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SACHRP October 9-10 2012 Meeting

Meeting Agenda 

Day 1 - Tuesday, October 9, 2012

Time Agenda Item Speaker(s)
  8:30 a.m. - 8:45 a.m. Welcome: Opening Remarks

Barbara Bierer, M.D.
SACHRP Chair

Jerry Menikoff, M.D., J.D.
Director, OHRP

  8:45 a.m. - 9:15 a.m. Opening Remarks
Swearing in of New Member
Howard K. 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. Subpart A Subcommittee (SAS) Daniel K. Nelson, M.S., CIP, SAS Co-chair
David Borasky, M.P.H., CIP, SAS Co-chair
10:15 a.m. - 10:30 a.m. BREAK All
10:30 a.m. - 12:00 p.m. SAS Discussion SACHRP
12:00 p.m. -  1:00 p.m. LUNCH All
1:00 p.m. -   1:30 p.m. Legal Status of E-Signatures Laura Odwazny, J.D.
Senior Attorney
Public Health Division
Office of General Counsel
1:30 p.m. -   3:30 p.m. Informed Consent Issues in Cluster Randomized Trials Andrew McRae, MD, Ph.D.
University of Calgary
3:30 p.m. -   3:45 p.m. Public Comment Public
3:45 p.m. -   4:00 p.m. Wrap-up Discussion and Adjourn Barbara Bierer, M.D.
SACHRP Chair

 

Day 2 - Wednesday, October 10, 2012

Time Agenda Item Speaker(s)
 8:30 a.m. -  8:45 a.m. Opening Remarks

Barbara Bierer, M.D.
SACHRP Chair

Jerry Menikoff, M.D., J.D.,
Director, OHRP

 8:45 a.m. - 10:30 a.m. Subcommittee on Harmonization (SOH) David Forster, J.D., SOH Co-chair
Mark Barnes, J.D., SOH Co-chair
10:30 a.m. - 10:45 a.m. BREAK All
10:45 a.m. - 12:30 p.m. NeuroNext IRB Experience

Pearl O"Rourke, M.D.
Director of Human Research Affairs for Partners Healthcare

Louise Ritz, M.B.A.
NIH/NINDS/Office of Clinical Research
Clinical Research Program Manager

12:30 p.m. - 1:30 p.m. LUNCH All
1:30 p.m. -  3:30 p.m. Internet Research Elizabeth Buchanan, Ph.D.
Endowed Chair in Ethics
Director of the Center for Applied Ethics
University of Wisconsni-Stout
 3:30 p.m. - 3:45 p.m. Public Comment Public
 3:45 p.m. -   4:00 p.m. Wrap-up Discussion and Adjourn Barbara Bierer, M.D.
SACHRP Chair