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July 10-11, 2013 Meeting

July 10, 2013 - July 11, 2013

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

July 10-11, 2013 Presentation Materials

Content created by Office for Human Research Protections (OHRP)
Content last reviewed March 29, 2016