July 10-11, 2013 Meeting

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

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