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 set up a Joint Data Registry Agreement (JDRA) – an agreement specifically developed to define roles, responsibilities, and GDPR-compliant governance for multicentre registry collaborations to enhance research.

The following documents may be required for obtaining local ethics approval. 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 therefore been approved by the Dutch Ethics Committee. We have translated the documents to English for clarity and to use as a reference, since ethical approval legislation differs between countries.