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National Institutes of Health

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... by the Federal Government, primarily the National Institutes of Health (NIH) ... National Institute of Environmental Health Sciences (NIEHS) ... – PowerPoint PPT presentation

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Title: National Institutes of Health


1
National Institutes of Health
2
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)

3
U. S. Department of Health and Human Services
The Secretary Deputy Secretary
Administration for Children and Families (ACF)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA
)
Administration on Aging (AoA)
Health Care Financing Administration (HCFA)
Indian Health Services (IHS)
National Institutes of Health (NIH)
Agency for Health Care Policy and
Research (AHCPR)
Centers for Disease Control and Prevention (CDC)
Substance Abuse and Mental Health
Services Administration (SAMHSA)
Program Support Center (PSC)
Agency for Toxic Substances and Disease
Registry (ATSDR)
4
NIH Extramural Awarding Components
  • 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)

5
A Typical Institute/Center
Office of the IC Director
National Advisory Council
Board of Scientific Counselors
Extramural
Intramural
Scientific Programs
Laboratory Studies
Clinical Studies
Grants
Contracts
6
22 Research Projects
  • R 01 Research Project To support a discrete,
    specified, circumscribed project to be performed
    by the named investigator(s) in an area
    representing his specific interest and
    competencies.
  • R 03 Small Research Grants To provide research
    support specifically limited in time and amount
    for studies in categorical program areas. Small
    grants provide flexibility for initiating studies
    which are generally for preliminary short-term
    projects and are non-renewable.
  • R 10() Cooperative Clinical Research (Grants)
    To support clinical evaluation of various methods
    of therapy and/or prevention in specific disease
    areas. These represent cooperative programs
    between participating institutions and principal
    investigators, and are usually conducted under
    established protocols.

7
22 Research Projects
  • R 18 Research Demonstration and Dissemination
    Projects To provide support designed to develop,
    test, and evaluate health service activities, and
    to foster the application of existing knowledge
    for the control of categorical diseases.
  • R 21 Exploratory/Developmental Grants To
    encourage the development of new research
    activities in categorical program areas.
    (Support generally is restricted in level of
    support and in time.)

8
Research Career Programs
  • K 01 Research Scientist Development Award -
    Research Training For support of a scientist,
    committed to research, in need of both advanced
    research training and additional experience.
  • K 02 Research Scientist Development Award -
    Research For support of a scientist, committed
    to research, in need of additional experience.
  • K 05 Research Scientist Award For the support of
    a research scientist qualified to pursue
    independent research which would extend the
    research program of the sponsoring institution,
    or to direct an essential part of this research
    program.
  • K 06() Research Career Awards To enable
    institutions to finance positions favorable to
    the intellectual growth and research productivity
    of established investigators of high competence
    for the duration of their careers.

9
Overall Peer Review Process
10
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

11
Review Process for a Research Grant
National Institutes of Health
Research Grant Application
School or Other Research Center
Center for Scientific Review
Assigns to IRG/Study Section IC
Study Section
Initiates Research Idea
Submits Application
Evaluates for Scientific Merit
Institute
Evaluates for Program Relevance
Advisory Councils and Boards
Allocates Funds
Conducts Research
Recommends Action
Institute Director
Takes final action for NIH Director
12
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----

13
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

14
Grant Application Receipt and Assignment
15
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

16
Applications are Assigned by
  • Referral Officers
  • Professional scientists, most of whom also serve
    as scientific review administrators of CSR study
    sections

17
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

18
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)

19
Sample Application Number
  • Individual Serial
    Amended
  • Research Number
  • Grant
  • 1 R01 CA 12345 01 A1
  • New National
    Grant
  • Application Cancer
    Support
  • Institute
    Year

20
Initial Review in CSR
21
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

22
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

23
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

24
Scientific Review Group or Study Section Actions
  • Scored, Scientific Merit Rating (priority scores
    and percentiles)
  • Unscored (lower half)
  • Deferral

25
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.

26
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.

27
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.

28
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

29
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

30
National Advisory Council or Board Review
31
Council Actions
  • Concurrence with study section action
  • Modification of study section action
  • Deferral for re-review

32
What Determines Which Awards Are Made?
  • Scientific merit
  • Program Considerations
  • Availability of funds

33
Preparation of an Application
34
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
35
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

36
Common Problems in Applications
  • 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
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