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AI-Driven Consent Simplification Study

NCT07303517 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Arash Naeim, MD, PhD · University of California, Los Angeles

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303517 on ClinicalTrials.gov