Fogarty International Center National Institutes of Health (NIH) Marya Levintova, Ph.D.

1. Fogarty International Center National Institutes of Health (NIH) Marya Levintova, Ph.D. International Health Program Officer for Russia, Eurasia and Arctic Affairs International Health Program Officer for Europe and EU (Acting) Division of International Relations Fogarty International Center National Institutes of Health Bridges in Life Sciences US-CEE Regional Networking Meeting IV Debrecen, Hungary April 5, 2009

2. Introduction to the NIH History Mission & Organization Funding Facts Funding opportunities for foreign researchers Fundamentals of the Grants Process Types of Grants Roles & Responsibilities: Yours & Ours Fundamentals of the NIH Grant Application process Registration Forms Today’s Topics

3. NIH Campus -- 1947

4. NIH Campus Today

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

6. 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

7. Fulfilling Our Mission • Support research by non-Federal scientists across U.S. and abroad • Train research investigators • Conduct research at the NIH laboratories • Foster communication of medical and health sciences information

8. NIH Organizational Structure Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review

9. Did You Know? • NIH is the Nation’s leading medical research agency • NIH Bethesda campus is world’s largest research organization • 6,000 scientists (18,000 employees) • 5 Nobel Prize winners • Over 50 members of the National Academy of Sciences • 11 of 27 IC Directors are members of Institute of Medicine • 3 Office of NIH Director staff • NIH Extramural Research Program • 105 Nobel Prize winners trained or funded by NIH • More than half of all American Nobel Prize winners

10. NIH Gets 1% of U.S. Budget U.S. budget

11. NIH Budget: Congressional Appropriations NIH FY 2008: Increase of $0.4 billion Doubling

12. NIH budget Total FY 2008 Budget: $29.46 Billion 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%)

13. Clinical Research Clinical Research Translational Research Translational Research Basic Research Basic Research Private Sector - $59B NIH - $29 B Balanced National Biomedical Research Portfolio

14. NIH – Extramural and Other Grant Awards, by Type • Research Grant Programs (8 types) • New Investigators Program (2 types) • Multiple Principal Investigators (NEW in Feb 2007) • Research Supplemental Programs (1 type) • Ruth L. Kirschstein National Research Service Awards (NRSA) (8 types) • Research Ethics and Training Grant Programs (2 types) • NIH Career Development (K) Awards (15 types) • Small Business Awards (1 type) • Other Programs (8 types) Source: http://grants2.nih.gov/grants/funding/funding_program.htm

15. NIH – Extramural Awards, by Type

16. NIH Grant Statistics Fiscal Year 2007 • Approx. 80,000 grant applications received • 47,243 research grants awarded ($20.35 billion) • 79% of NIH extramural awards - institutions of higher education

17. Mechanism of Support Predoctoral Institutional Training Grant (T32) GRADUATE/ MEDICAL STUDENT Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32) POST DOCTORAL EARLY CAREER MIDDLE Midcareer Investigator Award in Patient-Oriented Research (K24) SENIOR Senior Scientist Award (K05) NIH Research Training and Career Development Timetable Approx. Stage of Research Training and Development NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) Small Grant (R03) Independent Scientist Award (K02) Research Project Grant (R01) Exploratory/Development Grant (R21)

18. Funding Opportunities for Foreign Researchers Intramural program at NIH

19. Training Opportunities for Foreign Researchers at NIH Training opportunities at NIH are available for foreign national scientists through the NIH Visiting Program. More info at http://dis.ors.od.nih.gov/visitingprogram/01_vpmain.html. The Visiting Program is open to scientists at all career levels. There are two categories of program participants: • Visiting Fellows who receive awards for research training • Visiting Scientists who receive appointments to conduct research The NIH has long considered close interaction with foreign scientists in the conduct of collaborative research to be an essential ingredient in achieving its mission.

20. NIH Intramural Program, Visiting Fellows and Guest Researchers, by E.U. Member/Candidate Countries, 2005 N=966 x average stipend cost $50,000/yr = $48.3 million

21. Funding Opportunities for Foreign Researchers Extramural Opportunities

22. Eligibility for NIH Funding • In general, most NIH grants are available to: • Foreign institutions and international organizations • Principal Investigators and other personnel who are not U.S. citizens • Domestic organizations with a foreign component Note: Exceptions are based on the type of program or grant (e.g., training and fellowships, small business awards, etc. are not eligible) and any specific eligibility requirements noted in a particular Funding Opportunity Announcement.

