AI-Driven Consent Simplification Study
Purpose
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.
Conditions
- Informed Consent
- Comprehension
- Communication
- Disclosure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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)"
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Group 1-Adult participants - Arm A | Will review the original ICF |
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| Group 1 - Adult participants - Arm B | Will review the simplified ICF |
|
| Group 1- Adult participants - Arm C | Will listen to a podcast in conjunction to the original ICF |
|
| Group 1-Adult participants - Arm D | Will listen to a podcast in conjunction to the simplified ICF |
|
| Group 2 - Investigators | PIs who are health providers that perform clinical trials |
|
| Group 3 - IRB individuals | Individuals involved in IRB activities (chairs, committee members, staff) |
|
Recruiting Locations
Los Angeles, California 90095
More Details
- Status
- Recruiting
- Sponsor
- University of California, Los Angeles