Participant Disclosure

Information to consider for participant-facing consent materials

Version 2.13 · Effective 28 September 2026 · Alberta, Canada

Contents

• Why this document exists
• 1. Points that must be covered
• 2. Sample wording for a consent form
• 3. Keep the evidence

Why this document exists

Participants are not parties to the Terms of Use. Where you seek consent, your participant-facing materials are how they learn what the Software does and what risks its use may create.

Clause 12 of the Terms of Use requires you to cover the relevant substance of this document in your consent process, adapted as your REB/IRB directs and translated where needed. If your REB/IRB and applicable law permit a consent waiver or use of previously collected data, document that authority instead.

📌 Your REB/IRB must approve your consent materials

This document sets a minimum. It is not a template that has been approved for you. Your ethics board may require more, may require different wording, and must approve your consent materials before you use them. Nothing here is legal or ethical advice.

1. Points that must be covered

When consent is required, tell each participant, in language they understand and before any photograph is taken, the points below that apply to the study:

a. that photographs will be taken of their face and eyes, roughly how many, and on how many occasions;

b. that a photograph of a face or an eye identifies the person in it, and that using a study code instead of their name does not make the photograph anonymous; depending on how an image is processed and used, it may also be biometric data under applicable law;

c. that on a phone with a LiDAR scanner or a TrueDepth camera the app may also record a depth map (a measurement of the three-dimensional shape of their face, taken with the photograph and stored beside it), and that this is sensitive information about facial geometry and may be biometric data under applicable law; and that for the eyelid measurement taken with the front camera the phone’s face-tracking system follows their face while the photograph is taken, and the eyelid positions and depth map stored come from that tracking;

d. that where the study has Live Photos turned on the app also records a short, silent movie of about three seconds around each photograph (no sound is recorded), which is a moving picture of their face stored beside the photograph, and that this is identifying in the same way the photograph is;

e. that for pupil measurements the phone’s flash or torch is shone at close range into each eye, for some measurements after a short wait in a darkened room, and that this is dazzling for a moment and can leave a brief after-image;

f. what will be recorded alongside the images: the study code, the date, any study variables or demographic details, and any notes;

g. where and how the photographs are stored: that they are held on personal computers and phones, that the photographs and the information recorded with them are encrypted there under a password the study team holds, that this lowers the risk of exposure without removing it, and that how many records exist and when they were made remain readable;

h. that the research software is uncertified experimental research software, is not a medical device, and that nothing it produces will be used in their care or reported back to them or to their clinicians as a clinical finding;

i. that copies of photographs may be saved automatically to the phone’s own photo library, and from there uploaded to a cloud photo service, possibly stored outside the country; and whether that setting is on in your study;

j. that data are transferred between the researcher’s own devices, and may be exported, shared with named collaborators, and included in figures in publications and presentations; and exactly what form any published image will take (full face, cropped to the eyes, or censor bar), since a censor bar does not make an image anonymous;

k. that automated computer models will analyse the images, that these models may work less well for some people than others, and that no model output will be used to make any decision about them; and that while the camera screen is open the phone also checks the live preview a few times a second to see whether their head is facing the camera straight on, and that those preview frames are looked at and discarded, not kept;

l. that despite reasonable care, the images and data could be lost, stolen, leaked, published, or linked back to them, and that this cannot be undone once it happens;

m. who to contact about privacy, and how to complain to a privacy regulator;

n. how long the data will be kept, where, and what happens at the end;

o. how to withdraw: that they may withdraw at any time without giving a reason and without any effect on their care, what will be erased if they do, and what cannot be recovered, such as data already published, already shared with a collaborator, or already included in a completed analysis;

p. that participation is voluntary, and that their clinician’s care of them does not depend on it. This matters most when the researcher is also their treating clinician, in which case the power imbalance must be addressed explicitly;

q. who the data controller is, and how to reach the data protection officer, where a data-protection regime applies to you;

r. the legal basis for the processing and, where the data are special-category data, the additional condition relied on. Research-ethics consent is not automatically the same as the legal basis required by privacy law;

s. that a digital map of face and iris geometry is created and stored. Where a biometric-privacy statute applies, explain whether the map or the processing is regulated, the specific purpose for creating it, how long it will be kept, whether it may be sold, leased, traded, or otherwise used for profit, and who may receive it. Some statutes, including Illinois’ BIPA, may require a written release and a public retention-and-destruction policy;

t. the rights available to the participant under applicable law, any research limitation you rely on, and the named authority to which they may complain.

2. Sample wording for a consent form

The text below covers the points above in plain language. It is a starting point for your own consent form, not an approved document. Adapt it to your study, your jurisdiction, and your REB/IRB’s requirements, and have them approve it before use.

Use the Copy button to put this text on the clipboard.

⚠️ Complete every bracket and describe the risk accurately

Square brackets mark facts only you know. A bracket that is left in, or deleted without being answered, leaves the form incomplete. Confirm the camera-roll setting on the phone rather than relying on memory. Describe the safeguards and residual risk for your actual study; this document cannot assess the likelihood of a breach in your environment.

ABOUT THE PHOTOGRAPHS IN THIS STUDY

What we will do We will take photographs of your face and eyes using a phone or camera. We will use a research app to place markers on the photographs and measure distances around your eyelids and eyes. We may repeat this at more than one visit. While the camera is open, the phone checks the live picture a few times a second to see whether your head is straight; those checks are not saved. [If pupil measurements are part of this study: For some measurements we will shine the phone’s flash or torch close to your eye, sometimes after you have sat briefly in a darkened room. It is bright for a moment and may leave an after-image. Tell us if bright light is a problem for you, and you can ask us to stop at any time.]

