AI-Driven Consent Simplification Study (ACCESS)

May 4, 2026 updated by: University of California, Los Angeles

ACCESS: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

UCLA patients, principal investigators (PIs) and institutional review board (IRB) members will be enlisted to evaluate 1 of the ICFs. Patient cohort will be identified using the Mental Health and Smart Technology Registry, The Diabetes Research Registry, and/or the EMBRACE registry and contacted by email. The PI cohort will be identified by direct referrals.

Description

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)"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1-Adult participants - Arm A
Will review the original ICF
Behavioral: Original ICF
Participant will review the original ICF
Group 1 - Adult participants - Arm B
Will review the simplified ICF
Behavioral: AI Simplified ICF
Participant will review the AI Simplified ICF
Group 1- Adult participants - Arm C
Will listen to a podcast in conjunction to the original ICF
Behavioral: Original ICF
Participant will review the original ICF
Behavioral: Podcast - Original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Group 1-Adult participants - Arm D
Will listen to a podcast in conjunction to the simplified ICF
Behavioral: AI Simplified ICF
Participant will review the AI Simplified ICF
Behavioral: Podcast - Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Group 2 - Investigators
PIs who are health providers that perform clinical trials
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.
Group 3 - IRB individuals
Individuals involved in IRB activities (chairs, committee members, staff)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (immediately after reviewing the ICF materials)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
Participant understanding and comprehension of the study
Time Frame: Day 1
10-15 questions specific to the ICF and the study protocol
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Arash Naeim, MD, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-24-6074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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