Ethics Approval

e-REC

e-REC is approved by the Science Committee of Internal Medicine at the Leiden University Medical Center, the Netherlands and the National Ethics Service and Information Governance authorities in the UK. No identifiable personal information is captured in e-REC and therefore patient consent is not required. The reported data are stored on a secure server in the Leiden University Medical Center, and all information provided is kept in compliance with the General Data Protection Regulation (GDPR 2016/679).

Core Registry

The Core Registry is approved by the Science Committee of Internal Medicine at the Leiden University Medical Center, the Netherlands and the National Ethics Service and Information Governance authorities in the UK. The Core Registry does not collect any information on names, addresses and local hospital numbers. All information is kept strictly confidential and handled through secure password protected electronic systems and only those who are directly involved with the Registry are able to obtain access. All information is stored on a secure server in the Leiden University Medical Center in compliance with the General Data Protection Regulation (GDPR 2016/679).

The information collected by the Core Registry is what is expected to be collected during routine clinical care and aggregated data may be shared with approved users to perform or develop new research studies. Patients can also access their own information in the Core Registry. The Patient Information Folder with Informed Consent allow greater patient involvement through functions such as dynamic consent and completion of patient reported outcomes. Centres that recruit through a process of opt-out consent can specify this when a new record is created.

We advise you to check if local approval is required at your own centre, and to apply for approval of the Core Registry, rather than submitting a separate study application. This helps avoid duplication and ensures that data collection aligns with the existing approved registry framework. Provided your ethics committee approves, you can start to enter data into our registries.

Please note that we will not be able to share or use any data entered into our database until a signed agreement is in place. Once you have reached a certain number of cases entered, or when a Study Group is interested in your data, we will contact you to establish a Joint Data Registry Agreement (JDRA) – an agreement specifically developed to define roles, responsibilities, and GDPR-compliant governance for multicentre registry collaborations to facilitate future research. Please find the document in the list below.

The JDRA can be considered a more advanced form of a DSA, specifically designed for the transfer and use of data between multiple centres participating in registries. Because the JDRA is tailored to registry-based, multicentre collaborations, it helps ensure a consistent legal and governance framework across all participating centres. We therefore kindly ask you to sign the JDRA instead of a standard DSA. Many centres have already signed our JDRA and actively participate in our registries, demonstrating both its practicality and acceptance.

If you have any concerns or legal questions regarding our JDRA, we have developed a Frequently Asked Questions section (use DPO/Legal button) on our website addressing the most common issues and providing further clarification. This resource is intended to facilitate the review process for your Data Protection Officer or Legal Team to support a smooth assessment of the agreement.

The following documents may be required to obtain local ethics approval from your centre. Please contact us if you need additional documents:

* Why are the documents regarding ethics approval only available in Dutch and English?
Our database is based in the Netherlands and has been approved by a Dutch Ethics Committee. Documents are translated to English for clarity and reference, as ethical requirements differ between countries.

**GDPR compliance and Data Protection
The EuRREB registry complies fully with the General Data Protection Regulation (GDPR). All personal data are processed securely and only for clearly defined research purposes, in line with applicable ethical and legal requirements. Where required, a Data Protection Impact Assessment (DPIA) has been conducted to assess and mitigate potential privacy risks associated with data processing activities within the registry. For reasons of security and data protection, the full DPIA is not publicly available. However it can be provided upon request to data protection officers, ethics committees, or participating centres.