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2022 PRIM&R Annual Conference

A Dialogue With the Feds

Insights into Key Recommendations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP)

Tuesday, December 13, 2022
3:00 PM – 4:00 PM ET
Location: Livestreamed
Livestreaming Session Icon CIP Accredited Human Subjects Research Networking Series
During this session, speakers from SACHRP will discuss the relevant issues, rationale, and final recommendations included in three key documents recently sent to the Secretary of Health and Human Services. Attendees should review these recommendations before attending this session: (1) A New Interpretation of the “Engaged in Research” Standard; (2) Recommendations on the OHRP Draft Guidance for Use of Single Institutional Review Board for Cooperative Research; and (3) New Challenges in Interactions among Sponsors, Clinical Trial Sites, and Study Subjects. This session will take place in Zoom meeting. The use of attendee video is encouraged for participation and interaction with your peers.

Learning Objectives:

  • Consider the ethical basis underlying case scenarios leading to engagement determinations
  • Identify complexities in single IRB review regarding knowledge of local context concerns
  • Understand how ambiguity over a sponsor or investigator’s role can compromise the integrity of study data or implicate privacy concerns.