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October 3-4, 2013 SACHRP Meeting

Meeting Agenda - (Note: This Meeting Was Cancelled)

Day 1 - Thursday, October 3, 2013

Time Agenda Item Speaker(s)
  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., SOH Co-chair
Mark Barnes, J.D., L.L.M., SOH Co-chair
10:15 a.m. - 10:30 a.m. BREAK All
10:30 a.m. - 12:00 p.m. Clustered Randomized Trials and Informed Consent David Forster, J.D., M.A., SOH Co-chair
12:00 p.m. -  1:00 p.m. LUNCH All
1:00 p.m. -   4:30 p.m. A Discussion of Cluster Randomization, Risk Assessment and Consent Requirements SACHRP Members
1:00 p.m. -   2:30 p.m. Population Effect of Universal Testing and Immediate ART to Reduce HIV Transmission, HPTN071. PoPART Mark Barnes, J.D., L.L.M., SOH Co-chair
2:30 p.m. - 4:30 p.m. NIH Collaboratory Trials Jerry Menikoff, M.D., J.D.
Director, OHRP
4:30 p.m. -   4:45 p.m. Public Comment Public
4:45 p.m. -   5:00 p.m. Wrap-up Discussion and Adjournment Jeffrey R. Botkin, M.D.
SACHRP Chair

 

Day 2 - Friday, October 4, 2013

Time Agenda Item Speaker(s)
 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 All
11:00 a.m. - 12:15 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
12:15 p.m. - 1:15 p.m. LUNCH All
1:15 p.m. -  3:00 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
3:00 p.m. - 4:00 p.m. Certificates of Confidentiality David Forster, J.D., M.A., SOH Co-chair
 4:00 p.m. -   4:15 p.m. Public Comment Public
 4:15 p.m. -   4:30 p.m. Wrap-up Discussion and Adjourn Jeffrey R. Botkin, M.D.
SACHRP Chair