                          Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                          Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                          Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                          You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                          For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                          Second Level Peer Review

                                                                          In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                          They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                          Possible Outcomes of Secondary Review

                                                                          Following Council review NIAID takes one of four actions for an application

                                                                          1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                          Why Applications Are Kept on Hold

                                                                          ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                          Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                          XI When You Have Not Obtained Funding

                                                                          What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                          Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                          Most Common Reasons for a Low Score (in priority order)

                                                                          - Lack of new or original ideas

                                                                          - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                          - Methods unsuitable or defective and not likely to yield results

                                                                          - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                          - Data management and analysis vague unsophisticated

                                                                          - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                          - Poor resources or facilities limited access to appropriate patient population

                                                                          From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                          When to Revise

                                                                          How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                          If the problems are repairable revise the application and resubmit it to the same study section

                                                                          Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                          - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                          Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                          vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                          If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                          For fatal flaws and weaknesses rethink your idea and start over

                                                                          Revising Your Application

                                                                          Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                          Respond to reviewersrsquo comments

                                                                          The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                          Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                          Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                          additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                          Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                          Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                          If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                          XII When Your Application Is Approved for Funding

                                                                          If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                          Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                          If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                          There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                          For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                          Documentation

                                                                          Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                          Human subjects

                                                                          For more information concerning the human subjects assurance contact OHRP at

                                                                          Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                          And find a wealth of guidance documents on the Web

                                                                          Animals in Research

                                                                          For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                          Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                          Or see the Web site at Office of Laboratory Animal Welfare

                                                                          What You Can and Cannot Pay for on a Grant

                                                                          In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                          OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                          For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                          Terms and Conditions of Award

                                                                          Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                          Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                          NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                          Reporting Requirements

                                                                          Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                          Address and phone number are

                                                                          NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                          For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                          Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                          Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                          Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                          Checklists

                                                                          BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                          HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                          RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                          RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                          rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                          SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                          BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                          PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                          DESIGN AND METHODS CHECKLIST

                                                                          General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                          Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                          Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                          Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                          ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                          BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                          BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                          Does the PIs salary exceed the government cap of $141300

                                                                          RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                          WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                          REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                          • howtopdf
                                                                            • Third Edition amended August 30 2001
                                                                            • The Original How to Write a Research Grant Application
                                                                              • I Before You Begin
                                                                                  • If the answer is yes
                                                                                  • Protection
                                                                                  • Inclusion
                                                                                  • Monitoring
                                                                                  • Reporting
                                                                                  • Training
                                                                                  • Certifications and assurances
                                                                                    • Most Common Reasons for a Low Score (in priority order)
                                                                                    • BEGINNING CHECKLIST
                                                                                    • HYPOTHESIS CHECKLIST
                                                                                    • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                    • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                    • SPECIFIC AIMS CHECKLIST
                                                                                    • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                    • PRELIMINARY DATA CHECKLIST
                                                                                    • DESIGN AND METHODS CHECKLIST
                                                                                    • General
                                                                                    • Approach
                                                                                    • ABSTRACT CHECKLIST
                                                                                    • BIOSKETCHES CHECKLIST
                                                                                    • BUDGET CHECKLIST
                                                                                    • RESOURCES CHECKLIST
                                                                                    • REVISING CHECKLIST

                                                                            Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

                                                                            If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

                                                                            At the Peer Review Meeting

                                                                            Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

                                                                            Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

                                                                            How Priority Scores Are Determined

                                                                            If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

                                                                            Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

                                                                            Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

                                                                            1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

                                                                            2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

                                                                            3 Deferred In some instances the scientific review group is unable to make an

                                                                            adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                            Summary Statements

                                                                            Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                            Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                            Appeal

                                                                            You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                            X How Funding Is Decided

                                                                            Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                            Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                            How Paylines Work

                                                                            Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                            Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                            Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                            You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                            For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                            Second Level Peer Review

                                                                            In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                            They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                            Possible Outcomes of Secondary Review

                                                                            Following Council review NIAID takes one of four actions for an application

                                                                            1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                            Why Applications Are Kept on Hold

                                                                            ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                            Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                            XI When You Have Not Obtained Funding

                                                                            What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                            Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                            Most Common Reasons for a Low Score (in priority order)

                                                                            - Lack of new or original ideas

                                                                            - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                            - Methods unsuitable or defective and not likely to yield results

                                                                            - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                            - Data management and analysis vague unsophisticated

                                                                            - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                            - Poor resources or facilities limited access to appropriate patient population

                                                                            From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                            When to Revise

                                                                            How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                            If the problems are repairable revise the application and resubmit it to the same study section

                                                                            Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                            - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                            Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                            vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                            If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                            For fatal flaws and weaknesses rethink your idea and start over

