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July 19-20, 2023 - SACHRP Meeting

July 19, 2023 - July 20, 2023

Materials may be accessed at Regulations.gov, docket # HHS-OASH-2023-0012.

Agenda

Wednesday, July 19, 2023

Time	Agenda Item
11:00 am - 11:15 am	Welcome Doug Diekema, MD SACHRP Chair Julie Kaneshiro Acting Director, OHRP
11:15 am – 11:45 am	Overview of FDA Draft Guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices Leonard Sacks, MD Associate Director for Clinical Methodologies FDA/CDER/Office of Medical Policy/Clinical Methodology Ryan Robinson, MD Medical Officer FDA/CDER/Office of Medical Policy/Clinical Methodology
11:45 am- 1:30 pm	SACHRP Discussion of FDA draft guidance Linda Coleman, JD Subpart A Subcommittee Co-chair
1:30 pm – 2:00 pm	BREAK
2:00 pm – 4:00 pm	Government Accounting Office (GAO) Report #GAO-23-104721, Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness; SACHRP Recommendation on GAO Report Recommendation #4 David Forster, J.D. Co-chair Subcommittee on Harmonization Susan Kornetsky, MPH Subpart A Subcommittee
4:00 pm - 4:15 pm	Public Comment
4:15 pm - 4:30 pm	Adjournment Doug Diekema, MD SACHRP Chair

Thursday, July 20, 2023

Time	Agenda Item
11:00 am - 11:15 am	Welcome Doug Diekema, MD SACHRP Chair Julie Kaneshiro Acting Director, OHRP
11:15 am – 11:30 am	Overview of Draft OHRP Guidance: Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions Natalie Klein, Ph.D. Director, Division of Policy and Assurances OHRP Kathi Hanna, Ph.D. Contractor, Division of Policy and Assurances OHRP
11:30 am – 1:30 pm	SACHRP Discussion of Draft Guidance David Borasky, MPH Subpart A Subcommittee Co-chair Cheryl Savini Subpart A Subcommittee
1:30 pm – 2:00 pm	BREAK
2:00 pm – 4:00 pm	Reserved
4:00 pm – 4:15 pm	Public Comment
4:15 pm – 4:30 pm	Adjournment Doug Diekema, MD SACHRP Chair

Webcast URL:

Content created by Office for Human Research Protections (OHRP)
Content last reviewed July 13, 2023