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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Adult participants - Arm A | Will review the original ICF |
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| Group 1 - Adult participants - Arm B | Will review the simplified ICF |
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| Group 1- Adult participants - Arm C | Will listen to a podcast in conjunction to the original ICF |
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| Group 1-Adult participants - Arm D | Will listen to a podcast in conjunction to the simplified ICF |
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| Group 2 - Investigators | PIs who are health providers that perform clinical trials |
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| Group 3 - IRB individuals | Individuals involved in IRB activities (chairs, committee members, staff) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Original ICF | Behavioral | Participant will review the original ICF |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (immediately after reviewing the ICF materials) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to read and understand informed consent | The time taken by each participant to complete reading and understanding of the ICF materials. | Day 1 |
| Participant understanding and comprehension of the study |
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Inclusion Criteria:
Group 1:
Group 2:
Group 3:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erinn Knox | Contact | (310) 490-4888 | eknox@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arash Naeim, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| AI Simplified ICF | Behavioral | Participant will review the AI Simplified ICF |
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| Podcast - Original ICF | Behavioral | Listen to a podcast that is developed to provide an engaging format for the original ICF. |
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| Podcast - Simplified ICF | Behavioral | Listen to a podcast that is developed to provide an engaging format for the simplified ICF. |
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10-15 questions specific to the ICF and the study protocol
| Day 1 |