Getting to Know how NIH Works: Peer Review of NIH Grant Applications

1. Getting to Know how NIH Works:Peer Review of NIH Grant Applications Hinda Zlotnik, Ph.D. Chief, MBRS Branch National Institute of General Medical Sciences

2. Grant Application to NIH Grant Application NIH

3. Principles of Success • Understand the NIH Mission and Organization • Understand the Peer Review Process • Apply your knowledge of the above to the grant application process • “Grantsmanship is a learned skill and should be viewed as a scholarly activity”

4. National Institutes of Health The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by: • conducting research in its own laboratories; • supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; • helping in the training of research investigators; and • fostering communication of medical information. http://www.nih.gov

5. National Institutes of Health • Much of the biomedical research in the United States is supported by the Federal Government, primarily the National Institutes of Health (NIH)

6. NIH Funded Research • More than 80% of NIH’s budget (> $28 billion dollars) is awarded through almost 50,000 competitive grants to more than 212,000 researchers at over 2,800 universities, medical schools, and other research institutions in every state and around the world. • About 10% of the NIH budget supports projects conducted by nearly 6,000 scientists in its own laboratories.

7. 2006 NIH Budget • 28+ Billion How can I get some of this money?

8. NIH Funded Research • NIH mission is based and defined in law • NIH budget is approved by Congress • NIH reports to Congress on success • NIH success is based on the success of the scientists it supports • NIH wants applicants to be successful scientists

9. 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 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

10. A Typical Institute/Center National Advisory Council Office of the IC Director Board of Scientific Counselors Extramural Intramural Scientific Programs Laboratory Studies Clinical Studies Grants Contracts

11. Basis for an Application Great Idea! NIH

12. Correct Way to Request Funds send NIH NIH Peer Review

13. Elements of Grant Success • Good Ideas • Good Presentation • Good Grantsmanship

14. Good Grantsmanship • Knowing and Understanding: • What to do • How to do it • When to do it • What to do when things don’t go as planned • Understanding the NIH Peer Review System!

15. Peer Review Process for a Research Grant Application

16. 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

17. Important Considerations: • Scientific Review Groups (SRGs) do not fund • INSTITUTES FUND!!! • SRGs judge the scientific and technical merit of applications • Institute staff use the SRG evaluations to make funding recommendations as well as consider the relevance of applications’ to the Institute’s mission, research priorities and portfolio of existing research

18. What are the deadlines for the submission of Research Grants? Ready to Apply for NIH Grant

19. Typical Timeline for a New Individual Research Project Grant Application (R01) There are three overlapping cycles per year: • Submit in February (June, October) • Review in June(October, February) • Council in September (January, May) • Earliest award in December (April, July) • Cycle 1---- • Cycle 2---- • Cycle 3----

20. What happens to a Research Grant once it arrives at NIH? National Institutes of Health School or Other Research Center Research Grant Application Center for Scientific Review • Serves as central receipt point for PHS Grant Applications • Assigns applications to CSR Integrated Review Groups/Study Sections or Institute Scientific Review Groups • Assigns applications to NIH Institute(s) as potential funding component(s) • Conducts initial scientific merit review of most research applications submitted to the NIH in more than 100 Scientific Review Groups (Study Sections) Initiates Research Idea Submits Application Conducts Research

21. CSR- Applications Submitted to NIH • Approximately 50,000 grant applications are submitted to NIH each year, of which 20-25% are funded • Competing grant applications are received for three review cycles per year

22. Applications are Assigned to: • Scientific review groups based on: • Specific review guidelines for each scientific review group • Institutes based on: • Overall mission of the Institute • Specific programmatic mandates and interests of the Institute

23. Who/What Determines which Group Reviews the Application? • Grant Mechanism • Type of application • CSR or Institute review • Referral and Review Staff • Past History (if any) of application • Principal Investigator • Letter Attached to application • You! - by the words you use in your application (in title, abstract, specific aims)

24. Assignment Notification Letter • Provides the number assigned to your application • Provides the name of the Scientific Review Group • Provides links to the roster of the membership of the Scientific Review Group • Provides the name and contact information of the SRA • Provides the name of the institute to which the application was assigned • Provides the dates of the Review Meeting and of when funding decisions will be made

