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Fundamentals of the NIH Grants Process

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Title: Fundamentals of the NIH Grants Process


1
Fundamentals of the NIH Grants Process
  • George Gardner
  • Office of Policy for Extramural Research
    Administration
  • October 28, 2008

2
This Mornings Topics
  • Introduction to the NIH
  • History
  • Mission Organization
  • Funding Facts
  • Fundamentals of the Grants Process
  • Grant Mechanisms
  • Submission and Review of Grant Applications
  • Grants Management Issues and Requirements

3
NIH Campus -- 1947
4
NIH Campus Today
5
NIH in 2008
One agency of 11 within U.S. Department of Health
and Human Services (HHS) Comprises 27 Institutes
and Centers (IC)
6
U. S. Dept. of Health and Human Services
Secretary of Health and Human Services
Administration for Children and Families (ACF)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA
)
Administration on Aging (AoA)
Center for Medicare Medicaid Services (CMS)
Indian Health Services (IHS)
National Institutes of Health (NIH)
Agency for Healthcare Research and
Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)
Substance Abuse and Mental Health
Services Administration (SAMHSA)
Agency for Toxic Substances and Disease
Registry (ATSDR)
7
NIH Organizational Structure
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 Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
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 Institute of Biomedical Imaging and
Bioengineering
National Center on Minority Health and Health
Disparities
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources
No funding authority

NIH Clinical Center
Center for Information Technology
Center for Scientific Review
8
NIH Mission
  • NIH is the steward of medical and behavioral
    research for the Nation
  • Our mission to acquire new knowledge to help
    prevent, detect, diagnose, and treat disease and
    disability
  • from the rarest genetic disorder to the common
    cold

9
NIH Gets 1 of U.S. Budget
10
What Stays at NIH? What Goes Elsewhere?
Total FY 2008 Budget 29.46 Billion
84 Outside NIH gt 325,000 Scientists gt 3,000
Organizations Worldwide
16 Inside NIH 2.9 B Intramural Research
(10) 1.2 B Staff Buildings (4) 0.6 B
Other (2)
11
NIH Grant Statistics
  • Fiscal Year 2007
  • Approx. 80,000 grant applications received (all
    mechanisms)
  • 47,243 research grants awarded (20.35 billion)
  • 79 of NIH extramural awards go to institutions
    of higher education

12
Fundamentals of the Grants Process
  • Grant Mechanisms

13
Whats the Difference Between Grants and
Contracts?
  • GRANT
  • Assistance
  • Government is Patron or Partner
  • Purpose
  • to support and stimulate research
  • Benefit a public purpose
  • Investigator initiated
  • CONTRACT
  • Acquisition
  • Government is Purchaser
  • Purpose
  • to acquire goods or services
  • The direct benefit and use of the government
  • Government initiated

14
Award MechanismsResearch Project Grants
  • Traditional R01
  • Exploratory/Development Grants R03/R21/R33/R34
  • Program Project P01
  • Research Center Grants P50
  • Small Business R41, R42, R43, R44

15
Research Training and Career Awards
  • Training Grants T
  • Institutional
  • Predoctoral and Postdoctoral
  • Trainees must be U.S. citizens
  • Fellowships (U.S. Domestic only) F
  • Individual
  • Predoctoral F31
  • Postdoctoral F32
  • Fellows must be U.S. citizens
  • Career Development Awards K

16
Cooperative Agreements (U)
  • Specialized Grant mechanism
  • Substantial NIH staff involvement in program and
    science
  • Typically initiated by NIH
  • Cooperative Agreement Kiosk

17
Fundamentals of the Grants Process
  • Submission and Review of Grant Applications

18
Writing a Grant Application
  • Components of successful applications
  • Strong Idea
  • Strong Science
  • Strong Presentation
  • Match idea/science to the right NIH Institute
  • Every IC has specific mission
  • Hone high-quality grantwriting skills
  • Communicate scientific content compellingly
  • Follow all the instructions

19
Writing a Grant Application
  • Research plan answers 4 essential questions
  • What do you intend to do?
  • Why is the work important?
  • What has already been done?
  • How are you going to do the work?
  • Successful applications typically are
  • Well-focused and explicitly written
  • Not overly ambitious
  • Understandable by a naïve reader

20
Review Issues Specific to Foreign Applicants
  • Applications from foreign institutions will be
    assessed by two additional review criteria not
    applied to applications from domestic
    institutions
  • Whether the project presents special
    opportunities for furthering research programs
    through the use of unusual talents, resources,
    populations or environmental conditions not
    available in the U.S. or the augment existing
    U.S. resources, and
  • Whether the project has the potential for
    significantly advancing the health sciences in
    the United States and the health of the people of
    the United States.
  • More at http//grants.nih.gov/grants/guide/notic
    e-files/NOT-OD-09-010.html

21
2 Level System for Application Review
1st Level
  • Scientific Review Group (SRG)
  • Independent outside reviewers
  • Evaluate scientific merit significance
  • Recommend length and level of funding

2nd Level
  • National Advisory Council
  • Assesses Quality of SRG Review
  • Makes Recommendation to
  • Institute Staff on Funding
  • Evaluates Program Priorities and Relevance
  • Advises on Policy

