Patient Information Leaflet for the EBMT

The EBMT is a not-for-profit organisation that consists of hospitals and professionals working in the field of clinical bone marrow transplantation and immune effector cell therapy. The EBMT maintains an international patient database known as the EBMT Registry. The Registry contains patients’ clinical data that is used in scientific research and assessments of the safety and efficacy of the treatments you receive. The goal of the Registry is to save the lives of patients with blood cancers and other life-threatening diseases.

In this leaflet, we would like to explain why we are asking you to share your data with the EBMT Registry; what the purpose of data processing is; which data is being collected; how your data is being protected and what your rights are. You are free to decide whether or not to share your data with the EBMT Registry. Please read this information leaflet carefully and discuss it with your partner, family or friends. Take as much time as you need to think about sharing your data.

If, after reading the information, you agree to take part, you will be asked to sign and date two copies of the consent form. You will be given one copy to keep and the other copy will remain in your patient file at the hospital. If you decide not to share your data or to withdraw at a later date, this will not affect the type or quality of treatment you receive. Please ask your treating physician if anything is not clear or if you would like some more information.

You are being invited to share your data with the EBMT Registry because you:

•  are a patient or donor involved in blood or bone marrow transplantation.
•  are diagnosed with bone marrow failures and receive immunosuppressive treatment, and/or
•  receive immune effector cell (IEC) therapy.

We ask your consent to submit your personal data to the EBMT Registry for the purposes described below in section 3.2. Personal data is defined as any information that relates to an identified or identifiable living individual.

If you decide to share your data with the Registry, data on your disease, treatment and response to treatment from routine clinic visits will be collected. You will not be required to visit the hospital specifically for this purpose. There are no additional procedures other than normal clinical practice.

If you decide not to share your data or to withdraw at a later date, this will not affect the type or quality of treatment you receive.

3.1 What data is being collected and processed?

We will need to use information from your medical records for the EBMT Registry. This information will include your:

•  Initials, date/year of birth, gender, unique patient number (UPN) given by your hospital, and country.
•  Medical history, physical examination, and results from blood and bone marrow examinations
•  Diagnosis
•  Transfusions, medication, and treatment
•  Response to treatment and complications

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. This is called ‘pseudonymisation’ of your data. We will keep all information about you safe and secure.

Some of your information will be sent to other countries. They must follow our rules and the European General Data Protection Regulation (GDPR (2016/679)) about keeping your information safe.

3.2 What is the purpose of collecting and processing your data?

The EBMT Registry

The primary function of the EBMT Registry is to collect clinical data on patients who have received blood and/or bone marrow transplantation and/or IEC therapy as part of their treatment. The data collected will be used for:

•  medical research which aims to further the knowledge base in the field of transplantation, IEC therapy and immunosuppressive therapy.
•  improving patient care at hospitals through:
- providing a reference of treatment results that hospitals can use for quality control
- the development of new and improved procedures for transplantation, IEC therapy and immunosuppressive therapy
- improving the quality of these procedures through the accreditation of the treating hospitals

Your data in the EBMT Registry will contribute to improvements in patient care and outcome.

The EBMT works with many “Collaboration Partners” internationally, including national registries, national health authorities, and researchers from scientific/clinical institutions. Therefore, we also request your consent to share your personal data with these EBMT partners to fulfil the purpose described above.

For the purposes described below, the EBMT may also work with the European Medicines Agency (EMA; www.ema.europa.eu/ema), national health authorities, Health Technology Assessment bodies, and the marketing authorisation holders (MAHs; the pharmaceutical companies owning the therapies that patients like you are receiving).

Post-authorisation obligations relating to IEC therapies

In Europe, IEC therapies can only be used to treat patients after the EMA authorises MAHs to sell their therapy. The EMA may request the MAHs to conduct additional post-authorisation studies to monitor the long-term safety and effectiveness of the product. The EMA has recommended that the MAHs collaborate with the EBMT for the conduct of these studies. For this purpose, the EBMT has developed the ‘EBMT Registry data processing framework for post-authorisation studies on immune effector cells’, which is publicly available on the EBMT website. This framework will allow the EBMT to assist MAHs with EMA imposed post-authorisation IEC therapy studies.

If you are receiving any IEC therapy as a part of your treatment at your hospital, the EBMT requests your consent to share your pseudonymised data in the EBMT Registry with the MAHs of the IEC therapy that you are receiving. This will help the MAHs comply with their obligations to the EMA and national health authorities. This will contribute to a better understanding of the safety and effectiveness of the product(s) you are receiving.

Health Technology Assessments

A health technology assessment (HTA) evaluates the social, economic, organisational and ethical impact of a medication or health technology. HTA bodies make these assessments to contribute to health policies that are safe and effective for patients. They also give recommendations on the financing or reimbursement of medications or health technologies by insurers and reimbursement agencies.

Data from the EBMT Registry can be a valuable source of data for HTAs. The EBMT facilitates HTA processes to support that new therapies become available to patients and are covered by national healthcare systems and health insurance policies.

HTA bodies and/or reimbursement agencies may request the EBMT to share pseudonymised data with them for their assessments of specific health technologies. More commonly, the HTA bodies and/or reimbursement agencies request MAHs to provide this data for their specific product. In this case the MAHs will approach the EBMT with the request to share the data necessary. To facilitate the assessments by the HTA bodies and/or reimbursement agencies, EBMT requests your consent to share your pseudonymised data with the MAHs and the HTA bodies and/or reimbursement agencies.

3.3 How is the data stored in the EBMT Registry?

The data is stored in an electronic, certified, secure database of the EBMT and is subject to the European data protection regulations. This database is located in a country that is part of the European Union and is under a stringent access control policy.

3.4 How long will the data be stored?

The EBMT will hold your data indefinitely so that it can be used in the future for scientific research purposes.

Collaboration Partners will hold your personal data for as long as it serves the purposes described above in section 3.2.

3.5 Who has access to the data in the EBMT Registry?

Access to the data in the EBMT Registry will be limited to EBMT research staff and authorised staff members at your hospital. Upon request from your hospital, access may be granted to your national registries in the field of blood and/or bone marrow transplantation and IEC therapy and/or your disease.

3.6 Who has access to your patient files?

Access to data from your medical records may be needed to verify that the data collection for the EBMT Registry is done accurately and in compliance with current regulations. Access to your hospital medical records will be restricted to:

•  the staff at your hospital
•  a monitor or auditor who has been commissioned by the EBMT
•  regulatory health authorities

All parties have a duty of confidentiality to you as a research participant. We request your consent to allow the above-mentioned access to your medical records for this purpose.

3.7 Will the data in the EBMT Registry be shared with any third parties?

With your consent, your personal data in the EBMT Registry may be shared with the Collaboration Partners for the purposes described above in section 3.2. As part of such collaborations, your personal data may be sent to countries outside of those covered by the GDPR (2016/679). The EBMT arranges GDPR-required safeguards to protect your personal data where it is sent to so-called third countries outside of the European Union that have not been recognised by the European Commission as providing an equivalent level of data protection.

3.8 What is the legal basis for processing the data and who is responsible?

The GDPR (2016/679) regulates the collection, storage and processing of personal data. The purpose of the regulation is to guarantee your privacy. To comply with these regulations, we ask you to give consent as the legal basis for the collection, processing and storage of your personal data in the EBMT Registry for the purposes described in section 3.23.1.

The EBMT and your hospital are joint ‘controllers’ of your personal data in the EBMT Registry. This means that they both determine the purpose of data processing (why) and the means of processing (how). Both the EBMT and your hospital are responsible for the protection of the data in the Registry.

In the event that your data in the EBMT Registry is shared with health authorities, HTA bodies, MAHs or other scientific/clinical collaboration partners for the purposes described above in section 3.2, these partners will also be a controller of your personal data for that specific purpose and therefore also be responsible for the protection of the data.

3.9 What are your rights (as a data subject)?

You are being asked to consent to your personal data being accessed, stored and processed. If you withhold consent, then your data will not be sent to the EBMT or to any of our collaborators and will not be used for the purposes of research to help future patients.

You have the right to withdraw your consent at any time in the future. This means you can stop sharing data with the EBMT Registry at any time, without giving a reason, but we will keep information about you that we already have.

We need to manage your records in specific ways for research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

3.10 Are there any extra costs involved if you decide to share your data with the Registry?

No extra costs are involved related to sharing your data and nor will you receive any payment for sharing your data with the Registry.

You can find out more about how we use your information:

•  at www.hra.nhs.uk/information-about-patients/
•  our leaflet available from www.hra.nhs.uk/patientdataandresearch
•  by asking one of the research team
•  by sending an email, or by calling a phone number mentioned below.
           Registry Holder (EBMT)
           EBMT Data Protection Officer
           E-mail: data.protection@ebmt.org
           Phone number: +34 93 453 8570