ACCESS: AI-Driven Consent Simplification Study
University of California, Los Angeles
Summary
The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research. The study will test the extent to which informed consent text can be improved by large language models (LLM; specifically, ChatGPT and NotebookLM) along with other AI tools (specifically, ElevenLabs) through qualitative and quantitative analyses. Simplifying such forms using genAI may facilitate better comprehension, ensuring truly informed consent. Improving informed consent form (ICF) comprehension can lead to more informed and willing participation in clinical studies. This improved understanding may result in higher enrollment rates, better subject retention, and more accurate data collection as individuals will have a clearer understanding of study procedures and risks.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Group 1: * Age 60 years and above * UCLA patient * English speaking * Ability to provide informed consent Group 2: * UCLA investigators who are health providers that perform clinical trials * Must be clinical research investigatory and staff actively involved in research operations at UCLA * English speaking Group 3: * Individuals involved in IRB activities (chairs, committee members, staff) * Must be a director or staff at UCLA * English speaking Exclusion Criteria: * Group 1: None * Group 2: PI and co-PIs of the study "Donor Chimerism and Graft Survival Following…
Interventions
- BehavioralOriginal ICF
Participant will review the original ICF
- BehavioralAI Simplified ICF
Participant will review the AI Simplified ICF
- BehavioralPodcast - Original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
- BehavioralPodcast - Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Location
- UCLALos Angeles, California