March 13, 2018 - March 14, 2018
Webcasts:
Agenda
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. |
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. Steven Woloshin, M.D., M.S., and Lisa M. Schwartz, M.D., M.S. |
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 |
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 |