Using AI to simplify informed consent forms
ACCESS: AI-Driven Consent Simplification Study
This pilot will use AI tools like ChatGPT, NotebookLM, and ElevenLabs to create simpler English consent texts and podcasts and test whether they help UCLA patients aged 60+, clinical investigators, and IRB staff understand consent information better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07303517 on ClinicalTrials.gov |
What this trial studies
This observational pilot applies large language models (ChatGPT and NotebookLM) and audio tools (ElevenLabs) to rewrite and present informed consent forms in plain language, then compares those versions to the original texts. Participants include three groups: UCLA patients aged 60 and older who can consent, UCLA clinical investigators and research staff, and UCLA IRB members and staff. The study uses both quantitative measures (readability scores, comprehension quizzes, and survey ratings) and qualitative feedback to judge understanding and acceptability. Interventions include the original ICF, AI-simplified ICF, and podcast versions of both texts to examine text and audio formats.
Who should consider this trial
Good fit: Ideal participants are English-speaking UCLA-affiliated individuals: patients age 60 or older able to consent, clinical research investigators and staff actively involved in UCLA research operations, and UCLA IRB members or staff.
Not a fit: People who are not English-speaking, not affiliated with UCLA, have severe cognitive impairment preventing consent, or need non-text accessibility accommodations may not benefit from this text- and audio-focused intervention.
Why it matters
Potential benefit: If successful, AI-simplified consent materials could make risks and procedures easier to understand, supporting more truly informed participation and potentially improving enrollment and retention.
How similar studies have performed: Previous work on plain-language consent forms has often improved readability and comprehension, but using generative AI and synthetic-audio podcasts for consent is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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)"
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Arash Naeim, MD, PhD — University of California, Los Angeles
- Study coordinator: Erinn Knox
- Email: eknox@mednet.ucla.edu
- Phone: (310) 490-4888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.