INFORMED CONSENT FORM — CANONIC Community Learning Study

inherits: hadleylab-canonic/IRBS

Axiom

Standard informed consent form for the CANONIC Community Learning Study. Provided for IRB review alongside the waiver request under 45 CFR 46.116(f). This form would be used if the waiver were not granted; the investigators believe waiver is justified because no PII exists in the data and subjects cannot be identified or contacted.

Study Title

Community Learning Patterns in Governed AI Health Navigation

Principal Investigator

Dexter Hadley, MD/PhD Hadley Lab — CANONIC Email: dexter@canonic.org

Co-Investigator

Marisa Nimrod, MD

1. Purpose of the Study

You are being asked to take part in a research study. This form explains the study so that you can decide whether you want to participate. Please read it carefully and ask questions about anything you do not understand.

The purpose of this study is to understand the types of health questions that people ask when using AI-powered cancer navigation services. By studying the questions that patients, caregivers, and clinicians ask, we hope to improve health navigation for communities in the Caribbean and the United States.

2. What You Will Be Asked To Do

If you agree to participate, you do not need to do anything differently. You may continue to use the health navigation service (CaribChat or MammoChat) as you normally would. The study will analyze the questions you ask, after they have been anonymized by the system. You will not be asked to complete surveys, undergo tests, or change your behavior in any way.

3. What Information Is Collected

When you ask a question through the navigation service, the system records three things:

What is recorded Example
The date 2026-03-15
Your question “Where can I get screened in Port of Spain?”
A random session code A random number that cannot be linked back to you

The system does not collect your name, email address, phone number, IP address, location, or any other information that could identify you.

4. What Information Is NOT Collected

The following information is never collected by the system:

5. Risks

The risks of this study are minimal. Because the system does not collect any information that could identify you, there is no risk of your identity being revealed. Your questions will be analyzed as part of a larger group, and no individual question will be attributed to an identifiable person in any publication.

6. Benefits

You may not benefit directly from this study. However, the study may help improve health navigation services for communities in the Caribbean and the United States by helping researchers understand what kinds of health questions people need answered.

7. Privacy and Confidentiality

Your privacy is protected by the design of the system itself, not by a policy manual. The system was built so that it is impossible to know who asked any particular question. There is no list linking your identity to your questions because your identity was never recorded in the first place.

The research team will analyze questions at the group level. Individual questions may be quoted as examples in publications, but they cannot be traced back to any individual because no identifying information exists.

8. Voluntary Participation

Your participation is voluntary. You may stop using the navigation service at any time without penalty. However, because questions are anonymized at the moment they are recorded, it is not possible to remove a specific person’s questions from the ledger after they have been submitted, since there is no way to know which questions belong to which person.

9. Questions

If you have questions about this study, you may contact:

Dexter Hadley, MD/PhD Email: dexter@canonic.org

If you have questions about your rights as a research participant, you may contact the IRB that reviewed this study.

By signing below, you confirm that you have read and understood this form, that your questions have been answered, and that you agree to participate in this study.

Field Value
Participant Name (printed)  
Participant Signature  
Date  
Person Obtaining Consent (printed)  
Person Obtaining Consent Signature  
Date  

11. Spanish Translation / Traducción al Español

A Spanish-language version of this informed consent form will be made available for participants who prefer to read and sign in Spanish, consistent with the study’s Spanish language subgroup analysis across both arms.

*IRBS CARIBCHAT ICF 2026-03-19*