Ethical considerations in the design and conduct of clinical trials of artificial intelligence

Ethical considerations in the design and conduct of clinical trials of artificial intelligence
JAMA Network Open; Alaa Youssef, PhD; Ariadne A. Nichol, BA; Nicole Martinez-Martin, JD, PhD; David B. Larson, MD, MBA; Michael Abramoff, MD, PhD; Risa M. Wolf, MD; Danton Char, MD, MS; 9/24
In this qualitative study, interviews with 11 investigators involved in clinical trials of AI [artificial intelligence] 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. 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. These considerations call for further guidance on where to focus empirical and normative ethical efforts to best support conduct clinical trials of AI and minimize unintended harm to trial participants.