A FHIR Consent Profile for European Research Biobanks.

Digital dynamic consent is a key element to improve the involvement of participants as proactive partners in research and requires the adoption of standard-based information models to support data reuse. In this work we present the HL7 FHIR Consent Profile we developed to integrate individual consent preferences on biobanked samples and relative information within the infrastructure of the the Biobanking and BioMolecular Resources European Research Infrastructure Consortium (BBMRI-ERIC). The Profile builds on the official HL7 FHIR Consent Resource and adopts the Common Condition of use Elements (CCE) terminology to express the participants' wills. A preliminary evaluation on a minimally optimized setup suggests that using the Profile's attributes in queries adds no significant performance overhead. The current version of the Profile is available online, together with a suite of demonstrative tools, and will be implemented for validation in the final prototype of a wider pilot of the Italian Node of BBMRI-ERIC within the Strengthening BBMRI.it Project.