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October 19 - 20, 2022 - SACHRP Meeting

October 19, 2022 - October 20, 2022

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

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

Webcast URL:

October 19, 2022

October 20, 2022

Content last reviewed October 7, 2022