                                                                            Revising Your Application

                                                                            Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                            Respond to reviewersrsquo comments

                                                                            The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                            Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                            Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                            additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                            Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                            Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                            If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                            XII When Your Application Is Approved for Funding

                                                                            If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                            Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                            If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                            There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                            For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                            Documentation

                                                                            Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                            Human subjects

                                                                            For more information concerning the human subjects assurance contact OHRP at

                                                                            Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                            And find a wealth of guidance documents on the Web

                                                                            Animals in Research

                                                                            For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                            Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                            Or see the Web site at Office of Laboratory Animal Welfare

                                                                            What You Can and Cannot Pay for on a Grant

                                                                            In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                            OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                            For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                            Terms and Conditions of Award

                                                                            Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                            Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                            NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                            Reporting Requirements

                                                                            Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                            Address and phone number are

                                                                            NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                            For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                            Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                            Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                            Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                            Checklists

                                                                            BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                            HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                            RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                            RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                            rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                            SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                            BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                            PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                            DESIGN AND METHODS CHECKLIST

                                                                            General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                            Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                            Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                            Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                            ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                            BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                            BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                            Does the PIs salary exceed the government cap of $141300

                                                                            RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                            WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                            REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                            • howtopdf
                                                                              • Third Edition amended August 30 2001
                                                                              • The Original How to Write a Research Grant Application
                                                                                • I Before You Begin
                                                                                    • If the answer is yes
                                                                                    • Protection
                                                                                    • Inclusion
                                                                                    • Monitoring
                                                                                    • Reporting
                                                                                    • Training
                                                                                    • Certifications and assurances
                                                                                      • Most Common Reasons for a Low Score (in priority order)
                                                                                      • BEGINNING CHECKLIST
                                                                                      • HYPOTHESIS CHECKLIST
                                                                                      • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                      • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                      • SPECIFIC AIMS CHECKLIST
                                                                                      • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                      • PRELIMINARY DATA CHECKLIST
                                                                                      • DESIGN AND METHODS CHECKLIST
                                                                                      • General
                                                                                      • Approach
                                                                                      • ABSTRACT CHECKLIST
                                                                                      • BIOSKETCHES CHECKLIST
                                                                                      • BUDGET CHECKLIST
                                                                                      • RESOURCES CHECKLIST
                                                                                      • REVISING CHECKLIST

                                                                              adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

                                                                              Summary Statements

                                                                              Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

                                                                              Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

                                                                              Appeal

                                                                              You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

                                                                              X How Funding Is Decided

                                                                              Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                              Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                              How Paylines Work

                                                                              Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                              Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                              Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                              You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                              For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                              Second Level Peer Review

                                                                              In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                              They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                              Possible Outcomes of Secondary Review

                                                                              Following Council review NIAID takes one of four actions for an application

                                                                              1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                              Why Applications Are Kept on Hold

                                                                              ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                              Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                              XI When You Have Not Obtained Funding

                                                                              What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                              Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                              Most Common Reasons for a Low Score (in priority order)

                                                                              - Lack of new or original ideas

                                                                              - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                              - Methods unsuitable or defective and not likely to yield results

                                                                              - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                              - Data management and analysis vague unsophisticated

                                                                              - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                              - Poor resources or facilities limited access to appropriate patient population

                                                                              From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                              When to Revise

                                                                              How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                              If the problems are repairable revise the application and resubmit it to the same study section

                                                                              Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                              - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                              Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                              vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                              If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                              For fatal flaws and weaknesses rethink your idea and start over

                                                                              Revising Your Application

                                                                              Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                              Respond to reviewersrsquo comments

                                                                              The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                              Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                              Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                              additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                              Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                              Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                              If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                              XII When Your Application Is Approved for Funding

                                                                              If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                              Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                              If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                              There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                              For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                              Documentation

                                                                              Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                              Human subjects

                                                                              For more information concerning the human subjects assurance contact OHRP at

                                                                              Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                              And find a wealth of guidance documents on the Web

                                                                              Animals in Research

                                                                              For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                              Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                              Or see the Web site at Office of Laboratory Animal Welfare

                                                                              What You Can and Cannot Pay for on a Grant

                                                                              In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                              OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                              For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                              Terms and Conditions of Award

                                                                              Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                              Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                              NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                              Reporting Requirements

                                                                              Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                              Address and phone number are

                                                                              NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                              For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                              Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                              Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                              Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                              Checklists

                                                                              BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                              HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                              RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                              RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                              rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                              SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                              BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                              PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                              DESIGN AND METHODS CHECKLIST

                                                                              General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                              Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                              Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                              Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                              ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                              BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                              BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                              Does the PIs salary exceed the government cap of $141300

                                                                              RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                              WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                              REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                              • howtopdf
                                                                                • Third Edition amended August 30 2001
                                                                                • The Original How to Write a Research Grant Application
                                                                                  • I Before You Begin
                                                                                      • If the answer is yes
                                                                                      • Protection
                                                                                      • Inclusion
                                                                                      • Monitoring
                                                                                      • Reporting
                                                                                      • Training
                                                                                      • Certifications and assurances
                                                                                        • Most Common Reasons for a Low Score (in priority order)
                                                                                        • BEGINNING CHECKLIST
                                                                                        • HYPOTHESIS CHECKLIST
                                                                                        • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                        • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                        • SPECIFIC AIMS CHECKLIST
                                                                                        • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                        • PRELIMINARY DATA CHECKLIST
                                                                                        • DESIGN AND METHODS CHECKLIST
                                                                                        • General
                                                                                        • Approach
                                                                                        • ABSTRACT CHECKLIST
                                                                                        • BIOSKETCHES CHECKLIST
                                                                                        • BUDGET CHECKLIST
                                                                                        • RESOURCES CHECKLIST
                                                                                        • REVISING CHECKLIST

                                                                                X How Funding Is Decided

                                                                                Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

                                                                                Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

                                                                                How Paylines Work

                                                                                Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

                                                                                Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

                                                                                Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

                                                                                You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

                                                                                For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

                                                                                Second Level Peer Review

                                                                                In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

                                                                                They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

                                                                                Possible Outcomes of Secondary Review

                                                                                Following Council review NIAID takes one of four actions for an application

                                                                                1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                                Why Applications Are Kept on Hold

                                                                                ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                                Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                                XI When You Have Not Obtained Funding

                                                                                What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                                Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                                Most Common Reasons for a Low Score (in priority order)

                                                                                - Lack of new or original ideas

                                                                                - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                                - Methods unsuitable or defective and not likely to yield results

                                                                                - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                                - Data management and analysis vague unsophisticated

                                                                                - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                                - Poor resources or facilities limited access to appropriate patient population

                                                                                From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                                When to Revise

                                                                                How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                                If the problems are repairable revise the application and resubmit it to the same study section

                                                                                Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                                - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                                Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                                vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                                If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                                For fatal flaws and weaknesses rethink your idea and start over

                                                                                Revising Your Application

                                                                                Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                                Respond to reviewersrsquo comments

                                                                                The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                                Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                                Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                                additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                                Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                                Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                                If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                                XII When Your Application Is Approved for Funding

                                                                                If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                                Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                                If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                                There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                                For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                                Documentation

                                                                                Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                                Human subjects

                                                                                For more information concerning the human subjects assurance contact OHRP at

                                                                                Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                                And find a wealth of guidance documents on the Web

                                                                                Animals in Research

                                                                                For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                Or see the Web site at Office of Laboratory Animal Welfare

                                                                                What You Can and Cannot Pay for on a Grant

                                                                                In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                Terms and Conditions of Award

                                                                                Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                Reporting Requirements

                                                                                Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                Address and phone number are

                                                                                NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                Checklists

                                                                                BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                DESIGN AND METHODS CHECKLIST

                                                                                General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                Does the PIs salary exceed the government cap of $141300

                                                                                RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                • howtopdf
                                                                                  • Third Edition amended August 30 2001
                                                                                  • The Original How to Write a Research Grant Application
                                                                                    • I Before You Begin
                                                                                        • If the answer is yes
                                                                                        • Protection
                                                                                        • Inclusion
                                                                                        • Monitoring
                                                                                        • Reporting
                                                                                        • Training
                                                                                        • Certifications and assurances
                                                                                          • Most Common Reasons for a Low Score (in priority order)
                                                                                          • BEGINNING CHECKLIST
                                                                                          • HYPOTHESIS CHECKLIST
                                                                                          • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                          • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                          • SPECIFIC AIMS CHECKLIST
                                                                                          • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                          • PRELIMINARY DATA CHECKLIST
                                                                                          • DESIGN AND METHODS CHECKLIST
                                                                                          • General
                                                                                          • Approach
                                                                                          • ABSTRACT CHECKLIST
                                                                                          • BIOSKETCHES CHECKLIST
                                                                                          • BUDGET CHECKLIST
                                                                                          • RESOURCES CHECKLIST
                                                                                          • REVISING CHECKLIST

                                                                                  Following Council review NIAID takes one of four actions for an application

                                                                                  1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

                                                                                  Why Applications Are Kept on Hold

                                                                                  ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

                                                                                  Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

                                                                                  XI When You Have Not Obtained Funding

                                                                                  What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                                  Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                                  Most Common Reasons for a Low Score (in priority order)

                                                                                  - Lack of new or original ideas

                                                                                  - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                                  - Methods unsuitable or defective and not likely to yield results

                                                                                  - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                                  - Data management and analysis vague unsophisticated

                                                                                  - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                                  - Poor resources or facilities limited access to appropriate patient population

                                                                                  From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                                  When to Revise

                                                                                  How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                                  If the problems are repairable revise the application and resubmit it to the same study section

                                                                                  Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                                  - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                                  Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                                  vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                                  If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                                  For fatal flaws and weaknesses rethink your idea and start over

                                                                                  Revising Your Application

                                                                                  Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                                  Respond to reviewersrsquo comments

                                                                                  The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                                  Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                                  Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                                  additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                                  Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                                  Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                                  If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                                  XII When Your Application Is Approved for Funding

                                                                                  If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                                  Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                                  If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                                  There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                                  For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                                  Documentation

                                                                                  Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                                  Human subjects

                                                                                  For more information concerning the human subjects assurance contact OHRP at

                                                                                  Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                                  And find a wealth of guidance documents on the Web

                                                                                  Animals in Research

                                                                                  For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                  Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                  Or see the Web site at Office of Laboratory Animal Welfare

                                                                                  What You Can and Cannot Pay for on a Grant

                                                                                  In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                  OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                  For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                  Terms and Conditions of Award

                                                                                  Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                  Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                  NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                  Reporting Requirements

                                                                                  Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                  Address and phone number are

                                                                                  NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                  For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                  Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                  Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                  Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                  Checklists

                                                                                  BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                  HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                  RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                  RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                  rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                  SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                  BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                  PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                  DESIGN AND METHODS CHECKLIST

                                                                                  General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                  Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                  Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                  Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                  ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                  BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                  BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                  Does the PIs salary exceed the government cap of $141300

                                                                                  RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                  WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                  REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                  • howtopdf
                                                                                    • Third Edition amended August 30 2001
                                                                                    • The Original How to Write a Research Grant Application
                                                                                      • I Before You Begin
                                                                                          • If the answer is yes
                                                                                          • Protection
                                                                                          • Inclusion
                                                                                          • Monitoring
                                                                                          • Reporting
                                                                                          • Training
                                                                                          • Certifications and assurances
                                                                                            • Most Common Reasons for a Low Score (in priority order)
                                                                                            • BEGINNING CHECKLIST
                                                                                            • HYPOTHESIS CHECKLIST
                                                                                            • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                            • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                            • SPECIFIC AIMS CHECKLIST
                                                                                            • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                            • PRELIMINARY DATA CHECKLIST
                                                                                            • DESIGN AND METHODS CHECKLIST
                                                                                            • General
                                                                                            • Approach
                                                                                            • ABSTRACT CHECKLIST
                                                                                            • BIOSKETCHES CHECKLIST
                                                                                            • BUDGET CHECKLIST
                                                                                            • RESOURCES CHECKLIST
                                                                                            • REVISING CHECKLIST

                                                                                    XI When You Have Not Obtained Funding

                                                                                    What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

                                                                                    Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

                                                                                    Most Common Reasons for a Low Score (in priority order)

                                                                                    - Lack of new or original ideas

                                                                                    - Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

                                                                                    - Methods unsuitable or defective and not likely to yield results

                                                                                    - Data collection confused in design inappropriate instrumentation poor timing or conditions

                                                                                    - Data management and analysis vague unsophisticated

                                                                                    - Inadequate expertise or knowledge of field for PI or too little time to devote to the work

                                                                                    - Poor resources or facilities limited access to appropriate patient population

                                                                                    From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

                                                                                    When to Revise

                                                                                    How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

                                                                                    If the problems are repairable revise the application and resubmit it to the same study section

                                                                                    Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

                                                                                    - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                                    Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                                    vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                                    If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                                    For fatal flaws and weaknesses rethink your idea and start over

                                                                                    Revising Your Application

                                                                                    Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                                    Respond to reviewersrsquo comments

                                                                                    The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                                    Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                                    Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                                    additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                                    Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                                    Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                                    If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                                    XII When Your Application Is Approved for Funding

                                                                                    If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                                    Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                                    If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                                    There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                                    For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                                    Documentation

                                                                                    Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                                    Human subjects

                                                                                    For more information concerning the human subjects assurance contact OHRP at

                                                                                    Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                                    And find a wealth of guidance documents on the Web

                                                                                    Animals in Research

                                                                                    For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                    Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                    Or see the Web site at Office of Laboratory Animal Welfare

                                                                                    What You Can and Cannot Pay for on a Grant

                                                                                    In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                    OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                    For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                    Terms and Conditions of Award

                                                                                    Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                    Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                    NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                    Reporting Requirements

