The Regulatory Landscape of Biobanks In Europe: From Accreditation to Intellectual Property

Overview

Journal Curr Genomics

Publisher Bentham Science Publishers

Date 2025 Feb 11

PMID 39931203

Authors

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

Nicola Fusco

Affiliations

Soon will be listed here.

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.

References

Llorian E, Kopac N, Waliji L, Borle K, Dragojlovic N, Elliott A . A Rapid Review on the Value of Biobanks Containing Genetic Information. Value Health. 2023; 26(9):1286-1295. DOI: 10.1016/j.jval.2023.02.017. View

Marr K, Phan P . The valorization of non-patent intellectual property in academic medical centers. J Technol Transf. 2020; 45(6):1823-1841. PMC: 7525762. DOI: 10.1007/s10961-020-09827-0. View

Mascalzoni D, Bentzen H, Budin-Ljosne I, Bygrave L, Bell J, Dove E . Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?. Ann Intern Med. 2019; 170(5):332-334. DOI: 10.7326/M18-2854. View

Bonizzi G, Capra M, Cassi C, Taliento G, Pala O, Sajjadi E . Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management. J Vis Exp. 2022; (189). DOI: 10.3791/63950. View

Ponchietti L, Muralha Antunes N, Utrilla Fornals A, Talving P, Garcea A, Roldon Golet M . Use of visual media in the era of European Union's General Data Protection Regulation: A practice-oriented guideline. Cir Esp (Engl Ed). 2021; 99(6):404-411. DOI: 10.1016/j.cireng.2021.02.005. View

Frascarelli C, Bonizzi G, Musico C, Mane E, Cassi C, Guerini Rocco E . Revolutionizing Cancer Research: The Impact of Artificial Intelligence in Digital Biobanking. J Pers Med. 2023; 13(9). PMC: 10532470. DOI: 10.3390/jpm13091390. View

Paskal W, Paskal A, Debski T, Gryziak M, Jaworowski J . Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785. PMC: 6132819. DOI: 10.1007/s12253-018-0418-4. View

Hills L . Working well with the informal leaders in your practice. J Med Pract Manage. 2015; 30(3):197-200. View

Williams R, Gupta D, Yong W . Orientation and Training of New Biobank Personnel. Methods Mol Biol. 2018; 1897:51-63. PMC: 6777715. DOI: 10.1007/978-1-4939-8935-5_6. View

10.

Parvinen L, Alamaki A, Hallikainen H, Maki M . Exploring the challenges of and solutions to sharing personal genomic data for use in healthcare. Health Informatics J. 2023; 29(1):14604582231152185. DOI: 10.1177/14604582231152185. View

11.

Gee S, Oliver R, Corfield J, Georghiou L, Yuille M . Biobank Finances: A Socio-Economic Analysis and Review. Biopreserv Biobank. 2015; 13(6):435-51. DOI: 10.1089/bio.2015.0030. View

12.

Smit J, Mostert M, van der Graaf R, Grobbee D, van Delden J . Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature. Eur J Hum Genet. 2023; 32(1):21-30. PMC: 10772063. DOI: 10.1038/s41431-023-01471-0. View

13.

Harati M, Williams R, Movassaghi M, Hojat A, Lucey G, Yong W . An Introduction to Starting a Biobank. Methods Mol Biol. 2018; 1897:7-16. PMC: 6777713. DOI: 10.1007/978-1-4939-8935-5_2. View

14.

Muller A, Hovanec J, Josephs B, Wiethege T, Bruning T, Behrens T . A Two-Level Biobank Data Protection Concept for Project-Driven Human Sample Collections. Biopreserv Biobank. 2019; 17(4):312-318. DOI: 10.1089/bio.2018.0112. View

15.

Sanchini V, Marelli L, Monturano M, Bonizzi G, Peruzzotti G, Orecchia R . A comprehensive ethics and data governance framework for data-intensive health research: Lessons from an Italian cancer research institute. Account Res. 2023; 32(1):59-76. DOI: 10.1080/08989621.2023.2248884. View

16.

Bonizzi G, Zattoni L, Capra M, Cassi C, Taliento G, Ivanova M . Standard operating procedures for biobank in oncology. Front Mol Biosci. 2022; 9:967310. PMC: 9459387. DOI: 10.3389/fmolb.2022.967310. View

17.

Evans C, Nieves C, Erickson N, Borrell L . Intersectional inequities in the birthweight gap between twin and singleton births: A random effects MAIHDA analysis of 2012-2018 New York City birth data. Soc Sci Med. 2023; 331:116063. DOI: 10.1016/j.socscimed.2023.116063. View

18.

Cicek M, Olson J . Mini-Review of Laboratory Operations in Biobanking: Building Biobanking Resources for Translational Research. Front Public Health. 2020; 8:362. PMC: 7399165. DOI: 10.3389/fpubh.2020.00362. View

19.

Sanchini V, Bonizzi G, Disalvatore D, Monturano M, Pece S, Viale G . A Trust-Based Pact in Research Biobanks. From Theory to Practice. Bioethics. 2015; 30(4):260-71. DOI: 10.1111/bioe.12184. View

20.

Gille F, Vayena E, Blasimme A . Future-proofing biobanks' governance. Eur J Hum Genet. 2020; 28(8):989-996. PMC: 7468350. DOI: 10.1038/s41431-020-0646-4. View