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Peer Review of NIH Research Grant Applications

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National Institutes of Health. Center for Scientific ... National Advisory Council or Board Review. Council Actions. Concurrence with study section action ... – PowerPoint PPT presentation

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Title: Peer Review of NIH Research Grant Applications


1
Peer Review of NIH Research Grant Applications
Center for Scientific Review National Institutes
of Health
2
Review Process for a Research Grant
National Institutes of Health
School or Other Research Center
Research Grant Application
Center for Scientific Review
Assign to IC IRG/ Study Section

Initiates Research Idea
Study Section
Submits Application
Review for Scientific Merit
Institute
Evaluate for Relevance
Advisory Councils and Boards
Allocates Funds
Conducts Research
Recommend Action
Institute Director
Takes final action
3
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

4
National Institutes of Health
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute on Aging
National Institute of Child Health and
Human Development
National Institute of Allergy and Infectious
Diseases
National Institute of Diabetes and Digestive
and Kidney Diseases
National Institute of Dental and Craniofacial Rese
arch
National Institute on Drug Abuse
National Institute of Environmental Health
Sciences
National Institute on Deafness and
Other Communication Disorders
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders
and Stroke
National Institute of General Medical Sciences
National Institute of Nursing Research
National Library of Medicine
National Center for Complementary and
Alternative Medicine
National Center on Minority Health and Health
Disparities
National Institute of Biomedical Imaging and
Bioengineering
Fogarty International Center
National Center for Research Resources
Center for Information Technology
Center for Scientific Review
Clinical Center
5
Center for Scientific Review (CSR)
6
Center for Scientific Review
  • Referral
  • Central Receipt Point for PHS Grant Applications
  • Institute Assignment (Potential Funding
    Component)
  • Assignment to Scientific Review Group in CSR or
    in an Institute
  • Scientific Review
  • More than 100 Study Sections that review
  • Research Grant Applications
  • Postdoctoral Fellowship Application
  • Academic Research Enhancement Award Applications
  • Small Business Innovation Research Applications

7
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

8
Assignment to CSR Study Sections
  • Applications are assigned to Integrated Review
    Groups (IRGs) for review. IRGs are clusters of
    scientifically-related study sections
  • The IRG assignment is based on specific referral
    guidelines for each IRG
  • Each of the 20 IRGs within CSR has 5 - 8 standing
    study sections

9
Organization Chart of Review Divisions Center for
Scientific Review National Institutes of
Health Department of Health and Human Services
Division of Biologic Basis of Disease
Division of Physiology and Pathology
Division of Clinical and Population-based Studies
Bioengineering Sciences and Technologies
AIDS and Related Research
Biobehavioral and Behavioral Processes
Biological Chemistry and Macromolecular Biophysics
Endocrinology, Metabolism, Nutrition and
Reproductive Sciences
Digestive Sciences
Brain Disorders and Clinical Neuroscience
Immunology
Health of the Population
Biology of Development and Aging
AIDS and Related Research
Hematology
Infectious Diseases and Microbiology
Risk, Prevention and Health Behavior
Integrative, Functional and Cognitive
Neuroscience
Cell Biology
Oncological Sciences
Surgical Sciences, Biomedical Imaging and
Bioengineering
Genes, Genomes and Genetics
Musculoskeletal, Oral and Skin Sciences
Molecular, Cellular and Developmental Neuroscience
Renal and Urological Sciences
Respiratory Sciences
Revised on April 16, 2003.
10
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)

