THE DMD REGISTRY

Please Read Carefully before Consenting to Join

INTRODUCTION

You or your child are registering voluntarily with the UK Duchenne Muscular Dystrophy Registry [the Registry] because it is understood that you or your child [the Participant] have a diagnosis of Duchenne or Becker Muscular Dystrophy. The Registry has been established by Action Duchenne Ltd who have appointed a Registry Curator. Data on the Registry is controlled by the Data Protection Act (1998) under UK Law and by the General Data Protection Regulation (GDPR) 2018. Please read this carefully and ask any questions you may have before making a decision whether or not to participate. You can contact the Registry, details at end of this information. It will be very important for you to understand the kind of information which Action Duchenne Ltd intends to keep in the Registry and the purposes for which it will be used.

You will be required to give your consent before registering you or your child. Information on giving consent is stated at the end of this document. Before clinicians or geneticists can send us any medical or genetic information you will also need to complete a Medical Release Consent Form, which can be printed during the registration process, or alternatively can be posted to you upon request from Action Duchenne Ltd. The signed hardcopy of the Medical Release Consent Form should be posted to the Registry Curator, address at the end of this information. Requests for medical or genetic information to clinicians or geneticists will be sent with a copy of the signed Medical Release form by post.

LEGAL NOTICE

Note: Access to this website is for authorised persons who have passed the eligibilty criteria. It is an offence under the UK Computer Misuse Act (1990) to attempt the following:-

(a) Unauthorised access to computer material.

(b) Unauthorised access with intent to commit or facilitate the commission of further offences.

(c) Unauthorised modification of computer material.

PURPOSE

The purpose of the Registry is to:

• Develop and encourage the development of more research into Muscular Dystrophy
• Facilitate research by collecting relevant data and making it available for specified research projects
• Use the information provided to understand the disease better
• Establish contact between clinicians, other health professionals, researchers and Registry participants
• Enhance clinicians’ and other health professionals’ ability to deliver treatments for this disease

IMPORTANT FACTS ABOUT THE REGISTRY

Participation is totally voluntary

• You may ask that your (or your child’s) data be removed or irreversibly anonymised at any time
• No one can find out if you (or your child) are in the Registry, except for the purposes listed
• No information will be given to insurance or related companies
• Any decision whether to join the Registry or to withdraw from it will not change your (or your child’s) medical care or legal rights
• Authorised researchers will look at your (or your child’s) anonymised data for the purposes of research projects which have been approved by Action Duchenne Ltd and the Registry Steering Committee
• Authorised health professionals will look at data on your (or your child’s) condition for a specific purpose which will benefit your (or your child’s) treatment and/or the treatment of other participants
• Your (or your child’s) personal details will not be shared with any authorised researcher, authorised health professional or any other third party without your consent. In most circumstances information will be anonymised
• The Registry is regulated by the Data Protection Act (1998) and GDPR (2018) and notification has been made of the purposes of the Registry to the Information Commissioner
• Any research that uses the Registry must have been passed by a medical ethics authority (e.g. NRES [National Research Ethics Service] in England working closely with authorities in Scotland, Wales and Northern Ireland) that is regulated by the EU Clinical Trials Directive 2001/20/EC, or a non-medical ethical authority (e.g. a university ethical committee) that has been approved by our Steering Committee
• If the medical or genetic data for you (or your child) changes after registration you will have to complete and return a new Medical Release Form so that we can obtain this data from your clinician or geneticist. This form will be available on request or can be downloaded from the website.

SENSITIVE PERSONAL DATA

The Registry will hold the following categories of sensitive personal data about you (or your child):

• Contact information (name, address, telephone and email)
• Basic medical information (date of birth, gender, NHS number)
• Biopsy result and tissue location
• Genetic variation information (DNA mutation)
• Medical interventions (e.g. during research projects)
• Adverse symptoms (e.g. during research projects)
• Clinical assessments (e.g. during research projects)
• Clinical surveys (e.g. post-treatment).

BENEFITS OF PARTICIPATION

Joining the Registry may give you or your child the opportunity to participate in research studies. If you are enrolled, you will receive a newsletter at least once a year about Registry activities and research advances in Duchenne Muscular Dystrophy.

