Getting to Know How NIH Works: Peer Review of NIH Applications

1. Getting to Know How NIH Works:Peer Review of NIH Applications Shawn R. Drew, Ph.D. Program Director National Institute of General Medical Sciences Oct. 2010

2. National Institutes of Health • Much of the biomedical research in the U.S. is supported by the Federal Government, primarily the National Institutes of Health

3. National Institutes of Health http://www.nih.gov • NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by: - conducting research in our own labs - supporting research outside NIH - training research investigators; and - fostering communication

4. 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 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 Center on Minority Health and Health Disparities Fogarty International Center National Center for Research Resources Clinical Center Center for Information Technology Center for Scientific Review National Institutes of Health

5. Typical NIH Institute/Center Office of the IC Director National Advisory Council Board of Scientific Counselors Intramural Extramural Scientific Programs Laboratory Studies Clinical Studies Grants Fellowships

6. NIH Funded Research • FY2010 ~$28 billion dollar budget • 10% = Intramural (~6,000 scientists in our own laboratories) • 80% = Extramural (50,000 competitive grants; 212,000 researchers; 2,800 colleges & universities)

8. $28 Billion Budget How can YOU get some of the money?

9. Submit Application to NIH Application NIH

10. Previously – Paper Applications Submitted to NIH through CSR • Approximately 50,000 applications are submitted to NIH each year • 20-25% are funded

11. Now Electronic Applications Submitted via Grants.gov • Approximately 50,000 applications are submitted to NIH each year • 20-25% are funded

12. Sample Application Number Type Serial Number Amended 1 F31 CA 12345 01 A1 New National Grant Application Cancer Support Institute Year

13. Scientific Review Groups (SRG) • SRG (or called Study Sections, or Initial Review Groups- IRG) are managed by a Scientific Review Administrator (SRA) who is a professional, usually at the Ph.D. level, whose scientific background is close to the expertise of the study section • Each standing study section has 12 - 24 members who are primarily from academia • As many as 60 - 100 applications are reviewed at each study section meeting

14. Scientific Review Administrator (SRA) • Selects reviewers and assigns applications to the reviewers (primary, secondary and reader) based on their areas of expertise • Manages Study Sections • Prepares Summary Statements (written critique)

15. Selection of Peer Reviewers Active and Productive Researchers Research Capability Non-Research Non-Doctoral Scientific Community

16. Selection of Peer Reviewers • Demonstrated Scientific Expertise • Doctoral Degree (or Equivalent) • Mature Judgment • Work Effectively in a Group Context • Breadth of Perspective • Impartiality • Interest in Serving • Adequate Representation of Women and Minority Scientists

17. What Happens at SRG Meetings? • Closed to the Public • Orientation • Conflict of Interest • Policies and Procedures • Introductions of persons present • Streamlining of Applications • Application-by-application discussion • Persons with conflicts of interest excused • Assigned reviewers (primary, secondary and reader) give preliminary scores • Discussion of application’s scientific and technical merit • Assigned reviewers first, then other members • Range of scores set • Every member scores every application • Human and animal subject codes; recommended changes to budget

18. What Happens at SRG Meetings?

19. Review of Applications • Applications are evaluated prior to the SRG meeting • SRG meeting is time for discussion and negotiation of a priority score and for making recommendations that best reflects the scientific and technical merit of the application

20. FELLOWSHIPS Student Mentor Proposed Research Environment RESEARCH GRANTS Significance Innovation Investigator Approach Environment Review Criteria

21. Research Involving Human Subjects Important Considerations • Is the proposed study exempt from human subject review? • Are there any apparent risks* to the human subjects? • Are the protections adequate? • What are the potential benefits to the subjects and to mankind? • Are the inclusions of minorities and both genders adequately addressed? *“Risks” include the possibility of physical, psychological, or social injury resulting from research

22. Inclusion of Women and Minorities in Clinical Research • Women and minorities must be considered for inclusion in all clinical research NIH supports OR • Appropriate justification must be provided to explain why they are not included in proposed research

23. Research Involving Children • Children must be considered for inclusion in all human subject research NIH supports • If children are not included, applicant must justify exclusion

24. Animal Welfare Important Considerations • Will anticipated results be for the good of society? • Will work be planned and performed by qualified scientists? • Will animals be treated so as to avoid any unnecessary discomfort, pain, anxiety, or poor health? *“Risks” include the possibility of physical, psychological, or social injury resulting from research

25. Hazardous Conditions Important Considerations • Are the necessary special facilities available to protect the environment and research personnel from potentially hazardous conditions? • Will biohazardous materials be handled appropriately? • Have employees been adequately trained in safe practices?

26. Scientific Review Group Actions • Score • Unscore • Defer

28. Summary Statement • Contains: • Overall Resume and Summary of Review • Essentially Unedited Critiques • Priority Score (and Percentile Ranking) • Budget Recommendations • Administrative Notes

29. How to Read the Summary Statement • Critique 1 -Investigator: strengths – experience in the field • Critique 2 -Investigator: weakness – little experience in the field • Resume: ~ a paragraph at top of summary statement that describes entire 12+ member panel, not just critiques of 2 people

30. Council Actions • Council = Second Level of Review • Role – to look at fairness of initial review • Concur with SRG action OR • Modify SRG action • Cannot change priority score • Defer for re-review; no changes allowed

31. Applicant may request IC & SRG Application (Grants.gov) Application to NIH (CSR) NIH Application Process Overview RFA CSR assigns to SRG, IC CSR sends to IC Summary Statement to PI Review by CSR SRG Review by IC SRG Second Level Council Review Fundable Not Fundable Applicant Notified and Given Feedback IC Negotiates Award PI Evaluates Feedback Award Ends, Renewal Application Prepared Revised Application Prepared

32. What Determines Funding? • Scientific merit • Program considerations • Availability of funds

33. Questions?Contact Information Shawn Drew, Ph.D. 301-594-3900 DrewL@mail.nih.gov