Framework for Review of Clinical Research Involving AI

Abstract

As part of the MRCT Center’s AI and Ethical Research project, the Framework for Review of Clinical Research Involving AI was co-developed by the MRCT Center and WCG, in collaboration with a diverse, multi-stakeholder task force.

This resource offers institutional review boards (IRBs) and other oversight entities a structured, practical approach to evaluating protocols that involve artificial intelligence in research with human participants. The framework addresses emerging ethical and regulatory challenges specific to AI—such as algorithmic bias, adaptive learning, data identifiability, and the need for human oversight—while aligning with foundational ethical principles and applicable U.S. regulations. Through tools including a decision tree for regulatory applicability, developmental stage-specific review guidance, and targeted ethical considerations, the framework supports consistent, thorough review processes that protect participants and promote the responsible use of AI in clinical research.