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SACHRP March 12-13, 2013 Meeting

Meeting 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.

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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.

Meeting Minutes

Presentation Materials