ERKReg Patient Informed Consent Forms
Which consent forms do I need to use?
Since 2022, new ERKReg informed consent forms have been 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 form versions available for (i) parents/legal representatives and (ii) adult patients. We have the documents available in all European languages.
Old version of the ICF
Updated version of the ICF
Do I need local ethics approval?
The ICF template has 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 be added.
We can also provide you with supporting information that might facilitate your application (e.g. study protocol, summary, list of data items). Get in touch with us for assistance: erkreg[at]med.uni-heidelberg.de
Please find all ERKReg informed consents below:
