Question  How generalizable are current National Institutes of Health (NIH) ethical principles for conduct of clinical trials to clinical trials of artificial intelligence (AI), and what unique ethical considerations arise in trials of AI?

Findings  In this qualitative study, interviews with 11 investigators involved in clinical trials of AI for diabetic retinopathy screening confirmed the applicability of current ethical principles but also identified unique challenges, including assessing social value, ensuring scientific validity, fair participant selection, evaluation of risk-to-benefit ratio in underrepresented groups, and navigating complex consent processes.

Meaning  These results suggest ethical challenges unique to clinical trials of AI, which may provide important guidance for empirical and normative ethical efforts to enhance the conduct of AI clinical trials.

Youssef A, Nichol AA, Martinez-Martin N, et al. Ethical Considerations in the Design and Conduct of Clinical Trials of Artificial Intelligence. JAMA Netw Open. 2024;7(9):e2432482. doi:10.1001/jamanetworkopen.2024.32482