The Sturge-Weber Foundation

All individuals diagnosed with Sturge-Weber syndrome or who have a port wine birthmark in the forehead and/or eye region are eligible to participate in the Registry.  For the purpose of this Consent the “affected individual” will refer to the person diagnosed with Sturge-Weber Syndrome or who have a port wine birthmark in the forehead and/or eye region. “You” will refer to the person entering the information. This may be the affected individual or a family member or guardian of the affected individual.

We are asking you to enter personal and other information into the The Sturge-Weber Foundation International Patient Registry (which we will call the Registry). It is important we explain what is involved and what will be done with the information you provide. “Understanding Your Participation”—this section—contains answers to questions about the information we want, why we want the information, how it might benefit you, and possible risks of giving us this information. After you have reviewed “Understanding Your Participation” you will be directed to the Informed Consent form. You will be asked a series of questions. If you answer, “yes” to these questions regarding participation and use of the information you are providing you will have “consented.” Participation is optional. If you have questions that are not answered in this document, please contact The Sturge-Weber Foundation (SWF) Registry Coordinator.

The registration process consists of five steps:

• Reviewing “Understanding Your Participation” (this section)
• Completing the Informed Consent form
• Creating your account
• Logging into the Registry
• Completing your profile questionnaire

To complete the registration process, please review this section and complete the Informed Consent form.  You give your informed consent to participate in the Registry by completing this form.

If you have any questions, please contact the Registry Coordinator.

What is a registry?

A registry is a place to store detailed information about affected individuals with a specific disease or syndrome.  The Sturge-Weber Foundation has been storing information shared by individuals since its inception in 1987.  In this case, the Registry is for affected individuals with Sturge-Weber syndrome (SWS), many of whom have already willingly shared their information during the last 25 years.  Establishing the Registry online addresses two critical needs. First, scientists studying SWS need accurate, firsthand information to understand how SWS affects people. Second, scientists who are ready to start studies, such as those who test new treatments, will need to access the Registry to identify people who may be eligible to participate in studies. If an affected individual looks like a good match for a scientist’s research, the scientist will contact the SWF. The SWF will then contact the family. Scientists will not contact families directly.

What are the benefits of collecting an affected individual’s information in a registry?

Although there is no direct benefit to any individual participating in the Registry, by collecting information on affected individuals in the Registry, scientists can:

1. Study why individuals have different symptoms.
2. Learn about how certain treatments work and don’t work.
3. Help medical professionals improve how they treat affected individuals with SWS.
4. Speed up research on SWS by collecting information that scientists can use.
5. Let affected individuals (or their families) know when they may be eligible for clinical research studies or clinical trials.

Who can sign the consent form?

Affected individuals over the age of 18 who understand the consent form (and thus do not have a legal custodian) are eligible to join the Registry on their own.  Otherwise, the legal guardian, parent, or custodian of the affected individual must indicate consent with an electronic signature (by typing their name at the bottom of the consent form) for the affected individual to join.  When the affected individual becomes 18 (and if they are able), consent will be obtained directly from the affected individual for continued participation.

Where will the data go?

All of the information you provide will be maintained in a safe (“secure”) computer, and any information that could identify you and your family members will not be shared without your approval.  The Registry meets HIPAA requirements relating to the security, privacy and confidentiality of your data. 

How will creating a profile affect me or my child?

This Registry has been created specifically for individuals with Sturge-Weber syndrome or facial port wine birthmark. Parents and guardians of persons with Sturge-Weber syndrome or facial port wine birthmark may register for them. After registering and creating a profile, you will be contacted periodically with information about new research studies/clinical trials as they become available, as well as upcoming SWF and related activities and resources.

Will I need to provide additional information?

It is important to have the most current information in the database to assist in developing research studies/clinical trials. Therefore, from time to time, we will ask you to update your/your child’s profile. Periodically updating this information will also keep you closely attuned to the status of your/your child’s health in relation to the larger Sturge-Weber syndrome community.

