THE NIH REVIEW PROCESS

1. THE NIH REVIEW PROCESS David Armstrong, Ph.D. Chief, Scientific Review Branch National Institutes of Mental Health National Institutes of Health Department of Health and Human Services

2. Applications Submitted to NIH • Approximately 80,000 grant applications are submitted to NIH each year of which 25-30% are funded. • Grant applications are received for three review cycles per year

3. Overall Peer Review Process

4. Dual Review System for Grant Applications • First Level of Review • Scientific Review Group (SRG) • Provides Initial Scientific Merit • Review of Grant Applications • Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review Council • Assesses Quality of SRG • Review of Grant Applications • Makes Recommendation to • Institute Staff on Funding • Evaluates Program Priorities • and Relevance • Advises on Policy

5. The NIH Grant Process WOW! What a great idea Investigator initiated research is core to the NIH grant process

6. RESEARCH PLAN • What do you intend to do? • Why is the work important? • What has already been done? • How are you going to do the work?

7. The NIH Grant Process (cont) SF424 Writing a grant application can be very time consuming January/February June/July October/November

8. The NIH Grant Process (cont) Soon all grant applications will be received electronically Center for Scientific Review receiving center

9. The NIH Grant Process (cont) Individual Research Grant Serial number Amended 1 R01 MH 123456 01 A1 Institute Grant Support Year New Application CSR’s x-ray security facility

10. The NIH Grant Process (cont) Just ten more reviewers to recruit and the roster is complete. Just 5 more reviewers to recruit Scientific Review Administrator Reviewer

11. Scientific Review Administrator Designated Federal official with overall responsibility for the review process, including: • Performing administrative and technical review of applications to ensure completeness and compliance • Selecting reviewers based on broad input • Managing study section meetings • Preparing summary statements • Providing any requested information about study section recommendations to Institutes and National Advisory Councils/Boards

12. The NIH Grant Process (cont) Finished! This is hard work. Critique IAR

13. The NIH Grant Process (cont) First level of review Score (100-500) Human subject concerns Inclusion criteria Vertebrate animal concerns Budget

14. REVIEW CRITERIA 1. Significance 2. Approach 3. Innovation 4. Investigator 5. Environment

15. Review Criteria (continued) • Significance:Does the study address an important problem? How will scientific knowledge be advanced? • Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? • Innovation:Are there novel concepts or approaches? Are the aims original and innovative? • Investigator: What is the investigator’s track record? If new, is the investigator appropriately trained? • Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

16. The NIH Grant Process (cont) Summary statement eRA Scientific Review Administrator

17. SUMMARY STATEMENT • Overall Resume and Summary of Review Discussion • Essentially Unedited Critiques • Priority Score and Percentile Ranking • Budget Recommendations • Administrative Notes

18. The NIH Grant Process (cont) Wow a 166 – Will I get paid? Second level of review National Advisory Mental Health Council

19. Yippee!! Now I only have to worry about getting tenure.

20. When Preparing an Application • Read instructions • Never assume that reviewers “will know what you mean” • Refer to literature thoroughly • State rationale of proposed investigation • Include well-designed tables and figures • Present an organized, lucid write-up • Obtain pre-review from faculty at your institution

21. Common Problems in Applications • Lack of new or original ideas • Absence of an acceptable scientific rationale • Lack of experience in essential methodology • Questionable reasoning in experimental approach • Uncritical approach • Diffuse, superficial, or unfocused research plan • Lack of contingency plan • Lack of sufficient experimental detail • Lack of knowledge of published relevant work • Unrealistically large amount of work • Uncertainty concerning future directions

22. Revising Applications Most applicants don't succeed at first try -- so they try again - You can resubmit up to two amended applications - You can use reviewer comments to amend your application - 43% of applications initially submitted to NIH in 1999 were eventually funded (includes all amendments)

23. www.nimh.nih.gov David Armstrong 301-443-3534 armstrda@mail.nih.gov