October 19 - 20, 2022 - SACHRP Meeting

October 19, 2022 - October 20, 2022

Webcasts:

Agenda

Wednesday, October 19, 2022

Time Agenda Item

11:00 am- 11:15 am

Welcome, Remarks from the Chair
Doug Diekema, M.D.
SACHRP Chair
Jerry Menikoff, M.D., J.D.
Director, OHRP

11:15 am – 11:45 pm

FDA Overview of NRPMs Protection of Human Subjects and Institutional Review Boards (87 FR 58733), and Institutional Review Boards; Cooperative Research (87 FR 58752)
Ann Meeker-O’Connell
Director, Office of Clinical Policy
Office of Clinical Policy and Programs, Office of the
Commissioner
U.S. Food and Drug Administration

11:45 pm- 2:00 pm

Recommendations on FDA NPRM Regarding Institutional Review Boards; Cooperative Research
(87 FR 58752)
Mark Barnes, J.D.
Subcommittee on Harmonization Co-Chair

2:00 pm – 2:30 pm

BREAK

2:30 pm – 4:15 pm

Recommendations on FDA NPRM Regarding Protection of Human Subjects and Institutional Review Boards
(87 FR 58733)
David Forster, J.D.
Subcommittee on Harmonization Co-chair

4:15 pm – 4:30 pm

Public Comment

4:30 pm

Adjournment
Doug Diekema, M.D.
SACHRP Chair

Thursday, October 20th, 2022

Time Agenda Item

11:00 am - 11:15 am

Welcome, Remarks from the Chair
Doug Diekema, M.D.
SACHRP Chair
Jerry Menikoff, M.D., J.D.
Director, OHRP

11:15 am – 1:00 pm

Recommendations on FDA NPRM Regarding Protection of Human Subjects and Institutional Review Boards
(87 FR 58733)
David Forster, J.D.
Subcommittee on Harmonization Co-chair
David Borasky, MPH
Subpart A Subcommittee Co-chair

1:00 pm – 2:00 pm

Considerations on the Use of Artificial Intelligence in Human Subjects Research
Stephen Rosenfeld, M.D.
Subcommittee on Harmonization Member

2:00 pm – 2:30 pm

BREAK

2:30 pm – 3:15 pm

Use of Social Media by Research Subjects: Ethical and Regulatory Considerations for the Protection of Human Research Subjects
David Forster, J.D.
Subcommittee on Harmonization Co-chair

3:15 pm – 4:15 pm

Reserved

4:15 pm – 4:30 pm

Public Comment

4:30 pm

Adjournment
Doug Diekema, M.D.
SACHRP Chair

Meeting Materials

All materials will be available at Regulations.gov, HHS-OASH-2022-0016.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed