Information For Parents

Before you agree for your child’s information to be collected in the A-T Registry, it is important that you understand what is involved and what will be done with the information they provide. This form contains answers to some of the questions you might have. Once you have completed it you will be asked to sing a consent form on behalf of your child. If they are old enough to understand the simplified information provided, they will be asked to sign the form as well.

If you have any questions after reading this information, please talk to your doctor or contact us before signing the form.

What is a patient registry and why do you want to create one?

A patient registry collects and stores patient medical information, family history and other related information for use in medical research. The purpose of the A-T Registry is to collect and store medical and other information from individuals with A-T or a related condition. As all these conditions are so rare, and symptoms often vary from patient to patient, doctors do not see enough patients regularly to build up a clear understanding of the condition.

Researchers studying A-T and related conditions need accurate information to understand how the diseases affect people. By bringing data from many patients in different countries together in one place, the Registry will enable them to do this and to gain new insights into symptoms and what causes them. This in turn will help the development of new treatments and better care for people with the conditions. Researchers will also be able to access the Registry to locate people who may be eligible to participate in particular studies, such as studies to test new treatments.

In addition, these registries will help researchers to answer questions such as how common A-T and related diseases A-T are across Europe and the rest of the world and will support other activities to improve patient care, such as the assessment of standards of care.

Whose data are you collecting in this registry?

This registry is for patients suffering from ataxia-telangiectasia (A-T) and a number of closely related conditions. These are:

  • Ataxia-oculomotor apraxia type 1 (AOA1)
  • Ataxia-oculomotor apraxia type 2 (AOA2)
  • Ataxia-telangiectasia-like disorder (ATLD)
  • Nijmegen breakage syndrome (NBS)
  • Nijmegen breakage syndrome-like disorder (NBSLD)

Who should fill in this form?

The registry will collect information on patients of all ages who are diagnosed with A-T or one of the related conditions indicated above. Where a person with the condition is aged 16 or over, understands the consent form and may legally provide their own consent (i.e. do not have a legal guardian) they may sign the consent form themselves. Otherwise, the legal guardian or parent of the patient must sign the consent form for the patient to join. When a minor participant becomes 16 (and if they are able to give consent), consent will be obtained directly from them for continued participation.

If the person with the condition is younger than 16 but can understand this information, they can sign the form themselves, but we need a parent or guardian to sign it too. A simplified information sheet and consent form for children to sign is available.

Whatever the child’s age, it is a good idea to talk it over with your family and to contact us if you have any questions.

What will happen if I join this registry?

If your child joins this registry, you will be asked to allow the medical centre treating them to provide medical information on their disease and diagnosis. To do this you will need to complete the consent form at the end of this document. The registry aims to share detailed medical and other information with researchers while protecting the patient’s privacy. One way the registry protects their privacy is to remove their name, address and other “identifying information” from their medical information before providing it to researchers.

Any doctor or medical centre wishing to add patients to the register will have to be registered with and sign an agreement with the Registry. Once they have done this they will input your child’s information to the registry. This information, with all Identifying information (e.g. name, address, date of birth) removed, will be sent to the registry database, where it will be stored on secured computers and servers and protected with encryption and passwords.

Apart from authorised staff at the centre which uploaded your information, only the registry director or an individual explicitly authorised by him will be able to decode your information and thus identify them if needed. Although we take measures to protect their privacy and confidentiality, because the condition is rare, there is a very small risk they may be identifiable from the information in the registry.

The registry will not share patients’ identifiable information with anyone outside the registry (unless you give your permission to share it). Researchers and clinicians can ask to have access only to the de-identified information. All applications to access data from the registry will need to be approved by the Registry’s Scientific Board, who will ensure that the research is scientifically valuable and that it has the necessary ethical approval. 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 people with particular conditions or symptoms for their studies. If an individual looks like a good match for a researcher’s study, the A-T Registry will contact them via their doctor; the researcher will not be able to contact them directly. The A-T Registry will provide you with information about the study and a way to contact the researcher if you wish to do so. If you decide that your child will take part in the trial, you will need to review and sign a separate consent form. You are completely free to make your own decision about any trial we inform you about. If you decide not to take part in a particular trial, your data will still be kept in the registry and we will continue to inform you about other trials unless you tell us not to. Please note that if we tell you about the existence of a trial, this does not imply that we endorse it.

Your child’s de-identified A-T Registry information may also be shared with other databases dealing with other related or rare conditions. This will allow more researchers to use the information to do research.

The AT Registry, which is run by the A-T Society, a registered charity (not-for-profit) organisation in the United Kingdom, is the guardian of the information contained within the registry.

It is intended that the registry will continue to operate for as long as there is a need for the information it contains and/ or as long as it is financially viable.

The registry has received full ethical approval from South Central – Berkshire Research Ethics Committee (17/SC/0075). The situation in other countries with vary from country to country.

How often your child’s registry information is updated will depend on how often you visit your medical centre, howver we will contact them at least once per year to remind them to keep your data updated. Their registry account can be updated whenever there is a change in their health, change in medication, or new symptom.

Do we have to participate in the registry and can we withdraw if we change our minds?

Providing information to the registry is completely voluntary. You do not have to contribute information. If your child does participate, they can withdraw from the registry at any time and for any reason.

Should you or your child change your mind and wish to withdraw from the registry, you will be free to do so without having to provide any explanation. Simply contact the registry and your child’s information will be removed from the database. However, information that has already been sent to a researcher for a specific study or shared with other registries prior to your request for removal cannot be retrieved or removed.

How will my child benefit from registering?

Participation in the registry is not likely to benefit you or your child directly in the short term. However, participation may help them and others with the same condition by increasing our understanding of it. It may also help people with other related conditions or diseases. Having an available registry of information about A-T may help speed up research, and 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. Your doctor will only provide information that they have gathered from seeing your child. You do not have to share any information that you do not want to share. One possible but unlikely risk is potential breaches in the security of the computer system. However, we take the security of your data extremely seriously and employ experts in the field to ensure the safety of all our data. Also, as all data is held anonymously there is little chance that it could be linked to your child’s personal details. In the event the there is a breach in the registry’s computer system, you will be notified promptly.

I want my child 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 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 child’s information in the Registry, they 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 my child to be involved in a clinical trial. Should we still register?

Absolutely. We hope that you will still be willing to register even if you don’t want your child to take part in a clinical trial. Their information may be useful to researchers who are trying to learn more about patients with A-T and related conditions.

What are my options if I do not want my child 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 A-T community. Your decision about whether or not to participate in this registry will not affect your child’s healthcare, medical treatment or insurance benefits.

By signing the form to authorise participation, 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 child’s 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.

Who do I contact with questions?

You should talk to your child’s doctor in the first place. But if you have any questions or concerns about the registration process or about participation in the registry, please contact the A-T registry at admin@atregistry.eu or ring Jo Reader on 01582 760733.