The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Ethics and Equity for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials,” describes key considerations and challenges with leveraging artificial intelligence and machine learning in pragmatic clinical trials.

The chapter provides guidance on responsible conduct of pragmatic clinical trial research involving artificial intelligence and machine learning, including navigating the institutional review board approval process, considerations for data procurement and consent, and choices regarding what data are procured and how they are used to build equity-enhancing algorithmic models.

For more on the ethical considerations of ePCTs, see the chapters on Privacy Considerations; Identifying Those Engaged in Research; Consent, Waiver of Consent, and Notification; Collateral Findings; Data and Safety Monitoring; and Ethical Considerations of Data Sharing in Pragmatic Clinical Trials.