What data is stored?
The registry contains patients’ personal details, such as name, address, date of birth and gender, so that they can be identified and contacted by the registry staff where appropriate. The registry also contains details of the symptoms people experience, such as the level of motor function and fatigue. Clinical data such as heart and lung function test results may also be added to the registry by the person’s doctor, who can be selected during the registration process. Results of genetic tests will also be stored in the registry because to develop treatments it is important that researchers have precise information about the genetic mutation that is responsible. This information should be provided by the selected doctor, or if patients have this information at hand it can be provided to the registry curator.
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 to 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 a 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 Myotonic Dystrophy 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.
Patient’s personal and medical data will be kept for an indefinite period at Newcastle University in the UK, under the responsibility of Dr Chiara Marini Bettolo. This data will be subject to the regulations on data protection (national laws related to General Data Protection Regulation (GDPR) (EU) 2016/679EU) and all information received from patients will be treated confidentially. The information will be encrypted and stored on a secure server located at Newcastle University in the UK.
Who enters your data and who has access to this?
Information entered into the registry is provided by either the patient themselves or the doctor involved in their care, after the patient has given consent for them to do so. A registry curator is employed to manage the registry and monitor the data.
The Registry is governed by an oversight committee (a Steering Committee) that includes doctors, scientists and patient organisations. It is their responsibility to monitor the registry appropriately and to review any requests for data, for example from a company planning a clinical trial. If a researcher or a company applies for access to the data in the registry, personally identifiable information such as your name, address, etc, does not go with it – the data about your condition is identified only by a code.
When a company wants help with recruiting patients to a clinical trial, the registry acts as a kind of ‘trusted intermediary’. The registry curator contacts everyone in the registry who meets the criteria for the trial and gives them details of how to proceed if they are interested. Usually this would involve you contacting the clinic running the trial to arrange an appointment to discuss the trial and what it involves. You would only need to do anything if you were interested in taking part.
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 neurologist/doctor 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 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.