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 be entered into an international registry which is supervised by TREAT-NMD. Your data will be stored securely and no unauthorised people will be able to gain access to any information about you. When planning clinical trials, researchers can search the registry for participants eligible for the trial, based on the patients’ clinical and genetic data. Only researchers who have been approved by their local ethics committee and by the UK FSHD Patient Registry Steering Committee are allowed access to the registry.
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 the trial. If they think that you meet the criteria and might benefit from the trial, 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 trial 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, you will be given information about how you can contact the researchers running the trial. If you decide to take part in the trial, you will need to review and sign a separate consent form. You are completely free to make your own decision about any trial we inform you about. If you decide not to take part in a particular trial, your data will still be kept in the registry and we will continue to inform you about other trials unless you tell us not to. Please note that if we tell you about the existence of a trial, 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/physician for a copy of your genetic report and also information on your respiratory and cardiac function).
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 or anything else that might be relevant to your disorder.
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. Researchers searching in the registry therefore cannot identify you personally from the information you have access to. 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 EU directive 95/46). 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 or educational institutions, nor to your spouse, other members of your family or your doctor!
Can I withdraw and have my data erased if I change my mind?
Your participation in this project is completely voluntary. The data protection act grants you 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.