Study Title: Smartphone Ocular Motor Digital Biomarkers of Brain (dys)function: Characterisation and Algorithm Development using the BrainEye Application.
Principal Investigator: A/Prof Joanne Fielding, joanne.fielding@braineye.com
Sponsor: BrainEye (Neuro Optica Operations Pty Ltd)
Study: Secondary Use of App-Collected Data for Research
Version number: 3
Date: 16/03/2026
Participant Information Sheet
1. What am I being invited to do?
You are invited to allow data collected during your use (or use by the person for whom you are providing consent) of the BrainEye application to be used for research purposes.
You are seeing this information because you are using the BrainEye app and are legally able to provide consent in your region, or a parent, guardian, or other person with lawful authority to provide consent on behalf of the BrainEye app user. This document explains the research use of the data collected during the use of The BrainEye app and will help you decide whether you wish to provide consent.
Your decision to allow or not allow research use of this data is entirely voluntary.
2. What is the purpose of this study?
The purpose of this research is to better understand normal and altered eye movements as measured using smartphone technology.
By analysing eye movement data from a large and diverse group of users, we aim to:
- characterise patterns of normal and altered eye movements
- develop and validate algorithms that measure eye movement behaviour
- improve the performance and scientific validity of eye-movement-based digital biomarkers
- publish aggregated research findings in scientific journals and presentations
This research uses data that have already been collected during your use (or use by the person for whom you are providing consent) of the app. No additional tasks, tests, or data collection are required.
3. Do I have to take part and can I change my mind?
No. Taking part in this research is completely voluntary. You or the person for whom you are providing consent can continue to use the BrainEye app without consenting to research.This decision will not affect access to the app or its features.
If you (or the person for whom you are providing consent) consent and later change your (or their) mind, you may withdraw your (or the person for whom you are providing consent) consent at any time without giving a reason.
If you withdraw:
- the data will be removed from future research analyses
- the data will also be removed from any aggregate research datasets or models where feasible
Withdrawal will not affect ongoing use of the app.
4. What do I have to do?
If you agree to take part, you will be asked to:
- Read this Participant Information Sheet
- Provide your electronic consent within the app by checking the box
No additional actions, tests, or appointments are required.
5. Your (or the person for whom you are providing consent) time and expenses
There is no payment or cost associated with this research. Participation involves only the secondary use of data already collected during app use.
6. What are the benefits of taking part?
There is no direct benefit to you (or the person for whom you are providing consent) for participating. The potential benefits are indirect and include contributing to scientific knowledge and the development of improved tools for measuring eye movements and brain function.
7. What are the risks and discomforts?
This is an observational research study that uses existing data collected during your (or the person for whom you are providing consent) normal use of the BrainEye app. No additional tests, tasks, or interactions are required for research purposes.
The overall risks associated with this research are low.
The main potential risk relates to privacy, as the data include eye-movement information derived from video recordings of your (or the person for whom you are providing consent) face. These privacy risks are not new and are the same as those that apply to normal use of the app. Information about how your (or the person for whom you are providing consent) data are collected, stored, protected, and transferred is provided in the BrainEye Terms and Conditions and Privacy Policy, which apply to all users of the app.
This research does not involve:
- any additional data collection beyond normal app use
- any additional video recording
- any changes to how your (or the person for whom you are providing consent) data are stored, protected, or transferred
- any new sharing of identifiable information
As a result, consenting to research does not increase your (or the person for whom you are providing consent) privacy risk beyond what already exists through use of the app.
No new physical, psychological, or medical risks are introduced by this research. No individual research results will be provided.
What sensitive information is being collected? BrainEye application will use your (or the person for whom you are providing consent) phone’s camera to record a video of your (or the person for whom you are providing consent) face and eye movements. This video is considered sensitive information because it is a recording of you (or the person for whom you are providing consent).
How will my identity and privacy be protected? We take your (or the person for whom you are providing consent) privacy and the security of your (or the person for whom you are providing consent) data very seriously. We have put multiple layers of protection in place to ensure your information is kept safe and confidential:
7.1. De-identification: All of your (or the person for whom you are providing consent) data is coded using an alphanumeric identifier. While research datasets are coded and de-identified, there is a technical capacity for re-identification under strict governance controls. Access to identifiable information is limited to authorised personnel for approved purposes only.
7.2. Secure Storage: All study data is stored in a highly secure, encrypted format on a professional cloud server located in Australia. This is like placing your (or the person for whom you are providing consent) information in a digital vault that requires multiple keys to open.
7.3. Restricted Access: Access to the identifying and deidentified data is strictly limited to authorised employees on the research team for approved purposes, as detailed in section 8. How will my information be used.
7.4. Confidential Reporting: No identifying images will be used in publications or presented at conferences. Any results from this study that are published or presented at conferences will be combined with data from all other participants and will be completely anonymous. It will be impossible for anyone to identify you (or the person for whom you are providing consent) from these reports.
8. How will my information be used
Your (or the person for whom you are providing consent) data will be used only for the following research purposes:
- analysis of eye-movement patterns
- development and validation of eye-movement algorithms
- scientific publication and presentation of aggregated findings
- internal research and quality assurance related to eye-movement measurement
9. Who is running and paying for this project?
This study is sponsored by BrainEye (Neuro Optica Operations Pty Ltd). It is important that you know that the researchers conducting this study are employees of BrainEye and may hold a financial interest (shares) in the company. This has been declared to the Human Research Ethics Committee, which has approved a plan to manage this conflict of interest.
10. Who has reviewed this project?
The Bellberry Human Research Ethics Committee, Australia has reviewed and approved this study in accordance with the Australian National Statement on Ethical Conduct in Human Research (2025). Should you wish to discuss the study with someone not directly involved, particularly in relation to complaints or your (or the person for whom you are providing consent) rights as a participant, you may contact the Director of HREC Operations, Bellberry Limited on 08 8361 3222.
For any questions about the study itself, please contact the Principal Investigator, A/Prof Joanne Fielding, joanne.fielding@braineye.com.
11. What happens if something goes wrong?
If you have any questions, concerns, or complaints about how the study is being conducted, you should first contact the research team.
Principal Investigator: A/Prof Joanne Fielding Email: joanne.fielding@braineye.com
Should you wish to discuss the study with someone not directly involved, or if you have a complaint about the conduct of the study or your (or the person for whom you are providing consent)) rights as a participant, you may contact the independent ethics committee that reviewed and approved the study.
Ethics Committee Contact: The Director of HREC Operations, Bellberry Limited Phone: 08 8361 3222
12. Can I access my results or the results of the study?
You (or the person for whom you are providing consent) will not receive individual test results from this study. The BrainEye test used in this project is experimental and not designed or validated for clinical or diagnostic use. Providing individual results could be misleading or cause unnecessary concern, as the meaning of any single result is not yet scientifically established.
Once the study is complete, a summary of the overall study findings will be prepared in clear language and made publicly available through academic publication and on the BrainEye website (www.braineye.com). You are welcome to access these results to learn about the general outcomes of the research.
By selecting “I agree” within the app, I confirm that:
- I have read and understood this Participant Information Sheet
- I understand that consenting to research is optional and not required to use the app
- I understand that data collected during use of the BrainEye app may be used for research purposes as described
- I understand that I can withdraw my consent at any time and that no new research use of the data will occur after withdrawal
- I am either providing consent for myself, or I am a parent, guardian, or other person with lawful authority providing consent on behalf of the BrainEye app user
- Where I am providing consent on behalf of another person, I confirm that I have legal authority to do so