October 16, 2018 - October 17, 2018
Webcasts:
Meeting Materials
Agenda
Day 1 - Tuesday, October 16, 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. - 9:15 a.m. |
Draft Recommendations |
Mark Barnes, J.D. |
9:15 a.m. - 10:30 a.m |
Panel Discussion 2. Parthena G. Psyllos, J.D. 3. Megan Kasimatis Singleton, J.D., 4. Barbara E. Bierer, M.D. 5. Tim Chulindra, PharmD, CIPM, 6. Heather H. Pierce, J.D., M.P.H. 7. Philip Desjardins, J.D. |
Mark Barnes, J.D., Moderator |
10:30 a.m. - 10:45 a.m. | BREAK |
|
10:45 a.m. - 11:45 p.m. |
Panel Discussion |
Mark Barnes, J.D. |
11:45 p.m. - 12:30 p.m. |
SACHRP Discussion |
Stephen Rosenfeld, M.D. |
12:30 p.m. - 1:15 p.m. |
LUNCH |
|
1:15 p.m. - 2:30 p.m. |
"Key Information" in Informed Consent Interpretation and Application of Section 116 (a)(5) |
David Borasky, M.P.H. SAS Co-chair |
2:30 p.m. - 3:45 p.m. | When is a Parent or Guardian "Reasonably Available" for Purposes of §46.408 (b) | Michele Russell-Einhorn, J.D. SOH Co-chair |
3:45 p.m - 4:30 p.m. |
Draft Recommendations, Revised |
Mark Barnes, J.D. SOH Co-chair |
4:30 p.m. - 4:45 p.m. | Public Comment | |
4:45 p.m. - 5:00 p.m. | Wrap-up and Adjourn | Stephen Rosenfeld, M.D. SACHRP Chair |
Day 2 - Wednesday, October 17, 2018
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. | Opening Remarks | Stephen Rosenfeld, M.D. SACHRP Chair |
8:45 a.m. - 10:300 a.m. | Discussion and Recommendation: Office of Inspector General Report, July 7, 2017: "OHRP Generally Conducted Its Compliance Activities Independtly, But Changes Would Strengthen Its Independence" |
Stephen Rosenfeld, M.D. SACHRP Chair |
10:30 a.m. - 10:45 a.m. | BREAK |
|
10:45 a.m. - 12:15 p.m. | Ethical Concerns Regarding Offer of Payment to Research Participants |
David Borasky, M.P.H. |
12:15 p.m. - 1:15 p.m. | LUNCH | |
1:15 p.m. - 2:15 p.m. | Interpreation of Revised Common Rule Exemptions §46.101 (b)(1) and (2) |
David Borasky, M.P.H. |
2:15 p.m. - 2:30 p.m. | Public Comment | |
2:30 p.m. - 2:45 p.m. | Wrap-up and Adjourn | Stephen Rosenfeld, M.D. SACHRP Chair |