March 13-14, 2018 - SACHRP Meeting

March 13, 2018 - March 14, 2018

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Welcome	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 9:30 a.m.	Overview of Secondary Use of Biospecimens and Data	OHRP Staff
9:30 a.m. - 10:30 a.m	FAQS on Broad Consent	Mark Barnes, J.D. SOH Co-chair
10:30 a.m. - 10:45 a.m.	BREAK
10:45 a.m. - 12:15 p.m.	FAQS on Biospecimens, Repositories and the Use of Consent under the Current and Revised Common Rule	Mark Barnes, J.D. SOH Co-chair
12:15 p.m. - 1:00 p.m.	LUNCH
1:00 p.m. - 2:00 p.m.	Continued Discussion of FAQS	Mark Barnes, J.D. SOH Co-chair
2:00 p.m. - 3:00 p.m.	Single IRB Review	Michele Russell-Einhorn, J.D. SAS Co-chair
3:00 p.m. - 4:15 p.m.	Impact of the European Union's General Data Protection Regulation on HHS Human Subjects Research	Mark Barnes, J.D. SOH Co-chair
4:15 p.m - 4:30 p.m.	Public Comment
4:30 p.m. - 4:45 p.m.	Wrap-up and Adjourn	Stephen Rosenfeld, M.D. SACHRP Chair

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Opening Remarks	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 9:00 a.m.	The Role of Key Information in the Revised Common Rule	Jerry Menikoff, M.D., J.D. Director, OHRP
9:00 a.m. - 10:30 a.m.	Insights into "Key Information"	Brian S. Alper, M.D. Vice President, Innovations and Evidence- Based Medicine Development, EBSCO Health Steven Woloshin, M.D., M.S., and Lisa M. Schwartz, M.D., M.S. Co-directors, Center for Medicine and the Media, Darmouth Institute for Health Policy and Clinical Practice
10:30 a.m. - 10:45 a.m.	BREAK
10:45 a.m. - 12:30 p.m.	"Key information" in Informed Consent: Interpretation and Application of Section 116 (a) (5)	David Forster, J.D. SOH Co-chair
12:30 p.m. - 1:00 p.m.	LUNCH
1:00 p.m. - 2:30 p.m.	Patient Representatives Perspectives on "Key Information" in Informed Consent	Diana Chingos SACHRP Member and Patient Advocate Jane Perlmutter, Ph.D. Patient Advocate Richard Knight, MBA Vice President and Chair, Public Policy Committee, American Association of Kidney Patients
2:30 p.m. - 3:30 p.m.	Reserved
3:30 p.m. - 3:45 p.m.	Public Comment
3:45 p.m. - 4:00 p.m.	Wrap-up and Adjourn	Stephen Rosenfeld, M.D. SACHRP Chair