Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape

Tzortzatou, Olga; Slokenberga, Santa; Reichel, Jane; Andrade, Andreia da Costa; Barbosa, Carla; Bekaert, Sofie; Veen, Evert-Ben van; Romeo-Casabona, Carlos M.; Cathaoir, Katharina Ó; Chassang, Gauthier; Debucquoy, Annelies; Derèze, Jean-Jacques; Dollé, Laurent; Fält, Sonja Eaker; Halouzka, Radek; Hartlev, Mette; Hisbergues, Michael; Hoppe, Nils; Huys, Isabelle; Kindt, Els; Befring, Anne Kjersti; Kozera, Łukasz; Krekora-Zając, Dorota; Lalova, Teodora; Mayrhofer, Michaela Th.; Negrouk, Anastassia; Pawlikowski, Jakub; Penasa, Simone; Pormeister, Kärt; Rial‐Sebbag, Emmanuelle; Siapka, Anastasia; Southerington, Tom; Stenbeck, Magnus; Šutalo, Maja; Tomasi, Marta; Valcke, Peggy; Falzon, Ruth

doi:10.1007/978-3-030-49388-2_22

Cited by 4 publications

(3 citation statements)

References 3 publications

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“…The GDPR recognizes the importance of large-scale data collection and analysis for scientific purposes stating in Recital 157 that ‘by coupling information from registries, researchers can obtain new knowledge of great value with regard to widespread medical conditions such as cardiovascular disease, cancer, and depression’ . The GDPR leaves room, however, for national derogations, and that has allowed some inconsistency in the legal landscape within the European Economic Area (EEA) to remain, adversely impacting the practice of clinical and scientific research [ 10–14 ]. The main uncertainties concern: (i) the concept of anonymization, specifically the circumstances under which pseudonymized data can be considered anonymized; (ii) the legal basis for processing personal data for secondary research and healthcare purposes; and (iii) the legal basis for cross-border (and especially outside the EEA) transfer of personal data for research and healthcare purposes.…”

Section: Introductionmentioning

confidence: 99%

Sharing sensitive data in life sciences: an overview of centralized and federated approaches

Rujano,

Boiten,

Ohmann

et al. 2024

Briefings in Bioinformatics

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Biomedical data are generated and collected from various sources, including medical imaging, laboratory tests and genome sequencing. Sharing these data for research can help address unmet health needs, contribute to scientific breakthroughs, accelerate the development of more effective treatments and inform public health policy. Due to the potential sensitivity of such data, however, privacy concerns have led to policies that restrict data sharing. In addition, sharing sensitive data requires a secure and robust infrastructure with appropriate storage solutions. Here, we examine and compare the centralized and federated data sharing models through the prism of five large-scale and real-world use cases of strategic significance within the European data sharing landscape: the French Health Data Hub, the BBMRI-ERIC Colorectal Cancer Cohort, the federated European Genome-phenome Archive, the Observational Medical Outcomes Partnership/OHDSI network and the EBRAINS Medical Informatics Platform. Our analysis indicates that centralized models facilitate data linkage, harmonization and interoperability, while federated models facilitate scaling up and legal compliance, as the data typically reside on the data generator’s premises, allowing for better control of how data are shared. This comparative study thus offers guidance on the selection of the most appropriate sharing strategy for sensitive datasets and provides key insights for informed decision-making in data sharing efforts.

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Section: Introductionmentioning

confidence: 99%

Sharing sensitive data in life sciences: an overview of centralized and federated approaches

Rujano,

Boiten,

Ohmann

et al. 2024

Briefings in Bioinformatics

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“…Furthermore, the ways that these documents or tools translate into practice differ widely - from changing consent practices ( Prictor et al, 2018 ; Mamo et al, 2020 ; Teare et al, 2021 ) to different ways of engaging participants ( Kaye et al, 2012 ; Goisauf and Durnová, 2018 ; Haas et al, 2021 ). To navigate this terrain, scholars have tried developing checklists, toolkits and other forms of instruments that can aid in practice or provide an overview against a fragmented domain ( Tzortzatou et al, 2021 ; Tzortzatou-Nanopoulou et al, 2023 ); however, it is clear one size fits all solutions are often not possible in this domain, not least due to lack of regulation, but rather due to the diversity within biobanking as well as across sites.…”

Section: Introductionmentioning

confidence: 99%

Risk mapping for better governance in biobanking: the case of biobank.cy

Akyüz,

Goisauf,

Martin

et al. 2024

Front. Genet.

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Introduction: Risk governance is central for the successful and ethical operation of biobanks and the continued social license for being custodians of samples and data. Risks in biobanking are often framed as risks for participants, whereas the biobank’s risks are often considered as technical ones. Risk governance relies on identifying, assessing, mitigating and communicating all risks based on technical and standardized procedures. However, within such processes, biobank staff are often involved tangentially. In this study, the aim has been to conduct a risk mapping exercise bringing biobank staff as key actors into the process, making better sense of emerging structure of biobanks.Methods: Based on the qualitative research method of situational analysis as well as the card-based discussion and stakeholder engagement processes, risk mapping was conducted at the biobank setting as an interactive engagement exercise. The analyzed material comprises mainly of moderated group discussions.Results: The findings from the risk mapping activity are framed through an organismic metaphor: the biobank as a growing, living organism in a changing environment, where trust and sustainability are cross-cutting elements in making sense of the risks. Focusing on the situatedness of the dynamics within biobanking activity highlights the importance of prioritizing relations at the core of risk governance and promoting ethicality in the biobanking process by expanding the repertoire of considered risks.Conclusion: With the organismic metaphor, the research brings the diverse group of biobank staff to the central stage for risk governance, highlighting how accounting for such diversity and interdependencies at the biobank setting is a prerequisite for an adaptive risk governance.

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“…It is highlighted that member states affect the GDPR’s flexibility in reference to data processing for scientific purposes ( Slokenberga, 2021 ). On the other hand, an analysis of each member state’s legislation reveals the discrepancies in such fundamental issues as the legal basis for data processing by biobanks or the concept of public interest ( Tzortzatou et al, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40

2021

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Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure–European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.

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Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape

Cited by 4 publications

References 3 publications

Sharing sensitive data in life sciences: an overview of centralized and federated approaches

Sharing sensitive data in life sciences: an overview of centralized and federated approaches

Risk mapping for better governance in biobanking: the case of biobank.cy

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40

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