El Paso Successful Grant Writing-MAS.ppt - Index - Institutional

Successful Grant Writing forSuccessful Grant Writing for NIH

Milton J. Hernández, Ph.D.Director

Michael A. Sesma, Ph.D.Program OfficialDirector

Division of Loan RepaymentOEP, OER, OD

gResearch Training and Career Development ProgramDivision of Developmental

National Institutes of HealthBethesda, MD [email protected]

pTranslational ResearchNIMH/NIHBethesda, MD. 20892@ g Bethesda, MD. [email protected]

“Anatomy” of Grant Process“Anatomy” of Grant Process

Program StaffProgram Staff ProgramProgramResearcherResearcherAnnouncementAnnouncement

or RFAor RFACollaboratorsCollaborators

Grant ApplicationGrant Application(R01, R03, R21,(R01, R03, R21,ev

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n IdeaIdeaInstitutionInstitution

( , , ,( , , ,K01, K08, etc.)K01, K08, etc.)

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NationalNationalAdvisoryAdvisoryProgram StaffProgram Staff

CSRCSRReferralReferralyy

CouncilCouncilProgram Staff Program Staff ReferralReferral

and Review and Review

Grant Writing for SuccessGrant Writing for SuccessGrant Writing for SuccessGrant Writing for Success

Writing the ApplicationWriting the Application

• Start early• Seek advice from colleagues• Seek advice from colleagues• Start with a good idea• Talk to your NIH Program Official(s)• Use the NIH webpage (www.nih.gov)• Remember review criteria• Follow instructions carefullyy

Transition to Electronic Submission (http://era.nih.gov/ElectronicReceipt/)( p g p )

What Determines Which Grants Are Funded?What Determines Which Grants Are Funded?What Determines Which Grants Are Funded?What Determines Which Grants Are Funded?

•• Scientific Scientific merit merit -- Priority ScorePriority Score

•• Program considerationsProgram considerations

•• Availability of fundsAvailability of funds

NIH Award MechanismsNIH Award Mechanisms

GrantsNumerous grant mechanismsR01s, R21s, R03s, K99’s, etc. Multi-project grants- PsInvestigator initiated (PA) or solicited (RFA)

Cooperative agreements“U” grants, used for complex studies, most clinical trial networksSubstantial NIH staff involvementSolicited (RFA)

ContractsN01sSolicited (RFP)

Three Ways to Work with an ICThree Ways to Work with an IC

Submit an application for a grant or contractApply for your own funding for a research project grant at any time Apply to a specific competition for grant set-asides (RFA)

ifi t t titi (RFP BAA)or a specific contract competition (RFP, BAA) Indirectly through someone who has funding from the IC

Collaborate with an extramural awardee as a sub-recipientCollaborate with our Intramural Research Program through material transfer agreements, etc.

Gain access to IC sponsored resourcesGet help and in-kind materials from our specimen resources, etc.

A l i f G ( S b i i )Applying for Grants (e-Submission)

Grant Submission DatesGrant Submission Dateshttp://http://grants.nih.gov/grants/funding/submissionschedule.htm#elecgrants.nih.gov/grants/funding/submissionschedule.htm#elechttp://http://grants.nih.gov/grants/funding/submissionschedule.htm#elecgrants.nih.gov/grants/funding/submissionschedule.htm#elec

Electronic SubmissionElectronic Submission

Most types of NIH grant applications are submitted y gelectronically via Grants.Gov eRA Commons is a web-based system for secure information exchange with applicants and applicant organizationsexchange with applicants and applicant organizations (http://commons.era.nih.gov/)Applicants must establish personal eRA Commons accounts t t k i d t t i dto track review progress and to retrieve scores and summary statements

You must register for e-submission

Register on Grants.govRegister with US CCR Obt i DUNS bObtain DUNS numberObtain Grants.gov credentialsAssign an AOR to submit grantsg gNon-US institution or organization may require additional registration with a North Atlantic Treaty Organization Commercial and Government Entity (NCAGE)Co e c a a d Go e e y ( C G )

