OPERA

Fundamentals of the NIH Grants Process

George Gardner

Office of Policy for Extramural Research Administration

October 28, 2008

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This Morning’s 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 2008One 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

Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

Secretary of Health and

Human Services

Secretary of Health and

Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services

(CMS)

Center for Medicare &

Medicaid Services

(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for Healthcare

Research and Quality(AHRQ)

Agency for Healthcare

Research and Quality(AHRQ)

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NIH Organizational Structure

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and

Bioengineering

No funding authority

NIHClinical Center

Centerfor Information

Technology

Center for Scientific

Review

National Center on Minority Health

and Health Disparities

Office of the Director

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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

$2,941

$29.5

NIH Rest of U.S. Budget

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What Stays at NIH? What Goes Elsewhere?

$24.7

$4.7

Spending at NIH

Spending Outside

84% Outside NIH> 325,000 Scientists > 3,000 Organizations Worldwide

16% Inside NIH $2.9 B Intramural Research (10%)$1.2 B Staff & Buildings (4%)$0.6 B Other (2%)

Total FY 2008 Budget: $29.46 Billion

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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

OPERA

Fundamentals of the Grants Process

Grant Mechanisms

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What’s the Difference Between Grants and Contracts?

GRANTAssistance

Government is Patron or Partner

Purpose:

to support and stimulate research

Benefit a public purpose

Investigator initiated

CONTRACTAcquisition

Government is Purchaser

Purpose:

to acquire goods or services

The direct benefit and use of the government

Government initiated

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Award Mechanisms:Research 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

OPERA

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/notice-files/NOT-OD-09-010.html

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2 Level System for Application Review

National Advisory Council Assesses Quality of SRG Review Makes Recommendation to Institute Staff on Funding

Evaluates Program Priorities and Relevance

Advises on Policy

Scientific Review Group (SRG) Independent outside reviewers Evaluate scientific merit & significance Recommend length and level of funding

1st Level

2nd Level

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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

OPERA

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 F&A costs (8%) are provided to support the costs

of complying with NIH and DHHS requirements

More at: http://grants.nih.gov/grants/guide/notice-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 Government’s 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?