October 21, 2015 - October 22, 2015
Webcasts:
Agenda
Day 1 - Wednesday, October 21, 2015
| 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. | Introduction of New Members Remarks |
Karen B. DeSalvo, M.D., M.P.H., M.Sc. Acting Assistant Secretary for Health |
| 9:15 a.m.- 10:00 a.m. | Overview of NPRM | Jerry Menikoff, M.D., J.D. Director, OHRP |
| 10:00 a.m.- 10:20 a.m. | Overview of SACHRP Recommendations on the NPRM | Jeffrey R. Botkin, M.D. SACHRP Chair |
| 10:20 a.m.- 10:30 a.m. | BREAK | |
| 10:30 a.m. - 12:30 p.m. | Mandated Single IRB Review Under the NPRM | Michele Russell-Einhorn, J.D. |
| 12:30 p.m.- 1:30 p.m. | LUNCH | |
| 1:30 p.m.- 4:15 p.m. | Biospecimens and Biospecimen Consent Under the NPRM | Mark Barnes, J.D., L.L.M. |
| 4:15 p.m.- 4:45 p.m. | Public Comment | 7#160; |
| 4:45 p.m.- 5:00 p.m. | Summary and Adjournment | Jeffrey R. Botkin, M.D. SACHRP Chair |
Day 2 - Thursday, October 22, 2015
| 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. | Informed Consent and Waiver Under the NPRM | David Borasky, M.P.H. |
| 10:30 a.m.- 10:45 a.m. | BREAK | |
| 10:45 a.m.- 12:00 p.m. | Informed Consent and Waiver Under the NPRM, cont'd | David Borasky, M.P.H. |
| 12:00 p.m.- 12:45 p.m. | LUNCH | |
| 12:45 p.m.- 2:45 p.m. | Exclusions and Exemptions Under the NPRM | David Forster, J.D. |
| 2:45 p.m.- 3:15 p.m. | Public Comment | |
| 3:15 p.m. - 3:30 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. SACHRP Chair |
