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Evaluation On-Demand Video

2024 PRIM&R Annual Conference

Single IRB

IRB Review

G08 - Let It Go! Strategies to Prevent Over-Regulation During Local Context Review

Wednesday, November 20, 2024
8:45 AM – 10:00 AM PT
Location: Signature Room
Human Subject Research - HSR Call for Session Proposal - CSP Deep Dive Series Live Session Recorded CIP Accredited Live Streamed Session
CLICK HERE to view captioning for this session! 

The regulatory shift toward the use of a single IRB has been justified by a presumed reduction in review timelines. The tendency for institutions that rely on an external IRB to wade into topics that are under the oversight of the reviewing IRB can prevent realization of these benefits. Learn how three separate institutions have incorporated strategies to prevent over-regulation during local context review.

Learning Objectives:

  • Learn about review processes that can be implemented to prevent IRB staff at a relying institution from considering items that do not fall under their regulatory purview
  • Explore strategies used to reduce the tendency of your relying sites to request changes to the protocol that do not fall under their regulatory purview
  • Discuss structural changes that can be made to your IRB staff roles and responsibilities that can reduce over-regulation