July 10, 2018 - July 11, 2018
Agenda
Day 1 - Tuesday, July 10, 2018
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. - 10:45 a.m. |
"Key Information" in Informed Consent: Interpretation and Application of Section 116 (a)(5) |
David Forster, J.D. SOH Co-chair |
10:45 a.m. - 11:00 a.m |
BREAK | |
11:00 a.m. - 12:00 p.m. | When is a Parent or Guardian "Reasonably Available" for Purposes of 46.408 (b) |
Michele Russell-Einhorn, J.D. |
12:00 p.m. - 12:15 p.m. |
Update from Division of Education Development |
Yvonne Lau, MBBS, MBHL, Ph.D. |
12:15 p.m. - 1:15 p.m. |
LUNCH |
|
1:15 p.m. - 2:15 p.m. | Payment for Subject Participation |
David Borasky, M.P.H. |
2:15 p.m. - 2:30 p.m. |
Office of Inspector General Report, July 7, 2017: "OHRP Generally Conducted its Compliance Activities Independently, but Changes Would Strengthen its Independence" |
Jerry Menikoff, M.D., J.D. Director, OHRP |
2:30 p.m. - 3:30 p.m. |
Discussion and Recommendation, Office of Inspector General Report |
Stephen Rosenfeld, M.D. SACHRP Chair |
3:30 p.m - 4:00 p.m. | Discussion of Possible Modification to SACHRP Recommendation for Revised Expedited Review List
|
David Borasky, M.P.H. SAS Co-chair |
4:00 p.m. - 4:15 p.m. |
Public Comment |
|
4:15 p.m. - 4:30 p.m. | Wrap-up and Adjourn | Stephen Rosenfeld, M.D. SACHRP Chair |
Day 2 - Wednesday, July 11, 2018
Time | Agenda Item | Speaker(s) |
---|---|---|
8:30 a.m. - 8:45 a.m. | Opening Remarks |
Stephen Rosenfeld, M.D. |
8:45 a.m. - 10:15 a.m. | Implementaton of Transition Provision to the Revised Common Rule (Presentation followed by discussion) |
Lauren Hartsmith, J..D. |
10:15 a.m. - 10:30 a.m. |
BREAK |
|
10:30 a.m. - 10:45 a.m. | Draft Guidance Relating to Burden-Reducing Provisions of the Revised Common Rule |
Irene Stith-Coleman, Ph.D. |
10:45 a.m. - 12:30 p.m. |
Discussion of Draft Guidance Relating to Burden-Reducing Provisions of the Revised Common Rule |
David Forster, J.D. and Mark Barnes, J.D. Michele Russell-Einhorn, J.D. and David Borasky, M.P.H. |
12:30 p.m. - 1:15 p.m. |
LUNCH |
|
1:15 p.m. - 3:00 p.m. | Update on EU General Data Protection Regulation |
Mark Barnes, J.D. |
3:00 p.m. - 3:15 p.m. |
Public Comment |
|
3:15 p.m. - 3:45 p.m. |
Reserved |
|
3:45 p.m. - 4:00 p.m. | Wrap-up and Adjourn | Stephen Rosenfeld, M.D. SACHRP Chair |