October 3-4, 2013 SACHRP Meeting

October 3, 2013 - October 4, 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

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