AI-Driven Consent Simplification Study (ACCESS)

University of California, Los Angeles (UCLA)

Status: Not yet enrolling

Conditions: Disclosure; Informed Consent; Comprehension; Communication

Treatments: Behavioral: AI Simplified ICF; Behavioral: Podcast - Simplified ICF; Behavioral: Podcast - Original ICF; Behavioral: Original ICF

Study type: Observational

Funder types: Other

Identifiers

NCT07303517

IRB-24-6074

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)"

Trial design

230 participants in 6 patient groups

Group 1-Adult participants - Arm A

Description:

Will review the original ICF

Treatment:

Behavioral: Original ICF

Group 1 - Adult participants - Arm B

Description:

Will review the simplified ICF

Treatment:

Behavioral: AI Simplified ICF

Group 1- Adult participants - Arm C

Description:

Will listen to a podcast in conjunction to the original ICF

Treatment:

Behavioral: Original ICF

Behavioral: Podcast - Original ICF

Group 1-Adult participants - Arm D

Description:

Will listen to a podcast in conjunction to the simplified ICF

Treatment:

Behavioral: Podcast - Simplified ICF

Behavioral: AI Simplified ICF

Group 2 - Investigators

Description:

PIs who are health providers that perform clinical trials

Treatment:

Behavioral: Original ICF

Behavioral: Podcast - Original ICF

Behavioral: AI Simplified ICF

Group 3 - IRB individuals

Description:

Individuals involved in IRB activities (chairs, committee members, staff)

Treatment:

Behavioral: Original ICF

Behavioral: Podcast - Original ICF

Behavioral: AI Simplified ICF