Ethics

e-REC

e-REC was launched by EuRRECA and was 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 or partially identifiable personal information is captured in e-REC and individual 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).

Centres are advised to check if they require local approvals at their own centre.

Additional information on the ethics approval (the Netherlands):

Ethics Approval

Science Committee Regulations

Core

The Core registry was launched by EuRRECA and 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. See also  ethics and information governance The information collected by the Core Registry is what is expected to be collected during routine clinical care and may be shared with approved users to perform or develop new research studies.  The information sheets and consent forms allow greater patient involvement through functions such as dynamic consent, completion of patient reported outcomes and opting to stay in touch through newsletters. These forms can be adapted by the individual centers for both EuRRECa as EuRR-Bone.

The Core Registry does not collect any information on names, addresses and local hospital numbers. Patients can also access their own information in the Core Registry. 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).

Country specific protocols for EuRR-Bone can be found here

Country specific protocols for EuRRECa can be found here

Centres that recruit through a process of opt-out consent can specify this when a new record is created. However local approval is required for the Core registry.