March 15, 2017 - March 16, 2017
Webcasts:
Meeting Materials
Agenda
NOTICE! Due to inclement weather, the March 15-16 meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has been cancelled.
Day 1 - Wednesday, March 15, 2017
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. |
Welcome and Introduction of New Members: |
Stephen Rosenfeld, M.D., |
8:45 a.m. - 9:15 a.m. | Overview of New Final Rule Sections, §§__.101(l), __.104(d)(3), and __.116(d) | Jerry Menikoff, M.D., J.D., Director, OHRP |
9:15 a.m. - 10:45 a.m. | Subcommittee on Harmonization Topic: Compliance and Transition Provisions, §__.101(l) |
David Forster, J.D. SOH Co-chair |
10:45 a.m. - 11:00 a.m. | Break | |
11:00 a.m. - 11:30 a.m. | Subcommittee on Harmonization Topic: Compliance and Transition Provisions, §__.101(l) |
David Forster, J.D. SOH Co-chair |
11:30 a.m. - 12:30 p.m. | Subpart A Subcommittee Topic: Benign Behavioral Interventions, §__ .104(d)(3) |
Michele Russell-Einhorn, J.D., SAS Co-chair |
12:30 p.m. - 1:15 p.m. | Lunch | |
1:15 p.m. - 2:15 p.m. | Subpart A Subcommittee Topic: Benign Behavioral Interventions, §__ .104(d)(3) |
Michele Russell-Einhorn, J.D., SAS Co-chair David Borasky, M.P.H., SAS Co-chair |
2:15 p.m. - 4:15 p.m. | Subcommittee on Harmonization Topic: Broad Consent, §__ .106(d) |
Mark Barnes, J.D. SOH Co-chair |
4:15 p.m. - 4:30 p.m. | Public Comment | |
4:30 p.m. - 4:45 p.m. | Summary and Adjournment |
Day 2 - Thursday, March 16, 2017
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. | Opening Remarks | Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m. - 9:00 a.m. | Overview of New Final Rule Section, §__.110 | Jerry Menikoff, M.D., J.D. Director, OHRP |
9:00 a.m. - 10:30 a.m. | Subpart A Subcommittee Topic: Expedited Review List, §__.110 |
Michele Russell-Einhorn, J.D., SAS Co-chair David Borasky, M.P.H., SAS Co-chair |
10:30 a.m. - 10:45 a.m. | Break | |
10:45 p.m. - 11:30 p.m. | Subpart A Subcommittee Topic: Expedited Review List, §__.110 |
Michele Russell-Einhorn, J.D., SAS Co-chair David Borasky, M.P.H., SAS Co-chair |
11:30 a.m. - 12:15 p.m. | Subcommittee on Harmonization Topic: Report of Incidental Findings |
David Forster, J.D. |
12:15 p.m. - 1:00 p.m. | Lunch | |
1:00 p.m. - 2:00 p.m. | Subcommittee on Harmonization Topic: FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" |
David Forster, J.D. SOH Co-chair |
2:00 p.m. - 3:30 p.m. | Reserved for Discussion of Revised Recommendations | |
3.30 p.m. - 3:45 p.m. | Public Comment | |
3:45 p.m. - 4:00 p.m. | Wrap-Up and Adjourn |