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@med.uni-heidelberg.de  

 

Please find all ERKReg informed consents below:

CroatianHR_Adult patientsHR_Parents/ patient representatives
CzechCZ_Adult patientsCZ_Parents/ patient representatives
DutchNL_Adult patientsNL_Parents/ patient representatives
EnglishEN_Adult patientsEN_Parents/ patient representatives
FinnishFI_Adult patientsFI_Parents/ patient representatives
FrenchFR_Adult patientsFR_Parents/patient representatives
GermanDE_Adult patients  DE_Parents/patient representatives
HungarianHU_Adult patientsHU_Parents/patient representatives
ItalianIT_Adult patientsIT_Parents/patient representatives
LithuanianLT_Adult patientsLT_Parents/patient representatives
Norwegian NOR_Adult patientsNOR_Parents/patient representatives 
PolishPL_Adult patientsPL_Parents/patient representatives
PortuguesePT_Adult patients PT_Parents/patient representatives
RomanianRO_Adult patients RO_Parents/patient representatives
SlovakianSK_Adult patients   SK_Parents/patient representatives
SlovenianSL_Adult patients   SL_Parents/patient representatives
SpanishES_Adult patients  ES_Parents/patient representatives
SwedishSE_Adult patients   SE_Parents/patient representatives
Turkish TR_Adult patients   TR_Parents/patient representatives
UkrainianUA_Adult patients  UA_Parents/patient representatives

Please find below an english version of ERKReg Information Sheet and Consent Form for children. You may add your own centre logo and adapt according to your needs. 

EnglishEN_children 7-11 years    EN_children 12-17 years