Preparing a R01 Research Application

Elizabeth S. Burnside, MD, MPH

Preparing a R01 Research Application

Objectives

• Motivation-Preparation• Regulations

– Directions/Changes– Relationship to Review Criteria

• Specific Guidance on Scientific Sections– Why grant fail– Why you can succeed!

Why the R01?

• Why and R01– Long-term funding

• Most awards for 3-5 years• Fund research infrastructure

– Often renewable– Highly valued

• Peer-reviewed • Recognized “stamp of approval”• Useful or required for promotion

Ready, Set, Plan!

• Get education you need– Understand appropriate funding sources

• Individual/program maturity

• Have Department/Institutional support– Find a mentor– Develop institutional collaborators

• Do a Review

Important Groundwork

• Think up a good idea– Review the literature– Give a lecture on the topic– Pay attention to feedback

• Reality test with a mentor– Refine the ideas together

TALK TO Program Directors or Project

Officers

Most Important

Follow the Directions

Read the Directions

Most Important = Least Exciting

Timeline for ChangesTimeline for Changes

Read about the application changes Read about the application changes nownow

Begin working on Research Strategy, but Begin working on Research Strategy, but wait to download the forms when they wait to download the forms when they become available starting December 1become available starting December 1

Use new forms for Use new forms for applications due on or applications due on or after January 25, 2010after January 25, 2010

What are the Directions?

• SF 424 (R&R)• Announcement

– PA (PAS or PAR)– RFA– RFP– FOA

DeadlinesDeadlinesFebFebJuneJuneOctOct

Alignment of the Application with Peer Review Criteria

• Application forms will be revised in three Application forms will be revised in three sections:sections:– Research plan– Resources– Biographical sketch

New Research Plan ComponentsNew Research Plan Components

Current Research Plan (Section 5.5) Restructured Research Plan (Section 5.5)1.Introduction to Application 1. Introduction to Application

2. Specific Aims 2. Specific Aims

3. Background and Significance 3. Research Strategy a. Significanceb. Innovationc. Approach

Preliminary Studies for New Applications Progress Report for Renewal/Revision

Applications

4. Preliminary Studies/Progress Report

5. Research Design and Methods

6. to 12. 4. to 10. (renumbered)

13. Select Agent Research 11. Select Agent Research (modified)

14. to 17. 12. to 15. (renumbered)

Other Components

6. Inclusion and Enrollment Report7. Progress Report Publication List8. Protection of Human Subjects9. Inclusion of Women and Minorities10. Targeted/Planned Enrollment11. Inclusion of Children12. Vertebrate Animals13. Select Agent Research14. Multiple PI Leadership Plan15. Consortium Arrangements16. Letters of Support17. Resource Sharing Plans

4. Inclusion and Enrollment Report5. Progress Report Publication List6. Protection of Human Subjects7. Inclusion of Women and Minorities8. Targeted/Planned Enrollment9. Inclusion of Children10. Vertebrate Animals11. Select Agent Research (modified)12. Multiple PI Leadership Plan13. Consortium Arrangements14. Letters of Support15. Resource Sharing Plan

Page Limits

Current Page Limit (Section 2-5 of the Research Plan)

New Page Limit (Research Strategy)

<25 6

25 12

>25 Follow Announcment Instructions

Main Proposal Components

• Specific Aims• Significance• Innovation• Approach

• Significance• Investigator(s)• Innovation• Approach• Environment

Review Criteria

NIH Review Criteria

• Significance– Does research:

• Address an important problem?• Advance knowledge in the field?• Effect existing concepts that drive the field?

NIH Review Criteria (con’d)

• Innovation– Are the aims original and innovative?– Are concepts, approaches or methods novel?– Does the project challenge existing paradigms

or develop new methodologies or technologies?

NIH Review Criteria (con’d)

• Approach– Are the conceptual framework, design,

methods and analyses adequately developed, well integrated and appropriate to the aims?

– Does the applicant acknowledge potential problem areas and consider alternative approaches?

