AI-Driven Consent Simplification Study
Recruiting now
Conditions studied: Informed Consent, Comprehension, Communication, Disclosure
In brief
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.
Key facts
- Study ID
- NCT07303517
- Run by
- University of California, Los Angeles
- People needed
- 230
- Starts
- 2026-01-08
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- UCLA — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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