An Informed Consent Form (ICF) template for the European Reference Networks (ERNs) has been developed in the framework of EJP RD.
It represents a research targeted ICF that can be adapted at ERN, national and site level and consists of two versions (one for patients and one for parents/legally designated representatives in case of minors or incapacitated subjects). Translated versions are also available in 26 languages.
This document was developed following a specific request from the ERNs to address their need to have an ICF for registries applicable in many contexts and acceptable by all Ethics Committees. Indeed, the previous use of the ICF developed for the Clinical Patient Management System (CPMS) in the framework of “ERKNet registry Ethics Approval” led to various legal interpretations and amendment requests by multiple Ethics Committees.
An Informed Consent Facilitation Group within EJP RD was established to address Ethical, Legal and Social Implications (ELSI) issues (specifically GDPR compliance) and provide a harmonized framework for ERN registry exploitation approval.
The development of this ICF benefited from previous experience with ICF submissions by 4 ERN Registries (ERKReg, EuRRECa, ENROL, VASCA) and from the utilization of “machine-readable” consent-related Ontologies (Data Use Ontology and Informed Consent Ontology). Several iterative expert reviews (including patient organizations and ERN representatives) were conducted to finalize the ICF.
The development of paediatric materials (including age-specific Information Sheets and Assent Forms) is ongoing together with the further mapping to standards & ontologies enabling/facilitating (semi)automated secured and customized, data discovery, access and re-use.