Main Proposal Components

• Specific Aims• Significance• Innovation• Approach

• Significance• Investigator(s)• Innovation• Approach• Environment

Review Criteria

Grant Components (other stuff)

• Abstract• Budgets and Budget Justification• Biosketches• Resources• Letters of Support (#14)

Revisions to Biographical Revisions to Biographical SketchSketch

• Personal Statement added: Personal Statement added: – Experience and qualifications particularly Experience and qualifications particularly

well-suited for your role in the projectwell-suited for your role in the project• Publications revised: Publications revised:

– no more than 15 publications no more than 15 publications – Emphasize recency, importance to the Emphasize recency, importance to the

field, and/or relevance to the application field, and/or relevance to the application

Revisions to ResourcesRevisions to Resources

• Instructions added to Resources:Instructions added to Resources:– How the scientific environment will How the scientific environment will

contribute to the probability of successcontribute to the probability of success– Institutional investment in the new Institutional investment in the new

investigator (ESI)investigator (ESI)• Instructions added to Research PlanInstructions added to Research Plan

– Select Agents Research describe the Select Agents Research describe the biocontainment resources (#11)biocontainment resources (#11)

Specifics

SF424 (R&R) Application and Electronic Submission Information is

available at:http://grants.nih.gov/grants/funding/

424/index.htm

Specific Aims

• Executive summary• Remainder of proposal must flow from it• MAJOR influence on reviewers

– may be the only page non-assigned reviewers read• Write it first, last and every day in between• Generally includes

– body/text– numbered aims & sub-aims

Hypothesis

Specific Aims

• Broad, clearly defined aims (generally 3)• Precise sub-aims

– Clear statement of work using “strong” terms such as define, determine, demonstrate

• Must accomplish goal and lead to endpoint• Don’t need to mention methods

– Methods accomplish aims, aims are not methods• Specific hypotheses

– correspond to the aims

Significance

• Why spend the money?– current state of knowledge, unresolved issues– Relationship to other work in the field– demonstrate potential impact on healthcare– know the study section & reference their work

• FOCUS IS VERY IMPORTANT– NOT too large in scope

Innovation

• What is novel?– Many opportunities for innovation

• scientific question is new• aims challenge existing paradigms• project develops new methodologies or technologies• concepts, approaches or methods are novel

Approach

• Overview– summarize work to be done and importance– often similar structure to body/text of Aims page– overall approach should be logical– think of this as “the big picture”

• Research team/environment– describe roles of key personnel– convince reviewers that you have the best possible team– highlight institutional strengths that make it likely the proposed

research will be successful

Preliminary Studies

• Demonstrate your expertise as a researcher– Show experience with specific techniques to be used– Demonstrate clinical expertise & access to patients– Highlight expertise of collaborators as complementary

• Results must support aims of study– ideally, suggest need for research you are proposing– Indicates that specific aims are reasonable– note: NIH uses 5% acceptable failure rate

Approach (con’d)

• Timeline/timetable– generally includes text & graphics– justify funding period or expect to be cut– detail verifies understanding of the project & methods

• Detailed methods– parallel aims/hypotheses –VERBATIM (check!)– include

• recruitment strategies, • sample size calculations• statistical approaches

– absolutely no “hand waving”

Approach (con’d)

• Anticipated results & limitations– important section that is frequently omitted– anticipate potential problems & propose

solutions– provides reviewer insight into how you might

handle the problems that will almost invariably arise

Why Grants Fail

• Poor science– the quality of the research is the most

important– sending in an application with poor science is the SUREST WAY TO FAIL

• Poor organization– if the proposal is hard to follow, the reviewer

will get frustrated and/or angry and simply give up

Why Grants Fail (con’d)

• Poor integration– Different parts of the proposal must clearly relate to

each other – convince the reviewer:• worth doing (Significance)• can be done (Preliminary studies)• has been carefully thought through (Approach)

• No Contradiction or superficiality– internally consistent– detailed enough

Why Grants Fail (con’d)

• Inadequate qualifications– PI (you) must be capable of doing the work– Collaborators & support personnel need to be

sufficiently qualified & adequately funded– Environment needs to have the infrastructure

to support scientific aims

Grant Writing Pointers

• Do a Review – Walk in their shoes

• Proposal should be interesting and easy to read– Use formatting for clarity– text, figures, legends must be legible to– ≥ margin & font guidelines– subheadings & boldings

Advice

• Talk early and often to project officers– Email first– Contact by phone

• Persistence… The way it used to be:

Rejection

Submission

Ugh !

FUNDINGYay !

Advice

• Talk early and often to project officers– Email first– Contact by phone

• Now only 2 application rounds!

Submission

Ugh !

FUNDINGYay !

Rejection

Conclusions

• Generate an OUTSTANDING PROPOSAL• Capture the reviewers’ interest• Focus … less is often more

Questions?