Massachusetts General HospitalPostdoc Association

Office for Research Career Development

Grantwriting:Who Reviews Grants?

Janet E. Hall, MDReproductive Endocrine Unit

Department of MedicineMassachusetts General Hospital

Boston, MA

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

Understanding the Review Process

Submission of a Grant

InitiatesResearch

Idea

Grant ApplicationPI

ConductsResearch

AllocatesFunds

NIH

Institution

Reviews theApplication

Submits theApplication

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?

Submission Jan-May May-Sept Sept-Jan

Initial Review June-Jul Oct-Nov Feb-Mar Group (IRG)

National Advisory Sept-Oct Jan-Feb May-Jun Council Board

Earliest Possible Dec 1 Apr 1 July 1 Funding

*** Dates are changing so stay currentCSR is considering new ways to shorten the review cycle.CSR is considering novel grant and review formats.

CHECK

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/ElectronicReceipt

CHECK

Grant Mechanisms

Grants for Different Career Stages: PhD

T32 F31

F32or T32

K22 R01 K02 R37

PhD FacultyPosition

GraduateStudent

IndependentPI

T32 - Institutional Training Grant - pre & post doctoral slots

F32 - Individual Minority Pre-DocF32 - Individual Postdoctoral FellowshipK22 - Research Scholar Dev’t Award*R03 – Small Grant *R21 – Exploratory Grant

K02 - Independent ScientistAward

R37 - Merit Award

R21R03

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 Patient-oriented 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/redbook/k08model.htm

• K23: http://www.nhlbi.nih.gov/funding/training/redbook/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/resources.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