U.S. Department of Health and Human Services

1. NIH International Opportunities —The Extramural PerspectiveSharon H. Hrynkow, Ph.D.Deputy Director,Fogarty International CenterNational Institutes of HealthPhone: 301-496-1415E-mail: sh141s@nih.govOslo, Norway —June 21, 2002

2. U.S. Department of Health and Human Services The Secretary Deputy Secretary Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Care Financing Administration (HCFA) Agency for Health Care Policy and Research (AHCPR) 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) Program Support Center (PSC)

3. National Institutes of Health Office of the Director National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research 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 Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine National Library of Medicine National Center on Minority Health and Health Disparities National Center for Research Resources Fogarty International Center Clinical Center Center for Information Technology Center for Scientific Review

4. National Institutes of Health Mission To uncover new knowledge that will lead to better health for everyone

5. NIH fulfills its mission by: • Conducting research in its own laboratories. • Supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. • Helping in the training of research investigators in the U.S. and abroad. • Fostering communication of medical and health sciences information in the U.S. and abroad.

6. NIH Budget Fiscal Year 2001 = $20,298 billion

7. NIH Authority • To award grants to foreign institutions • To support foreign collaborations

8. Why Foreign Grants? • NIH is committed to supporting the best biomedical research regardless of location • Special resources and/or populations may be located abroad • The interdisciplinary nature of modern biology demands extensive collaborations • The internet transcends international boundaries and facilitates collaborations • Disease knows no boundaries

9. NIH Research Grants A foreign scientist is eligible to apply as P.I. or co-investigator to pursue research in any area normally funded by NIH.

10. Possible Mechanisms Most research funded by NIH is via traditional investigator initiated grants (R01). Foreign institutions are eligible.

11. Definition A substantial foreign componentof a grant to a U.S. institution is defined as: The use of grant funds to provide support to any significant scientific element or segment of the project which is to be performed outside of the U.S. either by the grantee project staff or by a researcher employed by a foreign institution.

12. Other Possibilities • Collaborations with US Scientists • Can be done as subcontracts to grants to U.S. institutions • Individual Postdoctoral Fellowships • Special programs from the Fogarty International Center

13. Fogarty International Center, NIH Mission:Promote and support scientific research and training internationally to reduce disparities in global health. “Science for Global Health”

14. Fogarty International Center, NIH FIC fulfills its mission by: Advancing research and research training that prepares current and future health scientists to meet global health challenges. “Science for Global Health”

15. Fogarty International CenterDivision of International Training and Research • Extramural Training Grants — 12 Programs • Research Grants — 5 Programs • International Training Grants for U.S. citizens* Minority International Research Training Grant (MIRT)* Scientist Development fellowship (post-doc)* Foreign-funded fellowship (Japan)

16. Fogarty International CenterTraining Grants for Developing Countries • HIV/AIDS • Building Capacity in Support of ICIDR sites • Emerging Infectious Diseases • Environmental and Occupational Health • FIC-NLM Medical Informatics • Maternal and Child Health • Population and Health • Tuberculosis • Research Bioethics • Malaria • Clinical, Operational, and Health Services Research • Tobacco and Health Research

17. Fogarty International CenterSupport Available Through Training Grants • Masters and Doctoral Degrees * Tuition, Stipends, Travel, Related Expenses • Post-doctoral Fellowships* Tuition, Stipends, Travel, Related Expenses • Short Courses (in U.S. or In-country)* Tuition, Travel, Per diem • Training-related In-country research grants, Re-entry grants • Limited salary, Administrative support for U.S. university

18. Fogarty International CenterResearch Grants — 7 Programs • Ecology of Infectious Diseases • Fogarty International Research Collaboration Award (FIRCA) • HIV-AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA) • International Cooperative Biodiversity Groups (ICBG) • International Studies on Health and Economic Development • Proposed Global Health Research Initiative Program (GRIP) • for New Foreign Investigators • International Tobacco and Health Research and Capacity Building • Program

19. Fogarty International CenterProgram Characteristics • A systematic approach • Stability and Long-term Commitment • Response to Local Needs and Priorities • Long-term Mentoring • Mutual Reinforcement of Investments in Training and Research • Individual and Institutional Partnerships • Long-term mentoring • Advanced In-country Research (re-entry grants) • Empowerment and mutual respect • Networking • Flexibility • Leverage

20. Fogarty International CenterExtramural 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

21. European PIs may participate in FIC Programs: • Stigma – New • Clinical, Operational and Health Services Research Training on AIDS/TB - New • Small Grants Program on AIDS

22. Fogarty International CenterOn the Horizon • Brain Disorders in the Developing World • Trauma and Injury • Health, Environment, and Economic Development

23. NIH International Research Expenditures Fiscal Years 1994 to 2000 Dollars

24. Fiscal Year 1999NIH Research Awards by Region

25. Fiscal Year 1999NIH Foreign Components of Domestic Awards Amount Region

26. Grants & Contracts Foreign Component of Domestic Awards 1999 NIH European Funding Levels $8 6.7 $7 $6 $5 U.S. Dollars (in millions) 4.1 $4 $3 2 $2 1.4 0.7 0.7 $1 0.6 0.5 0.4 0 $0 UK France Germany Norway Italy Country

27. Examples of NIH-European Collaborations • Multi-site studies on environmental risk factors for cancer • Structural biology • Phase III clinical trials • Twin studies

28. Navigating Your Way

29. Info: Computer Retrieval of Information on Scientific Projects (CRISP)http://crisp.cit.nih.gov/

30. Use CRISP to learn: • What’s funded in your area? • Who’s funded to work in your area? • What NIH institutes support work similar to what you want to do? • What study sections review (and like) it?

