NIH OBSSR Summer Institute July 2012

1. Overview of the NIH Peer Review Process Kate Bent, RN, PhDSenior Advisor to the Director, Center for Scientific Review NIH OBSSR Summer Institute July 2012 National Institutes of HealthU.S. Department of Health and Human Services

3. My plan: • Overview: Submission and review processes Why? • The more you know about the process and your audience - the more likely you will be able to develop a solid application

4. NIH Peer Review System for Grant Applications First Level of Review Scientific Review Group (Study Section) • Second Level of Review • NIH Institute/Center Council

5. Center for Scientific Review

6. National Institutes of Health Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine National Library of Medicine National Institute on Minority Health and Health Disparities John E. Fogarty International Center National Center for Advancing Translational Research Clinical Center Center for Information Technology Center for Scientific Review

7. Your Application Goes to the NIH Center for Scientific Review (CSR) • Receives all NIH applications • Refers them to NIH Institutes/Centers and to scientific review groups • Reviews majority of grant applications for scientific merit Focal Point for Initial Review at NIH MISSION: To see that NIH grant applications receive fair, independent, expert, and timely reviews – free from inappropriate influences – so NIH can fund the most promising research.

8. CSR Peer Review – Fiscal Year 2011 • 85,000 applications received • 58,000 applications reviewed • 16,000 reviewers • 230 Scientific Review Officers • 1,465 review meetings

9. Applications Are Assigned to: • Institutes or Centers based on─ • Overall mission and guidelines of the Institute or Center • Specific programmatic mandates and interests of the Institute or Center • Integrated Review Groups based on─ • Specific review guidelines for each Integrated Review Group (IRG)

10. Cover Letter The cover letter should be used for a number of important purposes: • Suggest Institute/Center assignment • Suggest review assignment • Identify individuals in potential conflict and explain why • Identify areas of expertise needed to evaluate the application • Discuss any special situations It is NOT appropriate to use the cover letter to suggest specific reviewers.

11. The Study Section

12. Peer Review in CSR • CSR Study Sections are managed by a Scientific Review Officer (SRO) who is a doctoral-level professional, whose scientific background is close to the focus of the study section. • Each CSR standing study section has 12-25 regular members who are from the scientific community. • Temporary members are recruited as needed. • About 60-100 applications are normally reviewed at each study section meeting.

13. Role of the Scientific Review Officer • Performs administrative and technical review of applications to ensure completeness and accuracy • Selects reviewers based on broad input • Manages study section meetings • Prepares summary statements • Provides any requested information about study section recommendations to Institutes/Centers and National Advisory Councils/Boards Designated Federal Official with overall responsibility for the review process

14. How Reviewers Are Selected for Study Section Service • Demonstrated scientific expertise/research support • Doctoral degree or equivalent • Mature judgment • Work effectively in a group context • Breadth of perspective • Impartiality • Representation of women and minority scientists • Geographic distribution

15. Before the Study Section Meeting • Each application is assigned to 3 or more reviewers 5-6 weeks in advance • Reviewer assess each application by providing: • A preliminary Overall Impact score • Criterion Scores for each of the 5 Core Review Criteria • A written critique

16. The Study Section Meeting

17. At The Meeting Order of Review The average of the preliminary Overall Impact score from the assigned reviewers determines the review order Discussions start with the application with the best average preliminary Overall Impact score Clustering of Review New Investigator R01 applications are clustered Clinical applications & other mechanisms may be clustered (n ≥ 20) Not Discussed Applications About half the applications will be discussed Applications unanimously judged by the review committee to be in the lower half are not discussed

18. New and Early Stage Investigators • New Investigator (NI) • PD/PI who has not yet competed successfully for a substantial NIH research grant • Early Stage Investigator (ESI) • PD/PI who qualifies as a New Investigator AND is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent) http://grants.nih.gov/grants/new_investigators/

19. Electronic reviews are used when needed to recruit the best reviewers Alternative Review Platforms Internet Assisted Meetings Telephone Assisted Meetings Video Assisted Meetings Telepresence Meetings Hybrid meetings Your Application Could Be Reviewed Electronically

20. Review Criteria • Overall Impact • Assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved • Core Review Criteria • Significance • Investigator(s) • Innovation • Approach • Environment Review criteria each scored from 1-9

21. Scoring 9-point score scale is used to provide: • Criterion Scores for each of the 5 core review criteria • Overall Impact/Priority Score based on but not a sum of the core criterion scores plus additional criteria All applications receive scores: • Not discussedapplications will receive only initial criterion scores from the three assigned reviewers. • Discussedapplications also receive an averaged overall impact score from eligible (i.e., without conflicts of interest) panel members.

22. Additional Criteria Contribute to Overall Impact Scores Protections for human subjects Inclusions of women, minorities, and children Appropriate use of vertebrate animals Management of biohazards

23. Other Considerations which do Not Affect Overall Impact Scores Resource Sharing Plans: Data Model Organisms Genome Wide Association Studies Foreign Organizations Select Agents Budget

24. Your Summary Statement • Scores for each review criterion • Critiques from assigned reviewers • Administrative notes if any If your application is discussed, you also will receive: • An overall impact/priority score and percentile ranking • A summary of review discussion • Budget recommendations

25. Program Officer Summary Statement Impact/Priority Score 10-90 range Percentile in whole numbers Percentile: 29 New Indicator for Early Stage Investigators

26. Who Can Answer Your Questions? Before You Submit Your Application • A Program Officer at an NIH Institute or Center • Scientific Review Officer After You Submit • Your Scientific Review Officer After Your Review • Your Assigned Program Officer GrantsInfo: GrantsInfo@nih.gov – 301 435-0714

27. “You miss 100% of the shots you never take.” Wayne Gretzky

28. CSR and NIH Information Sources

29. NIH Guide For Grants and Contracts U.S. Department of Health and Human Services • Announces NIH Scientific Initiatives • Provides NIH Policy and Administrative Information • Supplies links to application forms • Available on the NIH Web Site: http://www.nih.gov

30. A Window to Your Application: eRA Commons eRA Commons is an online interface where a grant applicant can: • Check submitted grant application for errors and warnings and view final image • Track review assignment, view review outcomes (score, summary statements), find contact info • Update Personal Profile to ensure Early Stage Investigator eligibility is in place • Submit pre-award information (just in time) • View Notice of Award and other key documents And much more! https://commons.era.nih.gov/commons/

31. Check the Status of Your Application in NIH Commons

32. View the Videos • NIH Peer Review Revealed • NIH Tips for Applicants • What Happens to Your NIH Grant Application http://www.csr.nih.gov/video/video.asp

33. NIH Peer Review Information on the Web National Institutes of Health: http://www.nih.gov • Office of Extramural Research http://www.nih.gov/grants/oer.htm • Grants Policy http://www.nih.gov/grants/policy/policy.htm • Electronic Submission http://era.nih.gov/ElectronicReceipt Center for Scientific Review: http://www.csr.nih.gov • Resources for Applicants http://www.csr.nih.gov/ResourcesforApplicants • CSR Study Section Rosters http://www.csr.nih.gov/committees/rosterindex.asp • Review Group Meeting Dates http://www.csr.nih.gov/Committees/meetings/ssmeet1.asp

34. CSR Web Site: http://www.csr.nih.gov • About CSR • Applicant Resources • Study Sections • Rosters and Meetings

35. Helpful Handouts Insider’s Guide What Happens to NIH Grant Application to Peer Review Your Grant Application Useful Web Links http://cms.csr.nih.gov/publications/