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

2. 2 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

3. 3 NIH Campus -- 1947

4. 4 NIH Campus Today

5. 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. 6 U. S. Dept. of Health and Human Services Administration for Children and Families (ACF) Administration for Children and Families (ACF) Food and Drug Administration (FDA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Resources and Services Administration (HRSA) Secretary of Health and Human Services Administration on Aging (AoA) Administration on Aging (AoA) Center for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Services (CMS) Indian Health Services (IHS) Indian Health Services (IHS) National Institutes of Health (NIH) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Substance Abuse and Mental Health Services Administration (SAMHSA) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Healthcare Research and Quality (AHRQ) Agency for Healthcare Research and Quality (AHRQ)

7. 7 NIH Organizational Structure 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 Research 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 Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review National Center on Minority Health and Health Disparities Office of the Director

8. 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. 9 NIH Gets 1% of U.S. Budget

10. 10 What Stays at NIH? What Goes Elsewhere? 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

11. 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. OPERA Fundamentals of the Grants Process Grant Mechanisms

13. 13 What’s 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. 14 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

15. 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. 16 Cooperative Agreements (U) Specialized Grant mechanism Substantial NIH staff involvement in program and science Typically initiated by NIH Cooperative Agreement Kiosk

17. OPERA Fundamentals of the Grants Process Submission and Review of Grant Applications

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

21. 21 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 1 st Level 2 nd Level

22. 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. 23 1 st 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. 24 2 nd Level Review National Advisory Council or Board assesses quality of 1 st 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. 25 Who Makes Actual Funding Decisions? The Institute Director! Factors Considered: –Scientific Merit –Contribution to Institute Mission –Program Balance –Availability of Funds

26. OPERA Fundamentals of the Grants Process Grants Management Issues and Requirements

27. 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. 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. 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. 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. 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 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

32. 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. 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. 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. 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. 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 Government’s interests and effect positive change

37. 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. 38 Thank You! Any Questions?