Actively Recruiting
ACCESS: AI-Driven Consent Simplification Study
Led by University of California, Los Angeles · Updated on 2026-05-08
230
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how generative artificial intelligence (genAI) can improve the clarity and understanding of informed consent materials used in clinical research. The study focuses on testing whether large language models like ChatGPT and NotebookLM, alongside AI tools such as ElevenLabs, can simplify these documents to help participants better comprehend study procedures and risks. This pilot aims to promote truly informed consent, potentially increasing study enrollment, participant willingness, and data accuracy. The study involves different groups reviewing or listening to versions of informed consent forms (ICFs). Participants may review the original or AI-simplified ICF text or listen to podcasts based on either version. There are specific groups including adult participants, clinical investigators who conduct trials, and individuals involved in Institutional Review Board (IRB) activities. Each group experiences different formats of the consent material to assess understandability. During the study, participants' understanding will be evaluated immediately after reviewing or listening to the materials using the Quality of Informed Consent (QUIC) measure. Researchers will also track the time taken to read and understand the consent forms and assess participant comprehension of the study. The study is sponsored by the University of California, Los Angeles and involves adults aged 60 and over as patients, as well as clinical staff and IRB members, with assessments conducted on the first day of participation.
CONDITIONS
Brief Title
AI-Driven Consent Simplification Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Group 1: Age 60 years and above
- Group 1: UCLA patient
- Group 1: English speaking
- Group 1: Ability to provide informed consent
- Group 2: UCLA investigators who are health providers performing clinical trials
- Group 2: Clinical research investigators and staff actively involved in research operations at UCLA
- Group 2: English speaking
- Group 3: Individuals involved in IRB activities (chairs, committee members, staff)
- Group 3: Must be a director or staff at UCLA
- Group 3: English speaking
You will not qualify if you...
- Group 1: None
- Group 2: Principal Investigators and co-Principal Investigators 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)"
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 1 day
Participants review informed consent forms or listen to related podcasts depending on their assigned group. This involves engaging with either the original or AI-simplified consent materials in written or audio format.
1 visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
E
Erinn Knox
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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