Before you agree to register in the Global Dystonia Registry, it is important that you understand what is involved and what will be done with the information that you provide. This form contains answers to some of the question you might have. At the end of the form there is a section for you to sign to confirm that you agree to participate. If you have any other questions after reading this form, please contact us before signing the form.
What is a registry and what is its value?
Scientific advances over recent years have led to substantial changes in the treatment of many disorders. Unfortunately, these advances have not yet led to successful treatment for all the different forms of dystonia. However, new potential treatments will emerge as we learn more about the disorders. It is also likely that many of these new therapies will target specific genetic defects, which means that the treatments may be of particular value to people with familial dystonia. Once these potential treatments are identified, it will become necessary to test them in what are known as clinical trials. When a clinical trial is planned and implemented, it is very important that patients eligible for the trial be found and contacted quickly. The best way of ensuring that this can happen is to make sure that potential participants’ information is collected together in a single database, sometimes referred to as a “registry.” This registry contains all the information that researchers will need including key information about the disorder. The Global Dystonia Registry is this kind of registry; the registry will begin in the United States and, in time, expand to Europe and other countries.
Whose data will be collected in the registry?
Individuals eligible to join the Global Dystonia Registry include those persons with symptoms of dystonia or people who carry thedystonia gene but do not exhibit symptoms. This may include but is not limited to primary focal dystonia such as blepharospasm, cervical dystonia, craniofacial dystonia, limb dystonia, spasmodic dysphonia or writer’s cramp.
The primary goal of the Global Dystonia Registry is to collect information about people who might be suitable to participate in future clinical trials of new treatments. For this reason, the Global Dystonia Registry is intended only to capture information about people who are currently living; it is not a record of those who have already died.
Who should create an account and complete a profile in the Global Dystonia Registry?
Anyone may create an account, but we ask that only people with dystonia or a carrier of a dystonia gene complete a profile within the registry. It is, however, OK for someone not in a dystonia family to complete a profile on behalf of someone with dystonia, particularly if the person with dystonia is disabled and unable to complete the profile without assistance.
What do I have to do to complete my profile in Global Dystonia Registry?
All If you agree to take part in this project, you should read this patient information and sign the consent form at the end. You should then register with the system by providing a little bit of information about yourself to create a username and password. Once you have acquired these login details, you are ready to create your profile. To create your profile, we ask that you answer a series of questions. These questions will ask for some personal information, as well as for information about your family members who may have or have had dystonia.
How can I update my information if it changes?
To make sure that the data in the registry is correct and current, it is essential that we update it regularly. To do this, we will send you an email once a year asking you to tell us about any changes in your medical condition. We also ask that you inform us about any major changes in your circumstances or condition (e.g., change of address, new telephone number, development of dystonia in a family member, your own diagnosis of dystonia, etc.) if such changes occur in a period between updates. You may return to the GlobalDystonia Registry website at any time to update your profile.
What happens to the information I put in my profile, and who has access to it?
The goal of this registry is to make the information you provide searchable, while protecting your identity. De-identified data (information from which all personal identification has been removed) gathered from the profiles may be made available to medical researchers, in the hope that it will support breakthroughs and clinical trials that could lead to better treatments and care management. The Global Dystonia Registry Scientific Committee serves as the custodians of the de-identified data that is collected and compiled by the Global Dystonia Registry.
How is my privacy protected?
All of the information you provide will be maintained in a secure database, and any information that could identify you and your family members will not be shared without your expressed approval. Should new knowledge become available that may affect you and your family; that is, as clinical trials or research studies are developed for possible participation, you will be contacted and provided with information about the research study. You will then have the option to contact the researchers if you would like to learn more about participation in the research study. The investigator responsible for the research study or clinical trial will determine if you are eligible to participate and will be able to answer any questions about the research study/trial. The Global Dystonia Registry is deeply committed to issues of privacy, and will continue to take every available measure to ensure the security of your personal information.
As a parent/guardian, how deeply should I involve my child in the registration process?
We believe that it is important for all the people participating in this registry to be as informed as possible. Therefore, if you are a parent or legal guardian of a child under the age of 18, but feel that the child is old enough to understand the idea of the registry, we recommend that you talk with your child and obtain his cooperation to participate in this registry. We recommend that any individual over the age of 18 register for himself, unless the parent or guardian maintains legal guardianship. Adult individuals with dystonia may still need help to fill out the registration and answer the questions; it’s perfectly alright to provide that help.
What if I register myself in more than one registry/database?
The Global Dystonia Registry is currently the only focal dystonia. The goal of the Registry is to coordinate activities with other registries where possible. Personal identifiable information submitted to the Registry will always remain protected. At any time, you reserve the right to withdraw your information from the Registry. Simply contact the Global Dystonia Registry Coordinator info@globaldystoniaregistry.org and your profile will be removed.
How will I benefit from registering?
This registry is intended as a public service for the benefit of people with dystonia and their families. You will not receive any payment or any other financial benefit as a result of submitting your data to the registry. The results of the research facilitated by the registry may be patentable or have commercial potential. However, you will not receive patent rights and will not receive financial benefits from future commercial development. Nevertheless, there may be other benefits to participation, including the following:
- We will inform you if you might be a suitable candidate for a particular clinical trial or research study.
- The data collected might provide benefits to other patients with dystonia and/or to people who are at risk for developing dystonia
- You will be able to learn something about dystonia by reviewing the results of data analyses.
I want to be involved in a clinical trial. Is this guaranteed if I register?
Although one of the main goals of this registry is to make it easier for patients to participate in clinical trials, there is no guarantee that that you will be eligible for a trial.
I don’t want to participate in a trial. Should I still register?
We hope that you will still be willing to register, even if you don’t want to take part in a trial. Your information may still be useful to researchers who are trying to find out more about patients with dystonia and family members who are at risk for developing dystonia
Do I have to participate in the registry and can I withdraw my information if I change my mind?
Your participation in this project is entirely voluntary. Should you change your mind and wish to withdraw your data from the registry, you will be free to do so without having to provide any explanation. Simply contact the Global Dystonia Registry Coordinator coordinator@globaldystoniaregistry.org and your profile will be removed.
Who should I contact if I have questions?
If you have any questions regarding the Global Dystonia Registry or if you need to tell us about a change in your data, please email us at coordinator@globaldystoniaregistry.org This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Consent for Voluntary Participation:
By creating a user account and answering questions to create your profile, you acknowledge that you understand the information presented above as well as the nature of the registry. You also agree to give us permission (a) to store your data in the Global Dystonia registry, (b) to contact you for clarification or further information about data that you provide, (c) to contact you periodically to request that you update your profile, (d) to share de-identified information about you with others, and (e) to contact you with information about clinical trials and research in which you might be eligible to participate.
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