e-REC was launched by EuRRECA and was approved by 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 University of Glasgow and all information provided is kept in compliance with the UK Data Protection Act (2018) and 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 ethical approval:
The Core registry was launched by EuRRECA and approved by the National Ethics Service and Information Governance authorities in the UK. 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 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 University of Glasgow in compliance with the UK Data Protection Act (2018) and General Data Protection Regulation (GDPR 2016/679).
Centres that recruit through a process of opt-out consent can specify this when a new record is created. However local approval is requiered for the Core registry. More detailed information sheets and consent forms that have ethics and information governance approval have been created by EuRRECa specifically for the EuRRECa Core Registry for use by any centre. These 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.