Massachusetts General Hospital Postdoc Association Office for Research Career Development Grantwriting: Who Reviews Gran - PowerPoint PPT Presentation

Janet E. Hall, MD

Reproductive Endocrine Unit

Department of Medicine

Massachusetts General Hospital

Boston, MA

Today’s Goals

• 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?
• Resources

Understanding the Review Process

Institution

Reviews the

Application

NIH

Submits the

Application

Allocates

Funds

Conducts

Research

Grant Application

PI

Initiates

Research

Idea

• 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)

• 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

• 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

• 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 ($)

• 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)

• 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

• 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)

• 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

• 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)

• attempt to emphasize more innovative concepts and approaches rather than safe science
• SIGNIFICANCE
• APPROACH
• INNOVATION
• INVESTIGATOR
• ENVIRONMENT

• 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

• Institute
• acts on recommendations of the Initial Review Group and Council
• scientific merit
• programmatic considerations
• availability of funds

INSTITUTION

INVESTIGATOR

CHECK

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 current

CSR 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

Grant Mechanisms

R21

R03

F32

or

T32

K22

K02

R37

T32

F31

R01

Independent

PI

Graduate

Student

Faculty

Position

PhD

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

• 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

• 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

• 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.)

• 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

• 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

• 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

• 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

• Clinical Research Program
• Statistical Support
• Clinical Research Center
• Scientific Review Committee
• Research Affairs Administration

Ask your colleagues!

Ask your mentors!

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

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