What is the purpose of this patient registry?
A patient registry collects and stores patient medical information, family history and other related information for use in medical research. The purpose of the Multiple Sulfatase Deficiency registry is to collect and store medical and other information from individuals with the same condition. In addition to what is written here, you will be given supplemental information about the Multiple Sulfatase Deficiency Registry.
Patient information in this registry will be used for medical research and experimental clinical trials to better understand rare conditions/diseases and to develop new treatments. Researchers studying Multiple Sulfatase Deficiency need accurate information to understand how the condition affects people. In addition, researchers may access the Multiple Sulfatase Deficiency registry to locate people who may be eligible to participate in particular studies, such as studies to test new treatments. The Multiple Sulfatase Deficiency registry is sponsored by Multiple Sulfatase Deficiency Action Foundation (MSDAF) and 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 medical information on your (or the patient’s) disease and diagnosis. The registry aims is to share detailed medical and other information with researchers while protecting your privacy. One way the registry protects your privacy is to remove your name, address and other “identifying” information from your medical information before providing it to researchers. This information is “de-identified” because it has had all personal identifiers removed including your name, address, or other information that identifies you or your family. Your registry information will be labeled with a code number and stored on secured computers and servers and protected with encryption and passwords. Only authorized people who work in the registry will have access to the key to the code and will be able to identify you if needed. Although we take measures to protect your privacy and confidentiality, because your disease is rare, there is a small risk you may be identifiable from the information in the registry.
The registry will not share your identifiable information with anyone outside the registry (unless you give your permission to share it). Approved researchers and clinicians will be allowed to see only the de-identified information. Approved researchers and clinicians may use de-identified information to conduct research, including research on diseases unrelated to your (the patient’s) disease. They may also search the de-identified information to find patients for their studies. If a patient looks like a good match for a researcher’s study, the Multiple Sulfatase Deficiency registry or registry’s agent (such as genetic counselor) will contact you; the researcher will not be able to contact you directly. The Multiple Sulfatase Deficiency registry or agent will provide you with information about the study and a way to contact the researcher if you wish to do so.
The de-identified information collected and compiled by the registry belongs to the Multiple Sulfatase Deficiency community. Multiple Sulfatase Deficiency Action Foundation, through the Multiple Sulfatase Deficiency Patient Registry is the guardian of the information contained within the registry.
You will be asked to update your registry information at least once per year. Based on your preference for how you would prefer to be contacted, the registry will contact you each year to remind you to update your data. The registry may also ask you to fax or upload your genetic test results and any other relevant reports or testing results. Your registry account can be updated whenever there is a change in your health, change in medication, or new symptom. If the registry tries, on up to 3 occasions, but is unable to contact you, your account may become inactive.
Your participation is voluntary
Providing information to the registry and/or contributing blood or other is voluntary. You do not have to contribute information. If you do participate, you can withdraw from the registry at any time and for any reason by notifying the registry.
Right of withdrawal
Should you change your mind and wish to withdraw your information from the registry in which you are registered, you will be free to do so without having to provide any explanation. Simply contact the registry and your information will be removed from the database. Information that has already been shared with a researcher for a specific study prior to your request for removal cannot be retrieved or removed.
Participation in the registry is not likely to benefit you (or the patient) personally, medically or financially. However, participation may help members of your family and others with Multiple Sulfatase Deficiency by increasing the understanding of the condition and other similar conditions. Having an available registry of information about Multiple Sulfatase Deficiency may help speed up research, such research could eventually help researchers to learn whether or how treatments work, or help medical professionals improve how they treat the condition. Participants may receive information about opportunities to participate in research and clinical trials, as well as information about medical advances and other news from the registry.
Risks of participating
There is minimal risk in taking part in the registry. The registry may ask you to answer questions that can be sensitive and you may feel uncomfortable answering. You do not have to share any information that you do not want to share. Another possible but unlikely risk is potential breaches in the computer system. In the event the there is a breach in the registry’s computer system, you will be notified.
Participation of minors and adults unable to consent
Registry information will be collected on patients who are diagnosed with Multiple Sulfatase Deficiency. Patients over the age 18 who understand the consent form and legally provide their own consent (and thus do not have a legal guardian) are eligible to join the registry on their own. Otherwise, the legal guardian or parent of the patient must sign the consent form for the patient to join. When a minor participant becomes 18 (and if they are able), consent will be obtained directly from them for continued participation.
Other common questions
Who do I contact with questions?
If you have any questions about the registration process, about participation in the registry, or if you want to inquire about your rights as a participant in the registry please contact Multiple Sulfatase Deficiency Action Foundation registry at firstname.lastname@example.org. To report concerns about your participation in the registry, you can contact the registry at email@example.com.
I want to be involved in a clinical trial. If I register, is this guaranteed?
Although one of the goals of the registry is to make it easier for patients to participate in research, there is no guarantee that an individual patient will be eligible for a particular trial or contacted about a clinical trial. Even if you are contacted about possible eligibility based on your information in the registry, you may or may not meet the study requirements.
Please also be aware that if the registry informs you about a trial, this does not imply that the registry endorses it. Each study you enrol in will require that you sign an informed consent form for that study. Please make sure to discuss any study you are considering carefully with the research staff before signing its informed consent form.
I don’t want to be involved in a clinical trial. Should I still register?
Absolutely. We hope that you will still be willing to register even if you don’t want to take part in a clinical trial. Your information may be useful to researchers who are trying to learn more about patients with Multiple Sulfatase Deficiency.
What are my options if I do not want to be in the Registry?
You do not have to join this registry. Participation is voluntary. You do not need to participate in this Registry to remain a member of the Multiple Sulfatase Deficiency community. Your decision about whether or not to participate in this registry will not affect your healthcare, your medical treatment or insurance benefits.
By signing our consent forms you do not give away any legal rights or benefits to which you are otherwise entitled. If you do join, you can change your mind and withdraw from the registry at any time and request to remove any of your information that has not assigned yet to any specific study. You will not be able to remove any information that already has been assigned to a specific study.