AI-Driven Consent Simplification Study

University of California, Los Angeles230 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

230

Conditions

Informed Consent Comprehension Communication Disclosure

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)"

Outcomes

Primary Outcomes

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

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 1

Participant understanding and comprehension of the study

10-15 questions specific to the ICF and the study protocol