PatientCrossroads


           

Understanding Your Participation

Welcome to SIRCh

Welcome to the SADS International Registry for Channelopathies (SIRCh). SIRCh is a tool created to help advance research and understanding of SADS (Sudden Death Arrhythmia Syndrome) conditions.

SIRCh is owned by the SADS Foundation, a foundation committed to supporting families affected by SADS conditions through outreach, education, advocacy and research. The registry platform is provided by Patient Crossroads (PC), an international leader in rare disease patient registries.  

What is the consent process?

For the purpose of this Consent the “affected individual” will refer to the person diagnosed with a SADS condition.  “You” will refer to the person entering the information.  The person entering the data may be the affected individual or a family member or guardian of the affected individual (the person legally responsible for the care and maintenance of the affected individual). SADS International Registry of Channelopathies (SIRCh) will be referred to as The Registry.

We are asking you to enter personal and other information into the SADS International Registry of Channelopathies (SIRCh). It is important that we explain what is involved and what will be done with the information you provide. The following section contains answers to questions about the information we want, why we want the information and the benefits and possible risk of giving us this information. After you have reviewed this information you will be directed to the Patient Consent form. You will be asked a series of questions regarding participation and use of the information you are providing. If you answer, “yes” to these questions you will have “consented.” Participation is optional. If at anytime during this process you have questions that are not answered in this document, please contact the registry coordinator at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

What is a registry?

A registry is a place to store detailed information about affected individuals with a specific disease or syndrome. In this case, The Registry is for affected individuals with Sudden Arrhythmia Death Syndrome (SADS) conditions.  Establishing The Registry addresses two critical needs. First, scientists studying SADS conditions need accurate, firsthand information to better understand how SADS conditions affect 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 that may be eligible to participate in studies and clinical trials.  The Registry is sponsored by SADS Foundation and there is no cost to you to participate.

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

Participation does not benefit you directly. However, your participation may help others with SADS conditions by providing scientists with information for research. By collecting information on affected individuals in The Registry, scientists can:

  1. Assist researchers seeking participants for clinical trials and research studies.
  2. Speed up research in SADS conditions by collecting information that scientists can use.
  3. Communicate with the SADS community about upcoming research studies and clinical trials.
  4. Understand how SADS conditions can affect the quality of life and circumstances of people and families living with it.
  5. Help medical professionals improve how they treat individuals affected by SADS conditions.
  6. Learn how and why certain treatments work and don’t work.

Whose data are you collecting in The Registry?

Individuals who have a diagnosis of a SADS condition, including those who have passed away. The diagnosis must be confirmed by a physician.

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 patient must sign the consent 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.

What are the steps to filling out The Registry?

After you finish reading “Understanding Your Participation” you can decide if you want to participate in The Registry. If you choose to participate you will need to complete the consent form. The next step is to provide basic information to create a login username and password.  You will then be directed to the registration form where you will include your personal information and the affected individual’s information. After completing the registration form, you can answer the survey questions.

If more than one family member has a SADS condition you can create a single-family account. First register the individual with a SADS condition, and answer the survey. Then you will be able to add other family members with SADS conditions to the same account.

Will I be expected to provide The Registry with additional information in the future?

Yes. The Registry is most valuable for scientific research when it is kept up-to-date. Therefore, you will be asked to update your profile and information once a year. We will send out notifications annually to remind you. We also ask you to fax or upload your test results [such as genetic test results], and any other relevant reports. We also encourage you to update the registry whenever there is a change in relevant information (such as you or your child’s symptoms and treatment).

Who will have access to the medical and other records on The Registry?

The data collected and compiled by The Registry belongs to the SADS community. The SADS Foundation is the guardian of the information contained within The Registry. All of the information you provide will be maintained in a secure computer, and any information that could identify you and your family members will not be shared without your approval. The Registry has to follow rules to protect information about you. Federal and state laws also protect your privacy.

The goal of The Registry is to share detailed medical and other information with scientists and other researchers, while still protecting your privacy. This is done by hiding names, addresses and other “identifying” information from the researchers. We call this information “de-identified” because it has been removed of all personal identifiers. Your personal information that identifies you or your family will be labeled with a code number and stored in a secure place and protected with a password. Only authorized people who work in the registry will know the code and be able to identify you if needed. Your identifiable information will not be shared with anyone outside the registry (unless you give your permission to share it).

Approved scientists, researchers, and clinicians, will be allowed to see only the de-identified information and may search the de-identified information for patients for their studies. If a patient looks like a good match for a study and a researcher wants to contact you, he can do it only through The Registry. A registry agent will then contact you but the researcher will not contact you directly.

Your de-identified information will be shared with other databases such as the Global Rare Disease Patient Registry and Data Repository (GRDR).  We will combine our data with a few other databases in order to develop global knowledge of SADS conditions that may lead to new research studies, clinical trials, and clinical treatments.

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. An unlikely risk is potential breaches in the computer system. In the event the there is a breach in the Registries’ 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 that you or your family member will be eligible for a trial. 

Please note that even if the coordinators of a clinical trial believe that you might be eligible for the trial, based on the data about you stored in The Registry, it is still possible you do not meet the trial inclusion criteria after all. Please also be aware that if we inform you about the existence of a trial, this does not imply that we endorse it. In order to participate in any trial, you will need to fill out a separate 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 trial. Your information may still be useful to researchers who are trying to learn more about patients with SADS conditions.

Can I withdraw 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. Data accessed prior to your request for removal cannot be retrieved from researchers that have already accessed it.

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 SADS Foundation.

Who should I contact if I have any questions?

If you have any questions about the registration process or about participation in The Registry, please contact The Registry Coordinator at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

If there are questions in The Registry that you do not understand, first go to the Glossary tab found at the top for more information. If you have further questions, please contact The Registry Coordinator at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

To report problems that result from your participation in The Registry, you may contact the registry coordinator at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

To inquire about your rights as a participant in The Registry, you may also contact the University of Utah IRB for this study at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

For additional information regarding the terms and conditions of this web site or the privacy policy please go to Terms and Conditions | Privacy Policy.

 

 

Next