October 21-22, 2015 SACHRP Meeting

October 21, 2015 - October 22, 2015

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.	Introduction of New Members Remarks	Karen B. DeSalvo, M.D., M.P.H., M.Sc. Acting Assistant Secretary for Health
9:15 a.m.- 10:00 a.m.	Overview of NPRM	Jerry Menikoff, M.D., J.D. Director, OHRP
10:00 a.m.- 10:20 a.m.	Overview of SACHRP Recommendations on the NPRM	Jeffrey R. Botkin, M.D. SACHRP Chair
10:20 a.m.- 10:30 a.m.	BREAK
10:30 a.m. - 12:30 p.m.	Mandated Single IRB Review Under the NPRM	Michele Russell-Einhorn, J.D.
12:30 p.m.- 1:30 p.m.	LUNCH
1:30 p.m.- 4:15 p.m.	Biospecimens and Biospecimen Consent Under the NPRM	Mark Barnes, J.D., L.L.M.
4:15 p.m.- 4:45 p.m.	Public Comment	7#160;
4:45 p.m.- 5:00 p.m.	Summary 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.	Informed Consent and Waiver Under the NPRM	David Borasky, M.P.H.
10:30 a.m.- 10:45 a.m.	BREAK
10:45 a.m.- 12:00 p.m.	Informed Consent and Waiver Under the NPRM, cont'd	David Borasky, M.P.H.
12:00 p.m.- 12:45 p.m.	LUNCH
12:45 p.m.- 2:45 p.m.	Exclusions and Exemptions Under the NPRM	David Forster, J.D.
2:45 p.m.- 3:15 p.m.	Public Comment
3:15 p.m. - 3:30 p.m.	Wrap-up Discussion and Adjourn	Jeffrey R. Botkin, M.D. SACHRP Chair