Explanatory statement - Adults with a Friedreich Ataxia & Healthy Controls - FA App

Project ID: 26568
Project title: Remote Assessment of Cognition, Affect, and Motor Function in Ataxias

Dr Ian Harding
Monash University
Phone: +61 3 9905 9283
Email: ian.harding@monash.edu

Harding Lab Research Manager
Phone: +61 4 9292 3663
Email: harding.lab@monash.edu

You are invited to take part in this study. Please read this Explanatory Statement in full before deciding whether or not to participate in this research. If you would like further information, you are encouraged to contact the researchers via the phone numbers or email addresses listed above.

Who is eligible for this research?

The study is open to adults (at least 18 years old) with genetically confirmed Friedreich Ataxia (FA) or people without FA who are willing to be comparison participants. You may not be eligible to participate if you have a neurological diagnosis other than FA, or a psychiatric diagnosis (not including depression or anxiety). Your eligibility will be confirmed when you first enrol in the study.

What does the research involve?

The research project aims to evaluate short-term and long-term changes in the severity of FA symptoms using smartphone/tablet-based assessments. Individuals with FA experience changes in motor abilities, speech, emotions, and attention or concentration. Some symptoms get better or worse in severity on a short-term basis (i.e., day-to-day or week-to-week variation), while others change slowly over many years.

Measuring changes in disease severity usually requires a visit to your doctor or a research lab, and can therefore only occur infrequently (e.g., once per year). This makes it difficult to understand short-term changes. Research in other neurological diseases also indicates that more frequent measurement of symptoms can be useful in understanding disease progression. This may help improve management of FA symptoms and the design of clinical trials in the future.

In this project, you will be asked to complete a set of simple finger-tapping tasks, speech recordings, and questionnaires using the FA App once per month for at least six months. The tasks will take 20-30 minutes each month. If this approach appears promising, we may invite you to continue these monthly sessions beyond this period. We will also ask for details about your age, sex, GAA repeat length, and other personal and medical information.

Before commencing the study, we will ask for some information regarding your medical history to check your eligibility. You will then be asked to sign a consent form prior to any study assessments being performed.

Who is conducting the research?

This research has been initiated and is overseen by Dr Ian Harding, Senior Research Fellow at the Department of Neuroscience, Monash University, Melbourne, Australia.

The research tasks will be performed in the “FA App”, which is developed, owned, and operated by the not-for-profit philanthropic organisation “EndFA” (endfa.org).

Consenting to participate in the project and withdrawing from the research

Participation in any research project is entirely voluntary. If you do not wish to take part, you do not have to. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine treatment, your relationship with your Doctors or other health care workers, or opportunities to participate in other research projects.

You are free to withdraw from the project at any stage. If you do withdraw your consent during the research project, the researchers will not collect additional data from you, although we will ask you whether personal information and data already collected can be retained and used for the project results. You should be aware that any data already used to generate project results up to the time of your withdrawal cannot be deleted.

Possible benefits and risks to participants

There will be no direct benefit to you from your participation in this research. Your contributions will help improve knowledge of FA, which may contribute to better assessment options and clinical management in the future.

The assessments undertaken in this study are designed for research, and not to inform your clinical care. However, tracking of your performance on some tests will be provided regularly through the FA App.

Confidentiality

By signing the consent form, you consent to the research team collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. Your personal information will only be used for the purpose of this research project and it will only be disclosed with your permission, except as required by law.

Your personal information will only be accessible to members of the research team and authorised FA App administrators. In all other cases, your data will be assigned a unique code that cannot be linked to you by others.

Storage of data

Your confidential information will be kept securely on cloud-data servers with access managed by the FA App and local data servers with access managed by Monash University.

In accordance with relevant Australian and/or European privacy laws, irrespective of your country of residence, you have the right to request access to the information collected and stored by the research team about you. You also have the right to request that any information with which you disagree be corrected, and in some cases to be deleted (see ‘withdrawing from the research’, above). Please contact the research team named at the end of this document if you would like to access or alter your information.

Use of data for other purposes

It is possible that data collected for the purposes of this study may provide useful information for future research. This may include sharing the data from this study with other researchers through the FA App or by the research team.

Data from this project stored at Monash University will be managed by the research team and the Monash University Human Research Ethics Committee. Any future data use will need to be approved by a Human Research and Ethics Committee and all your identifying information will be removed to protect your privacy.

Future use of data stored on the FA App will be managed by the FA App in accordance with its data use and privacy policies, and will not be overseen by Monash University. Please refer to The FA App Privacy Policy and The FA App Health Data Policy, available in the app, for full details.

Results

It is anticipated that the results of this research project will be published and/or presented in scientific journals and conferences, and in academic and public forums. Only group-level data will be presented. Your individual data will not be reported, except with your permission.

Individual-level tracking of your performance on some tests will be provided regularly through the FA App. More in-depth individual reports will not available, but a report summarising the group-level outcomes of this research will be provided to you at the conclusion of the study, or on a yearly basis.

Further information and who to contact

The person you may need to contact will depend on the nature of your query. A member of the study team can be reached at the following:

Study Team (Harding Lab Research Manager, Monash University, Australia)

Telephone: +61 4 9292 3663 (during Australian business hours, or leave voice message) Emai: harding.lab@monash.edu

The Study Principal Investigator Dr Ian Harding can also be contacted directly at:

Telephone: +61 3 9905 9283 Email ian.harding@monash.edu

Complaints

Should you have any concerns or complaints about the conduct of the project, please contact:
Executive Officer, Monash University Human Research Ethics Committee
Monash University Human Research Ethics Committee (MUHREC)
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Tel: +61 3 9905 2052 Email: muhrec@monash.edu Fax: +61 3 9905 3831