WCG has partnered with the Multi-Regional Clinical Trials (MRCT) Center at Brigham and Women’s Hospital and Harvard to develop the Framework for Review of Clinical Research Involving AI. This resource offers a structured, practical approach to evaluating protocols that involve artificial intelligence in research with human participants to institutional review boards (IRBs) and other oversight entities. We will provide a presentation on the Framework, which will then lead to a panel discussion on the iterative process by which the Framework was created, how the Framework can be used with protocol review, and a discussion of other resources that are under development as part of the project.

A Framework for AI Adoption and Oversight in Clinical Research - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard