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AI-Driven Consent Simplification Study

Study acronym: ACCESS
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Phase changed: not specified → not applicable Show 5 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Dec 1, 2026 to Mar 11, 2026
    • Enrollment target: estimated 230 to confirmed 226
    • Eligibility criteria expanded, about 13 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. After reviewing the assigned consent information, participants will be asked a series of questions to capture their overall understanding. Then they will then be asked specific, multiple-choice questions about the content of the consent form.
Trial Details
NCT Number NCT07303517
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)		 Informed Consent, Comprehension, Communication, Disclosure
Related terms Communication
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov