The project’s activities form part of the Strengthening BBMRI.it project, funded by the European Union’s Next Generation Europe initiative and led by the Italian National Node (BBMRI.it) of BBMRI-ERIC. Specifically, the objectives of Work Package 2, dedicated to the Ethical, Legal and Social Implications (ELSI) infrastructure, include the development of a pilot project designed to:
1. dynamically integrate participants’ informed consent, represented using the international Common Conditions of Use Elements (CCE) terminology;
2. develop and co-create a BBMRI app for digital consent/assent;
3. characterise biobank samples using ELSI metadata (participants’ pseudonymised preferences translated into CCE) in an interoperable format;
4. provide a bidirectional digital interface between citizen-participants and biobanks, created in collaboration with the BBMRI community (including doctors, data protection officers and representatives of patients, citizens and mature minors);
5. define strategies and tools for a future extension of the results of the Italian pilot project beyond national borders, integrating ELSI metadata within the BBMRI-ERIC Federated Platform (FP), in particular within the Locator system.
The project focuses on the final point and aims to develop models and tools for exporting consent preferences, based on CCEs, from research biobank IT management systems (Biobank IT Management System – BIMS), in standard formats compatible with the BBMRI-ERIC Federated Platform.
