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2022 PRIM&R Annual Conference

Shared Oversight Challenges

B19 - Inconsistencies in Review and Regulatory Creep: Is it a Problem?

Monday, December 12, 2022
1:30 PM – 2:30 PM ET
Location: On-Demand
On-Demand Session CIP Accredited CPIA Icon Crossover Deep Dive Series
Differing organizational standards and inconsistent review processes cause anxiety and confusion for researchers. These occur between organizations, but also within the same committee when they review similar protocols. By design, these are local committees, reflecting the culture and individual experiences, but, often, there’s an underlying expectation that there is always a single “right” conclusion they should be landing on in each case. What is the role of trust in the review process? How do you document the "why"? How do we communicate with researchers?

Learning Objectives:

  • Explore strategies for achieving consistency and what can be done to ensure ethical review, protection of subjects, and a standardized and fair process
  • Discuss how committees support the decisions they make in gray areas
  • Consider communication approaches for explaining ethical reasoning to investigators