1. Belinda Seto, Ph.D. Acting Deputy Director for Extramural Research National Institutes of Health Human Subjects Research Enhancements Awards Renaissance Marriott Hotel Washington D.C. March 5-7, 2003 3rd Annual Medical Research Summit

2. TOPICS Background Opportunity Status Next steps More information

3. BACKGROUND  Under increasing scrutiny in recent years  Institutions now facing increasing demands for those conducting research  Oversight  Enhanced protections  Increased education Institutions Conducting Clinical Research Involving Human Subjects

4.  Institutional Responsibilities  Ensure greater patient protection  Promote patients’ rights and understanding of research  Train investigators in ethical and scientific aspects of human subjects research BACKGROUND Institutions Conducting Clinical Research Involving Human Subjects

5. Consequence of additional procedures  Consequence of additional procedures and safeguards and safeguards  Creates burden for institutions in providing adequate resources BACKGROUND Institutions Conducting Clinical Research Involving Human Subjects

6. OPPORTUNITY NIH resources available to strengthen grantee institutions’ efforts to protect their human research subjects.

7.  Short-term support to address institutional resource needs institutional resource needs  New human advocacy programs  Improve/expand existing programs  Strengthen oversight of human subjects research research OPPORTUNITY Human Subjects Research Enhancement Award (S07)

8. Human Subjects Research Enhancement Award  Infrastructure support for managing all aspects of clinical studies  Activities to strengthen oversight of human subjects research and enhance protection of research subjects PURPOSE KEY: Sustainability of projects once award period ends

9.  Educational initiatives for investigators, administrators and IRB members -- safe/ethical conduct of clinical research  Development of tracking systems for monitoring -- adverse event reporting -- human subjects protocols and clinical sites  Systems for coordinating activities of multiple IRBs PROGRAM DESCRIPTION Human Subjects Research Enhancement Award Scope of Activities (examples)

10. RFA Issued (Receipt Date = May 7, 2002) http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-02-003.html  Sponsored by NIH I/Cs that support clinical research  Pilot to support 174 institutions --receive significant NIH support for clinical research  Applications reviewed for adherence to guidelines and cost allowability  Funds transferred from sponsoring ICs to NCRR (administering awards ) STATUS Human Subjects Research Enhancements Award

11. HUMAN SUBJECTS AND ETHICS-RELATED EDUCATIONAL INITIATIVES, PROGRAMS, OR WEB SITES FOR PIs, IRBs INFRASTRUCTURE, PROGRAMS, TECHNICAL DEVELOPMENT FOR TRACKING SYSTEMS FOR MONITORING ADVERSE EVENTS WEB SITES, INFRASTRUCTURE OR EQUIPMENT TO FACILITATE IRB OR MULTIPLE IRBs. TOOLS TO LINK IRBs, COMPLIANCE, CONFLICT OF INTEREST, DATA SAFETY MONITORING BOARDS SYSTEMS FOR SECURITY OF HUMAN SUBJECTS DATA MANUAL TO AUTOMATED DATA MANAGEMENT ENHANCE OR IMPROVE EXISTING HUMAN SUBJECTS MONITORING PROCESS STATUS Scope of Activities Funded* *S07 SITES MAY HAVE MULTIPLE SCOPE OF ACTIVITY PROJECTS # Sites% Total Sites 82 50 63 19 12 56 58 35 44 13 9 39

12. PROVIDE NETWORKING OR LINKS BETWEEN MULTIPLE IRBs OR STUDY SITES WEB-BASED SUBMISSION, REVIEW, TRACKING OF PROTOCOLS AND IRB MONITORING PROGRAMS FOR ASSESSMENT, EVALUATION AND/OR INDEPENDENT OVERSIGHT EDUCATION OF PARTICIPANTS COMMUNITY OUTREACH, EDUCATION AND SPEAKERS VIDEO AND/OR TELECONFERENCING INFRASTRUCTURE # Sites% Total Sites 38 64 31 9 15 13 27 45 22 6 11 9 *S07 SITES MAY HAVE MULTIPLE SCOPE OF ACTIVITY PROJECTS STATUS Scope of Activities Funded* (cont.)

13. OTHER S07 RR18123-01 Develop policies and administrative support to accomplish "local concept review" of protocols to be conducted in developing countries, using informants such as Peace Corps volunteers, graduate students or missionaries from the relevant countries. S07 RR18213-01 Train groups in Africa and Asian regional offices using new human subjects research ethics curriculum and then to offer Train the Trainer sessions. Additional components of application is to translate the human subjects curriculum into Chinese *S07 SITES MAY HAVE MULTIPLE SCOPE OF ACTIVITY PROJECTS STATUS Scope of Activities Funded* (cont.)

14.  Grantees to meet in D.C. to share information  Types of initiatives  Challenges encountered  Successful strategies Human Subjects Research Enhancement Award NEXT STEPS

15. FOR MORE INFORMATION… http://grants1.nih.gov/grants/policy/hsrea/hsrea.htm Human Subjects Research Enhancement Award Website  Provides access to community of awardee activities  Chat room (grantees only) to promote exchange of ideas and progress

16. http://grants1.nih.gov/grants/policy/hsrea/hsrea.htm

17. Grantee institutions can benefit from NIH Human Subjects Research Enhancement Awards to enhance their efforts to protect their human research subjects. CONCLUSION