AI Tools In Informed Consent: What Sponsors Need To Know About Risk

Artificial intelligence is becoming a common part of the informed consent process, but not all AI tools carry the same level of risk. While some applications simply improve formatting or assess reading level, others generate participant-facing content, draft consent language, or attempt to tailor materials for specific populations. Understanding the difference is essential for sponsors responsible for ensuring accuracy, compliance, and participant trust.

The greatest concerns arise when AI creates new content rather than edits existing information. Fluent, polished outputs can still contain factual inaccuracies, introduce bias, misrepresent risks and benefits, or overlook regulatory and institutional requirements. Even seemingly convincing visuals may contain protocol-specific errors that are easy to miss. As AI adoption grows, human oversight remains critical, particularly when reviewing risk disclosures, medical terminology, and culturally relevant communications.

Learn how to evaluate AI tools based on their function, identify where oversight is most needed, and build a risk-based approach that protects both research participants and study integrity.