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Office for Human Research Protections (OHRP)

The Department of Health and Human Services
Meeting of the
Secretary’s Advisory Committee on Human Research Protections (SACHRP)
Tuesday, July 20, 2010 — Wednesday, July 21, 2010
The Sheraton National Hotel
900 South Orme Street, Arlington, Virginia


Tuesday, July 20, 2010


8:30 am — 8:35 am

Welcome: Opening remarks
Barbara Bierer, M.D.

8:35 am — 8:45 am

Report of Issues/Remarks
Jerry Menikoff, M.D., J.D.,
Director, OHRP

8:45 am — 10:30 am

Subpart A Subcommittee Report
Dan Nelson, M.S., CIP
Elizabeth A. Bankert, M.A.
SAS Co-chairs

10:30 am — 10:45 am


10:45 am — 11:45 am

Subpart A Subcommittee Report, cont'd

11:45 am — 12:45 pm


12:45 pm — 3:15 pm

Ethics Consultations as Part of IRB Review

Norman Fost, M.D., M.P.H.
Professor, Pediatrics and Medical History and Bioethics
Director, Program in Bioethics
University of Wisconsin Hospital

Benjamin S. Wilfond, M.D.
Director, Treuman Katz Center for Pediatric Bioethics
Seattle Children's Hospital
Professor and Chief, Division of Bioethics, Department of Pediatrics
University of Washington School of Medicine

Susan Kornetsky, M.P.H.
Director, Clinical Research Compliance
Children's Hospital, Boston

Joachim F. Hallmeyer, M.D.
Associate Professor, Psychiatry and Behavioral Sciences Stanford University School of Medicine

3:15 pm — 3:30 pm


3:30 pm — 4:45 pm

Subpart A Subcommittee Report, cont’d
Future Directions

4:45 pm — 5:00 pm

Public Comment

4:45 pm — 5:00 pm

Wrap-up and Adjourn


Wednesday, July 21, 2010


8:30 am — 8:45 am

Barbara Bierer, M.D.

8:45 am — 10:30 am

The Internet in Human Subjects Research

Elizabeth Buchanan, Ph.D.
Director, Center for Information Policy Research
School of Information Studies
University of Wisconsin-Milwaukee

Montana Miller, Ph.D.
Assistant Professor, Department of Popular Culture Bowling Green State University

Michael Zimmer, Ph.D.
Assistant Professor, School of Information Studies
Associate, Center for Information Policy Research
University of Wisconsin-Milwaukee

John Palfrey, J.D.
Vice Dean, Library and Information Services
Faculty Co-Director, Berkman Center for Internet and Society
Harvard Law School

10:30 am — 10:45 am


10:45 am — 11:45 am

Panel Follow-up Discussion

11:45 am — 12:30 pm


12:30 pm — 2:45 pm

Implications from the Havasupai Case

William L. Freeman, M.D., M.P.H., C.I.P.
Program Director, Northwest Indian College Center for Health
Human Protections Administrator
Northwest Indian College

Pearl O'Rourke, M.D.
Director, Human Research Affairs
Partners HealthCare System, Boston, MA

Carletta Tilousi
Havasupai Tribal Council Member

2:45 pm — 3:00 pm


3:00 pm — 4:45 pm

Subcommittee on Harmonization Report
David Forster, J.D.
Mark Barnes, J.D.

4:45 pm — 5:00 pm

Public Comment

5:50 pm — 5:15 pm

Wrap-up Discussion and Adjourn