Fundamentals of the NIH Grants Process

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Fundamentals of the NIH Grants Process

• George Gardner
• Office of Policy for Extramural Research
  Administration
• October 28, 2008

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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

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NIH Campus -- 1947
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NIH Campus Today
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NIH in 2008
One agency of 11 within U.S. Department of Health
and Human Services (HHS) Comprises 27 Institutes
and Centers (IC)
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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)
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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
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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

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NIH Gets 1 of U.S. Budget
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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)
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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

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Fundamentals of the Grants Process

• Grant Mechanisms

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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

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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

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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

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Cooperative Agreements (U)

• Specialized Grant mechanism
• Substantial NIH staff involvement in program and
  science
• Typically initiated by NIH
• Cooperative Agreement Kiosk

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Fundamentals of the Grants Process

• Submission and Review of Grant Applications

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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

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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

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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

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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

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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

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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

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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

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Who Makes Actual Funding Decisions?

• The Institute Director!
• Factors Considered
• Scientific Merit
• Contribution to Institute Mission
• Program Balance
• Availability of Funds

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Fundamentals of the Grants Process

• Grants Management Issues and Requirements

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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

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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

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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/
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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

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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

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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

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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

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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
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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
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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

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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

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Thank You!

• Any Questions?