Artificial intelligence (AI) is both a component of human participant research as well as utilized in the design, planning, and analysis of research. Through a collaborative project with academia, industry, and Institutional Review Boards (IRBs), WCG and the Multi-Regional Clinical Trials Center (MRCT Center) convened representative experts to develop a framework and resources designed to help IRBs, researchers, institutions, and industry stakeholders assess research protocols and evaluate the risk-to-benefit ratio of AI in research. The resources include a web-based tool that guides the reviewer through different considerations based on the intended use of AI in research, the foreseeable risks, and potential mitigation strategies. We will report on the insights and challenges we faced while creating these resources and discuss some of the challenges we uncovered as we developed the tool.   

Learning Objectives: 

1. Introduction to the ethical review framework for clinical research involving AI to the broader research community.
2. Discuss how the framework aligns with existing regulations and ethical standards. 
3. Expert panel discussion on both the challenges of developing the tool and how to navigate the ethical considerations in research that includes AI