11
The Musculoskeletal, Oral and Skin Sciences
MOSS IRG will consider research applications
that address structural systems that are
prerequisite for physical form, mechanical
function, movement, and integrity of the body.
These structural systems and their components are
the basis for the organization of the study
sections of this IRG and are described according
to the following topical areas skeleton,
spine, bone, connective tissue, extracellular
matrix, and their related diseases/disorders
dental/oral and craniofacial and their related
diseases/disorders skeletal muscle, limb, and
their related diseases/disorders joints and
their related diseases/disorders, including
rheumatic diseases skin and its related
diseases/disorders. Autoimmune diseases are
specifically included. For these topical areas,
the studies considered range from molecular
genetics and stem cell research to animal models
and clinical trials. For each major topical
area, the research applications may include
studies of basic biology, including growth,
development, maturation, and aging biomaterials
for prostheses/orthotics and implants
pathogenesis and therapeutics physical
rehabilitation exercise mechanobiology/biomechan
ics injury and repair, including adaptation,
plasticity, degeneration, and regeneration
diagnostic markers and biomarkers cell and
gene-based therapies and clinical outcomes and
trials. The following Study Sections are
included within the MOSS IRG Oral, Dental and
Craniofacial Sciences ODCS Skeletal Biology
Development and Disease SBDD Skeletal Biology
Structure and Regeneration SBSR Skeletal Muscle
Biology and Exercise Physiology
SMEP Musculoskeletal Rehabilitation Sciences
MRS Arthritis, Connective Tissue, and Skin
ACTS General Medicine B Study Section
GMB Chronic Fatigue Syndrome/ Fibromyalgia
Syndrome Special Emphasis Panel CFS SEP Urology
Study Section UROL SEP Bioengineering Research
Partnerships/Grants Special Emphasis Panel
SSS-M MOSS Small Business Activities SBIR/STTR
SEPs
Musculoskeletal, Oral and Skin Sciences IRG MOSS
12
Assignment to Institutes
  • Applications are referred to an Institute or
    Center as the potential funding component
  • This assignment is based on a match between the
    research proposed and the overall mission of the
    Institute or Center
  • Where applications are appropriate for more than
    one Institute or Center, multiple assignments are
    made

13
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

14
Selection of Peer Reviewers
Active and Productive Researchers
Research Capability
Non-Research
Non-Doctoral
Scientific Community
15
Criteria For Selection of Peer Reviewers
  • 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

16
Review Process for a Research Grant Application
17
Review of Research Grants
  • REVIEW CRITERIA
  • Significance
  • Approach
  • Innovation
  • Investigator
  • Environment
  • Overall Evaluation Score Reflects Impact on
    Field

18
Review Criteria (continued)
  • Significance Does the study address an important
    problem? How will scientific knowledge be
    advanced?
  • Approach Are design and methods well-developed
    and appropriate? Are problem areas addressed?
  • Innovation Are there novel concepts or
    approaches? Are the aims original and
    innovative?
  • Investigator Is the investigator appropriately
    trained?
  • Environment Does the scientific environment
    contribute to the probability of success? Are
    there unique features of the scientific
    environment?

19
Research Involving Human Subjects
  • Important Considerations
  • Is the proposed study exempt from human subject
    review?
  • Are there any apparent risks to the human
    subjects?
  • Are the protections adequate?
  • What are the potential benefits to the subjects
    and to mankind?
  • Are the inclusions of minorities and both genders
    adequately addressed?

Risks include the possibility of physical,
psychological, or social injury resulting from
research.
20
Research Involving Children
Children must be considered for inclusion in all
human subject research supported by NIH
  • Effective for all new applications received after
    October 1, 1998
  • Child is defined as an individual under age 21
  • If children are included, Investigator must
    address
  • age range
  • expertise of investigative team
  • facilities
  • sufficient numbers

21
Animal Welfare
  • Important Considerations
  • Will the anticipated results be for the good of
    society?
  • Will the work be planned and performed by
    qualified scientists?
  • Will the animals be treated so as to avoid any
    unnecessary discomfort, pain, anxiety, or poor
    health?
  • Species chosen
  • Animals in short supply

22
Scientific Review Group or Study Section Actions
  • Scored, Scientific Merit Rating (priority scores
    and percentiles)
  • Unscored (lower half)
  • Deferral

23
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

24
National Advisory Council or Board Review
25
Council Actions
  • Concurrence with study section action
  • Modification of study section action
  • Deferral for re-review

26
What Determines Which Awards Are Made?
  • Scientific merit
  • Program Considerations
  • Availability of funds

27
Information on the World Wide Web Selected Sites
of Interest
  • National Institutes of Health (http//www.nih.gov)
  • Office of Extramural Research (http//www.nih.gov/
    grants/oer.htm)
  • Grants Policy (http//www.nih.gov/grants/policy/po
    licy.htm)
  • Center for Scientific Review (http//www.csr.nih.g
    ov)
  • Referral and Review (http//www.csr.nih.gov/refrev
    .htm)
  • Overview of Peer Review Process (http//www.
    csr.nih.gov/review/peerrev.htm)
  • CSR Study Section Rosters (http//www.csr.nih.gov/
    committees/rosterindex.asp)
  • NIH Peer Review Notes (http//www.csr.nih.gov/prn
    otes/prnotes.htm)
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