AI-Driven Consent Simplification Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT07303517
Status
Recruiting
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Conditions

  • Communication
  • Comprehension
  • Disclosure
  • Informed Consent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 8, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
230 participants (estimated)

Arms

  • Arm: Group 1-Adult participants - Arm A
    Will review the original ICF
  • Arm: Group 1 - Adult participants - Arm B
    Will review the simplified ICF
  • Arm: Group 1- Adult participants - Arm C
    Will listen to a podcast in conjunction to the original ICF
  • Arm: Group 1-Adult participants - Arm D
    Will listen to a podcast in conjunction to the simplified ICF
  • Arm: Group 2 - Investigators
    PIs who are health providers that perform clinical trials
  • Arm: Group 3 - IRB individuals
    Individuals involved in IRB activities (chairs, committee members, staff)

Primary Outcome Measure

Quality of Informed Consent (QUIC) [ Time Frame: Day 1 (immediately after reviewing the ICF materials) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-

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By research site
UCLA· Los Angeles, CA

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