What we will record We will record the photographs, a study code that stands in for your name, the date, and some information about you that the study needs. [If depth-capable phones are used: Some phones also record a depth map with the photograph, which is a measurement of the three-dimensional shape of your face that the app uses to work out real distances in millimetres. For the eyelid measurement, the phone’s face-tracking camera follows your face while the photograph is taken, and the eyelid positions it records come from that.] [If Live Photos are turned on for this study: The app also records a short, silent movie of about three seconds around each photograph (no sound is recorded), so that a blink or a glance at the wrong moment can be corrected by choosing a different moment from the movie instead of taking the photograph again.] We will keep the list that links your study code to your name somewhere separate and secure, away from the photographs.

Photographs can identify you, and the app records facial geometry A photograph of your face or your eye can identify you, even without your name attached to it. The app also creates and stores a digital map of the shape of your eyelids and iris. Where the phone recorded one, the app also stores a depth map of the shape of your face, and where the study records them, a short, silent movie of your face. In some places the law may treat that map as biometric data or a biometric identifier. Using a study code instead of your name reduces the risk but does not make any of this anonymous. [If a biometric-privacy law applies to you, state here: the specific purpose the map is created for, exactly how long it will be kept, that it will not be sold, leased, traded, or otherwise profited from, and who it may be disclosed to, and obtain a separate signature for this section.]

Who is responsible, and on what basis [Institution] is responsible for your information. You can contact [name/role] at [contact], or our data protection officer at [contact]. We use your photographs and information to carry out scientific research [state your legal basis and, if special-category data are processed, the additional condition you rely on]. We will also ask for your written consent as an ethical requirement, which may be separate from that legal basis.

Where the photographs are kept The photographs are stored on the study team’s own computers and phones using research software. The photographs, and the information recorded with them (the study code, dates, measurements, and notes) are encrypted on those devices. Encryption is meant to stop someone who gets hold of the files from reading them without the study team’s password. It lowers the chance of your information being seen by someone who should not see it. It does not remove that chance, and nobody can promise that information kept this way will never be exposed. Some details are not encrypted: how many records there are and the dates they were made. Copies the study team exports, shares, or prints are not encrypted at all. In this study, the phone is set to save an extra copy of each photograph into the phone’s own photo library: ☐ NO ☐ YES. [If YES: state whether those copies are uploaded to iCloud Photos or another photo service and where the provider says they may be stored. If NO: state that this setting does not save photographs to the photo library, then separately describe device backups, cloud-synchronised backup folders, and every other cloud route used by the study. Do not leave this blank.] [Also state: who has access, where the devices are kept, whether backups are made and where they are stored, and how long everything will be held.]

The software is research software The app used in this study is experimental research software. It is not a medical device, no health regulator has checked it, and it is not approved for use in patient care. It does not show normal ranges or make a diagnosis. Nothing it measures or calculates will be used to diagnose you, to plan your treatment, or to make any decision about your care, and its results will not be added to your medical record. If you have a concern about your eyes or eyelids, please raise it with your own doctor. The people who wrote the app receive none of your information: it stays on the study team’s devices.

Computer models look at the photographs Automatic computer programs find landmarks on the photographs. These programs are not perfect and can work less well for some people than others. Nothing they produce will be used to make any decision about you.

Who will see the photographs [Name who has access.] We may share the study data with named collaborators. We may publish the results, and this may include images. [State exactly what will be published: for example, “we will only publish close-up images of the eye region with any identifying features removed”, or “we would like to publish a photograph of your face, and we will ask you separately for permission to do that”. Note that covering the eyes with a bar does not make a photograph anonymous.]

The risks The main risk in this study is to your privacy. Photographs and information could be lost, stolen, seen by someone who should not see them, or published accidentally. If that happened, your photographs could be linked back to you, and it could not be undone. The steps we take to reduce that risk are: [list them: device encryption, who has access, where devices are kept, what is not copied to the cloud, how long data are kept]. We want you to know about this risk before you decide.

Your choice, and changing your mind Taking part is entirely up to you. If you say no, or if you change your mind later, it will not affect your care in any way. You can withdraw at any time, without giving a reason, by contacting [name, contact details]. If you withdraw, we will erase your photographs and study data from [list the places you will erase: the study devices, backups, exports, and the phone’s photo library if copies were made there] within [period]. We cannot take back anything already published, already shared outside the study team, or already included in a completed analysis, and we may be required to keep some records for [period] to show the research was done properly. We will tell you exactly what is kept and why.

Your rights, questions and complaints Depending on the law that applies, you may have rights to ask for access, correction, erasure, restriction, or portability, or to object to processing. [State the rights that apply to this study and any lawful research limitation, including why it applies.] For questions about the study, contact [name, contact details]. If you are unhappy with how your information is handled you can complain to [privacy contact / REB name and contact details], and to [the relevant privacy commissioner or supervisory authority, named, with contact details].

3. Keep the evidence

• Retain signed consent documentation for every participant, for as long as your REB/IRB and your law require.
• Record which version of the consent materials each participant signed.
• Record any withdrawal, when it was received, and what you erased in response.
• Keep the code-to-identity key outside the Software, secured separately.
• Keep this disclosure and the Terms of Use with your study documentation, since your REB may want to see what the software you used does.

Text fingerprint (SHA-256): 420f64f9ddd9bc905626a7c4451745f8878e37779d9feb12f86b92475183b7cc