Register on eRA CommonsBoth applicant and organization must registerO ti i t tiOne-time registrationEnables you to receive and transmit information or application electronically This process may take 4 8 weeksThis process may take 4-8 weeks

Applying for an NIH GrantApplying for an NIH Grant

“I don’t really care about that administrative stuff!”But it is IMPORTANT:

To understand how NIH works!To understand how NIH works!Easy to disengage and only focus on the lab

Network with NIH staffTalk to us at meetings, on the phone, by emailThe squeaky wheel gets the oilIf I don’t know you, how can I help you?If I don t know you, how can I help you?

Understand how NIH peer review worksLearn what works and what doesn’t in peer review AND funding

Are You a “New Investigator”?Are You a “New Investigator”?Are You a New Investigator ?Are You a New Investigator ?NIH fosters research independence of early career investigatorsDefinition: Has not previously served as PI on any PHS grant

Except for R03, R15, R21 or mentored K awardsGet special considerations during peer review and IC funding decisionsResource web site with further information

grants1.nih.gov/grants/new_investigators

Are you an Early Stage Investigator (ESI)?NIH fosters research independence of early career investigatorsgDefinition: Has completed his or her terminal research degree or medical residency—whichever

10date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grantresearch grant Get special considerations during peer review and IC funding decisionsg

Where are applications reviewed?

CSR

•Study Sections

•Research Project Grants (R01s)•AREA Grants (R15s)•Fellowships (F32s & F31s)SBIRs•Study Sections •SBIRs

•Shared Instrumentation Grants•Small Grants (R03s)•Exploratory/Developmental Grant (R21s)

INSTITUTES

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•Program Project Grants (P01s)•Center Grants (P30s)

•Scientific Review Groups•Contract Review Ctees.

•Center Grants (P30s)•Training Grants (T32s)•K Grants•RFAs (some of which will be for R01s)C t t•Contracts

Wh r th P r R i r ?Who are the Peer Reviewers?

Established Investigators few assistantEstablished Investigators - few assistant professorsDemonstrated scientific expertiseDemonstrated scientific expertiseMature judgment Breadth of perspectiveBreadth of perspectiveImpartialityAdequate representation of women and minority q p yscientistsDiversity of expertises represented

Peer Review: Evaluation CriteriaPeer Review: Evaluation Criteria

Review of applications based on NIH standard i it ireview criteria

SignificanceApproachApproachInnovationInvestigatorEnvironment

Also initiative specific review criteria, when applicableDifferent criteria for training related applications

Peer Review: New NIH Scoring SystemPeer Review: New NIH Scoring System

Score Descriptor Additional Guidance on Strengths/Weaknesses

1 Exceptional Exceptionally strong with essentially no weaknesses1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with negligible weaknesses

3 Excellent Very strong with only some minor weaknesses y g y

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weaknesses

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

Peer Review: ProcessPeer Review: Process

Th SRO d f i th t l t NThe SRO prepares an order of review that clusters New Investigator (NI) applications, Early Stage Investigator applications (ESIs) and clinical applications if feasible.NI and ESI applications are identified for reviewers so there can be appropriate review in context of career stage. Expectations of preliminary data and publication track recordExpectations of preliminary data and publication track recordless than for established investigators.

MOST IMPORTANT SLIDE!Most common reasons for not receiving funds:

Lack of new or original ideasLack of new or original ideasDiffuse, superficial or unfocused research planLack of knowledge of published relevant workLack of experience in the essential methodologyUncertainty concerning the future directionsQuestionable reasoning in experimental approachg p ppAbsence of acceptable scientific rationaleUnrealistically large amount of workL k f ffi i t i t l d t ilLack of sufficient experimental detailUncritical approach

Formula for Successful Applications

Start with a Good IdeaStart with a Good Idea

Does it address an important problem?Will scientific knowledge be advanced?Does it build upon or expand current knowledge?Is it feasible …

to implement?to investigate?

Good GrantsmanshipGood Grantsmanship

Contact NIH program staff earlyAssess IC interest & “goodness of fit”Assess IC interest & goodness of fitAre there related FOAs?Searching web sites is good start butSearching web sites is good start … but follow up with personal contactSend a 2 3 page concept paper to aSend a 2 – 3 page concept paper to a program contact

Good GrantsmanshipWhat’s a Concept Paper?

Good Grantsmanship

Facilitates productive discussion with Program OfficialStudy Goals

You want support from which IC to do what?ppProblem/Background

Why does this topic need study?Significance

Why this is important to the field?Research Question

What hypotheses will you test?Design/AnalysisDesign/Analysis

What study design and statistical approach do you propose?Team

Who will be the key participants and collaborators?Who will be the key participants and collaborators?

Good GrantsmanshipGood Grantsmanship

Collaborate with other investigatorsFill gaps in your expertise and trainingAdd critical skills to your teamAdd critical skills to your team

“Team Science” is the new directionSupport for multidisciplinary research projectspp p y p jConsider the Multiple-PI Model

Talk to NIH program contact if the project involves multiple PIs

grants1 nih gov/grants/multi pigrants1.nih.gov/grants/multi_pi

Good GrantsmanshipGood Grantsmanship

Ask a colleague to review your draftAsk a colleague who does not already know

h t i t d t dwhat you intend to doAsk a colleague who is not your best friend

Y d ft i d t d t dYour draft reviewers need to understandWhat you intend to doWhy you believe it is important to doWhy you believe it is important to do Exactly how you are going to do it

Leave enough time to make revisionsLeave enough time to make revisions

Good Presentation

Read the application instructions carefully3 Simple Steps:

Read the application instructions carefullyRead the application instructions carefullyD ’t f tDon’t forget … ... read the application instructions carefully

http://enhancing-peer-review.nih.gov/restructured_applications.html

Alignment of Application Format with Review Criteria

Core Review Criteria Application

Significance Research Strategya. Significance

Investigator(s) BiosketchPersonal Statement

Innovation Research StrategyInnovation Research Strategyb. Innovation

Approach Research Strategypp gyc. Approach

Environment ResourcesE iEnvironment

Application Changes

Ch t th t f li tiChanges to three parts of application:Biographical sketchResearch PlanResources

Changes in page limits and format

Application Changes: Biographical Sketch (4 pages)

P l St t t h i dPersonal Statement – why experience and qualifications make the applicant particularly well suited for role in the projectwell-suited for role in the projectPublications limited to 15

5 t t5 most recent5 best5 most rele ant to the application5 most relevant to the application

Restructured Research Plan:

Previous Previous ApplicationApplication New ApplicationNew ApplicationSignificance, Innovation, Approach

Background and Background and SignificanceSignificance

Research StrategyResearch Strategya.a. SignificanceSignificancea.a. SignificanceSignificanceb.b. InnovationInnovationcc ApproachApproach

Research Design and Research Design and MethodsMethods c.c. ApproachApproach

•• Preliminary Studies Preliminary Studies for New Applicationsfor New Applications

Preliminary Preliminary Studies/Progress Studies/Progress

•• Progress Report for Progress Report for Renewal/RevisionRenewal/Revision

ggReportReport

Review Criteria now aligned with Application Format

Application Changes: Resources

Facilities and Other ResourcesFacilities and Other Resources(in 424 part of the R&R Other Project Information; in 398

the Resources Format Page)

Environment - New instruction to address how scientific environment will contribute to probabilityscientific environment will contribute to probability of success, unique features of environment, etc. For ESIs, provide description of institutional , p pinvestment in success of the investigator.

