NIH Review Procedures

1. NIH Review Procedures Betsy Myers Hospital for Special Surgery

2. General Process for Proposal Review • Applicant has idea • Forms are submitted • Proposal is reviewed for scientific merit • Summary statement is prepared • Funding Institute or Center gives information to applicant www.csr.nih.gov

3. Receipt and Review Process at NIH • >10,000 applications arrive at given deadline! • Receipt/review process organized in 3 cycles per year

4. Assignment Process at NIH • Assignment based on Abstract, Specific Aims, more if needed • Each application assigned to funding Institute(s)/Center(s) • Application also assigned to Integrated Review Group (IRG) within Center for Scientific Review (CSR) or to Institute/Center (IC) review group

5. Assignment Process at NIH • CSR: • R01s, R03s, R21s, Small business, Fellowships • Reviews for >1 Institute • IC Review: • Program projects, Training grants, Career development awards, Responses to Requests for Applications • Specific to Institute

6. Assignment Process at NIH • Application then assigned to Study Section • NIH officials will consider requests for these assignments • Cover letter

7. Process at NIH Scientific Review Administrator (SRA) of Study Section decides on reviewers from within members of Study Section or from ad hoc members

8. Appointment of Reviewers to Study Section • SRA recruits members of Study Section • Qualifications • Expert with training and experience in relevant scientific field • Level of formal education • Quantity and quality of relevant research • PI on research project comparable to those being reviewed

9. Appointment of Reviewers to Study Section SRA also needs to address • Diversity in gender, race, ethnicity and geographic distribution • Fairness and evenhandedness in review • Willingness to do the work required • Ability to write and present clearly

10. Appointment of Reviewers to Study Section Types of appointments to study section • Regular: Typically several years • Temporary: One time on standing study section, may lead to regular appointment • Special emphasis panel: One time only

11. Roster of Study Section Available Online Meeting Roster - ZRG1    MOSS-A 91 (4/6/2005 - 4/6/2005) CENTER FOR SCIENTIFIC REVIEWSPECIAL EMPHASIS PANELZRG1 MOSSA4/6/2005-4/6/2005MEETING ROSTER CHAIRPERSON--------------------------------------MYERS,  ELIZABETH  R. , PHDASSOCIATE PROFESSORWEILL MEDICAL COLLEGE OF CORNELL UNIVERSITYASSOCIATE SCIENTIST, HOSPITAL FOR SPECIAL SURGERYNEW YORK,  NY 10021 MEMBERS----------------ADAMS,  JOHN   S. ,  MDPROFESSORDEPARTMENT OF MEDICINECEDARS-SINAI MEDICAL CENTERLOS ANGELES,  CA 90048 AHLGREN,  SARA   C. ,  PHD… http://www.csr.nih.gov/Committees/rosterindex.asp

12. Assignment of Applications to Reviewers • SRA matches grant applications to specific reviewers • Tries to ensure • Appropriate expertise • Diverse scientific viewpoints • Tries to avoid • Overload of particular reviewer • Potential conflict of interest

13. Assignment of Applications to Reviewers 2 reviewers and 1 discussant (typically) are assigned to each proposal • Primary reviewer • Secondary reviewer • Reader (does not need to prepare written review prior to meeting of study section) Could be more – Tertiary, more Readers

14. NIH Review Criteria NIH review criteria for unsolicited research project grant applications (R01, R03, R21) • Significance • Important problem • Advancement of scientific knowledge or clinical practice • Influence on methods that drive the field

15. NIH Review Criteria • Approach • Adequate development and integration of design, methods, analyses • Acknowledgment of potential problems, alternatives • Innovation • Challenge to existing paradigms • Novel concepts, approaches, methods

16. NIH Criteria • Investigator • Appropriate training, experience • Complementary and integrated team • Environment • Conducive to probability of success • Unique features of scientific environment • Institutional support

17. NIH Criteria • Other criteria • Gender/minority/children inclusion • Budget • Protection of humans, animals, and environment • Overall rating • Numerical score that reflects overall impact

18. REVIEW CRITERIA: “K” Awards • Candidate • Career Development Plan • Research Plan • Mentor/Co-Mentor(s) • Environment & Institutional Commitment

19. NIH Numerical Rating Priority score: Single, global score for proposal WORST BEST 5.0 4.0 3.0 2.0 1.0 Lowest Priority Average application Highest Priority Strong in all categories

20. Guide to Calibrating Score

21. Submitting Critique Before Meeting Electronic submission of reviews • Several days before meeting, reviewers upload score and written critique • Once uploaded, can then read other reviewers’ scores and reviews • Once uploaded, reviewer cannot make changes to scores or critiques until after meeting

22. Study Section Meeting Streamlined Applications • Definition: • Not in upper half • Priority score higher than 3 • Does not apply to career awards, fellowships (R13, R18, F06, F32/33) 5.0 4.0 3.0 2.0 1.0

23. Study Section MeetingStreamlining Streamlining Procedure • Reviewers asked ahead of time to recommend applications not in upper half (“unscored” or “streamlined”) • SRA compiles list • List discussed at beginning of meeting • Any member may ask for proposal to be discussed

24. Study Section MeetingStreamlining Benefits and rationale • Gives time for in-depth discussion of better applications • Saves costs if meeting is shortened • Reduces work of scientific review administrators Less than 25% of applications will be funded

25. Study Section MeetingStreamlining • If application is streamlined, applicant receives unaltered written critiques • Fate of unscored applications?

26. Study Section MeetingReview Procedures Review procedure for proposals to be scored • Chair introduces application • Each reviewer gives preliminary numerical score or range • Primary reviewer covers description and comments • Other assigned reviewers add comments

27. Study Section MeetingReview Procedures Review procedure, continued • Discussion ensues • Consensus is not necessary • Chair calls for priority rating • Every members scores

28. Resume Summary Statement is prepared • SRA asks reviewers to modify critiques to reflect discussion • SRA writes resume and summary of discussion in front • Summary Statement (“Pink Sheets”) sent to applicant

29. Final Score • Average of all scores multiplied by 100 • Example: • Average of raw scores from review panel = 1.88 • Final score = 188

30. Percentiles • Percentiles indicate your rank relative to other applications reviewed by group • 0.1 (best) to 99.5 (worst) •  percentage of proposals receiving better score during last year • Example: Score: 188, Percentile: 11

31. Applications Used in Percentile Conversion • R01 reviewed at standing study section • Percentile of score relative to all scores from current round plus last two rounds (1 year) • R01 reviewed at special emphasis panel • May be percentiled against distribution of all CSR scores

32. Funding Decision Flowchart http://www.niaid.nih.gov/ncn/grants/charts/flowchart_funding.htm

33. Thank you