This study is not yet accepting patients

AI-Driven Consent Simplification Study

a study on Informed Consent Comprehension Communication Disclosure

Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
study ends around
Principal Investigator
by Arash Naeim, MD, PhD (ucla)
Headshot of Arash Naeim
Arash Naeim

Description

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.

Official Title

ACCESS: AI-Driven Consent Simplification Study

Keywords

Informed Consent, Comprehension, Communication, Disclosure, Informed Consent Readability, Plain language, Simplified consent forms, Research ethics, Original ICF, AI Simplified ICF, Podcast - Original ICF, Podcast - Simplified ICF, IRB individuals

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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)"

Lead Scientist at University of California Health

  • Arash Naeim, MD, PhD (ucla)
    Dr. Naeim is a Professor of Medicine in both the Division(s) of Hematology-Oncology and Geriatric Medicine at the David Geffen UCLA School of Medicine as well as a Professor of Bioengineering in the Henry Sameuli School for Engineering and Applied Science.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07303517
Study Type
Observational
Participants
Expecting 230 study participants
Last Updated