1. Massachusetts General Hospital Postdoc Association Office for Research Career Development Grantwriting: Who Reviews Grants? Janet E. Hall, MD Reproductive Endocrine Unit Department of Medicine Massachusetts General Hospital Boston, MA

2. 1.Understanding the Review Process –what happens when you submit a grant to the NIH (or other agency)? –how does this influence how you prepare your application? –who can you talk to? 2.Resources Today’s Goals

3. Understanding the Review Process

4. Submission of a Grant Initiates Research Idea Grant Application PI Conducts Research Allocates Funds NIH Institution Reviews the Application Submits the Application

5. What’s in the Box? NIH is one of eight health agencies that are part of the US DHHS NIH is composed of 27 separate Institutes or Centers Office of the Director Nat’l Cancer Institute Nat’l Eye Institute Nat’l Heart, Lung & Blood Institute Nat’l Human Genome Research Institute Nat’l Institute on Aging Nat’l Institute on Alcohol Abuse & Alcoholism National Institute of Allergy & Infectious Diseases Nat’l Institute of Arthritis & Musculoskeletal & Skin Diseases Nat’l Institute of Child Health & Human Development Nat’l Institute on Deafness & Other Communication Disorders Nat’l Institute of Dental Research Nat’l Institute of Diabetes & Digestive & Kidney Diseases Nat’l Institute on Drug Abuse Nat’l Institute of Environ Hlth Sciences Nat’l Institute of General Medical Sciences Nat’l Institute of Mental Health Nat’l Institute of Neurological Disorders & Stroke Nat’l Institute of Nursing Research Nat’l Library of Medicine Nat’l Center for Research Resources John E. Fogarty International Center Warren Grant Magnuson Clinical Center Center for Information Technology Center for Scientific Review (CRS, formerly DRG)

6. Know your NIH Institute! Look at NIH Institute-specific websites (www.niddk.nih.gov) Learn Institute’s research priorities Look at Institute’s application success rates (# applications; # awards): http://grants1.nih.gov/grants/award/success.htm

7. Types of Scientific Review Groups ScientificGroups (SRG) CSR Regular Study Sections Special Study Sections Special Emphasis Panels Institutes Scientific Review Groups Contract Review Committees Applications Reviewed Research Project Grant Academic Research Enhancement Awards Postdoctoral Fellowships Small Business Innovation Research Shared Instrumentation Program Projects Centers Institutional Training Grants Contracts RFA’s Conference Grants Career Awards Some Small Grants

8. NIH System of Peer Review Center for Scientific Review assigns to Study Section & Institute/Center Study Section evaluates for Scientific Merit Institute evaluates for Program Relevance Advisory Councils and Boards recommends action Institute Director takes final action for NIH Director ($)

9. Initial Review: Scientific Merit Assignment to Study Section Information Sent to Investigator assignment number name, address and telephone number of the scientific review administrator (SRA) of the Review Group to which the application is assigned assigned Institute contact and telephone number (s)

10. Who Assigns the Applications? Referral Officers Professional Scientists most of whom also serve as Scientific Review Administrators of CSR Study Sections Can I Influence the Assignment? Cover Letter indicate the Study Section which you think is most appropriate study section rosters and overall interests are posted Reorganization is ongoing indicate the Institute(s) likely to be interested in funding your work

11. Initial Review: Scientific Merit Constitution of Study Section by SRA ensures expertise to review all grants distributes grants among reviewers Grants Forwarded to Reviewers reviewed for conflict of interest and appropriateness of assignment each reviewer will have 8-12 grants to review in full as primary, secondary or reader reviewers will receive all grants (60-75 in total)

12. Initial Review: Scientific Merit CSR Study Sections review 80,000 applications per year ~ 70-75% of applications reviewed by NIH uses ~18,000 external reviewers Study Section Membership ~ 16 members - regular and ‘ad hoc’ term is 3-4 years with staggered appointments Criteria for Selection to Study Section demonstrated scientific expertise mature judgement, balanced perspective, and objectivity personal integrity - critical re confidentiality representation - women, minority, clinical

13. Initial Review: Scientific Merit Preparation of Review scientific review using established criteria Streamlined Review - bottom half Study Section Meeting 3 times/year x 2 days members/chair, SRA, Institute Representatives review bottom half grants individual discussion of all top half grants primary, secondary, reader, full group and final vote by all members (1 high --- 5 low)

14. Criteria-Based Review attempt to emphasize more innovative concepts and approaches rather than safe science SIGNIFICANCE APPROACH INNOVATION INVESTIGATOR ENVIRONMENT

