July 25, 2017 - July 26, 2017
Webcasts:
Meeting Materials
Agenda
Day 1 - Tuesday, July 25, 2017
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. - 10:45 a.m. |
Subpart A Subcommittee Topic: |
Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair |
10:45 a.m. - 11:00 a.m | BREAK | |
11:00 a.m. - 12:30 p.m. | Subpart A Subcommittee Topic: Expedited Review List, §__.110 |
Michele Russell-Einhorn, J.D. |
12:30 p.m. - 1:30 p.m. |
LUNCH |
|
1:30 p.m. - 3:30 p.m. |
Subcommittee on Harmonization Topic: |
Mark Barnes, J.D. |
3:30 p.m. - 4:30 p.m. | Reserved for Discussion of Revised Recommendations | |
4:30 p.m. - 4:45 p.m. |
Public Comment |
|
4:45 p.m - 5:00 p.m. |
Summary and Adjournment |
Day 2 - Wednesday, July 26, 2017
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. - 10:30 a.m. | Subpart A Subcommittee Topic: "Context" as a Consideration for Single IRB Review, §__ .114 (b)(2)(ii) |
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. | Subcommittee on Harmonization Topic: Institutional Implementation Considerations Surrounding §__ .104(d)(4)(iii) |
Mark Barnes, J.D. |
12:30 p.m. - 1:15 p.m. | LUNCH | |
1:15 p.m. - 2:30 p.m. | Reserved for Discussion of Revised Recommendations | |
2:30 p.m. - 3:00 p.m. | Public Comment | |
3:00 p.m. - 3:15 p.m. | Wrap and Adjournment |