Preparing a R01 Research Application

1. Preparing a R01 Research Application Elizabeth S. Burnside, MD, MPH

2. Objectives • Motivation-Preparation • Regulations • Directions/Changes • Relationship to Review Criteria • Specific Guidance on Scientific Sections • Why grant fail • Why you can succeed!

3. 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

4. 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

5. Important Groundwork TALK TO Program Directors or Project Officers • 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

6. Most Important Most Important = Least Exciting Read the Directions Follow the Directions

7. Timeline for Changes Read about the application changes now Begin working on Research Strategy, but wait to download the forms when they become available starting December 1 Use new forms for applications due on or after January 25, 2010

8. What are the Directions? Deadlines Feb June Oct • SF 424 (R&R) • Announcement • PA (PAS or PAR) • RFA • RFP • FOA

9. Alignment of the Application with Peer Review Criteria • Application forms will be revised in three sections: • Research plan • Resources • Biographical sketch

10. New Research Plan Components

11. Other Components • Inclusion and Enrollment Report • Progress Report Publication List • Protection of Human Subjects • Inclusion of Women and Minorities • Targeted/Planned Enrollment • Inclusion of Children • Vertebrate Animals • Select Agent Research (modified) • Multiple PI Leadership Plan • Consortium Arrangements • Letters of Support • Resource Sharing Plan • Inclusion and Enrollment Report • Progress Report Publication List • Protection of Human Subjects • Inclusion of Women and Minorities • Targeted/Planned Enrollment • Inclusion of Children • Vertebrate Animals • Select Agent Research • Multiple PI Leadership Plan • Consortium Arrangements • Letters of Support • Resource Sharing Plans

12. Page Limits

13. Main Proposal Components • Specific Aims • Significance • Innovation • Approach • Significance • Investigator(s) • Innovation • Approach • Environment Review Criteria

14. NIH Review Criteria • Significance • Does research: • Address an important problem? • Advance knowledge in the field? • Effect existing concepts that drive the field?

15. 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?

16. 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?

17. Main Proposal Components • Specific Aims • Significance • Innovation • Approach • Significance • Investigator(s) • Innovation • Approach • Environment Review Criteria

18. Grant Components (other stuff) • Abstract • Budgets and Budget Justification • Biosketches • Resources • Letters of Support (#14)

19. Revisions to Biographical Sketch • Personal Statement added: • Experience and qualifications particularly well-suited for your role in the project • Publications revised: • no more than 15 publications • Emphasize recency, importance to the field, and/or relevance to the application

20. Revisions to Resources • Instructions added to Resources: • How the scientific environment will contribute to the probability of success • Institutional investment in the new investigator (ESI) • Instructions added to Research Plan • Select Agents Research describe the biocontainment resources (#11)

21. Specifics SF424 (R&R) Application and Electronic Submission Information is available at: http://grants.nih.gov/grants/funding/424/index.htm

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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”

29. 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

30. 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

31. 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

32. 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

33. 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

34. Advice • Talk early and often to project officers • Email first • Contact by phone • Persistence… The way it used to be: Rejection FUNDING Ugh ! Yay ! Submission

35. Advice • Talk early and often to project officers • Email first • Contact by phone • Now only 2 application rounds! FUNDING Rejection Ugh ! Yay ! Submission

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

37. Questions?