RecruitingNot Applicable

AI-Driven Consent Simplification Study

United States230 participantsStarted 2026-01-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)"

What they're measuring

Quality of Informed Consent (QUIC)

Timeframe: Day 1 (immediately after reviewing the ICF materials)

Trial details

NCT IDNCT07303517

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

Contact for this trial

Erinn Knox

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