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]  


Please find all ERKReg informed consents below:

Croatian HR_Adult patients HR_Parents/ patient representatives
Czech CZ_Adult patients CZ_Parents/ patient representatives
Dutch NL_Adult patients NL_Parents/ patient representatives
English EN_Adult patients EN_Parents/ patient representatives
Finnish FI_Adult patients FI_Parents/ patient representatives
French FR_Adult patients FR_Parents/patient representatives
German DE_Adult patients   DE_Parents/patient representatives
Hungarian HU_Adult patients HU_Parents/patient representatives
Italian IT_Adult patients IT_Parents/patient representatives
Lithuanian LT_Adult patients LT_Parents/patient representatives
Norwegian  NOR_Adult patients NOR_Parents/patient representatives 
Polish PL_Adult patients PL_Parents/patient representatives
Portuguese PT_Adult patients  PT_Parents/patient representatives
Romanian RO_Adult patients  RO_Parents/patient representatives
Slovakian SK_Adult patients    SK_Parents/patient representatives
Slovenian SL_Adult patients    SL_Parents/patient representatives
Spanish ES_Adult patients   ES_Parents/patient representatives
Swedish SE_Adult patients    SE_Parents/patient representatives
Turkish  TR_Adult patients    TR_Parents/patient representatives
Ukrainian UA_Adult patients   UA_Parents/patient representatives