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Evaluation

2025 PRIM&R Annual Conference

Research Oversight Leaders and Institutional Officials

Navigating Ethical Challenges

Emerging Challenges and Innovations in Research

E01 - PLENARY: Making the Ethical Oversight of Clinical Trials Fit for Purpose

Saturday, November 8, 2025
1:45 PM - 3:00 PM ET
Location: Room 343-344
Human Subject Research - HSR Thought Leader Series Call for Session Proposal - CSP
CLICK HERE to view captioning for this session! 

Traditional research ethics oversight systems, while ethically appropriate for many clinical trials including those testing new interventions, are ill-suited to evaluate many contemporary research approaches, such as comparative effectiveness and other research studying interventions already on the market and in widespread clinical use. The mismatch in ethics oversight systems for many research activities inappropriately overprotects patients from many low-risk activities while under protecting patients from medical care that lacks rigorous evaluation. This session will consider whether ethics oversight of these studies should be based upon two morally relevant features: How much would participation increase risks/burdens, relative to usual or recommended clinical care? And, how much would participation restrict a meaningful decision that patients would or should have available to them in clinical care?

Learning Objectives:

  • Identify ethical challenges in existing oversight approaches for comparative effectiveness research, pragmatic clinical trials, and other research approaches that deliberately integrate research and clinical care
  • Critically appraise a proposed framework for guiding ethics oversight to make it more "fit for purpose" for clinical trials, including considering how oversight for different types of clinical research may vary
  • Identify opportunities to satisfy ethical goals while facilitating important research