Recruiting

Generative AI

Sponsor:

UCLA

Code:

NCT07303517

Conditions

Informed Consent

Comprehension

Communication

Disclosure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Original ICF

AI Simplified ICF

Podcast - Original ICF

Podcast - Simplified ICF

Study Details

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.

Conditions

Informed Consent

Comprehension

Communication

Disclosure

Study ID

NCT07303517

Start date

Jan 8, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

230 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1-Adult participants - Arm A

Will review the original ICF

Group 1 - Adult participants - Arm B

Will review the simplified ICF

Group 1- Adult participants - Arm C

Will listen to a podcast in conjunction to the original ICF

Group 1-Adult participants - Arm D

Will listen to a podcast in conjunction to the simplified ICF

Group 2 - Investigators

PIs who are health providers that perform clinical trials

Group 3 - IRB individuals

Individuals involved in IRB activities (chairs, committee members, staff)

Interventions

Original ICF

Participant will review the original ICF

AI Simplified ICF

Participant will review the AI Simplified ICF

Podcast - Original ICF

Listen to a podcast that is developed to provide an engaging format for the original ICF.

Podcast - Simplified ICF

Listen to a podcast that is developed to provide an engaging format for the simplified ICF.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Erinn Knox

(310) 490-4888eknox@mednet.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Informed Consent Readability
  • Plain language
  • Simplified consent forms
  • Research ethics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-08.