AI-Driven Consent Simplification Study
ACCESS
ACCESS: AI-Driven Consent Simplification Study
1 other identifier
interventional
226
1 country
1
Brief 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. 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
December 26, 2025
CompletedStudy Start
First participant enrolled
January 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2026
CompletedSeptember 17, 2026
September 1, 2026
2 months
December 8, 2025
September 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Informed Consent (QUIC)
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 Outcomes (2)
Time to read and understand informed consent
Day 1
Participant understanding and comprehension of the study
Day 1
Study Arms (6)
Group 1-Adult participants - Arm A
EXPERIMENTALWill review the original ICF
Group 1 - Adult participants - Arm B
EXPERIMENTALWill review the simplified ICF
Group 1- Adult participants - Arm C
EXPERIMENTALWill listen to a podcast in conjunction to the original ICF
Group 1-Adult participants - Arm D
EXPERIMENTALWill listen to a podcast in conjunction to the simplified ICF
Group 2 - Investigators
EXPERIMENTALPIs who are health providers that perform clinical trials
Group 3 - IRB individuals
EXPERIMENTALIndividuals involved in IRB activities (chairs, committee members, staff)
Interventions
Participant will review the AI Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Participant will review the original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arash Naeim, MD, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 26, 2025
Study Start
January 8, 2026
Primary Completion
March 11, 2026
Study Completion
March 11, 2026
Last Updated
September 17, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share