31. Hints for CRISP : • CRISP includes only funded projects; all information is public. • Format help is under the ? button for each field. • Abstracts are provided by the investigator at the beginning of the project. • Other DHHS agency awards are included (e.g., CDCP, FDA). Intramural projects at NIH and FDA are included.

32. The Division of Receipt & Referral at the Center for Scientific Review (CSR) of NIH Over 40,000 Applications a Year Where Do NIH Applications Go?

33. What Does Receipt & Referral at NIH Do? • Data Entry from the Face Page of the Application or Page 1 • Assignment to the Initial Review Group (IRG) • Assignment to the NIH Institute or Center (IC) • Information Resource for Applicants and NIH Extramural Staff • Process and Arbitrate Requests for IRG and IC assignments

34. Ideas in the Form of Research Proposals Institute Advisory Councils Scientific Review NIH Grantees • Scientists and public members examine the institute portfolio. • Assess programs • Approve applications • Provide policy advice NIH receives over 25,000 research proposals each year (~1/3 in response to targeted themes) Applications are evaluated in a competitive peer review system. Annual progress and fiscal reports are mandatory and reviewed by NIH staff. NIH Priorities and Opportunities Evaluated in Peer Review

35. What Assignments are Made for Unsolicited Applications? • For Unsolicited Applications: Mostly R01, R15, and some R21 proposal About 75% of total NIH applications • Assignment to Institute(s) or Center(s) for Potential Funding • Assignment to IRG for Review by Study Section or Scientific Review Group (SRG) at CSR

36. Solicited Applications are responsive to: PAs (Program Announcements) RFAs (Request for Applications) About 25% of Total Applications Assignment to Specific NIH Institutes or Centers Requesting Applications for both: Institute Review and Institute Funding What Assignments are Made for Solicited Applications?

37. Preparation Timeline Use this timeline as a guide to plan how much time you'll need to complete your application, or work backward from the due date to calculate your prep time. Find receipt dates for all grant types at NIH's Standard Receipt Dates and Review and Award Cycles.

38. Application Receipt Dates: • Unsolicited: 3 times per year: February 1 June 1 October 1 • Solicited • See RFA or PA

39. Receipt to Review Timeline This timeline gives you an idea of what to expect afteryou send NIH your application

40. The Five Review Criteria are Intended to Emphasize I M P A C T

41. Research Project Evaluation Criteria(listed in Form PHS 398) • Significance • Approach • Innovation • Investigator • Environment

42. Significance • Does this study address an important problem? • If the aims of the application are achieved, how will scientific knowledge be advanced? • What will be the effect of these studies on the concepts or methods that drive the field?

43. Commonly Heard Comments at Study Meetings: • Will the study fill a big gap in the field? • Is this important work only a few people are doing? • Why didn’t I think of this? • Even if all experiments work, no one will care or use the data. • The results will generate limited interest and not be applicable to other systems/organisms.

44. Approach • Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? • Does the applicant acknowledge potential problem areas and consider alternative tactics?

45. Commonly Heard Comments at NIH Study Section Meetings: • This grant was a pleasure to read because it was well thought out and well written. • The proposed experiments are clear, logical and creative. • The experiments do not appropriately test the hypothesis. • The experiments are hard to follow.

46. Innovation • Does the project employ novel concepts, approaches or methods? • Are the aims original and innovative? • Does the project challenge existing paradigms or develop new methodologies or technologies?

47. Commonly Heard Comments at NIH Study Section Meetings: • The PI will develop new approaches to answer previously unanswerable questions. • This is a novel mechanism to explain previously perplexing results. • The methods are standard, but the questions asked are novel and the results will have wide impact. • The questions and approaches have been asked and used by other laboratories.

48. Investigator • Is the investigator appropriately trained and well suited to carry out this work? • Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?

49. Commonly Heard Comments at NIH Study Section Meetings: • The PI has a strong record of research productivity in the field. • The PI is known for careful, rigorous, and exciting research. • The collaborators and PI have a longstanding research relationship. • The expertise of the collaborators is complementary to that of the PI. • The PI’s postdoc experience should prepare him to conduct the studies, however, the single publication listed makes this difficult to assess. • There are no letters from the listed collaborators. • The collaborator appears to be very busy, questioning his commitment to the proposed research.

50. Environment • Does the scientific environment in which the work will be done contribute to the probability of success? • Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? • Is there evidence of institutional support?