October 17, 2017 - October 18, 2017
Webcasts:
Meeting Materials
Agenda
Day 1 - Tuesday, October 17, 2017
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. |
Welcome |
Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP |
8:45 a.m. - 9:15 a.m. |
Introducing OHRP's Public Outreach Website About Research Participation |
Yvonne Lau, M.D. OHRP |
9:15 a.m. - 10:30 a.m | Subcommittee on Harmonization Topic: HIPAA and Exemption §104 (d) (4) (iii) |
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 Topic: |
Mark Barnes, J.D. |
12:15 p.m. - 1:15 p.m. |
LUNCH |
|
1:15 p.m. - 3:00 p.m. | Subpart A Subcommittee Topic: "Context" in Single IRB Review |
Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair |
3:00 p.m. - 4:30 p.m. |
Subpart A Subcommitte Topic: |
Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair |
4:30 p.m - 4:45 p.m. |
Public Comment |
|
4:45 p.m. - 5:00 p.m. | Wrap-up and Adjourn |
Day 2 - Wednesday, October 18, 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. - 10:15 a.m. | Recent FDA Experience with Review under 21 CFR 50.54; Lessons Learned | Robert "Skip" Nelson, M.D., Ph.D. Deputy Director and Senior Pediatric Ethicist Donna Snyder, M.D. Pediatric Ethicist / Team Lead Office of Pediatric Therapeutics, FDA |
10:15 a.m. - 10:30 a.m. | BREAK | |
10:30 a.m. - 11:45 a.m. | Changes to NIH Certificate of Confidentiality |
Taunton Paine, M.A. |
11:45 a.m. - 12:45 p.m. | LUNCH | |
12:45 p.m. - 1:30 p.m. | Reserved. HIPAA and Exemption §104 (d)(4)(iii) | |
1:30 p.m. - 2:30 p.m. | Reserved, other | |
2:30 p.m. - 2:45 p.m. | Public Comment | |
2:45 p.m. - 3:00 p.m. | Wrap-up and Adjourn |