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Evaluation View Video

2025 PRIM&R Annual Conference

Navigating Ethical Challenges

Emerging Challenges and Innovations in Research

Regulatory Frameworks and Compliance

B02 - Navigating the New Frontier: IRB Challenges with Complex Innovative Trial Designs

Friday, November 7, 2025
1:45 PM - 3:00 PM ET
Location: Room 324-326
Human Subject Research - HSR Deep Dive Series Live Streamed Session Live Session Recorded CIP Accredited
CLICK HERE to view captioning for this session! 

This session will introduce why the FDA is encouraging industry to move toward complex innovative design protocols and what IRBs should know about these types of trials. Discussed will be some history of why these are becoming more frequent now and some background as to why the Bayesian statistics framework offers advantages but also some challenges. Cases will be presented to highlight areas that IRBs should consider when reviewing these types of protocols.

Learning Objectives:

  • Define Complex Innovative Designs (CIDs) and identify common types, such as adaptive trials and master protocols, that may be submitted for IRB review
  • Articulate the primary advantages and disadvantages of CIDs from a human research protection perspective
  • Analyze the unique and heightened ethical challenges that CIDs present to core IRB principles, including informed consent, benefit-risk assessment, and justice