Informed Consent for Participating in the Global SPG11 and SPG15 Patient Reported Registry for Hereditary Spastic Paraplegia Types 11 and 15, or SPG11 and SPG15, sponsored by The Maddi Foundation.
We invite you to take part in the Global Patient Reported Registry for Hereditary Spastic Paraplegia Types 11 and 15, or SPG11 and SPG15, sponsored by The Maddi Foundation.
We want you to know that:
For the purpose of this consent form, “the patient” refers to the person diagnosed with SPG11 or SPG15 disease and whom registry information will be collected. If you are signing this consent form on behalf of your child or another adult for whom you are family member or guardian who is legally responsible for the care and health of the patient, “You” refers to the person providing the information.
A patient registry is a place that collects and stores patient medical information, family history and other related information for use in medical research. The purpose of the SPG11 and SPG15 disease registry is to document information to enable scientists to better understand these conditions and other rare diseases. The registry is for patients with Hereditary Spastic Paraplegia Types 11 and 15, or SPG11 and SPG15.
Patient information in this registry will be used for building medical research. Researchers studying SPG11 and SPG15 need accurate information to understand how the disease affects people. In addition, researchers may access the SPG11 and SPG15 registry to locate people who may by eligible to participate in their research studies. The Global Patient Reported Registry for Hereditary Spastic Paraplegia Types 11 and 15, or SPG11 and SPG15 is owned and sponsored by The Maddi Foundation.
Patients and their families can also decide whether they would like to be involved in community building through online Facebook groups dedicated to SPG11, SPG15 and Hereditary Spastic Paraplegia.
What will happen if you participate in joining the Registry?
If you participate, you will be asked to provide contact information and brief medical information on your (or the patient’s) disease and diagnosis. You will provide the information by filling out the online forms on your computer. You may be asked to obtain some information from your medical records. It may take approximately 20-30 minutes to enter the information. You do not need to enter all the information in one session.
The registry aims to share medical and other information with researchers while protecting your privacy and confidentiality. One way the registry protects your privacy is to remove your name, address and other “identifying” information before providing it to researchers. This is classed as “de-identified” because it has had all the personal identifiers removed such as your name, address, or other information that identifies you or your family. Your registry information will be assigned a code and stored on secured computers and servers with a protected password. Only authorized people who work on the registry will have access to the key code. While we take measures to protect your privacy and confidentiality, as your disease is rare, there is a small risk that you may be identifiable from the information in the registry.
We will not share identifiable information with anyone outside the registry unless you give your permission to share it. Approved researchers, clinicians and companies will only be allowed to see the de-identified data. Approved researchers, clinicians and companies may also use the de-identified information to conduct research on the disease, the researchers may also conduct research on diseases which are unrelated to the participants disease.
You may be asked to update the registry information at least once a year. This will be voluntary but will help tremendously to keep the information current. The Registry may send you a reminder to update your information. Please also contact the registry to update any information, if possible whenever there is a change in the patient’s health or medication, or when new symptoms appear.
Your participation is voluntary
Taking part in the registry is entirely voluntary. You do not have to contribute information. If you do participate, you can withdraw at any time for any reason.
Right to withdraw
You may withdraw from the registry at any time and for any reason. Simply contact the registry and your information will be removed from the database. Information that has already been shared to any specific researcher or company prior to your request cannot be retrieved or removed.
What are the possible benefits of taking part?
We hope that by creating the Hereditary Spastic Paraplegia 11 and Hereditary Spastic Paraplegia 15, SPG11 and SPG15 registry may help us identify patients quickly and will be able provide a clearer picture of the frequency and the course of this disorder. Having an available registry of information about Hereditary Spastic Paraplegia 11 and Hereditary Spastic Paraplegia 15 may help speed up research, such research could eventually help researchers to learn whether or how treatments work, or help medical professionals improve on how they treat the disease. 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 and Benefits
There is minimal risk in taking part in the registry. The information requested may include questions that can be sensitive and that you may feel uncomfortable answering. You do not have to share any information that you do not want to share.
Although we will protect your privacy and confidentiality to the extent possible, there is a small chance that those with a rare disease might be identifiable from the information in the registry. Another possible but unlikely risk is the potential breaches in the computer system. In the event that there may be a breach in the registry’s computer system, you will be notified.
Participation in this registry may not benefit you directly – personally, medically, or financially. However, your participation may help increase understanding of your disease or condition or other diseases.
Who do I contact for further information?
If you have any questions about the registration process or about participation in the registry, please contact The Maddi Foundation at firstname.lastname@example.org
Should I Register?
We hope that you will be willing to register as your information may be useful to researchers who are trying to learn more about Hereditary Spastic Paraplegia, SPG11 and SPG15.
What are my options if I do not want to be in the Registry?
Participation is voluntary you do not have to sign the registry. You do not need to participate in this registry to remain a member of SPG11 and SPG15 community such as the online facebook groups. Your participation will not affect your healthcare, your medical treatment or insurance benefits.
By signing our conset form, you do not give away your legal rights or benefits to which you are otherwise entitled to. If you do join, you can change your mind and withdraw from the registry at any time.
Checking the boxes on our Google Form and adding your name means (a) you understand the content of the informed consent, (b) you have had the time to consider fully whether you would like to participate to join the registry and (c) you agree to participate: