AI-Driven Consent Simplification Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Original ICF, AI Simplified ICF, Podcast - Original ICF, Podcast - Simplified ICF.
- Who it may be relevant to
- Registry conditions: Informed Consent, Comprehension, Communication, Disclosure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ACCESS: AI-Driven Consent Simplification Study
Overview
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.
Interventions
- Behavioral Original ICF
Participant will review the original ICF - Behavioral AI Simplified ICF
Participant will review the AI Simplified ICF - Behavioral Podcast - Original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF. - Behavioral Podcast - Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Primary outcome measures
- Quality of Informed Consent (QUIC) [Time frame: Day 1 (immediately after reviewing the ICF materials)]
Secondary outcome measures (2)
- Time to read and understand informed consent [Time frame: Day 1]
- Participant understanding and comprehension of the study [Time frame: Day 1]
Eligibility 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)"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- UCLA — Los Angeles
Identifiers
NCT: NCT07303517 · IRB-24-6074