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Evaluation On-Demand Video

2024 PRIM&R Annual Conference

IRB Review

Emerging Research Challenges and Breaking Issues

H04 - Comparative Effectiveness Research (CER): When Important Research Does Not Fit the Regulatory Mold

Wednesday, November 20, 2024
10:30 AM – 11:45 AM PT
Location: Room 431-432
Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP Live Streamed Session Live Session Recorded CIP Accredited
CLICK HERE to view captioning for this session! 

Ten years after OHRP issued a determination letter that investigators of the SUPPORT study were in violation of the federal regulations on informed consent, resources and support for IRB's review and oversight of CER remains sparse. Despite draft guidance from OHRP published in 2014, IRBs struggle with identifying research procedure risks and determining the overall risk for the studies, assessing what qualifies as adequately addressing informed consent requirements, and determining the applicability of FDA regulations. With additional institutional interest in supporting evidence-based practice research, CER is increasing in frequency and IRBs must be prepared to properly review this research.

Learning Objectives:

  • Define CER studies
  • Examine the existing regulatory framework and identify challenges with applying regulations to CER studies
  • Discuss case studies of CER where IRBs came to divergent conclusions to illustrate difficult aspects of these reviews