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RECRUITING
NCT07303517

AI-Driven Consent Simplification Study

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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.

Official title: ACCESS: AI-Driven Consent Simplification Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

230

Start Date

2026-01-08

Completion Date

2026-12-01

Last Updated

2026-03-13

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

UCLA

Los Angeles, California, United States