October 29-30, 2014 SACHRP Meeting

October 29, 2014 - October 30, 2014

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.	Swearing in and Welcome to New Members	Wanda K. Jones, Dr.P.H. Principal Deputy Assistant Secretary for Health HHS
9:15 a.m.- 10:00 a.m.	Tribute to Felix A. Khin-Maung-Gyi, PharmD., M.B.A.	Daniel K. Nelson, M.S., CIP, Former SAS Co-chair
10:00 a.m.- 10:30 a.m.	Subcommittee on Harmonization	David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair
10:30 a.m.- 10:45 a.m.	BREAK
10:45 a.m.- 12:15 p.m.	Subcommittee on Harmonization, continued	David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair
12:15 p.m.- 1:15 p.m.	LUNCH
1:15 p.m.- 2:30 p.m.	Subcommittee on Harmonization, continued	David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair
2:30 p.m.- 4:30 p.m.	HHS Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care	Jerry Menikoff, M.D., J.D. Director, OHRP
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. SACHRP Chair

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.- 10:00 a.m.	The Evolution of Consent in Low Risk Studies: Lessons from Online Survey Research	B. R. Simon Rosser, Ph.D., M.P.H., LP Professor & Director HIV/STI Intervention & Prevention Studies Program Division of Epidemiology & Community Health University of Minnesota School of Public Health
10:00 a.m.- 10:30 a.m.	Subpart A Subcommittee	David Borasky, MPH, CIP, SAS Co-Chair Michele Russell Einhorn, J.D., SAS Co-Chair
10:30 a.m.- 10:45 a.m.	BREAK
10:45 a.m.- 12:30 p.m.	Subpart A Subcommittee, continued	David Borasky, MPH, CIP, SAS Co-Chair Michele Russell Einhorn, J.D., SAS Co-Chair
12:30 p.m.- 1:30 p.m.	LUNCH
1:30 p.m.- 2:30 p.m.	Incident Reporting and Corrective Action Plans; Reports from OHRP’s Division of Compliance Oversight	Kristina Borror, Ph.D., OHRP
2:30 p.m.- 2:45 p.m.	Public Comment
2:45 p.m. - 3:00 p.m.	Wrap-up Discussion and Adjourn	Jeffrey R. Botkin, M.D. SACHRP Chair