How is my/my child's 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, the SWF, based on the information you placed in your profile, will then put you in contact with the investigators responsible for the proposed research study/clinical trial, so you can decide if you want to learn more.  Your or your child’s identifying information will not be given to investigators and investigators will not contact you directly.  After you contact them, the investigator(s) responsible for the research study/clinical trial will determine if you or your child is eligible to participate and is responsible to answer any questions about the research study/clinical trial. The SWF is deeply committed to issues of privacy and identity, and will continue to take every available measure to ensure the security of your personal information.

What happens to the information I put in my/my child’s 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 will be made available to the Sturge-Weber syndrome community of registered affected individuals, family, friends, caregivers, scientists and medical researchers, and scientists and clinicians from industry in the hope this de-identified information will support breakthroughs and clinical trials that could lead to better treatments and care management.  Documentation of aggregated data, like we are doing through the Registry, increases collective knowledge about Sturge-Weber syndrome and increases the chance of finding better treatments.

The de-identified data collected and compiled by this Registry belongs to the SWF. The SWF is the guardian of the information contained within the Registry. Some of this de-identified information will also be shared with databases focusing on global knowledge of conditions like SWS.

A subset of de-identified information collected from each profile will be shared with global databases with which the SWF collaborates, in order to develop global knowledge of Sturge-Weber syndrome that may lead to new research studies/clinical trials and improved clinical treatment.

The Registry has to follow rules to protect information about you. Federal and state laws also protect your privacy.

What are the risks to registering?

There is minimal risk in taking part in the Registry. The Registry includes questions that can be sensitive and you may feel uncomfortable answering. You do not have to share any information you do not want to. Another unlikely risk is a potential breach in the security of the computer system. In the event the there is a breach in the Registry computer system, all participants will be notified.

I want to be involved in a clinical trial. If I register, is this guaranteed?

Although one of the main goals of the Registry is to make it easier for affected individuals to participate in research, there is no guarantee that you or your family member will be eligible for a trial.  Please also note that even if the coordinators of a clinical trial believe you might be eligible for the trial based on the data about you stored in the Registry, it is still possible you may not meet the trial inclusion criteria after all. Please be aware that if we inform you about the existence of a trial, this does not imply we endorse it. In order to participate in any trial, you will need to fill out a separate informed consent form administered by the investigator.

I don’t want to be involved in a clinical trial.  Should I still register?

Absolutely.  We hope 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 learn more about SWS.

What if I register myself/my child in more than one registry/database?

It is alright if you participate in more than one registry. The goal of the SWF is to coordinate activities with other registries where possible. The SWF will put in place checks and safeguards to help identify duplication of registrants/affected individuals and to coordinate with other registries in placing information in global databases. You and your child's personal identification that you have provided to the SWF will always remain protected.

Can I withdraw from the registry 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 Registry Coordinator and all of your data will be removed from the database going forward. Data accessed prior to your request for removal cannot be retrieved from researchers who have already accessed it.

As a parent/guardian, how deeply should I involve my child in the registration process?

We believe 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 the child is old enough to understand the idea of the Registry, we recommend you talk with your child and obtain their cooperation to participate in this Registry. We recommend any individual over the age of 18 register for themselves, unless the parent or guardian maintains legal guardianship. Adult individuals with Sturge-Weber syndrome may still need help to fill out the registration and answer the questions; it’s perfectly alright to provide that help. If you have any questions regarding the registration process, a Registry Coordinator is available to discuss them with you.

What are my options if I do not want to be in the Registry?

You do not have to join this Registry.

Will it cost me anything to be in this Registry?

No.

Who should I contact if I have any questions?

If there are questions in the Registry that you do not understand, first go to the Glossary for more information. If you have further questions, please contact the Registry Coordinator or click on “Ask an Expert” and submit your question.  If you have any questions about the registration process or about participation in the Registry, please contact the Registry Coordinator.  You may also contact the Registry Coordinator to inquire about your rights as a participant in the Registry, or to report problems that result from your participation in the Registry.

Thank you for considering and hopefully joining the thousands of other dedicated champions and their families that care to find SWS answers through research…for a reason, a season, or a lifetime!

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