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
Participant will review the original ICF
Participant will review the AI Simplified ICF
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
UCLA
Los Angeles, California, United States
RECRUITINGQuality 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)
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
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.