Good Presentation

TitleCaptures the essence of goals and objectivesCaptures the essence of goals and objectives

AbstractConcise presentation of the projectCo c se p ese a o o e p ojecStatement of significance Hypotheses and research questionsMethods and analyses

Some reviewers may see only these

Good Presentation

Organize the Research Strategy to answer 4 essential questions:essential questions:

What do you intend to do?

Why is the work important?

What has already been done?What has already been done?

How are you going to do the work?

Good PresentationGood Presentation

Address the Core review criteriaAddress the Core review criteria Significance: Does the study address an important problem? How will scientific knowledge be advanced?problem? How will scientific knowledge be advanced?

Approach: Are design and methods well-developed and appropriate? Are problem areas addressed?

Innovation: Are there novel concepts or approaches? Are the aims original and innovative?

Investigator: Is the investigator appropriately trained?

Environment: Does the scientific environment contribute to the probability of success? Are there unique features of thethe probability of success? Are there unique features of the scientific environment?

Good Presentation

P id ll f d h lProvide well-focused research planKeep specific aims simple … and specificLink hypotheses to specific aimsExplain method chosen to test everyExplain method chosen to test every hypothesisDon’t ander from the main themeDon’t wander from the main themeA conceptual model can clarify ideas

Good Presentation

Be realistic … not overly ambitiousDiscuss potential problem areas p pDiscuss possible solutions

Explain rationale for your decisions p yBe explicitReviewers cannot read your mindReviewers cannot read your mind … Don’t assume they know what you intend

Good Presentation

Prepare a reviewer-friendly applicationBe well organized and clearg

Use logical transitions between sections

Add ti h di j d iAdd section headings -- major and minor

Make tables and figures easy to view

Eliminate all mispeelings and type-O’s

Good Presentation

Prepare a reviewer-friendly applicationBe well organized and clearg

Use logical transitions between sections

Add ti h di j d iAdd section headings -- major and minor

Make tables and figures easy to view

Eliminate all misspellings and typo’s

Good Review

Get to the right review groupGet to the right review groupMake sure your application goes to the right review group*review groupTitle, abstract, specific aims all point to the main goals of your projectgoals of your projectInclude a Cover Letter

suggest IC and review group assignment*suggest IC and review group assignmentOutline key expertise needed for appropriate reviewdo not name specific reviewers

* Consult with Program Officer

Good Review

Good Presentation will keep your reviewers happyReviewers often work late at night Help them stay alert and interested p yMake your application easy to read and easy to understandConvince reviewers to advocate for your idea

Get reviewers on your side!Get reviewers on your side!

Good LuckGood Luck

Results from:Good Ideas Good GrantsmanshipGood Presentation Good ReviewGood Review

Elements of an Outstanding G A li iGrant Application

New or original ideasNew or original ideasPilot data (essential for R01/ less critical for Fs and Ks)Fs and Ks)Focused, incisive research planKnowledge of published relevant workKnowledge of published relevant workExperience in the essential methodologyFuture directions and contingency plansFuture directions and contingency plans

Writing an R01 (Regular Research Grant)Di l f i iDirectly from a senior reviewer

W it S ifi Ai ti d di ith tWrite Specific Aims section and discuss with mentor or an NIH granteeGive yourself four weeks to write first draftFull draft to mentor one month before submission date

Read and follow the instructions (electronic 424)Prepare budget with budget personPrepare budget with budget person

Write for a general scientific audienceSimple is betterpRepetition is good

Writing an R01 (cont’d)

You must have simple testable hypothesis that is supported by preliminary datasupported by preliminary data

Study Sections are conservativeNo preliminary data = No awardNo preliminary data No award

Demonstrate medical significanceRationale, limitations of methods, controls, and back-up plans are criticalDetails of methods are unimportant (boring) but make sure the reviewers know you know the methods and say sothe reviewers know you know the methods and say soGet collaborators and consultants- strong letters