23. Peer Review of Foreign Grant Applications • Standard Review Criteria is used in evaluating and scoring applications from both Domestic and Foreign Institutions • Foreign Grant Applications also receive the following assessment: • Does the project present opportunities for furthering research programs in other countries that are not readily available in the U.S. or that augment existing U.S. resources? • Does the proposed project have specific relevance to the mission and objectives of an Institute or Center and have the potential for significantly advancing the health sciences in the United States?

24. Finding the opportunity announcements: http://grants.nih.gov

25. U.S. Grants & Funding Opportunities www.Grants.Gov: • Find grant opportunities • 26 Federal grant-making agencies • Register • Allows organization to apply for U.S. grants • Process may take up to 30 days • Apply for grants • Find electronic submission resources • Track your application

26. FIC Organizational Structure

27. Research and Research Training • ~$50 million in grant awards • 1/3 Research, 2/3 Research Training • Awards range $10,000 - $1 million • Low and Middle Income Countries • Research Capacity Development and Equity

28. Research Grants • Millennium Challenge grants – Non-communicable diseases • Fogarty International Research Collaboration Award (FIRCA) • International Cooperative Biodiversity Groups (ICBG) • Ecology of Infectious Diseases (EID) • International Studies on Health and Economic Development (ISHED) • Int’l Tobacco and Health Research and Capacity Building Program • Global Research Initiative Program for New Foreign Investigators (GRIP) • Stigma and Global Health Research Program • Brain Disorders in the Developing World: Research Across the Lifespan

29. Training Grants • Generally institutional training grant to U.S. universities and non-profit research institutions in response to a specific request for applications (RFA) • Awardees are generally current NIH grant recipients with demonstrated research collaboration with foreign research institutions • Purpose – support training for research-capacity building for scientists from developing nations

30. Training Grants – 14 programs • Fogarty International Collaborative Trauma and Injury Research Training • International Clinical, Operational, and Health Services Research Training Awards for HIV/AIDS and Tuberculosis • International Maternal and Child Health Research Training • Fogarty International Clinical Research Scholars Training • Informatics Training for Global Health • International Collaborative Genetics Research Training • International Clinical, Operational, and Health Services Research Training Awards for Malaria • Global Infectious Diseases Research Training • International Research Ethics Education and Career Development • International Training Program in Environmental and Occupational Health • Global Research Training in Population Health • AIDS International Training and Research • Framework Programs for Global Health • International Research Scientist Development Awards

31. Additional funding resources

32. Looking for collaborators? http://crisp.cit.nih.gov/

38. Fundamentals of the Grants Process Grant Mechanisms

39. 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 What’s the Difference Between Grants and Contracts?

40. 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

41. Research Training and Career Awards • Training Grants – T • Institutional • Predoctoral and Postdoctoral • Fellowships – F • Individual • Predoctoral – F31 • Postdoctoral – F32 • Career Development Awards – K

42. Cooperative Agreements (U) • Specialized Grant mechanism • Substantial NIH staff involvement in program and science • Typically initiated by NIH • Cooperative Agreement Kiosk http://odoerdb2-2.od.nih.gov/oer/programs/coop/

43. Fundamentals of the Grants Process Team Players

44. Grants are awarded to institutions as represented by AORs PD/PIs manage and perform the science Research Administrators support business aspects of the grant Successful grants require close coordination between all members of the grantee team. Authorized Organizational Reps Research Administrator Principal Investigator Grantee Institution Team

45. The Grantee Institution • Actual recipient of award • Legally responsible for proper conduct and execution of grant • Provides fiscal management • Provides oversight on allocation decisions • Assures compliance with Federal, NIH, and organization-wide requirements

46. Responsibilities of the Authorized Organization Representative (AOR) [aka Authorized Organizational Official (AO)][aka Signing Official (SO)] • Designated Representative of the grantee institution • Accountable for appropriately utilizing Federal funds and for the performance of a project • Signs all official correspondence to NIH, including grant applications, financial reports, assurances, and certifications.

47. Responsibilities of the Principal Investigator(s) (PIs) • Designated by the grantee institution • Responsible for the scientific and technical aspects of project • Directly manages the project on a day-to-day basis • Assures scientific compliance by maintaining contact with the NIH Program Officer • Coordinates with other PIs on projects with multiple PIs

48. Responsibilities of the Research Administrator • Acts as an agent of the PI and Authorized Organizational Representative: • Gathers information needed to ensure compliance with Federal regulations, as well as organization-wide requirements • Provides essential grant-related support • Cannot assume responsibilities assigned to the Authorized Organizational Representative or the PI

49. The NIH Extramural Team Review Staff Grants Management Program Staff

50. Who Ya Gonna’ Call? • If someone needs help with their application before the review?…