AI In Informed Consent: What's Your Risk?

AI can make informed consent materials easier to develop, edit, and tailor, but greater automation can also introduce greater risk. From readability tools and plain-language editors to large language models and content generators, each use case requires a different level of oversight.

Sponsors need to consider whether AI-generated changes preserve the meaning of research terminology, remain consistent with the protocol, communicate risks and benefits accurately, and appropriately address cultural context. As AI takes a larger role in drafting content, thorough human review becomes increasingly important, including clinical review of medical language and additional scrutiny of information participants rely on when deciding whether to enroll.

Explore five common applications of AI in informed consent, their relative risk levels, and the checks sponsors should complete before AI-assisted materials reach an IRB or study participant.