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NCT Number: NCT07303517

AI-Driven Consent Simplification Study

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.

Recruiting

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Key information

Conditions

Informed Consent Behavior Communication Comprehension Disclosure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA

Los Angeles, California, 90095, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1:

  • Age 60 years and above
  • UCLA patient
  • English speaking
  • Ability to provide informed consent

Group 2:

  • UCLA investigators who are health providers that perform clinical trials
  • Must be clinical research investigatory and staff actively involved in research operations at UCLA
  • English speaking

Group 3:

  • Individuals involved in IRB activities (chairs, committee members, staff)
  • Must be a director or staff at UCLA
  • English speaking

Exclusion criteria

  • Group 1: None
  • Group 2: PI and co-PIs of the study "Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)"
  • Group 3: Individuals from the IRB who have reviewed the study submission for "Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)"

Treatment and study plan

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.

Primary outcomes

  1. Quality of Informed Consent (QUIC)

    Time frame: Day 1 (immediately after reviewing the ICF materials)

    The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge.

Secondary outcomes

  1. Time to read and understand informed consent

    Time frame: Day 1

    The time taken by each participant to complete reading and understanding of the ICF materials.

  2. Participant understanding and comprehension of the study

    Time frame: Day 1

    10-15 questions specific to the ICF and the study protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Erinn Knox

CONTACT

[email protected]

(310) 490-4888

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

ACCESS: AI-Driven Consent Simplification Study

Acronym: ACCESS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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