CONFIDENTIALITY

The Registry is controlled by Action Duchenne Ltd in compliance with the Data Protection Act (1998) and GDPR (2018).

DATA CONTROLLER

Action Duchenne Ltd will act as Data Controller (under the Data Protection Act 1998 and GDPR 2018). Action Duchenne Ltd will appoint a Registry Curator who is responsible for collecting, storing, handling and processing your data. In order to administer the Registry, to maintain the data and to update the data they will have access to all the data in the Registry. They are also responsible for informing the Information Commissioner’s Office of the purposes for which your data is held. All employees of Action Duchenne Ltd have signed an express condition of confidentiality to keep your information confidential. Action Duchenne Ltd will only access the data for the purposes for which the Registry is kept.

ELIGIBILITY

Registration and access is only authorised to people who are registered with a clinician in their country of residence because they have been diagnosed as having either Duchenne or Becker Muscular Dystrophy, are a carrier of a variant in the Dystrophin gene or are the parent or guardian of a child with a variant in the Dystrophin gene.

STEERING COMMITTEE

A Steering Committee made up of at least five senior health professionals and researchers will be responsible for authorising and approving all access to the Registry by any researcher and/or Health Professional for the purposes of a specific research project or for the purposes of a specific course of treatment.

DATA OWNER

Action Duchenne Ltd will be regarded as the Data Owner (under the Data Protection Act 1998 and GDPR 2018). This means that Action Duchenne Ltd are responsible for access to the data in the Registry.

YOUR RIGHT TO ACCESS DATA

Under the Data Protection Act (1998) and GDPR 2018 you have the right to access any data held about you on the Registry. To exercise this right you can contact the Registry Curator. The Registry also holds data specific to research projects. This research data may sometimes not be made accessible until after the specific research project has been completed if the nature of the research project requires this to be released at a future date. Online access allows you to securely view and update your own data using a secure internet connection and password. The purpose of this is to encourage your involvement and reduce the burden on Action Duchenne to respond to data requests under the Data Protection Act (1998) and GDPR 2018.

ACCESS BY HEALTH PROFESSIONALS

Health professionals such as clinicians and geneticists will be asked to release your (or your child’s) medical data using the Participant Medical Release Form. These health professionals will be able to see all participants medical data excluding personal contact details. Other authorised health professionals may be granted permission by the Steering Committee to look at anonymised data on your (or your child’s) condition for a specific purpose which will benefit your (or your child’s) treatment and/or the treatment of other participants. If a health professional needs to contact you personally regarding a research project, the Registry Curator will pass on this request to you and where appropriate your clinician. Your personal contact details will not be released to any health professional without your consent.

ACCESS BY RESEARCHERS

Because of the nature of the research it is not possible to declare all the researchers or organisations that, in the future, might have access to the data in the Registry. However, any access to the data in the Registry must firstly be authorised by the Steering Committee. Access to your data by researchers will be anonymous, as you will be identified using an anonymous reference code. If a researcher needs to contact you personally regarding a research project, the Action Duchenne Registry Curator will pass on this request to you and where appropriate your clinician. Your personal contact details will not be released to any researcher or any other third party without your consent.

CONFIDENTIALITY OF RECORDS

We will keep your data private secure. Your data is protected under the Data Protection Act (1998) and by GDPR 2018. Unauthorised third party access will not be allowed. Results of research carried out using anonymised data from the Registry may be presented at meetings or in publications. Your health information will be accessed to help research and possibly to develop or plan new test procedures, treatments or products. Health information may be used to report results of research to sponsors and regulators. It may be audited by regulators to make sure that we are following regulations, policies and plans. In these circumstances the information will be accessed anonymously.

ETHICAL APPROVAL

Any research that uses the Registry must have been passed by a medical ethics authority (e.g. NRES [National Research Ethics Service] in England working closely with authorities in Scotland, Wales and Northern Ireland) that is regulated by the EU Clinical Trials Directive 2001/20/EC, or a non-medical ethical authority (e.g. a university ethical committee) that has been approved by our Steering Committee.

SECURITY

The computer on which the Registry service runs is sited in a secure data centre. This data centre features resilient infrastructure, including multiple levels of 24/7 security, stable high-capacity power supplies, redundant storage, multiple peering arrangements, fire protection, environmental controls and on-site support. The service is managed via secure internet connections, with physical as well as software security enabling access to only authorised personnel. It is password protected and has a firewall. The service is managed and supplied by Nvisage Ltd. and their authorised partners on behalf of Action Duchenne Ltd. The Registry is regularly backed up to prevent loss of data.

DATA TRANSFERS

In the event that a research project outside the Registry needs your data it will only be transferred when the following conditions are met: The research cannot be done within the Registry database. For example computing the frequency of genetic variants can be done on the Registry database. Any data transferred is anonymous. The Steering Committee (consisting of senior medical professionals) has validated that the research will help achieve the goals of the Registry. In addition, under the Data Protection Act or GDPR a transfer of data can only be made outside the European Economic Area (EU and Iceland, Liechtenstein and Norway), where there is “adequate protection” for the rights and freedoms of the individuals. Before any decision to transfer data outside the European Union is made Action Duchenne Ltd will take legal advice for the test of adequacy.

WITHDRAWAL OR COMPLETION

At some time in the future the Registry may cease to operate. It is anticipated that this will occur when it no longer is required to achieve the purposes for which it has been registered. For example, if treatments have become widely available and long term studies have been completed. At that point in time you will be contacted to inform you that the Registry is closing, and we will either seek consent for the data to be transferred to a clinical database or to be made irrevocably anonymous, or to inform you that the data will be deleted. If you decided to participate in the Registry your data will be held in the Registry until the Registry ceases to operate or you indicate that you wish to withdraw your data. You can always cancel your consent to participate by writing to the Registry Curator. If you revoke your participation you may be contacted and given the option of your personal data being kept anonymously, rather than deleting it. Cancelling your participation will not change your medical care or legal rights. By signing this consent form, you give us permission to use and/or share your data for the purposes stated above.

COMPLAINTS

Should you wish to make a complaint regarding the Registry please contact Action Duchenne Ltd at [email protected] or write to the address below.

CONTACT

For more information about the DMD Registry please contact:

Registry Curator
Action Duchenne Ltd
49-51 East Road
London
N1 6AH
Tel: 020 7250 8240
[email protected]

WHO CAN GIVE CONSENT

The law recognises that a child can consent to their data being held or accessed under the Data Protection Act or GDPR if the child has reached an age when he/she can decide for himself/herself, whether or not to agree. It is generally accepted that by the age of 12 a child can be expected to have sufficient understanding to decide whether or not to agree to their data being supplied or accessed.

If the person with parental responsibility feels that the child does not have sufficient understanding to consent, then the parent can consent on the child’s behalf until the child either reaches such understanding or the child reached the age of 18 whichever is the earlier. Where a child is under the age of 12 then parental consent will always be required.

PARENTAL RESPONSIBILITY

The person(s) with parental responsibility will usually, but not invariably, be the child’s birth parents. People with parental responsibility for a child include: the child’s mother; the child’s father if married to the mother at the child’s conception, birth or later; a legally appointed guardian; adoptive parent; the local authority if the child is on a care order; or a person named in a residence order in respect of the child. Fathers who have never been married to the child’s mother will only have parental responsibility if they are registered on the child’s birth certificate, if they have a court order granting parental responsibility, or a parental responsibility agreement.

STATEMENT OF CONSENT

By accepting to join the DMD Registry I confirm the following:

• I have read the contents of this legal information.
• I confirm that I have read and understood the information provided and have had the opportunity to ask questions.
• I confirm that I have had sufficient time to consider whether I want myself to participate in the Registry.
• I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.
• I understand that my data may be looked at by a responsible individual authorised by Action Duchenne Ltd and the Steering Committee, for specific research or treatment. I give permission for these approved individuals to have access to my information.
• I agree to take part in the Registry.
• My child is under the age of 12 and I am signing on behalf of my child as a person with parental responsibility.
• My child is aged between 12 and 18 and does not have the capacity to understand why his consent is being sought. I am giving consent as the person with parental responsibility.
• I am over the age of 12 years and I have understood the purposes for which my consent is being requested which have been explained to me.