Crafting An Outstanding NIH Grant Application An insider’s perspective

1. Crafting An Outstanding NIH Grant ApplicationAn insider’s perspective Martin Padarathsingh, Ph.D. Referral Officer & Scientific Review Administrator Center for Scientific Review/NIH Research Proposal Consultant, H. Lee Moffitt Cancer Center & Research Institute

2. Outline • NIH Peer Review Process • Grantsmanship Guidelines • Study Section Actions • Application - Revision

3. Review Process for a Research Grant REVIEW PROCESS FOR A RESEARCH GRANT National Institutes of Health Principal Investigator School or Other Research Center Center for Scientific Review Assign to IC and IRG Scientific Review Group Initiates Research Idea Submits application Review for Scientific Merit Institute Evaluate for Relevance Advisory Council or Board Recommend Action Allocates Funds Institute Director Conducts Research

4. NEW February 5 June 5 October 5 REVISED (Competing) March 5 July 5 November 5 Receipt Deadlines – R01/Fellowship Applications Receipt DeadlinesR01 Applications • FELLOWSHIP • April 8 • August 8 • December 8

5. Applications Submitted to NIH

6. Duties of Referral Officers Applications Funding Institutes SRA/Study Section CSR, Institutes • Assignment to Funding Institutes • Assignments to Study Sections Reviewers Study Section Meeting

7. Assignment of Applications • The applications are first examined by Asst. Chiefs in the Division of Referral and Review; they are forwarded to the appropriate Referral Officer based on the area of proposed research. Referral Officers ensure that the applications are assigned to the appropriate Initial Review Groups (IRGs). • There are about 23 IRGs, specializing in Oncology, Cell Biology, Immunology, Neurology etc. Each IRG has multiple study sections

8. Applications Related to Cancer • There are 17 study sections within the ONC IRG. They cover a wide spectrum of cancer research ranging from basic biology, drug discovery, translational sciences and clinical trials. • Each application is assigned to a specific study section based on the type of studies proposed. This assignment is determined by the Referral Officers and the SRAs of the ONC IRG. • Some applications will be assigned to a Special Emphasis Panel based on certain criteria.

9. Presubmission Preparation Interact with NIH staff & Colleagues • Scientific Review Administrator - Identify study session • Program Director - Specific research areas - RFA’s, PA’s, special initiatives • Seek the advice of colleagues at your home institution

10. Other Types of Awards • MERIT Awards Provides extended funding period for outstanding competing renewal RO1 applications • Shannon Awards Provides funding for grants from new investigators who are marginally outside the paylineapplications • Minority Supplements

11. When Preparing Your Application • Read Instructions – PHS 398/SF424 • Attention to Administrative Details • Font Size Font Size • Animal and Human Studies • Letters from Collaborators • Appendices – Manuscripts • Mentor (Fellowship)

12. When Preparing Your Application Cont. • Never assume that the reviewers “will know what you mean” - CLARITY • Refer to the literature thoroughly • State rationale of proposed investigation • Present an organized, lucid write-up • Include well-designed tables and figures • Obtain pre-view from colleagues - in essence an internal pre-review before submission to the NIH

13. Review Criteria • Significance • Approach • Innovation • Investigator • Environment • Budget is not considered in the scientific evaluation

14. Significance • Important area of research • Target sites: breast, lung, prostate, skin… • Carcinogenesis mechanisms • Development of new reagents, methodology, treatment • Convince the reviewers that the proposed work is important

15. Approach • Hypothesis and Mechanism • Preliminary Data - should be strong and convincing • Specific Aims • Experimental Design - questions • Results, impact, future directions • Potential Pitfalls and Alternatives

16. Potential Pitfalls and Alternatives A substantial weakness is a serious lack of potential problems and alternative possible results, and consequent alternative approaches which will be utilized. This imparts the impression that the success of the proposal is absolutely dependent on achieving the expected results.

17. Innovation • Novel concepts and approaches • Project challenges existing paradigms and/or introduces new paradigms • Original and innovative aims • Innovative use of existing technologies • Development of new reagents, models, methodologies and technologies

18. Investigator • Appropriate training and expertise • Productivity – track record • Collaborators and consultants • Network

19. New Investigator • A person who has never been a pi on a NIH RO1 grant • Check new investigator box (2) on PHS 398 face page • Productivity • Independence, resources • Letters of support from collaborators and chairperson • Period of award • Paylines – special treatment (?)

20. Environment • Intellectual and physical environment • Unique features – facilities, resident experts • Does the scientific environment contribute to the probability of success?

21. Streamlining: Pre-study Section Action • Divide applications into upper and lower halves • Unscore applications in lower half • Decision to unscore – MUST BE UNANIMOUS • Unscored applications are not discussed. Applicants receive unedited critiques from the reviewers in their Summary Statements

22. Scientific Review Group or Study Section Actions • Scored, Scientific Merit Rating: priority scores • Unscored: unanimous decision • Deferred

23. Priority Scores • Outstanding 1.0 – 1.5 • Excellent 1.5 – 2.0 • Very Good 2.0 – 2.5 • Good 2.5 – 3.5 • Acceptable 3.5 – 5.0 • Unscored applications fall in the range of 3.0 -5.0; they are not without scientific merit!

24. Outstanding Application • Proposed studies are highly significant • Addresses important questions • Potential for providing valuable insights • Solid foundation for proposed studies • Novel concepts

25. Options If Not Funded • Revise and Resubmit (2 Chances) • Funding Outside the Payline • Exception, Shannon, Private Foundations, Supplementary Support (Competing Renewal) • Program Director’s Advice • Scientific Review Administrator’s Advice • Give up (I hope not!)

26. Revision • Introduction – 3 pages • Diplomacy: thank the reviewers • State concerns fully and provide response

27. Introduction Format • Concerns by Reviewers and Response • Reviewer 1: - Concern 1 - Response 1 • Reviewer 2: - Concern 1 - Response 1

28. Other Funding Organizations • Other Government Agencies – Cancer Research: • Department of Defense Funding Initiatives • Office of Orphan Products Development (FDA) • Veterans Health Administration

29. Private Foundations • American Cancer Society • Burroughs Wellcome Fund • The Charlotte Geyer Foundation • Damon Runyon Cancer Research Foundation • Robert Wood Johnson Foundation

30. Summary • NIH/NCI Grant Funding is becoming highly competitive • Applications should be prepared with utmost diligence and insight • The help and advice of SRAS at CSR, program officers at the institutes, and colleagues at your institution who have been successful will provide an added advantage in crafting an outstanding application

31. Questions & Answers Martin Padarathsingh, Ph.D. Referral Officer & Scientific Review Administrator Center for Scientific Review/NIH Research Proposal Consultant, H. Lee Moffitt Cancer Center & Research Institute