October 29, 2014 - October 30, 2014
Webcasts:
Meeting Materials
Agenda
Day 1 - Wednesday, October 29, 2014
| 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. | Swearing in and Welcome to New Members | Wanda K. Jones, Dr.P.H. Principal Deputy Assistant Secretary for Health HHS |
| 9:15 a.m.- 10:00 a.m. | Tribute to Felix A. Khin-Maung-Gyi, PharmD., M.B.A. | Daniel K. Nelson, M.S., CIP, Former SAS Co-chair |
| 10:00 a.m.- 10:30 a.m. | Subcommittee on Harmonization | David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair |
| 10:30 a.m.- 10:45 a.m. | BREAK | |
| 10:45 a.m.- 12:15 p.m. | Subcommittee on Harmonization, continued | David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair |
| 12:15 p.m.- 1:15 p.m. | LUNCH | |
| 1:15 p.m.- 2:30 p.m. | Subcommittee on Harmonization, continued | David Forster, J.D., M.A., C.I.P., SOH Co-chair Mark Barnes, J.D., SOH Co-chair |
| 2:30 p.m.- 4:30 p.m. | HHS Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care | Jerry Menikoff, M.D., J.D. Director, OHRP |
| 4:30 p.m.- 4:45 p.m. | Public Comment | |
| 4:45 p.m.- 5:00 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. SACHRP Chair |
Day 2 - Thursday, October 30, 2014
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. – 8:45 a.m. | Opening Remarks |
Jeffrey R. Botkin, M.D. Jerry Menikoff, M.D., J.D. |
| 8:45 a.m.- 10:00 a.m. | The Evolution of Consent in Low Risk Studies: Lessons from Online Survey Research |
B. R. Simon Rosser, Ph.D., M.P.H., LP Professor & Director HIV/STI Intervention & Prevention Studies Program Division of Epidemiology & Community Health University of Minnesota School of Public Health |
| 10:00 a.m.- 10:30 a.m. | Subpart A Subcommittee | David Borasky, MPH, CIP, SAS Co-Chair 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. | Subpart A Subcommittee, continued | David Borasky, MPH, CIP, SAS Co-Chair Michele Russell Einhorn, J.D., SAS Co-Chair |
| 12:30 p.m.- 1:30 p.m. | LUNCH | |
| 1:30 p.m.- 2:30 p.m. | Incident Reporting and Corrective Action Plans; Reports from OHRP’s Division of Compliance Oversight |
Kristina Borror, Ph.D., OHRP |
| 2:30 p.m.- 2:45 p.m. | Public Comment | |
| 2:45 p.m. - 3:00 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. SACHRP Chair |
