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 Today’s Goals 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 Understanding the Review Process Submission of a Grant Grant Application PI Initiates Research Idea Institution Reviews the Application Submits the Application Conducts Research Allocates Funds NIH 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) 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 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 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 ($) 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) 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 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) 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 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) Criteria-Based Review • attempt to emphasize more innovative concepts and approaches rather than safe science • • • • • SIGNIFICANCE APPROACH INNOVATION INVESTIGATOR ENVIRONMENT 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 Awarding of Grants Institute • acts on recommendations of the Initial Review Group and Council • scientific merit • programmatic considerations • availability of funds INSTITUTION INVESTIGATOR How Long Does it Take? CHECK Submission Jan-May May-Sept Sept-Jan Initial Review Group (IRG) June-Jul Oct-Nov Feb-Mar National Advisory Council Board Sept-Oct Jan-Feb May-Jun Earliest Possible Funding Dec 1 Apr 1 July 1 *** Dates are changing so stay current CSR is considering new ways to shorten the review cycle. CSR is considering novel grant and review formats. R01 Applications are now Electronic CHECK * 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/ElectronicReceipt Grant Mechanisms Grants for Different Career Stages: PhD R03 T32 Graduate Student F32 or T32 F31 PhD K22 R21 R01 K02 Faculty Position R37 Independent PI T32 - Institutional Training Grant K02 - Independent Scientist - pre & post doctoral slots Award F32 - Individual Minority Pre-Doc R37 - Merit Award F32 - Individual Postdoctoral Fellowship K22 - Research Scholar Dev’t Award *R03 – Small Grant *R21 – Exploratory Grant 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 “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 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 Patientoriented Research (M.D.) 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 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 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 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 Resources 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! 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 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.org • Private Foundations (examples): • ADA www.diabetes.org , JDRF www.jdrf.org