Announcing the Framework for Review of Clinical Research Involving AI: New Guidance for Ethical Oversight
The future of clinical research is being shaped by artificial intelligence, demanding new tools, new thinking, and a renewed commitment to protecting human participants.
Recently, WCG joined with the MRCT Center to announce the release of the Framework for Review of Clinical Research Involving AI, a groundbreaking resource co-developed by a diverse, multi-stakeholder task force of experts in bioethics, AI, clinical research, and regulatory affairs. Dr. Donna Snyder, executive physician at WCG, played a key leadership role in the framework’s development, helping to drive forward WCG’s mission of advancing ethical, efficient research worldwide.
Navigating AI’s New Ethical Terrain
As the use of artificial intelligence expands in clinical studies, oversight entities face complex questions unprecedented in traditional research. Issues such as algorithmic bias, adaptive learning, data identifiability, and the role of human oversight have emerged as critical considerations, demanding fresh approaches to participant protection and regulatory compliance.
The new framework — developed as part of the MRCT Center’s AI and Ethical Research project — offers institutional review boards (IRBs) and similar oversight bodies a structured, practical guide to navigating these challenges. Rooted in foundational ethical principles, the resource provides:
- A downloadable decision tree to determine regulatory applicability for AI-enabled studies.
- Review guidance tailored to the developmental stage of the AI being investigated.
- Targeted ethical considerations addressing the unique risks and benefits of AI in human research.
By supporting consistency and clarity in IRB processes, the framework empowers organizations to both uphold participant protections and promote the responsible, innovative application of AI in clinical research.
Expert Insights: Webinar Replay Available Now
To mark the framework’s public launch, MRCT Center and WCG convened a thought-provoking webinar featuring a panel of distinguished experts, including Dr. Snyder and WCG’s Currien MacDonald, medical chair director. As well as Mary Gray from Microsoft Research and Kevin Nellis from SUNY Downstate. Together, the panelists explored the framework’s goals, shared firsthand perspectives on its practical application, and discussed anticipated challenges and opportunities in the oversight of AI-enabled research.
Missed the live event? Watch the webinar replay to hear directly from the experts about how this new guidance can inform, empower, and advance ethical clinical research involving artificial intelligence.
Learn More
- Download the Framework for Review of Clinical Research Involving AI by clicking here.
- Watch the webinar replay by clicking here.
- Explore WCG’s leadership in IRB review and next-generation clinical research solutionsby clicking here.