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

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 biom...

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Published inCurrent genomics Vol. 26; no. 1; pp. 15 - 23
Main Authors Corradi, Antonella, Bonizzi, Giuseppina, Sajjadi, Elham, Pavan, Francesca, Fumagalli, Marzia, Molendini, Luigi Orlando, Monturano, Massimo, Cassi, Cristina, Musico, Camilla Rosella, Leoni, Luca, Frascarelli, Chiara, Pala, Oriana, Rocco, Elena Guerini, Albini, Adriana, Orecchia, Roberto, Fusco, Nicola
Format Journal Article
LanguageEnglish
Published United Arab Emirates Bentham Science Publishers 01.01.2025
Benham Science Publishers
Subjects
Biobanks
Biological materials
Biological properties
Biomarkers
Data processing
Ethical standards
Heterogeneity
Information processing
Intellectual property
International standards
Inventions
Life Sciences, Genetics & Genomics, Genetics & Heredity
Nucleotides
Privacy
biological materials
clinical studies
translational research
transparency and consent
biomarkers
Biobanks
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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.
AbstractList 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.
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.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.
Author Cristina Cassi
Roberto Orecchia
Nicola Fusco
Giuseppina Bonizzi
Antonella Corradi
Luca Leoni
Francesca Pavan
Marzia Fumagalli
Massimo Monturano
Adriana Albini
Luigi Orlando Molendini
Camilla Rosella Musico
Chiara Frascarelli
Elena Guerini Rocco
Elham Sajjadi
Oriana Pala
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  surname: Pala
  fullname: Pala, Oriana
  organization: Division of Pathology, European Institute of Oncology IRCCS, Milan, Italy
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  surname: Fusco
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  organization: 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
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Keywords biological materials
clinical studies
translational research
transparency and consent
biomarkers
Biobanks
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Snippet Biobanks are necessary resources for the storage and management of human biological materials, such as biofluids, tissues, cells, or nucleotides. They play a...
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SubjectTerms Biobanks
Biological materials
Biological properties
Biomarkers
Data processing
Ethical standards
Heterogeneity
Information processing
Intellectual property
International standards
Inventions
Life Sciences, Genetics & Genomics, Genetics & Heredity
Nucleotides
Privacy
Title The Regulatory Landscape of Biobanks In Europe: From Accreditation to Intellectual Property
URI https://www.doi.org/10.2174/0113892029313697240729091922
https://www.ncbi.nlm.nih.gov/pubmed/39931203
https://www.proquest.com/docview/3165530195
https://www.proquest.com/docview/3165416007
https://pubmed.ncbi.nlm.nih.gov/PMC11808582
Volume 26
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