Manager: Luisa Minghetti
Heal Italia’s Biobanks and Sample Collections
A key strength of the Heal Italia consortium lies in the availability of human biological material collected and preserved in research biobanks and sample collections managed by many of the participating institutes and entities.
The scientific information that can be derived from human biological material—thanks to the continuous technological advancements in the “omics” sciences—is central to the progress of translational research and precision medicine. Human biological material, understood as both biological samples and the associated epidemiological, clinical, and experimental data, represents the most critical resource for translating advances in molecular medicine and omics technologies into improved human health. Its value increases proportionally to the quantity and quality of the associated information.
Research involving the use of human biological material must be conducted in accordance with fundamental ethical principles, ensuring transparency and respect for the individual from whom the material originates, and obtaining explicit consent from participants for the use of their biological material for research purposes. Whenever possible, the use of residual biological material should be preferred over the collection of new samples, provided that ethical requirements, participants’ rights, and minimum quality standards of the material are duly respected.
The research biobank plays a key role in ensuring research quality, compliance with ethical standards, and the protection of participants’ rights. The biobanking process ensures that the collection and use of biological material are conducted in accordance with ethical and regulatory principles, while also safeguarding the quality of samples through the implementation of standard operating procedures (SOPs) and through the sharing of biobanked samples and research results (access policy).
To promote the use of biological material in adherence to the highest quality standards and to ethical principles consistent with Italian legislation and international recommendations, Heal Italia has initiated an active dialogue with BBMRI.it, the Italian node of BBMRI-ERIC, the European Research Infrastructure for biobanks and biomolecular resources.
BBMRI-ERIC is a distributed infrastructure composed of National Nodes across 22 European Member States, along with 3 Observer States and one international organization. It was established in 2013 under EU legislation as a European Research Infrastructure Consortium (ERIC) with the objective of facilitating responsible access to high-quality samples, data, and biomolecular resources through multidisciplinary expertise and highly specialized services.
The Italian node, BBMRI.it, was established in the same year by a joint decree of the Ministry of Health and the Ministry of University and Research, designating Professor Marialuisa Lavitrano as National Coordinator/Director of the National Node, based at the University of Milano-Bicocca. The Istituto Superiore di Sanità serves as the representing entity for Italy within the European ERIC consortium.
The BBMRI.it network currently includes 54 biobanks hosted by institutions (universities, hospitals, IRCCS, research entities) that have signed the BBMRI-ERIC Partner Charter.
BBMRI.it collaborates with 14 patient associations and supports 290 research groups through its Help Desk and the Common Services in the IT (Common Service IT), Quality (Common Service Quality), and Ethical-Legal-Social (Common Service ELSI) domains, with the objective of advancing research in personalised medicine.
The collaboration between Heal Italia and BBMRI.it was formalised through a Memorandum of Understanding signed on 26 June 2025. With this agreement, Heal Italia and BBMRI.it reaffirm their shared objective of raising awareness among the scientific community and civil society about the importance of biobanking and the crucial role of biobanks in unlocking the potential of personalised medicine.
To this end, the joint action of Heal Italia and BBMRI.it will be structured along two main lines:
- the establishment of a thematic network dedicated to personalised medicine (“the Heal Italia Biobank Network”) within the BBMRI.it infrastructure, identifying biobanks hosted by institutions belonging to the Heal Italia network that are already part of BBMRI.it;
- the promotion and facilitation of the affiliation to BBMRI.it of biobanks and/or collections hosted by institutions within the Heal Italia network—particularly those located in Southern Italy—that intend to align with BBMRI.it policies on sample access, data protection, informed consent, and the adoption of an appropriate quality system. To this end, BBMRI.it and Heal Italia will collaborate with biobanks to ensure compliance with all the requirements defined in the BBMRI.it “Self-Assessment Questionnaire”. Newly admitted biobanks and/or collections will expand the thematic Heal Italia biobank network dedicated to personalised medicine.
The Memorandum of Understanding therefore aims to sustain close cooperation with related organisations, simplify the rights and obligations of both parties, and establish a framework of trust, collaboration, and fairness that will support the implementation of new joint initiatives.
The institutions that embark on this path will be able to benefit from the support of the infrastructure which, in addition to the aforementioned Common Services, includes the tools developed within the framework of the PNRR project “Strengthening BBMRI.it”.
This initiative is specifically aimed at enhancing the digital capabilities of biobanks and improving the visibility of available biological resources in both the European and national catalogues, as well as supporting the development of new nodes within the Infrastructure.