Content created by Office for Human Research Protections (OHRP)
May 18, 2016 - May 19, 2016
Agenda
Day 1 - Wednesday, May 18, 2016
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. - 8:45 a.m. | Welcome: Opening Remarks | Jeffrey R. Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
| 8:45 a.m. - 10:15 a.m. | A Summary of NPRM Public Comment | Lauren Hartsmith, J.D., OHRP |
| 10:15 a.m. - 10:30 a.m. | Break | |
| 10:30 a.m. - 12:30 p.m. | Subpart A Subcommittee Report: Considerations for Single IRB Review |
Michelle Russell-Einhorn, J.D. SAS Co-chair |
| 12:30 p.m. - 1:30 p.m. | Lunch | |
| 1:30 p.m. - 2:45 p.m. | Subpart A Subcommittee Report: Minimal Risk Informed Consent Models |
David Borasky, M.P.H. SAS Co-chair |
| 2:45 p.m. - 3:00 p.m. | Break | |
| 3:00 p.m. - 4:30 p.m. | Subcommittee on Harmonization Report: Return of Individual Research Results |
David Forster, J.D. SOH Co-Chair |
| 4:30 p.m. - 4:45 p.m. | Public Comment | |
| 4:45 p.m. - 5:00 p.m. | Summary and Adjournment |
Day 2 - Thursday, May 19, 2016
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. - 8:45 a.m. | Opening Remarks | Jeffrey Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
| 8:45 a.m. - 10:30 a.m. | Subcommittee on Harmonization Report: "Benchmarking" in Human Subjects Research |
David Forster, J.D. SOH Co-chair |
| 10:30 a.m. - 10:45 a.m. | Break | |
| 10:45 a.m. - 12:45 p.m. | Subcommittee on Harmonization Report: "Waiver of Consent in Cluster Randomized Trials" |
David Forster, J.D. SOH Co-chair |
| 12:45 p.m. - 1:30 p.m. | Lunch | |
| 1:30 p.m. - 2:15 p.m. | Reserved for Discussion of Revised Recommendations | |
| 2:15 p.m. - 2:30 p.m. | Public Comment | |
| 2:30 p.m. - 2:45 p.m. | Wrap and Adjournment |