Communication, Comprehension, Disclosure, Informed Consent
Conditions
Keywords
Informed Consent Readability, Plain language, Simplified consent forms, Research ethics
Brief 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. After reviewing the assigned consent information, participants will be asked a series of questions to capture their overall understanding. Then they will then be asked specific, multiple-choice questions about the content of the consent form.
Interventions
BEHAVIORALOriginal ICF
Participant will review the original ICF
BEHAVIORALAI Simplified ICF
Participant will review the AI Simplified ICF
BEHAVIORALPodcast - Original ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
BEHAVIORALPodcast - Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Informed Consent (QUIC) | Day 1 (immediately after reviewing the ICF materials) | The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to read and understand informed consent | Day 1 | The time taken by each participant to complete reading and understanding of the ICF materials. |
| Participant understanding and comprehension of the study | Day 1 | 10-15 questions specific to the ICF and the study protocol |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORArash Naeim, MD, PhD
University of California, Los Angeles
Outcome results
None listed