                                                                                    Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                    Address and phone number are

                                                                                    NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                    For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                    Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                    Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                    Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                    Checklists

                                                                                    BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                    HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                    RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                    RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                    rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                    SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                    BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                    PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                    DESIGN AND METHODS CHECKLIST

                                                                                    General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                    Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                    Does the PIs salary exceed the government cap of $141300

                                                                                    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                    • howtopdf
                                                                                      • Third Edition amended August 30 2001
                                                                                      • The Original How to Write a Research Grant Application
                                                                                        • I Before You Begin
                                                                                            • If the answer is yes
                                                                                            • Protection
                                                                                            • Inclusion
                                                                                            • Monitoring
                                                                                            • Reporting
                                                                                            • Training
                                                                                            • Certifications and assurances
                                                                                              • Most Common Reasons for a Low Score (in priority order)
                                                                                              • BEGINNING CHECKLIST
                                                                                              • HYPOTHESIS CHECKLIST
                                                                                              • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                              • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                              • SPECIFIC AIMS CHECKLIST
                                                                                              • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                              • PRELIMINARY DATA CHECKLIST
                                                                                              • DESIGN AND METHODS CHECKLIST
                                                                                              • General
                                                                                              • Approach
                                                                                              • ABSTRACT CHECKLIST
                                                                                              • BIOSKETCHES CHECKLIST
                                                                                              • BUDGET CHECKLIST
                                                                                              • RESOURCES CHECKLIST
                                                                                              • REVISING CHECKLIST

                                                                                      - Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

                                                                                      Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

                                                                                      vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

                                                                                      If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

                                                                                      For fatal flaws and weaknesses rethink your idea and start over

                                                                                      Revising Your Application

                                                                                      Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

                                                                                      Respond to reviewersrsquo comments

                                                                                      The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

                                                                                      Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

                                                                                      Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

                                                                                      additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                                      Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                                      Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                                      If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                                      XII When Your Application Is Approved for Funding

                                                                                      If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                                      Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                                      If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                                      There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                                      For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                                      Documentation

                                                                                      Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                                      Human subjects

                                                                                      For more information concerning the human subjects assurance contact OHRP at

                                                                                      Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                                      And find a wealth of guidance documents on the Web

                                                                                      Animals in Research

                                                                                      For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                      Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                      Or see the Web site at Office of Laboratory Animal Welfare

                                                                                      What You Can and Cannot Pay for on a Grant

                                                                                      In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                      OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                      For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                      Terms and Conditions of Award

                                                                                      Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                      Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                      NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                      Reporting Requirements

                                                                                      Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                      Address and phone number are

                                                                                      NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                      For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                      Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                      Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                      Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                      Checklists

                                                                                      BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                      HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                      RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                      RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                      rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                      SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                      BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                      PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                      DESIGN AND METHODS CHECKLIST

                                                                                      General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                      Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                      Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                      Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                      ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                      BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                      BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                      Does the PIs salary exceed the government cap of $141300

                                                                                      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                      • howtopdf
                                                                                        • Third Edition amended August 30 2001
                                                                                        • The Original How to Write a Research Grant Application
                                                                                          • I Before You Begin
                                                                                              • If the answer is yes
                                                                                              • Protection
                                                                                              • Inclusion
                                                                                              • Monitoring
                                                                                              • Reporting
                                                                                              • Training
                                                                                              • Certifications and assurances
                                                                                                • Most Common Reasons for a Low Score (in priority order)
                                                                                                • BEGINNING CHECKLIST
                                                                                                • HYPOTHESIS CHECKLIST
                                                                                                • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                • SPECIFIC AIMS CHECKLIST
                                                                                                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                • PRELIMINARY DATA CHECKLIST
                                                                                                • DESIGN AND METHODS CHECKLIST
                                                                                                • General
                                                                                                • Approach
                                                                                                • ABSTRACT CHECKLIST
                                                                                                • BIOSKETCHES CHECKLIST
                                                                                                • BUDGET CHECKLIST
                                                                                                • RESOURCES CHECKLIST
                                                                                                • REVISING CHECKLIST

                                                                                        additions deletions and changes in the revised application and address the main criticisms in the summary statement

                                                                                        Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

                                                                                        Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

                                                                                        If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

                                                                                        XII When Your Application Is Approved for Funding

                                                                                        If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                                        Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                                        If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                                        There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                                        For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                                        Documentation

                                                                                        Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                                        Human subjects

                                                                                        For more information concerning the human subjects assurance contact OHRP at

                                                                                        Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                                        And find a wealth of guidance documents on the Web

                                                                                        Animals in Research

                                                                                        For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                        Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                        Or see the Web site at Office of Laboratory Animal Welfare

