October 3, 2013 - October 4, 2013
Meeting Materials
Agenda
(Note: This Meeting Was Cancelled)
Day 1 - Thursday, October 3, 2013
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. - 8:45 a.m. | Welcome: Opening Remarks |
Jeffrey R. Botkin, M.D. Jerry Menikoff, M.D., J.D. |
| 8:45 a.m. - 9:15 a.m. | Welcome and Remarks | Howard Koh, M.D., M.P.H. Assistant Secretary for Health U.S. Department of Health and Human Services |
| 9:15 a.m. - 10:15 a.m. | Subcommittee on Harmonization (SOH) | David Forster, J.D., M.A., SOH Co-chair Mark Barnes, J.D., L.L.M., SOH Co-chair |
| 10:15 a.m. - 10:30 a.m. | BREAK | All |
| 10:30 a.m. - 12:00 p.m. | Clustered Randomized Trials and Informed Consent | David Forster, J.D., M.A., SOH Co-chair |
| 12:00 p.m. - 1:00 p.m. | LUNCH | All |
| 1:00 p.m. - 4:30 p.m. | A Discussion of Cluster Randomization, Risk Assessment and Consent Requirements | SACHRP Members |
| 1:00 p.m. - 2:30 p.m. | Population Effect of Universal Testing and Immediate ART to Reduce HIV Transmission, HPTN071. PoPART | Mark Barnes, J.D., L.L.M., SOH Co-chair |
| 2:30 p.m. - 4:30 p.m. | NIH Collaboratory Trials | Jerry Menikoff, M.D., J.D. Director, OHRP |
| 4:30 p.m. - 4:45 p.m. | Public Comment | Public |
| 4:45 p.m. - 5:00 p.m. | Wrap-up Discussion and Adjournment | Jeffrey R. Botkin, M.D. SACHRP Chair |
Day 2 - Friday, October 4, 2013
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. - 8:45 a.m. | Opening Remarks |
Jeffrey Botkin, M.D. Jerry Menikoff, M.D., J.D., |
| 8:45 a.m. - 10:30 a.m. | Subpart A Subcommittee (SAS) | Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair |
| 10:30 a.m. - 11:00 a.m. | BREAK | All |
| 11:00 a.m. - 12:15 p.m. | Subpart A Subcommittee (SAS), Continued | Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair |
| 12:15 p.m. - 1:15 p.m. | LUNCH | All |
| 1:15 p.m. - 3:00 p.m. | Subpart A Subcommittee (SAS), Continued | Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair |
| 3:00 p.m. - 4:00 p.m. | Certificates of Confidentiality | David Forster, J.D., M.A., SOH Co-chair |
| 4:00 p.m. - 4:15 p.m. | Public Comment | Public |
| 4:15 p.m. - 4:30 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. SACHRP Chair |
