Title:The Regulatory Landscape of Biobanks In Europe: From Accreditation to Intellectual Property
Volume: 26
Issue: 1
Author(s): Antonella Corradi, Giuseppina Bonizzi, Elham Sajjadi, Francesca Pavan, Marzia Fumagalli, Luigi Orlando Molendini, Massimo Monturano, Cristina Cassi, Camilla Rosella Musico, Luca Leoni, Chiara Frascarelli, Oriana Pala, Elena Guerini Rocco, Adriana Albini, Roberto Orecchia and Nicola Fusco*
Affiliation:
- Biobank for Translational and Digital Medicine, European Institute of Oncology IRCCS, Milan, Italy
- Division of Pathology, European Institute of Oncology IRCCS, Milan, Italy
- Department of Oncology and Hemato-Oncology, University of Milan, Italy
Keywords:
Biobanks, translational research, clinical studies, transparency and consent, biological materials, biomarkers.
Abstract: Biobanks are necessary resources for the storage and management of human biological
materials, such as biofluids, tissues, cells, or nucleotides. They play a significant role in the development
of new treatments and the advancement of basic and translational research, especially in
the field of biomarkers discovery and validation. The regulatory landscape for biobanks, which is
necessary to safeguard both privacy and scientific discoveries, exhibits significant heterogeneity
across different countries and regions. This article outlines the standards that modern biobanks
should fulfill in the European Union (EU), including general, structural, resource, process, and
quality requirements. Special attention is given to the importance of transparency and donor
consent following the General Data Protection Regulation (GDPR) and the ISO 20387:2018, the
international standard specifies general requirements for biobanks. A dedicated section covers the
preparation of donor information materials, emphasizing consent for research involvement and personal
data processing. The delicate balance between donors' privacy rights and scientific research
promotion is also discussed, with a focus on the patenting and economic use of biological material-
derived inventions and data. Considering these factors, it would be warranted to refine legal
frameworks and foster interdisciplinary collaboration to ethically and responsibly expand biobanking.
