Online informed consent form
You are invited to take part in a research study. A person who takes part in a research study is called a research subject, or research participant.
In this consent form “you” generally refers to the research subject (i.e. the person with ataxia). If you are being asked as the legally authorised representative, parent, or guardian to complete the survey with a minor, “you” in the rest of this form generally means the research subject. “We” refers to the research team, which includes four ataxia patient organisations, and research teams at three universities.
What should I know about this research?
• This form summarises information about our research study.
• Taking part in this research involves completing an online survey.
• Taking part in this research is voluntary. You can stop at any time. If you prefer not to answer a question, you will have the option to select 'prefer not to answer' or skip the question.
• You can choose not to take part. There will be no penalty or loss of benefits to which you are otherwise entitled.
• All responses to the survey will be anonymous. Therefore, once your responses have been submitted it will not be possible to withdraw your consent or your responses.
• You can ask questions about this study by contacting Ataxia UK (by emailing research@ataxia.org.uk or calling +44207 587 3929) or the National Ataxia Foundation (NAF) (by emailing research@ataxia.org or calling +1-763-553-0020) or the Ataxia Charlevoix- Saguenay Foundation (by emailing ataxia@arsacs.com or calling +1-514-370-3625).
• Ask all the questions you want before you decide to participate.
Why is this research being done?
The purpose of the study is to collect opinions about gene therapy research from people diagnosed with a genetic ataxia from a number of different countries. People with genetic ataxias can complete the survey, or family members can complete it on their behalf, with their consent.
Genetic forms of ataxia are caused by mutations in one or more genes. The mutated gene responsible for the ataxia is passed along from generation to generation by family members who carry it. Some of the common forms of genetic ataxias are Friedreich’s ataxia (FA), ARSACS, Spinocerebellar ataxias type 1, 2, 3, 27B, CANVAS or Ataxia Telangiectasia (AT), and there are many others. Gene therapy is a potential treatment for genetic ataxias. We are interested in learning about opinions to gene therapy from people with all types of hereditary ataxias, as long as the genetic diagnosis has been confirmed. To be eligible to participate, you or your family member must have a clear diagnosis of ataxia caused by a mutation in a specific gene. The results will be used to provide information to researchers developing future treatment trials for genetic ataxias, and to improve patient interactions during the development of such treatments.
This project is being conducted as part of the TREAT-ARCA research project funded by European Joint Programme for Rare Diseases. This project also received funding from the biopharmaceutical company UCB.
The research team includes:
• Celeste Suart, National Ataxia Foundation, USA & Canada
• Julie Greenfield, Ataxia UK, London, UK
• Emily Cutting, Ataxia UK, London, UK
• Andreas Nadke, DHAG, Germany
• Chantal Gobeil, ARSACS Foundation, Canada
• Manuela Corti, Associate Professor, University of Florida, USA
• Shandra Trantham, University of Florida, USA
• Matthis Synofzik, University of Tuebingen, Germany
• Bernard Brais, McGill, Montreal, Canada
• Christian Rummey, CDS GmbH, Basel, Switzerland