25. Sample Application Number Individual Serial Amended Research Number Grant 1 R01 CA 12345 01 A1 New National Grant Application Cancer Support Institute Year

26. Scientific Review Groups

27. Scientific Review Groups (Study Sections) • CSR Study Sections 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 CSR 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

28. Scientific Review Administrator • Performs administrative and technical review of applications • Selects reviewers and assigns applications to the reviewers based on their areas of expertise • Manages study sections • Prepares summary statements • Provides requested information about study section recommendations to Institutes and National Advisory Councils/Boards

29. Criteria For 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

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

31. Study Section Meeting

32. What Happens in a Study Section Meeting? • Closed to the Public • Orientation • Conflict of Interest • Policies and Procedures • Introductions of persons present • Role of persons present • Streamlining of Applications • Application by application discussion • Persons with conflicts of interest are 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 • Assignment of gender, minority, and children codes, human subject codes; recommended changes to budget

33. What is Streamlining? • Process by which reviewers judge which applications are in the lower half of those assigned for review • Applications for lower half are evaluated by the reviewers prior to attending the meeting but they are not discussed at the Scientific Review Group meeting. • Streamlined applications receive a written critique.

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

35. Review of Research Grants REVIEW CRITERIA: • Significance • Approach • Innovation • Investigator • Environment

36. Review Criteria • 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: Is the investigator appropriately trained? • Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

37. 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.

38. Inclusion of Women and Minorities in Clinical Research • Women and minorities must be considered for inclusion in all clinical research supported by NIH or • Appropriate justification must be provided to explain why they are not included in the proposed research

39. Research Involving Children • Children must be considered for inclusion in all human subject research supported by NIH Effective for all new applications received after October 1, 1998 • If children are not included, must justify exclusion.

40. Animal Welfare Important Considerations • Will the anticipated results be for the good of society? • Will the work be planned and performed by qualified scientists? • Will the animals be treated so as to avoid any unnecessary discomfort, pain, anxiety, or poor health? • Species chosen • Animals in short supply

41. 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 trained adequately in safe practices? Note: Research using recombinant DNA techniques must meet NIH guidelines as determined by the Office of Recombinant DNA Activities (ORDA). Study Sections need only identify the scientific merit and any biohazards in such research.

42. Scientific Review Group or Study Section Actions • Scored, Scientific Merit Rating (priority scores and percentiles) • Priority Scores: 1 (best) to 5 (poorest) • Unscored (lower half) • Deferral

43. Action • Scored -- Scientific Merit Rating 1.0 to approximately 3.0 Based on the relevant review criteria, the application is judged to be in the upper half of applications reviewed by the study section or scientific review group. The recommendation can be for the requested time and amount or for an adjusted time and amount. A priority score is provided, and a summary statement prepared that incorporates the written critiques plus a resume and summary of the discussion.

44. Action • Unscored Application is unanimously judged to be in the lower half of applications reviewed by the study section or scientific review group. No priority score is assigned. The summary statement provided to the applicant is a compilation of reviewers’ comments prepared prior to the meeting.

45. Action • Deferral The study section cannot make a recommendation without additional information. This information may be obtained by a project site visit or by submission of additional material by the applicant.

46. Summary Statement • Once applications are reviewed, the results are documented by the SRA in a summary statement and forwarded to the Institute (and the PI) where a funding decision is made: • The summary statement contains: • Overall Resume and Summary of Review Discussion • Essentially Unedited Critiques • Priority Score and Percentile Ranking • Budget Recommendations • Administrative Notes

47. National Advisory Council or Board Review

48. Council Actions • Concurrence with study section action • Modification of study section action • Cannot change priority score • Deferral for re-review-no changes allowed

49. What Determines Which Awards Are Made? • Scientific merit • Program Considerations • Availability of funds

50. Review Process for a Research Grant National Institutes of Health School or Other Research Center Research Grant Application Center for Scientific Review Assigns to IRG/Study Section & IC Study Section Initiates Research Idea Submits Application Evaluates for Scientific Merit Institute Evaluates for Program Relevance Advisory Councils and Boards Allocates Funds Conducts Research Recommends Action Institute Director Takes final action for NIH Director