AI-Driven Consent Simplification Study
ACCESS: AI-Driven Consent Simplification Study
University of California, Los Angeles
230 participants
Jan 8, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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 Criteria3
- 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)"
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Interventions
Participant will review the original ICF
Participant will review the AI Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07303517