July 10, 2013 - July 11, 2013
Meeting Materials
Agenda
Wednesday, July 10, 2013 – Thursday, July 11, 2013
Hubert H. Humphrey Building, Room 800
Wednesday, July 10, 2013
Time | Agenda Item |
---|---|
8:30 a.m. – 8:45 a.m. |
Welcome: Opening Remarks Jeffrey R. Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m.- 9:15 a.m. |
Welcome and Remarks Howard Koh, M.D., M.P.H. Assistant Secretary for Health U.S. Department of Health and Human Services |
9:15 a.m.- 10:15 a.m. |
Subcommittee on Harmonization (SOH) David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair> |
10:15 a.m.- 10:30 a.m. |
BREAK |
10:30 a.m. – 11:30 a.m. |
Clustered Randomized Trials and Informed Consent David Forster, J.D., M.A., C.I.P., SOH Co-chair Bernard Lo, M.D. President The Greenwall Foundation Professor of Medicine Emeritus Director Emeritus, Program in Medical Ethics University of California San Francisco Charles Weijer, M.D., Ph.D. Professor of Philosophy and Medicine Canada Research Chair in Bioethics Western University, London, Canada Monica Taljaard, Ph.D. Scientist, Ottawa Hospital Research Institute Clinical Epidemiology Program Assistant Professor, University of Ottawa |
11:30 a.m.- 1:00 p.m. |
CRT Discussion |
1:00 p.m. – 2:00 p.m. |
LUNCH |
2:00 p.m.- 3:00 p.m. |
Certificates of Confidentiality David Forster, J.D., M.A., C.I.P., SOH Co-chair Ann Hardy, Dr. Ph. NIH Extramural Human Research Protections Officer and Coordinator, Certificates of Confidentiality Program Cheryl Crawford Watson, J.D. Senior Advisor, Human Subjects Protection Officer Office of the Director National Institute of Justice Office of Justice Programs U.S. Department of Justice |
3:00 p.m. – 3:45 p.m. |
COC Discussion |
3:45 p.m. – 4:15 p.m. |
SACHRP Future Directions |
4:15 p.m. – 4:30 p.m. |
Public Comment |
4:30 p.m.- 4:45 p.m. |
Wrap-up Discussion and Adjourn |
Thursday, July 11, 2012
Time | Agenda Item |
---|---|
8:30 a.m. – 8:45 a.m. |
Opening Remarks |
Jeffrey Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D., Director, OHRP |
|
8:45 a.m.- 10:30 a.m. |
Subpart A Subcommittee (SAS) Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair |
10:30 a.m. – 11:00 a.m. |
BREAK |
11:00 a.m.- 12:15 p.m. |
Subpart A Subcommittee (SAS) Continued |
12:15 p.m.- 1:15 p.m. |
LUNCH |
1:15 p.m. – 3:00 p.m. |
Electronic Informed Consent David Forster, J.D., M.A., C.I.P. Vice President, Office of Compliance Western Institutional Review Board Anthony J. Costello, Ph.D Chief Executive Officer Mytrus Justin McCarthy, J.D. Senior Vice President, Associate General Counsel Chief Counsel – Worldwide Research & Development Pfizer Inc. Jeffrey Kahn, PhD, MPH Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy Johns Hopkins University Berman Institute of Bioethics |
3:00 p.m.- 3:15 p.m. |
Public Comment |
3:15 p.m. – 3:30 p.m. |
Wrap-up Discussion and Adjourn |