March 13-14, 2018 - SACHRP Meeting

March 13-14, 2018 - SACHRP Meeting

Day 1 - Tuesday, March 13, 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

Day 2 - Wednesday, March 14, 2018

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

 

Webcast URL: 

The SACHRP webcast can be accessed at https://videocast.nih.gov/

March 13, 2018 - Day 1

March 14, 2018 - Day 2

 

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on August 23, 2017