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Evaluation Live Stream

2025 PRIM&R Annual Conference

Emerging Challenges and Innovations in Research

Regulatory Frameworks and Compliance

A02 - Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical Tools

Friday, November 7, 2025
10:30 AM - 11:45 AM ET
Location: Ballroom II
Human Subject Research - HSR Learning Lab Series CIP Accredited Live Streamed Session Live Session Recorded
CLICK HERE to view captioning for this session! 

AI is increasingly integrated both as a component of human participant research and in the design, planning, and analysis phases. To support the regulatory and ethical review of clinical research involving AI, effective tools and resources are essential. Through a collaborative effort among academia, industry, and IRBs, practical resources have been developed to assist IRBs, researchers, institutions, and industry stakeholders in assessing research protocols and evaluating the risk-benefit balance of AI applications. These resources include a web-based decision tree that guides reviewers through key considerations based on AI’s intended use, associated risks, and mitigation strategies. Additionally, a collection of case studies provides deeper insight into specific AI research scenarios. This session will share the challenges encountered and lessons learned during development and introduce these tools to the community.

Learning Objectives:

  • Share insights and challenges encountered in developing resources and tools to support the regulatory and ethical review of research involving AI
  • Offer resources to support thorough and effective review processes that address AI’s impact on research
  • Discuss specific case examples illustrating the use of AI within research protocols