Which consent forms do I need to use?
Since 2022, new ERKReg informed consent forms are in place. These were developed by the European Joint Programme on Rare Diseases (EJP RD) and should be used in all ERN registries. We have adapted the generic template according to the ERKReg needs. There are two ERKReg informed consent forms version available for (i) parents/legal representatives and (ii) adult patients. We have the documents available in all European langues.
Please get in touch with us at erkreg[at]erknet.org, we will be happy to provide you with them and further instructions.
Do I need a local ethics approval?
The ICFs template have been developed by a team of legal experts (ELSI - ethical, legal, societal issues) of EJP RD. They consider all aspects of GDPR. However, local ethics approval for the use is needed. Before starting with ERKReg, please get in touch with your local ethics committee and data protection office. In the generic document, there is also space for national or local rules/regulations to add.
We can also provide you with supporting information that might faciliate your application (e.g. study protocol, summary, list of data items). Get in touch with us for assistance.