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2023 PRIM&R Annual Conference

FDA Regulated Research

H02 - [IN-PERSON/RECORDED] OHRP, FDA, and the General Accountability Office (GAO) Report on IRB Oversight and Effectiveness: A Conversation With the PRIM&R Community

Wednesday, December 6, 2023
1:45 PM – 2:45 PM ET
Location: Ballroom AB
Live Session Recorded Human Subjects Research Deep Dive Series CIP Accredited
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

In its recent report on actions needed to improve federal oversight and effectiveness of IRBs, the GAO recommended that OHRP and FDA convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects (Recommendation 4). In this session, OHRP and FDA will provide an overview of ongoing efforts to gather input from stakeholders regarding approaches to measure IRB effectiveness and will facilitate a group discussion regarding the general themes emerging from those interactions. This session will also serve as a forum for session attendees to provide input on approaches to examining IRB effectiveness at their individual institutions. Attendees are encouraged to prepare comments in advance to share with FDA and OHRP at the session.

Learning Objectives:

  • Recognize OHRP and FDA�s initial efforts to solicit input from the stakeholder community regarding methods used to examine IRB effectiveness
  • Identify common themes arising from OHRP/FDA stakeholder interactions to-date
  • Provide input on their opinions and experiences with assessing IRB effectiveness at individual institutions