                                                                                        What You Can and Cannot Pay for on a Grant

                                                                                        In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                        OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                        For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                        Terms and Conditions of Award

                                                                                        Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                        Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                        NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                        Reporting Requirements

                                                                                        Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                        Address and phone number are

                                                                                        NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                        For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                        Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                        Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                        Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                        Checklists

                                                                                        BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                        HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                        RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                        RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                        rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                        SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                        BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                        PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                        DESIGN AND METHODS CHECKLIST

                                                                                        General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                        Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                        Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                        Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                        ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                        BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                        BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                        Does the PIs salary exceed the government cap of $141300

                                                                                        RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                        WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                        REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                        • howtopdf
                                                                                          • Third Edition amended August 30 2001
                                                                                          • The Original How to Write a Research Grant Application
                                                                                            • I Before You Begin
                                                                                                • If the answer is yes
                                                                                                • Protection
                                                                                                • Inclusion
                                                                                                • Monitoring
                                                                                                • Reporting
                                                                                                • Training
                                                                                                • Certifications and assurances
                                                                                                  • Most Common Reasons for a Low Score (in priority order)
                                                                                                  • BEGINNING CHECKLIST
                                                                                                  • HYPOTHESIS CHECKLIST
                                                                                                  • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                  • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                  • SPECIFIC AIMS CHECKLIST
                                                                                                  • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                  • PRELIMINARY DATA CHECKLIST
                                                                                                  • DESIGN AND METHODS CHECKLIST
                                                                                                  • General
                                                                                                  • Approach
                                                                                                  • ABSTRACT CHECKLIST
                                                                                                  • BIOSKETCHES CHECKLIST
                                                                                                  • BUDGET CHECKLIST
                                                                                                  • RESOURCES CHECKLIST
                                                                                                  • REVISING CHECKLIST

                                                                                          XII When Your Application Is Approved for Funding

                                                                                          If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

                                                                                          Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

                                                                                          If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

                                                                                          There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

                                                                                          For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

                                                                                          Documentation

                                                                                          Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

                                                                                          Human subjects

                                                                                          For more information concerning the human subjects assurance contact OHRP at

                                                                                          Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

                                                                                          And find a wealth of guidance documents on the Web

                                                                                          Animals in Research

                                                                                          For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                          Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                          Or see the Web site at Office of Laboratory Animal Welfare

                                                                                          What You Can and Cannot Pay for on a Grant

                                                                                          In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                          OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                          For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                          Terms and Conditions of Award

                                                                                          Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                          Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                          NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                          Reporting Requirements

                                                                                          Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                          Address and phone number are

                                                                                          NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                          For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                          Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                          Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                          Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                          Checklists

                                                                                          BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                          HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                          RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                          RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                          rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                          SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                          BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                          PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                          DESIGN AND METHODS CHECKLIST

                                                                                          General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                          Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                          Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                          Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                          ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                          BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                          BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                          Does the PIs salary exceed the government cap of $141300

                                                                                          RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                          WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                          REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                          • howtopdf
                                                                                            • Third Edition amended August 30 2001
                                                                                            • The Original How to Write a Research Grant Application
                                                                                              • I Before You Begin
                                                                                                  • If the answer is yes
                                                                                                  • Protection
                                                                                                  • Inclusion
                                                                                                  • Monitoring
                                                                                                  • Reporting
                                                                                                  • Training
                                                                                                  • Certifications and assurances
                                                                                                    • Most Common Reasons for a Low Score (in priority order)
                                                                                                    • BEGINNING CHECKLIST
                                                                                                    • HYPOTHESIS CHECKLIST
                                                                                                    • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                    • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                    • SPECIFIC AIMS CHECKLIST
                                                                                                    • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                    • PRELIMINARY DATA CHECKLIST
                                                                                                    • DESIGN AND METHODS CHECKLIST
                                                                                                    • General
                                                                                                    • Approach
                                                                                                    • ABSTRACT CHECKLIST
                                                                                                    • BIOSKETCHES CHECKLIST
                                                                                                    • BUDGET CHECKLIST
                                                                                                    • RESOURCES CHECKLIST
                                                                                                    • REVISING CHECKLIST

                                                                                            Animals in Research

                                                                                            For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

                                                                                            Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

                                                                                            Or see the Web site at Office of Laboratory Animal Welfare

                                                                                            What You Can and Cannot Pay for on a Grant

                                                                                            In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

                                                                                            OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

                                                                                            For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

                                                                                            Terms and Conditions of Award

                                                                                            Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

                                                                                            Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

                                                                                            NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

                                                                                            Reporting Requirements

                                                                                            Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                            Address and phone number are

                                                                                            NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                            For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                            Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                            Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                            Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                            Checklists

