Informed ConsentACCESSNCT07303517
AI-Driven Consent Simplification Study
A study testing Original ICF, AI Simplified ICF and Podcast - Original ICF in people with Informed Consent and Comprehension, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent, Comprehension, Communication
- What is being tested?
- Original ICF, AI Simplified ICF and Podcast - Original ICF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1:
- Age 60 years and above
- UCLA patient
- English speaking
- Ability to provide informed consent
- Group 2:
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: ACCESS: AI-Driven Consent Simplification Study
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.
After reviewing the assigned consent information, participants will be asked a series of questions to capture their overall understanding. Then they will then be asked specific, multiple-choice questions about the content of the consent form.
- Conditions
- Informed Consent, Comprehension, Communication, Disclosure
- Being tested
- Original ICF, AI Simplified ICF, Podcast - Original ICF, Podcast - Simplified ICF
- Keywords
- Informed Consent Readability, Plain language, Simplified consent forms, Research ethics
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original ICFBehavioural
Participant will review the original ICF
AI Simplified ICFBehavioural
Participant will review the AI Simplified ICF
Podcast - Original ICFBehavioural
Listen to a podcast that is developed to provide an engaging format for the original ICF.
Podcast - Simplified ICFBehavioural
Listen to a podcast that is developed to provide an engaging format for the simplified ICF.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Adult participants - Arm A | Experimental | Will review the original ICF Receives: Behavioral: Original ICF |
| Group 1 - Adult participants - Arm B | Experimental | Will review the simplified ICF Receives: Behavioral: AI Simplified ICF |
| Group 1- Adult participants - Arm C | Experimental | Will listen to a podcast in conjunction to the original ICF Receives: Behavioral: Original ICF; Behavioral: Podcast - Original ICF |
| Group 1-Adult participants - Arm D | Experimental | Will listen to a podcast in conjunction to the simplified ICF Receives: Behavioral: AI Simplified ICF; Behavioral: Podcast - Simplified ICF |
| Group 2 - Investigators | Experimental | PIs who are health providers that perform clinical trials Receives: Behavioral: Original ICF; Behavioral: AI Simplified ICF |
| Group 3 - IRB individuals | Experimental | Individuals involved in IRB activities (chairs, committee members, staff) Receives: Behavioral: Original ICF; Behavioral: AI Simplified ICF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (immediately after reviewing the ICF materials)
Secondary outcomes (2)
Time to read and understand informed consent
The time taken by each participant to complete reading and understanding of the ICF materials.
Measured: Day 1
Participant understanding and comprehension of the study
10-15 questions specific to the ICF and the study protocol
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start8 Jan 2026
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arash Naeim, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303517
- Sponsor's protocol ID
- IRB-24-6074
- Acronym
- ACCESS
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS: AI-Driven Consent Simplification Study
- ClinicalTrials.gov ID
- NCT07303517
- Acronym / sponsor ID
- ACCESS / IRB-24-6074
- Conditions
- Informed Consent, Comprehension, Communication, Disclosure
- Keywords
- Informed Consent Readability, Plain language, Simplified consent forms, Research ethics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
After reviewing the assigned consent information, participants will be asked a series of questions to capture their overall understanding. Then they will then be asked specific, multiple-choice questions about the content of the consent form.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1-Adult participants - Arm A | Experimental | Behavioral: Original ICFWill review the original ICF |
| Group 1 - Adult participants - Arm B | Experimental | Behavioral: AI Simplified ICFWill review the simplified ICF |
| Group 1- Adult participants - Arm C | Experimental | Behavioral: Original ICF, Behavioral: Podcast - Original ICFWill listen to a podcast in conjunction to the original ICF |
| Group 1-Adult participants - Arm D | Experimental | Behavioral: AI Simplified ICF, Behavioral: Podcast - Simplified ICFWill listen to a podcast in conjunction to the simplified ICF |
| Group 2 - Investigators | Experimental | Behavioral: Original ICF, Behavioral: AI Simplified ICFPIs who are health providers that perform clinical trials |
| Group 3 - IRB individuals | Experimental | Behavioral: Original ICF, Behavioral: AI Simplified ICFIndividuals involved in IRB activities (chairs, committee members, staff) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 60 years and above
- UCLA patient
- English speaking
- Ability to provide informed consent
- UCLA investigators who are health providers that perform clinical trials
Key exclusion criteria (3 listed)
- 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)"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Original ICFParticipant will review the original ICF | Behavioural | Group 1- Adult participants - Arm C, Group 1-Adult participants - Arm A, Group 2 - Investigators, Group 3 - IRB individuals |
| AI Simplified ICFParticipant will review the AI Simplified ICF | Behavioural | Group 1 - Adult participants - Arm B, Group 1-Adult participants - Arm D, Group 2 - Investigators, Group 3 - IRB individuals |
| Podcast - Original ICFListen to a podcast that is developed to provide an engaging format for the original ICF. | Behavioural | Group 1- Adult participants - Arm C |
| Podcast - Simplified ICFListen to a podcast that is developed to provide an engaging format for the simplified ICF. | Behavioural | Group 1-Adult participants - Arm D |
Primary outcome
Quality of Informed Consent (QUIC)
Time frame: Day 1 (immediately after reviewing the ICF materials)
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.
2 secondary outcomes
Time to read and understand informed consent
Time frame: Day 1
Participant understanding and comprehension of the study
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Naeim, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Original ICF, AI Simplified ICF and Podcast - Original ICF in people with Informed Consent and Comprehension, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Informed Consent (QUIC) (time frame: Day 1 (immediately after reviewing the ICF materials)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.