AI-Driven Consent Simplification Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 60 years and above
UCLA patient
English speaking
Ability to provide informed consent
Disqualifiers
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)"
Trial population
UCLA patients, principal investigators (PIs) and institutional review board (IRB) members will be enlisted to evaluate 1 of the ICFs. Patient cohort will be identified using the Mental Health and Smart Technology Registry, The Diabetes Research Registry, and/or the EMBRACE registry and contacted by email. The PI cohort will be identified by direct referrals.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Original ICF
BehavioralParticipant will review the original ICF
AI Simplified ICF
BehavioralParticipant will review the AI Simplified ICF
Podcast - Original ICF
BehavioralListen to a podcast that is developed to provide an engaging format for the original ICF.
Podcast - Simplified ICF
BehavioralListen to a podcast that is developed to provide an engaging format for the simplified ICF.
Treatment groups
230 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Group 1-Adult participants - Arm A1 intervention
Group B: Group 1 - Adult participants - Arm B1 intervention
Group C: Group 1- Adult participants - Arm C2 interventions
Group D: Group 1-Adult participants - Arm D2 interventions
Group E: Group 2 - Investigators3 interventions
Group F: Group 3 - IRB individuals3 interventions
Trial outcomes
Primary outcomes
1
Quality of Informed Consent (QUIC)
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.
Time frame
Day 1 (immediately after reviewing the ICF materials)Secondary outcomes
1
Time to read and understand informed consent
The time taken by each participant to complete reading and understanding of the ICF materials.
Time frame
Day 12
Participant understanding and comprehension of the study
10-15 questions specific to the ICF and the study protocol
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov