Biobanks and Patient Representatives Together in a Participatory Process: From the BBMRI.it Informed Consent Matrix to the Informed Consent Model of TNGB—Fondazione Telethon Network of Genetic Biobanks

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INTRODUCTION: Over the last decade, European Regulations have altered the landscape of the ethical, legal, and societal implications (ELSI). In 2017-2018, the BBMRI.it Common Service (CS) ELSI led two working groups on informed consent (IC) involving key biobanking stakeholders (i.e., patients, biobankers, research institutions, ELSI experts). Both groups aimed to collaboratively develop an IC matrix for biobanking research, serving as an ethical-legal-societal coproduced framework for a dynamic informative process. METHODS: (GDPR). Consequently, BBMRI.it CS ELSI and TNGB established a living laboratory involving biobankers and patient representatives, including UNIAMO F.I.M.R.-Italian Alliance for Rare Diseases. In this setting, the TNGB IC model update served as a training ground to implement the BBMRI.it matrix. This matrix offered a concretely collaborative framework, emphasizing dialogue, multidisciplinary approaches, pluralism, and progressive co-production. Methodologically, the laboratory was set up through several teleconferences and collaborative work on a shared platform. RESULTS: Key milestones included developing a shared terminology, structuring content logically, and linking information directly to governance. Crucial discussions addressed sample preservation duration, depletion of the last aliquot, commercial use, return of results, and minors' participation in biobanking. CONCLUSION: The new TNGB IC model shows how an inclusive, equitable, and participatory approach involving all rare disease biobanking stakeholders and infrastructures is an effective way to produce documents and best practices that are legally compliant and also aligned with ELSI and patient, public involvement and engagement standards.

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