Artificial intelligence for informed decision-making during clinical trial consent: A scoping review of applications, outcomes, and ethical considerations

Clinical trials are essential for advancing medical treatments but face persistent challenges including slow recruitment, high costs, and complex regulatory demands. Artificial intelligence (AI), particularly large generative AI, has emerged as a potential tool to improve efficiency across multiple stages of trial design and conduct. One ethically sensitive domain is the informed consent process, where AI may support comprehension through document generation, conversational interfaces, and personalized explanations. Consent process in clinical trials is a longitudinal process, which includes information disclosure, decision supports, comprehension, dynamic conversations, and documentations. While early studies suggest potential benefits, concerns remain regarding safety, biases, and undue influence. The literature is rapidly expanding but fragmented across empirical studies and ethical analyses, warranting a scoping review to map the field.