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March 12-13, 2013 Meeting

March 12, 2013 - March 13, 2013

Agenda

Day 1 - Tuesday, March 12, 2013

Time	Agenda Item	Speaker(s)
CLOSED SESSION
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.	Ethics Training	HHS Staff
9:15 a.m.- 10:15 a.m.	FACA Training	HHS Staff
10:15 a.m. - 10:30 a.m.	Break	All
OPEN SESSION
10:30 a.m. - 10:45 p.m.	Welcome and Opening Remarks	Jeffrey R. Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
10:45 a.m. - 11:15 a.m.	Welcome and Remarks	Howard Koh, M.D., M.P.H. Assistant Secretary for Health U.S. Department of Health and Human Services
11:15 a.m. - 12:30 p.m.	SACHRP Background and teh Rulemaking Process	HHS Staff
12:30 p.m.- 1:30 p.m.	Lunch	All
1:30 p.m.- 2:30 p.m.	Discussion of SACHRP Members' Priorities	Jeffrey R. Botkin, M.D. SACHRP Chair
2:30 p.m. – 3:15 p.m.	HIPAA/HITECH Rulemaking Changes	Christina Heide, J.D. Senior Health Information Privacy Policy Specialist Office for Civil Rights
3:15 p.m. - 4:30 p.m.	Subcommittee on Harmonization (SOH)	David Forster, J.D., SOH Co-chair Mark Barnes, J.D., SOH Co-chair
4:30 p.m. – 4:45 p.m.	Public Comment
4:45 p.m.- 5:00 p.m.	Wrap-up Discussion and Adjourn	Jeffrey R. Botkin, M.D.

Day 2 - Wednesday, March 12, 2013

Time	Agenda Item	Speaker(s)
8:30 a.m. – 8:45 a.m.	Opening Remarks	Jeffrey R. Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m.- 11:00 a.m.	Focus: Improving the Informed Consent Process	Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine Johns Hopkins Berman Institute of Bioethics Heather H. Pierce, JD, MPH Senior Director Science Policy and Regulatory Counsel Association of American Medical Colleges Jeanne M. Adler, RN, MPH, CCRP Clinical Investigations Branch Cancer Therapy Evaluation Program National Cancer Institute Jeffrey S. Abrams, M.D. Associate Director, Cancer Therapy Evaluation Program Acting Director for Clinical Research Associate Director of the Cancer Therapy Evaluation Program, National Cancer Institute
11:00 a.m. - 11:15 a.m.	Break	All
11:15 a.m.- 12:30 p.m.	Subpart A Subcommittee (SAS)	Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair
12:30 p.m.- 1:30 p.m.	Lunch	All
1:30 p.m.- 2:15 p.m.	Subpart A Subcommittee (SAS) - continued	Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair
2:15 p.m. – 3:30 p.m.	Human Subjects Research and the Internet	Elizabeth Buchanan, Ph.D. Endowed Chair in Ethics Director of the Center for Applied Ethics University of Wisconsin-Stout Dean R. Gallant, A.B. Assistant Dean for Research Policy and Administration Harvard University
3:30 p.m. – 3:45 p.m.	Public Comment	Public
3:45 p.m.- 4:00 p.m.	Wrap-up Discussion and Adjourn	Jeffrey R. Botkin, M.D.

March 12-13, 2013 Presentation Materials

Content last reviewed March 29, 2016