The NIH Grant Review Process

1. The NIH Grant Review Process Hiram Gilbert, Ph.D. Dept. of Biochemistry, Baylor College of Medicine Xander Wehrens, M.D. Ph.D. Dept. of Molecular Physiology & Biophysics, and Medicine, BCM

2. Overview of This Presentation • Introduction into NIH grant review process • Review criteria • NIH review cycles • VIDEO of mock study section • Recent changes at the NIH (application, scoring, revision, new investigator)

3. Review Process • All applications are reviewed • But streamlined process: • Top applications: brief discussion • Bottom application: unscored (full critiques • Mid-range: 10-15 min discussion • ‘Peer review’

4. Center for Scientific Review • CSR handles review of NIH grant applications • Handles 55,000 – 70,000 grant applications /yr • Only 20-30% receive funding (recently <20%) • Grants are reviewed by study sections http://cms.csr.nih.gov/

5. CSR - Study Sections Study section clusters:

6. Study Section Description http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescriptionNew/CVRSIRG/LIRR.htm

7. Roster of Study Section

8. Study Section • Goal: to provide thorough and objective reviews of all applications • Chair – guides discussion • SRO – scientific review officer, federal official, provides orientation about NIH policies and regulations • Up to 20-30 members

9. Conflict of Interest • A reviewer shall not review an application if: • A reviewer has a professional, personal, or financial interest in an application • If an application is submitted by the reviewer, a relative, close friend, or a collaborator. • If the reviewer is listed on a budget page.

10. Confidentiality • Everything associated with the review process and committee is confidential. • Reviewers may not take home applications or unpublished papers. • Applicants may not contact study section members to discuss critiques.

11. Review Criteria (1/5) • Significance • Address important problem? • If aims achieved, how will scientific knowledge advance? • Effects of proposed studies on concepts or methods that drive field?

12. Review Criteria (2/5) • Innovation • Novel concepts, approaches, methods? • Aims original and innovative? • Challenge paradigms or develop new methods?

13. Review Criteria (3/5) • Approach • Conceptual framework, design, methods and analyses adequately developed? • Well integrated and appropriate for aims? • Potential problem acknowledged?

14. Review Criteria (4/5) • Investigator • Appropriately trained? • Work appropriate to experience level PI and collaborators? • Environment • Contribute to success • Take advantage to unique scientific environment

15. Review Criteria (5/5) • Human and Vertebrate Animal Subjects • Compelling rationale for using humans/ animals? • Humans: adequacy protections against risk, benefits of research for subjects and others? • Inclusion age groups, different ethnicities, etc.

17. MOVIE[6:48 - 34:06]

18. Changes in Application Structure Restructured application forms, page limits.

19. Changes in Scoring System Old system 1.0 - 5.0 (only 41 discriminations) New system 1.0 - 9.0 Not recommended for further consideration Percentile ranking

20. Changes in Scoring System http://enhancing-peer-review.nih.gov/scoring&reviewchanges.html

21. Changes in Revisions Beginning with original new and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment (A1) to the original application. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).

22. Changes in Revisions http://www.nhlbi.nih.gov/funding/policies/operguid.htm

23. Early Stage & New Investigator New investigator: PI who has not previously successfully competed for a significant NIH research award. Exempt: R00, R21, et al. 2009: Early Stage Investigator (ESI): New investigators who are <10 years from completing their terminal research degree or medical residency

24. Early Stage & New Investigator

25. Questions ?