Dear Participant
You are either suffering from Metachromatic Leukodystrophy (MLD), are part of an MLD family or are the guardian of a patient with MLD. You have been asked to participate in the MLD UK disease registry.
Please read this form carefully to understand what participation in the MLD UK disease registry will mean for you. Please feel free to contact the MLD Support Association UK if you have any questions about the contents of this form. If after reading the information in this form, you would like to be part of the registry, you will be asked to provide your consent by signing the form.
Definitions
For the purpose of this Consent form, “the patient” refers to the person diagnosed with Metachromatic Leukodystrophy (MLD). Registry information will be collected on patients who are diagnosed with MLD. “You”, the participant, refers to the person providing the information, who may be the patient himself or herself, or a family member or guardian, who is legally responsible for the care and health of the patient.
Purpose
The purpose of the MLD UK registry is to collect and store clinical and other information from patients with MLD or a related disease. Patient information in this registry will be used to :-
• Track trends about the number of people with the disease and the types of treatments they are using
• Create a natural history of MLD types.
• Increase the understanding of the condition.
• Locate patients who may be eligible for clinical trials
Researchers studying MLD need accurate information to understand how the disease affects people. In addition, researchers may request to access the MLD registry to locate patients who may be eligible to participate in clinical trials, such as trials to test new treatments. A formal research proposal must be received and approved by the Registry sponsor (MLD Support Association UK) before researchers are given access to registry data. Because of the rarity of MLD, researchers need to collect data from several countries to get enough information, therefore we ask you to consent to this sharing.
There is no cost to you to participate.
What will happen if you join this registry?
If you join this registry, you will be asked to provide data on where you live and how you prefer to be contacted and clinical information on your (or the patient’s) disease and diagnosis.
Once consent has been provided you will be given a subject number and access details. Consents will be stored in a safe locked cabinet. You will be given access to complete the questionnaire online after which the registry data manager will enter the data.
When you are completing the questionnaire, you will be answering a series of initial questions.
You may be asked to provide your genetic test results and any other relevant reports or testing results.
You will be asked to provide updated information once a year, or until such time as you decide you no longer want to participate.
You can update the information more frequently if there is a progression in your disease or a change of treatment.
If you prefer to complete the questionnaire in paper format, this can be done at a face to face meeting with an authorised representative from MLD Support Association UK. Alternatively, the paper questionnaire can be provided to you, completed and returned by registered post to MLD Support Association UK. An authorised representative of MLD Support Association UK will then enter the data into the registry database on your behalf.
The registry anonymised data can be made available to researchers while protecting your privacy.
