The Department of Health and Human Services
Meeting of the
Secretary's Advisory Committee on Human Research Protections (SACHRP)
Thursday, December 11 & Friday, December 12, 2003
The Sheraton Four Points Hotel
The Franklin Room
1201 K Street, NW
Washington, DC 2005
(202) 289-7600
DRAFT AGENDA
Thursday, December 11, 2003| 8:30 a.m. - 8:35 a.m. | Welcome, Opening Remarks Ernest Prentice, Ph.D. Chairman, SACHRP |
| 8:35 a.m. - 8:45 a.m. | Report on Issues Bernard A. Schwetz, D.V.M., Ph.D. Acting Director, OHRP |
| 8:45 a.m. - 9:00 a.m. | Overview of Charges to Subcommittees Ernest Prentice, Ph.D. |
| 9:00 a.m. - 10:30 a.m. | Subpart D Subcommittee |
| 10:30 a.m. - 10:45 a.m. | BREAK |
| 10:45 a.m. - 12:15 p.m. | Subpart C Subcommittee |
| 12:15 p.m. - 1:30 p.m. | LUNCH |
| 1:30 p.m. - 2:30 p.m. | HRPP Accreditation Subcommittee |
| 2:30 p.m. - 3:30 p.m. | Public Comment |
| 3:30 p.m. - 3:45 p.m. | BREAK |
| 3:45 p.m. - 5:00 p.m. | Summary of Day's Activities Ernest Prentice, Ph.D. |
| 8:30 a.m. - 9:00 a.m. | Additional Subcommittee Business Ernest Prentice, Ph.D. |
| 9:00 a.m. - 10:30 a.m. | International Research Issues Panel International Activities & Challenges Melody Lin, Ph.D. Deputy Director, OHRP Experiences & Challenges in International Research David Borasky, CIP Associate Director, Office of International Research Ethics Family Health International Infrastructure and Management of Non-Domestic IRBs Helen McGough, M.A., CIP Director, Human Subjects Division University of Washington |
| 10:30 a.m. - 10:45 a.m. | BREAK |
| 10:45 a.m. - 12:15 p.m. | Adverse Event Reporting Issues - Panel #1 Overview of Regulatory Requirements Michael Carome, M.D. Associate Director for Regulatory Affairs, OHRP Dr. David LePay, M.D., Ph.D. Senior Advisor on Clinical Science Office of Science and Health Coordination Office of the Commisioner Food and Drug Administration IRB Perspective John Zaia, M.D. Chair, Institutional Review Board Beckman Research Institute of City of Hope Patricia Scannell, B.A., CIP Director, Human Studies Committee Washington University |
| 12:15 p.m. - 1:15 p.m. | LUNCH |
| 1:15 p.m. - 2:45 p.m. | Adverse Event Reporting Issues - Panel #2 Drug Industry Perspective Peter K. Honig, M.D., M.P.H. Merck Research Laboratories Device Industry Perspective Barbara Westrum Director, Corporate Clinical Affairs Medtronic NIH Perspective Amy Patterson, M.D. Director, Office of Biotechnology Activities Office of Science Policy National Institutes of Health Role of Data Safety Monitoring Boards Susan Ellenberg, Ph.D. Director, Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research Food and Drug Administration |
| 2:45 p.m. - 3:00 p.m. | BREAK |
| 3:00 p.m. - 4:00 p.m. | Public Comment |
| 4:00 p.m. - 5:00 p.m. | Future Business Issues |
| 5:00 p.m. | ADJOURN |