ERN Registries Generic Informed Consent Forms

An Informed Consent Form (ICF) template has been developed for European Reference Networks (ERNs) through ERDERA’s predecessor, EJP RD.

This template addresses the need for a research-focused ICF that can be adapted for use at ERN, national, and individual site levels. It is available in two versions: one for adult patients and another for parents or legally designated representatives of minors or incapacitated individuals. Each of these forms are also available in 26 translated versions.

This initiative arose from a direct request from ERNs, who sought a registry-applicable ICF that would be widely accepted by Ethics Committees across various contexts. Previous attempts to use an ICF developed for the Clinical Patient Management System (CPMS) within the “ERKNet registry Ethics Approval” framework resulted in diverse legal interpretations and numerous amendment requests from Ethics Committees.

To address these Ethical, Legal, and Social Implications (ELSI) issues, particularly regarding GDPR compliance, and to establish a harmonised framework for ERN registry exploitation approval, an Informed Consent Facilitation Group was established within EJP RD.

The development of this ICF drew upon the valuable experience gained from ICF submissions by four ERN Registries (ERKReg, EuRRECa, ENROL, VASCA).

It also benefited from the use of “machine-readable” consent-related ontologies, specifically the Data Use Ontology and the Informed Consent Ontology. The final ICF was shaped through several rounds of expert review, involving patient organisations and ERN representatives.

Work is currently underway to develop paediatric materials, including age-specific Information Sheets and Assent Forms. Further efforts are also focused on mapping to standards and ontologies to enable and facilitate secure, customised, and semi-automated data discovery, access, and re-use.