NCT07303517

AI-Driven Consent Simplification Study

ACCESS: AI-Driven Consent Simplification Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Informed Consent
• Comprehension
• Communication
• Disclosure

Interventions

Type	Name	Description
BEHAVIORAL	Original ICF	Participant will review the original ICF
BEHAVIORAL	AI Simplified ICF	Participant will review the AI Simplified ICF
BEHAVIORAL	Podcast - Original ICF	Listen to a podcast that is developed to provide an engaging format for the original ICF.
BEHAVIORAL	Podcast - Simplified ICF	Listen to a podcast that is developed to provide an engaging format for the simplified ICF.

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-26
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States