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Evaluation On-Demand Video

2024 PRIM&R Annual Conference

IRB Review

Social, Behavioral, and Educational Research

IRB Fundamentals

H09 - Exempt Study Review: How to Find Flexibilities in the Current Regulations

Wednesday, November 20, 2024
10:30 AM – 11:45 AM PT
Location: Ballroom 1
Human Subject Research - HSR Call for Session Proposal - CSP Learning Lab Series Live Session Recorded CIP Accredited Live Streamed Session
CLICK HERE to view captioning for this session! 

IRBs are under pressure from their researchers to review research proposals as quickly as possible while still maintaining regulatory and institutional compliance. When studies are not subject to Common Rule or FDA regulations, it may be appropriate to determine that some studies are Exempt, which would not meet the categories at 104 when commensurate protections are implemented. This session will explore various flexibilities (including an Exempt Self-Determination mechanism) employed at two biomedical/SBER campuses.

Learning Objectives:

  • Understand the areas of flexibility inherent in the regulations and the concepts behind flexing the regulations for "unregulated" studies
  • Discuss how an Exempt Self-Determination pathway can be implemented to reduce administrative burden while maintaining regulatory and institutional compliance
  • Learn how to determine what commensurate protections may be implemented based on study characteristics when flexing the regulations for "unregulated" studies