Transcript Peer Review of NIH Research Grant Applications

National Institutes of
Health
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)
U. S. Department of Health and Human Services
The
Secretary
Deputy Secretary
Administration for
Children and Families
(ACF)
Administration on
Aging
(AoA)
Food and Drug
Administration
(FDA)
Health Resources
and Services
Administration
(HRSA)
Health Care Financing
Administration
(HCFA)
Agency for
Health Care Policy
and Research
(AHCPR)
Indian Health
Services
(IHS)
National Institutes
of Health
(NIH)
Centers for
Disease Control
and Prevention
(CDC)
Agency for Toxic
Substances and
Disease Registry
(ATSDR)
Substance Abuse and
Mental Health Services
Administration
(SAMHSA)
Program Support
Center
(PSC)
NIH Extramural Awarding Components
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National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Library of Medicine (NLM)
National Institute of Child Health and Human Development (NICHD)
National Institute of Deafness and Other Communication Disorders (NIDCD)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research (NIDCR)
National Eye Institute (NEI)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute for Nursing Research (NINR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Research Resources (NCRR)
National Human Genome Research Institute (NHGRI)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Fogarty International Center (FIC)
National Center on Minority Health and Health Disparities (NCMHD)
A Typical Institute/Center
National
Advisory
Council
Office of the IC
Director
Extramural
Board of
Scientific
Counselors
Intramural
Scientific
Programs
Grants
Contracts
Laboratory
Studies
Clinical
Studies
Overall Peer Review Process
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
Review Process for a Research Grant
National Institutes of Health
Research
Grant
Application
Initiates
Research
Idea
School or Other
Research Center
Center for Scientific Review
Assigns to IRG/Study Section & IC
Study Section
Submits Application
Evaluates for Scientific Merit
Institute
Evaluates for Program Relevance
Advisory Councils and Boards
Conducts
Research
Allocates Funds
Recommends Action
Institute Director
Takes final action for NIH Director
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----
NIH Grant Receipt, Review,
and Award Schedule
Jan-May
May-Sept
Sept-Jan
June-July
Oct-Nov
Feb-Mar
Sept-Oct
Jan-Feb
May-June
Dec 1
Apr 1
July 1
Receipt Dates
Review Dates
National Advisory Council Board Dates
Earliest Possible Beginning Date
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
Study Sections
Grant Application
Receipt and Assignment
Applications Submitted to NIH
 Approximately 60,000
grant applications are
submitted to NIH each
year, of which 25-30%
are funded
 Competing grant
applications are received
for three review cycles
per year
Applications are Assigned
by
Referral Officers:
Professional scientists, most of
whom also serve as scientific
review administrators of CSR
study sections
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
Assignment to CSR Study Sections
(continued)
Within an IRG, applications are assigned for review to
 Standing Study Sections when the subject matter of
the application matches the referral guidelines for the
study section
 Ad Hoc Special Emphasis Panels (SEPs) when the
subject matter does not fit into any study section, or
when assignment of an application to the most
appropriate study section would create a conflict of
interest. Also used for special mechanisms (e.g.,
fellowships, SBIRs, AREAS)
Sample Application Number
Individual
Research
Grant
1
R01
New
Application
Serial
Number
CA
National
Cancer
Institute
12345
Amended
01
Grant
Support
Year
A1
Initial Review in CSR
Peer Review in CSR
 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
Scientific Review Administrator
 Performs administrative and technical review
of applications
 Selects reviewers
 Manages study sections
 Prepares summary statements
 Provides requested information about study
section recommendations to Institutes and
National Advisory Councils/Boards
Criteria For Selection of Peer Reviewers
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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
Scientific Review Group or Study
Section Actions
 Scored, Scientific Merit Rating
(priority scores and percentiles)
 Unscored (lower half)
 Deferral
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.
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.
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.
Post Scientific Review
Group Actions
 Calculations of priority scores and percentile
rankings
 Preparation of summary statements
 Removal of applications from National
Advisory Council / Board consideration
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
National Advisory
Council or Board Review
Council Actions
 Concurrence with study section
action
 Modification of study section action
 Deferral for re-review
What Determines Which
Awards Are Made?
 Scientific merit
 Program Considerations
 Availability of funds
Preparation of an Application
PHS Research Grant
Application Kit (form PHS 398)
Mail Completed Forms To:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
ROCKLEDGE II ROOM 1040 MSC-7710
BETHESDA MD 20892-7710
When Preparing an Application
 Read instructions
 Never assume that reviewers “will know what you
mean”
 Refer to literature thoroughly
 State rationale of proposed investigation
 Include well-designed tables and figures
 Present an organized, lucid write-up
 Obtain pre-review from faculty at your institution
Common Problems in Applications
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Lack of new or original ideas
Absence of an acceptable scientific rationale
Lack of experience in the essential methodology
Questionable reasoning in experimental approach
Uncritical approach
Diffuse, superficial, or unfocused research plan
Lack of sufficient experimental detail
Lack of knowledge of published relevant work
Unrealistically large amount of work
Uncertainty concerning future directions