15. Council Review Priority Score average of all scores x 100 ranking tabulated from the results of the current and two previous review meetings percentiles preparation of summary statement (pink sheet) Institute’s National Advisory Council scientific and public representatives ~12-15 meet 3x/yr to advise the Institute on its programs and priorities and review research applications review of application based on scientific merit and relevance to the Institute’s programs and priorities

16. Awarding of Grants Institute acts on recommendations of the Initial Review Group and Council scientific merit programmatic considerations availability of funds INSTITUTION INVESTIGATOR

17. How Long Does it Take? SubmissionJan-MayMay-SeptSept-Jan Initial ReviewJune-JulOct-NovFeb-Mar Group (IRG) National AdvisorySept-OctJan-FebMay-Jun Council Board Earliest PossibleDec 1Apr 1July 1 Funding *** Dates are changing so stay current CSR is considering new ways to shorten the review cycle. CSR is considering novel grant and review formats. CHECK

18. R01 Applications are now Electronic * No paper applications will be allowed * Applicants and grants offices should prepare Now! * BIG process change -- Involves change in application form -- Must use application form from specific Funding Opportunity Announcement in the NIH Guide * Grants offices must submit applications Get more info at http://era.nih.gov/ElectronicReceipthttp://era.nih.gov/ElectronicReceipt CHECK

19. Grant Mechanisms

20. Grants for Different Career Stages: PhD T32F31 F32 or T32 K22 R01 K02R37 PhD Faculty Position Graduate Student Independent PI T32 - Institutional Training Grant - pre & post doctoral slots F32 - Individual Minority Pre-Doc F32 - Individual Postdoctoral Fellowship K22 - Research Scholar Dev’t Award *R03 – Small Grant *R21 – Exploratory Grant K02 - Independent Scientist Award R37 - Merit Award R21R03

21. NIH Career Development Programs (“K” Awards) fourteen different mechanisms articulate with Career Stage: Mentored, Mid-career, Senior interact with other NIH Awards use “K Kiosk” or “Career Award Wizard”: http://grants.nih.gov/training

22. “Career” or K-series Awards designed to “protect” time, i.e., free up time currently spent in clinic or on administrative or teaching duties most are for early career development provide ‘salary’ not ‘stipend’ meant to train U.S. citizens/permanent residents –K99 is an exception to this policy limited to U.S. research/clinical institutions

23. K-series Awards K01 – Mentored Research Scientist Development Award (Ph.D.)- usually basic research K08 – Mentored Clinical Scientist Development Award (M.D. or other clinical degree)- usually basic research K23 – Mentored Patient-oriented Research Career Development Award (M.D. or other clinical degree) K99/R00 – Pathway to Independence (PI) Awards K22- Transition Award- 2-3 years at NIH; 2-3 years at extramural academic institution in U.S. K24 – Mid-Career Investigator Award in Patient- oriented Research (M.D.)

24. Elements Reviewed in Mentored K Award Applications Qualifications of candidate –prior training –letters of recommendation –publications** Mentors –previous mentoring experience –expertise in area of research –current funding Research project –hypothesis driven –preliminary data –reasonable in time frame –logical sequence of studies –appropriate safeguards Career development plan –‘enrichment’ –training –future plans Environment

25. Mentored Clinical Scientist Career Development Award (K08/K23/K99) Essential components of grant application: –career development plan must be carefully documented may include coursework may work toward a graduate degree –mentorship must be strong and appropriate –Institutional commitment to career development must be clear

26. Who reviews K award applications? K award applications are generally reviewed by Institute-specific study sections, NOT the Center for Scientific Review (CSR) check the roster of study section members BEFORE the review http://era.nih.gov/roster/index.cfm

27. R-series grants R01s – Research project grants unsolicited and in response to Funding Opportunity Announcements (e.g. PAs and RFAs) R21s – Exploratory/Developmental grants usually only in response to FOAs R03s – Small grants only in response to FOAs

28. Resources

29. Use the Institutional Resources Available to You Clinical Research Program –Statistical Support Clinical Research Center –Scientific Review Committee Research Affairs Administration Ask your colleagues! Ask your mentors!

30. Grant Resources Sample K award applications K08: http://www.nhlbi.nih.gov/funding/training/r edbook/k08model.htm K23: http://www.nhlbi.nih.gov/funding/training/r edbook/k23models.htm

31. Use the Resources Available to You NIH (www.nih.gov) Office of Extramural Research Grants Policy Institute Personnel New Investigators http://grants.nih.gov/grants/new_investigators/reso urces.htm Center for Scientific Review Referral & Review overview of Peer Review Process SRG Study Section Rosters NIH Peer Review Notes Grants Net www.grantsnet.orgwww.grantsnet.org Private Foundations (examples): ADA www.diabetes.org, JDRF www.jdrf.orgwww.diabetes.orgwww.jdrf.org