                                                                                            BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                            HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                            RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                            RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                            rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                            SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                            BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                            PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                            DESIGN AND METHODS CHECKLIST

                                                                                            General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                            Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                            Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                            Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                            ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                            BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                            BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                            Does the PIs salary exceed the government cap of $141300

                                                                                            RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                            WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                            REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                            • howtopdf
                                                                                              • Third Edition amended August 30 2001
                                                                                              • The Original How to Write a Research Grant Application
                                                                                                • I Before You Begin
                                                                                                    • If the answer is yes
                                                                                                    • Protection
                                                                                                    • Inclusion
                                                                                                    • Monitoring
                                                                                                    • Reporting
                                                                                                    • Training
                                                                                                    • Certifications and assurances
                                                                                                      • Most Common Reasons for a Low Score (in priority order)
                                                                                                      • BEGINNING CHECKLIST
                                                                                                      • HYPOTHESIS CHECKLIST
                                                                                                      • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                      • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                      • SPECIFIC AIMS CHECKLIST
                                                                                                      • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                      • PRELIMINARY DATA CHECKLIST
                                                                                                      • DESIGN AND METHODS CHECKLIST
                                                                                                      • General
                                                                                                      • Approach
                                                                                                      • ABSTRACT CHECKLIST
                                                                                                      • BIOSKETCHES CHECKLIST
                                                                                                      • BUDGET CHECKLIST
                                                                                                      • RESOURCES CHECKLIST
                                                                                                      • REVISING CHECKLIST

                                                                                              Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

                                                                                              Address and phone number are

                                                                                              NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

                                                                                              For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

                                                                                              Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

                                                                                              Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

                                                                                              Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

                                                                                              Checklists

                                                                                              BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                              HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                              RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                              RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                              rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                              SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                              BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                              PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                              DESIGN AND METHODS CHECKLIST

                                                                                              General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                              Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                              Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                              Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                              ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                              BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                              BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                              Does the PIs salary exceed the government cap of $141300

                                                                                              RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                              WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                              REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                              • howtopdf
                                                                                                • Third Edition amended August 30 2001
                                                                                                • The Original How to Write a Research Grant Application
                                                                                                  • I Before You Begin
                                                                                                      • If the answer is yes
                                                                                                      • Protection
                                                                                                      • Inclusion
                                                                                                      • Monitoring
                                                                                                      • Reporting
                                                                                                      • Training
                                                                                                      • Certifications and assurances
                                                                                                        • Most Common Reasons for a Low Score (in priority order)
                                                                                                        • BEGINNING CHECKLIST
                                                                                                        • HYPOTHESIS CHECKLIST
                                                                                                        • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                        • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                        • SPECIFIC AIMS CHECKLIST
                                                                                                        • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                        • PRELIMINARY DATA CHECKLIST
                                                                                                        • DESIGN AND METHODS CHECKLIST
                                                                                                        • General
                                                                                                        • Approach
                                                                                                        • ABSTRACT CHECKLIST
                                                                                                        • BIOSKETCHES CHECKLIST
                                                                                                        • BUDGET CHECKLIST
                                                                                                        • RESOURCES CHECKLIST
                                                                                                        • REVISING CHECKLIST

                                                                                                Checklists

                                                                                                BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

                                                                                                HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

                                                                                                RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

                                                                                                RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

                                                                                                rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

                                                                                                SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                                BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                                PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                                DESIGN AND METHODS CHECKLIST

                                                                                                General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                                Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                                Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                                Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                                ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                                BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                                BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                                Does the PIs salary exceed the government cap of $141300

                                                                                                RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                                WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                                REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                                • howtopdf
                                                                                                  • Third Edition amended August 30 2001
                                                                                                  • The Original How to Write a Research Grant Application
                                                                                                    • I Before You Begin
                                                                                                        • If the answer is yes
                                                                                                        • Protection
                                                                                                        • Inclusion
                                                                                                        • Monitoring
                                                                                                        • Reporting
                                                                                                        • Training
                                                                                                        • Certifications and assurances
                                                                                                          • Most Common Reasons for a Low Score (in priority order)
                                                                                                          • BEGINNING CHECKLIST
                                                                                                          • HYPOTHESIS CHECKLIST
                                                                                                          • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                          • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                          • SPECIFIC AIMS CHECKLIST
                                                                                                          • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                          • PRELIMINARY DATA CHECKLIST
                                                                                                          • DESIGN AND METHODS CHECKLIST
                                                                                                          • General
                                                                                                          • Approach
                                                                                                          • ABSTRACT CHECKLIST
                                                                                                          • BIOSKETCHES CHECKLIST
                                                                                                          • BUDGET CHECKLIST
                                                                                                          • RESOURCES CHECKLIST
                                                                                                          • REVISING CHECKLIST