R01 Common Errors

Not discussing literature that is contrary to your ideasN t di i t th d li it ti f d tNot discussing strengths and limitations of your data-don’t let reviewer do it for you!Proposing too much for 3 or 5 yearsProposing too much for 3 or 5 yearsCommon criticisms:

“This Specific Aim could serve as an entire grant in and of itself”“Research is unfocused”“St d i biti ”“Study is overambitious”“Not clear investigator has needed experience”

R01 Common Errors (cont’d)

Lack of relationship to diseasepMethodology over Biology is not goodDescriptive vs Hypothesis-driven

“Looking at” (bad) vs “testing” (good)“Fishing expedition” (bad)

No biostatistical supportSample size (power) calculations for animal or human studiesstudiesInadequate control group

Specific Aims

The most critical page in the applicationIt is a one page summary of the application

Wh i thi bl i ifi t?Why is this problem significant?What is the exciting preliminary data?What are the hypothesis supported by the data?What are the hypothesis supported by the data?

Simple list of your Aims is goodBe generalAvoid long (laundry) list of things you are going to do2-3 Specific Aims is sufficient

Research Strategy

Assume you are not writing for an experty g pEmphasize general medical importance and then specific importance of your topicAvoid jargonAvoid jargonDiscuss controversies in the areaAvoid selective citation of the literatureMake your story interesting- make the reviewer want to read more!Correct English grammar and attention to typographicalCorrect English, grammar, and attention to typographical errors is important.Reviewers like a “pretty” application.

Preliminary Data

Show primary data for critical methodsAbout 10-15 readable figures or tables Progress Report- for renewals

Restate Aims (avoid laundry list)Publication list MUST be very strong No production no grantPublication list MUST be very strong. No production- no grant

Convince reviewer that you can do what you propose

Approach (Methods)

Do you have the right tools and experience?Is this the right model system/preparation?Are there adequate controls?Are you discussing the pitfalls and alternatives?Avoid details (volumes, components of buffers)Show a time line - reviewers like them

Response to Critiques - When you resubmit an application

You have 1 page to explain how you revised the application in response to issues identified by the reviewers - make it easy for reviewer to find your “answers”reviewers make it easy for reviewer to find your answersMisunderstandings are your fault- if they missed a key fact in a figure or table, maybe it wasn’t clear enoughBe diplomatic and positive (most reviewer’s comments areBe diplomatic and positive (most reviewer s comments are good). Don’t argue with reviewers.Avoid tone that says “You (the reviewer) don’t know anything about this area”anything about this areaAddress every single criticismAvoid overstating your data

Don’t give up!!

Initial failure is commonUnderstand which parts of the application process areUnderstand which parts of the application process are under your controlLearn from a failed submission and succeed - majority dodo

Study criticisms in Summary StatementDiscuss with program to decide if problems are p g prepairableAttend diligently to each criticismKeep a positive tone and attitudeKeep a positive tone and attitude

“Highly improved” amended applications tend to do well.

www nih govwww.nih.gov

grants1.nih.gov/grants/oer.htm

NIH OERNIH Guide for Grants and ContractsNIH Guide for Grants and Contracts

NIH Guide for Grants and Contracts

Official publication listing NIH funding and policyOfficial publication listing NIH funding and policy noticesPublished weeklyyList grants and contracts

Request for Applications (RFA)Request for Applications (RFA)Program Announcements (PA)Request for Proposals (RFP)Request for Proposals (RFP)

Research Portfolio Online Reporting Tool (RePORT) http://report.nih.gov/index.aspx

A Searchable database of federally supported biomedical research -- Replaces C.R.I.S.P. Access reports, data, analyses, expenditures, results of NIH supported research activitiesId tif A l IC( ) h tf liIdentify, Analyze IC(s) research portfolios, funding patterns, funded investigators:

• Identify areas with many or few funded projects• Identify NIH-funded investigators and their research• Identify potential mentors/collaborators

grants1.nih.gov/grants/grant_tips.htm

www.niaid.nih.gov/ncn/grants/