ACCESS Study on Using AI to Simplify Informed Consent Forms Improving Understanding and Accessibility for Clinical Research Participants

What this Trial Is About

Researchers are exploring how generative artificial intelligence genAI can improve the clarity and understanding of informed consent materials used in clinical research. The study focuses on testing whether large language models like ChatGPT and NotebookLM, alongside AI tools such as ElevenLabs, can simplify these documents to help participants better comprehend study procedures and risks. This pilot aims to promote truly informed consent, potentially increasing study enrollment, participant willingness, and data accuracy. The study involves different groups reviewing or listening to versions of informed consent forms ICFs. Participants may review the original or AI-simplified ICF text or listen to podcasts based on either version. There are specific groups including adult participants, clinical investigators who conduct trials, and individuals involved in Institutional Review Board IRB activities. Each group experiences different formats of the consent material to assess understandability. During the study, participants understanding will be evaluated immediately after reviewing or listening to the materials using the Quality of Informed Consent QUIC measure. Researchers will also track the time taken to read and understand the consent forms and assess participant comprehension of the study. The study is sponsored by the University of California, Los Angeles and involves adults aged 60 and over as patients, as well as clinical staff and IRB members, with assessments conducted on the first day of participation.

AI-Driven Consent Simplification Study