22
Who Reviews Grant Applications?
  • Scientist peers with appropriate expertise --
    recruited by the Scientific Review Officer
  • Assigned to specific applications based on
    content
  • 4 year term typical
  • Temporary reviewers sought as needed

23
1st Level Review
  • Standing study section typically has 12-24
    members
  • 3 face-to-face meetings each year
  • Review 60 - 100 applications at each meeting

24
2nd Level Review
  • National Advisory Council or Board assesses
    quality of 1st level review
  • Concurs with or modifies action of Scientific
    Review Groups
  • Reads summary statements only
  • Can also designate application as High or Low
    program priority

25
Who Makes Actual Funding Decisions?
  • The Institute Director!
  • Factors Considered
  • Scientific Merit
  • Contribution to Institute Mission
  • Program Balance
  • Availability of Funds

26
Fundamentals of the Grants Process
  • Grants Management Issues and Requirements

27
Typical Grant Funding Process
  • Projects are programmatically approved for
    support in their entirety (project period) but
    are funded in annual increments (budget periods)
  • Total project period initial competitive
    segment additional competitive segments
    extensions
  • Amounts shown for subsequent years in a
    competitive segment represent projections

28
Typical Grant Funding Process
  • Future funding is contingent on satisfactory
    progress, availability of funds, and the
    continued best interest of the Federal government
  • No legal obligation to provide funding beyond the
    ending date of the current budget period on the
    NoA
  • The decision to fund the next budget period is
    formalized by the issuance of an NoA

29
Cost Principles
  • The White House Office of Management and Budget
    (OMB) has created government-wide principles on
    what allowable costs may be paid for with
    government grant funds.
  • OMB Circular A-21 - Educational Institutions
  • OMB Circular A-122 Non-Profits
  • OMB Circular A-87 State/Local Governments
  • 45 CFR Part 74, Appendix E - Hospitals
  • 48 CFR Subpart 31.2 (FAR) For-profits
  • Foreign institutions comply with the applicable
    cost principles depending on the type of
    organization

http//www.whitehouse.gov/omb/circulars/
30
Administrative Standards
  • OMB has also issued administrative requirements
    for grantees.
  • OMB Circular A-110 - Uniform Administrative
    Requirements for Grants and Agreements with
    Universities, Hospitals and Other Non-Profit
    Organizations (domestic and foreign)
  • OMB Circular A-102 Grants and Cooperative
    Agreements to State and Local Governments

31
Grants Management Issues Specific to Foreign
Grantees
  • Financial and Budgetary Issues
  • Construction costs are not allowable but minor
    alterations and renovations (under 500,000 are
    allowable)
  • Payment is made by U.S. Treasury check on a
    quarterly advance basis.
  • Detailed budgets are required in all grant
    applications
  • Customs fees, import duties, and currency
    fluctuation payments are not allowable
  • Limited FA costs (8) are provided to support
    the costs of complying with NIH and DHHS
    requirements
  • More at http//grants.nih.gov/grants/guide/notic
    e-files/NOT-OD-09-010.html

32
NIH Administrative and Fiscal Monitoring
Requirements
  • NIH requires grantees to submit the following
    documents to ensure successful operation and
    compliance with grant terms and conditions
  • Annual Progress Report
  • (PHS 2590)
  • Annual Financial Status Reports (FSR)
  • Invention Reporting
  • Yearly Audits (as applicable)
  • Final Closeout Reports

33
Audit Requirements
  • In general, grantees that expend 500,000 or more
    per year under Federal grants, cooperative
    agreements, and/or procurement contracts to have
    an annual audit by a public accountant or a
    Federal, State, or local government audit
    organization.
  • Foreign and Commercial (for-profit) organizations
    are subject to audit provisions contained in 45
    CFR 74.26 (d) and the NIH Grants Policy Statement

34
Human Subjects Protection
  • Safeguarding the rights and welfare of
    individuals who participate as subjects in
    research based on DHHS regulations and
    established, internationally recognized ethical
    principles.
  • DHHS Office of Human Subjects Research
    Protections (OHRP) oversees all issues for
    Federally-funded research involving people
  • Refer to website for information and resources

www.hhs.gov/ohrp
35
Humane Animal Research
  • Grantees are responsible for the humane care and
    treatment of animals under NIH-supported
    activities.
  • NIH Office of Laboratory Animal Welfare (OLAW)
    oversees policies for humane animal care and use.
  • Refer to website for information and resources

grants.nih.gov/grants/olaw
36
Corrective Actions/Enforcement
  • Technical Assistance first!
  • Failure to comply with Terms and Conditions of
    Award may result in enforcement actions
  • Examples modification of terms, more frequent
    financial reporting, suspension, withholding of
    support, termination
  • Special terms and conditions to protect the
    Governments interests and effect positive change

37
Reports Required to Close Out a Grant
  • Final Financial Status Report (FSR)
  • Final Invention Statement and Certification
  • Final Progress Report
  • Closeout reports are due within 90 days of
    project period end date

38
Thank You!
  • Any Questions?
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