                                                                                                  SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

                                                                                                  BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

                                                                                                  PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

                                                                                                  DESIGN AND METHODS CHECKLIST

                                                                                                  General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

                                                                                                  Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

                                                                                                  Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                                  Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                                  ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                                  BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                                  BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                                  Does the PIs salary exceed the government cap of $141300

                                                                                                  RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                                  WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                                  REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                                  • howtopdf
                                                                                                    • Third Edition amended August 30 2001
                                                                                                    • The Original How to Write a Research Grant Application
                                                                                                      • I Before You Begin
                                                                                                          • If the answer is yes
                                                                                                          • Protection
                                                                                                          • Inclusion
                                                                                                          • Monitoring
                                                                                                          • Reporting
                                                                                                          • Training
                                                                                                          • Certifications and assurances
                                                                                                            • Most Common Reasons for a Low Score (in priority order)
                                                                                                            • BEGINNING CHECKLIST
                                                                                                            • HYPOTHESIS CHECKLIST
                                                                                                            • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                            • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                            • SPECIFIC AIMS CHECKLIST
                                                                                                            • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                            • PRELIMINARY DATA CHECKLIST
                                                                                                            • DESIGN AND METHODS CHECKLIST
                                                                                                            • General
                                                                                                            • Approach
                                                                                                            • ABSTRACT CHECKLIST
                                                                                                            • BIOSKETCHES CHECKLIST
                                                                                                            • BUDGET CHECKLIST
                                                                                                            • RESOURCES CHECKLIST
                                                                                                            • REVISING CHECKLIST

                                                                                                    Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

                                                                                                    Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

                                                                                                    ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

                                                                                                    BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

                                                                                                    BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

                                                                                                    Does the PIs salary exceed the government cap of $141300

                                                                                                    RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                                    WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                                    REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                                    • howtopdf
                                                                                                      • Third Edition amended August 30 2001
                                                                                                      • The Original How to Write a Research Grant Application
                                                                                                        • I Before You Begin
                                                                                                            • If the answer is yes
                                                                                                            • Protection
                                                                                                            • Inclusion
                                                                                                            • Monitoring
                                                                                                            • Reporting
                                                                                                            • Training
                                                                                                            • Certifications and assurances
                                                                                                              • Most Common Reasons for a Low Score (in priority order)
                                                                                                              • BEGINNING CHECKLIST
                                                                                                              • HYPOTHESIS CHECKLIST
                                                                                                              • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                              • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                              • SPECIFIC AIMS CHECKLIST
                                                                                                              • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                              • PRELIMINARY DATA CHECKLIST
                                                                                                              • DESIGN AND METHODS CHECKLIST
                                                                                                              • General
                                                                                                              • Approach
                                                                                                              • ABSTRACT CHECKLIST
                                                                                                              • BIOSKETCHES CHECKLIST
                                                                                                              • BUDGET CHECKLIST
                                                                                                              • RESOURCES CHECKLIST
                                                                                                              • REVISING CHECKLIST

                                                                                                      Does the PIs salary exceed the government cap of $141300

                                                                                                      RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

                                                                                                      WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

                                                                                                      REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

                                                                                                      • howtopdf
                                                                                                        • Third Edition amended August 30 2001
                                                                                                        • The Original How to Write a Research Grant Application
                                                                                                          • I Before You Begin
                                                                                                              • If the answer is yes
                                                                                                              • Protection
                                                                                                              • Inclusion
                                                                                                              • Monitoring
                                                                                                              • Reporting
                                                                                                              • Training
                                                                                                              • Certifications and assurances
                                                                                                                • Most Common Reasons for a Low Score (in priority order)
                                                                                                                • BEGINNING CHECKLIST
                                                                                                                • HYPOTHESIS CHECKLIST
                                                                                                                • RESEARCH PLAN - PLANNING CHECKLIST
                                                                                                                • RESEARCH PLAN - PROCESS CHECKLIST
                                                                                                                • SPECIFIC AIMS CHECKLIST
                                                                                                                • BACKGROUND AND SIGNIFICANCE CHECKLIST
                                                                                                                • PRELIMINARY DATA CHECKLIST
                                                                                                                • DESIGN AND METHODS CHECKLIST
                                                                                                                • General
                                                                                                                • Approach
                                                                                                                • ABSTRACT CHECKLIST
                                                                                                                • BIOSKETCHES CHECKLIST
                                                                                                                • BUDGET CHECKLIST
                                                                                                                • RESOURCES CHECKLIST
                                                                                                                • REVISING CHECKLIST

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