Data protection

Where will my data be stored?

In the questionnaire we ask you for some personal data and some information about your condition. The information that you enter will also be added  o an international registry which is supervised by TREAT-NMD, which is a global neuromuscular network with the aim of facilitating the development of new treatments. Your data will be stored securely and no unauthorised users will be able to gain access to any information about you. When planning research and clinical trials, researchers can enquire with the registry to see whether participants may be eligible for clinical trial or specific research, based on their clinical and genetic data. Only once a researchers’ enquiry has been approved by their local ethics committee and by the UK FSHD Patient Registry Steering Committee, may aggregated, de-identified data be shared.

In the registry, your data will only be identified by an anonymous code, not by your name. This means that when researchers search the registry they will not be able to find out your personal information (name, address, etc.), but only the information they need to know about your condition that will help them decide whether you might be suitable for a clinical trial or research study. If they think that you meet the criteria and might benefit from the clinical trial or research study, they will contact the person in charge of the registry. Staff working for the registry will “de-code” the data to find out the personal details and will contact you to give you information about the clinical trial or research study or about any other issues relevant to your condition. They will not give your name or personal information to the researchers.

If you are interested in the information that you receive about a particular clinical trial or research study, you will be given information about how you can contact the researchers running this. If you decide to take part in this, you will need to review and sign a separate consent form. You are completely free to make your own decision about any clinical trial or research study we inform you about. If you decide not to take part in this, your data will still be kept in the registry and we will continue to inform you about other clinical trials or research study unless you tell us not to. Please note that if we tell you about the existence of a clinical trial or research research, this does not imply that we endorse it.

Who will have access to my medical records?

Staff in charge of the registry might need to gain access to your medical records to obtain information necessary to the project (for example we will need to ask your geneticist/healthcare professional for a copy of your genetic report).

How will I be identified in the registry?

Your personal details (name, address etc.) have to be stored in the registry so that we can contact you if we need to inform you about possible clinical trials and research study or anything else that might be relevant to your condition.

This data will be stored in a secure manner and your records will be assigned a unique code. Your records will only be identified by this unique code. Only the person in charge of the registry (Dr Chiara Marini Bettolo) and persons explicitly appointed by her will be able to “de-code” the data to get access to your personal details.

Will my data be kept confidential?

Creating a registry requires the existence of a file containing a patient’s personal and medical data. This file will be subject to the regulations on data protection (national laws related to General Data Protection Regulation (GDPR) (EU) 2016/679EU). All information we receive from you will be treated confidentially. The information will be encrypted and stored on a secure server.

Third parties wishing to have access to the data in the registry (such as researchers or companies planning clinical trials or conducting research on new therapies) will only have access to anonymous information identifiable by a code. Before they are granted access even to this anonymous information, they have to have permission from the registry steering committee. Your personal data will not be made available to employers, government organisations, insurance companies, nor to your spouse, other members of your family or your doctor, unless stated!

Can I withdraw and have my data erased if I change my mind?

Your participation in this project is completely voluntary. In line with the regulations on data protection you have the right to access your own data and to rectify them or withdraw them completely at any time. Should you wish to withdraw your data from the registry you will be free to do so without having to provide any explanation. If you wish to withdraw, you should get in touch with the staff in charge of the registry.