1. Grant Writing Thomas S. Buchanan NIH Review Process Study Sections Review Criteria Summary Statement Responding to a Review

2. NIH Study Section Meeting Each Study Section has 12-23 regular members plus temporary ad hoc members university, government, industry scientists “ regular ” and “ ad hoc ” One regular member is chair Scientific Review Officer (SRO) is NIH ’ s overseer and works for CSR Up to 60-100 proposals reviewed in a session

3. NIH Study Section Meeting Each proposal is assigned to a primary reviewer a secondary & usually a tertiary reviewer can have 1-3 “ readers ” (do not write full reviews) Each reviewer has about 10 reviews to write and several proposals to read Everyone is free to discuss/comment Everyone scores every proposal

4. Reviewers Reviewers are not blinded to the applicants because they must assess their qualifications The applicants will be told who was on the review panel Reviewers leave the room during the discussion if they work at the applicant ’ s institution are otherwise close to the applicant

5. NIH study section meeting

6. “ Streamlining ” or triage at start reviewers provide list of proposals they reviewed that were in bottom half if assigned reviewers agree and no one objects, proposal not scored or discussed anyone can object, no argument necessary Usually < half streamlined Norm is ~10-20 min. per discussed proposal

7. NIH study section meeting Initial level of enthusiasm Primary reviewer presents the proposal description positive and negative aspects Secondary & tertiary reviews follow detail depends on extent of agreement Readers comment, general discussion 1º, 2º, 3º reviewers suggest scores Everyone writes down their own score

8. NIH study section meeting Scores are 1 (best) to 9 (worst) Anything ≥ 5 should be streamlined Mean score of all study section members x 10 = reported score (i.e., scale = 10-90)

9. NIH study section meeting Calculating an R01 ’ s percentile score: All the applications for the current study section meeting are pooled with those from the previous 2 meetings of the same study section; total = N The scores are rank-ordered and i th application ’ s percentile is calculated as 100 x (i - 0.5) / N

10. Ethics, Etiquette, and Politics The SRO and chair are ethics watchdogs no conflicts of interest, real or perceived no discussions of application between reviewer and applicant, before or afterward all discussions of applications between reviewers must occur in session The mood of the room is professional Other NIH administrators usually present

11. NIH Funding Decisions Funding is based on 2 levels of review study section - 90% of the decision the institute’s advisory council The “ council ” = intramural and extramural scientists and administrators assess quality of reviews decide on grant ’ s budget factor in legislative mandates cannot alter the scientific evaluation or score

12. Program Manager Note that the Program Manager at the Institute has almost no say in the initial review process This is very different than at NSF The Program Manager can help guide you towards particular funding mechanisms (R01 vs R03, etc.) Once a proposal receives a priority score, the Program Manager has some discretion to “ help ” borderline proposals.

13. NIH Review Process Video clip from CSR http://youtu.be/fBDxI6l4dOA

14. How to Improve your Grant Proposal Assessment, revisions, etc.

15. Afterwards: the Summary Statement Study section, roster Score, percentile Budget recommendations Summary of the discussion Reviewers ’ critiques

16. The Critique For R and P grants (e.g., R03, P01), the five scored criteria for research grant applications are Significance, Investigator(s), Innovation, Approach, and Environment. Other grant types have different scored criteria (e.g., K, F, T and S awards) The final score for any grant is based on overall impact.

18. Overall Impact (R & P awards) “Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed)”

19. 1. Significance “Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?”

20. 2. Investigators(s) “Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?”

21. 3. Innovation “Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?”

22. 4. Approach (1 of 2) “Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?”

23. 4. Approach (2 of 2) “If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?”

24. 5. Enviornment “Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?”

25. Additional Review Criteria These might not affect the score, but can influence reviewers’ enthusiasm: Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals Biohazards Budget Resource Sharing Plan (Data Sharing Plan, Sharing Model Organisms, & Genome Wide Associate Studies) These are not discussed by SS until after the proposal is scored.

26. Responding to a Review How not to respond to a review http://youtu.be/H69n3LmwlTI

27. Afterwards: the Revision Carefully analyze the critiques what was uniformly disliked what should be changed vs. re-explained what additional data could be provided Are there words of encouragement embedded in the criticisms? Are significant strengths mentioned? “... above average enthusiasm… ”

28. Afterwards: the Revision If the chances for successfully addressing the criticisms seem good, revise begin with “ Introduction ” addressing reviewers ’ criticisms be gracious, respond positively you may or may not get the same reviewers, but your attitude and effort to respond will be appreciated

29. Afterwards: the Revision You get 1 chance to revise; after that you have to submit a “ different ” proposal If you revise and resubmit promptly, you will have 2 proposals in the “ pool ” oddities of scoring and funding occur if you were close to the funding cutoff, this may increase your odds of success

30. Summary: the “ do ’ s ” good idea, science, and application mechanistic, testable hypotheses convincing, appropriate preliminary data detailed research plan, based on statistical planning write clearly, state your case as rationally and convincingly as possible revise repeatedly before submission

31. Summary: the “don’ts” Not too simple, not too ambitious the problem must be significant 10 hypotheses is probably too many! avoid sloppy writing use spell checker, check your grammar don't make unsupported statements don't wait until the last minute; it shows!

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35. Sample Summary Statements Courtesy of Hank Donahue Go hereGo here!