ArticleEuropean journal of human genetics : EJHG2019
The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks.
Article in European journal of human genetics : EJHG, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
41 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature.European journal of human genetics : EJHG · 2024Pooled it
- Ethical Principles, Constraints and Opportunities in Clinical Proteomics.Molecular & cellular proteomics : MCP · 2021Pooled it
- Patient and IRB perspectives on biobank consent models: implications for international policy from Taiwan.BMC medical ethics · 2026Article
- Fully Anonymized Digital Health Data Acquisition in a Research Partnership Using a Blinded Deidentification Proxy in the HerzFit App: Implementation Study.JMIR formative research · 2026Article
- Enhancing translational research in metastatic cancer through an open science environment: the UPTIDER experience.NPJ precision oncology · 2025Article
- "Your Tumour Can Save Lives": Re-examining Singapore's Consent Procedures for the Use of De-identified Bio-specimens in Research.Asian bioethics review · 2025Article
- Consent and its discontents: the case of UK Biobank.Medicine, health care, and philosophy · 2025Article
- Review
- The MUnich SArcopenia Registry (MUSAR) : Paving the way for increased visibility, more frequent diagnoses and innovative new treatment.Zeitschrift fur Gerontologie und Geriatrie · 2025Article
- Review
- Datagraphy: toward a systematic approach to dataset discovery.GigaScience · 2025Article
- Ethical and social reflections on the proposed European Health Data Space.European journal of human genetics : EJHG · 2024Article
- Improving prenatal diagnosis through standards and aggregation.Prenatal diagnosis · 2024Review
- Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.Frontiers in medicine · 2024Article
- GBA/GBN-position on the feedback of incidental findings in biobank-based research: consensus-based workflow for hospital-based biobanks.European journal of human genetics : EJHG · 2023Article
- Initiatives, Concepts, and Implementation Practices of the Findable, Accessible, Interoperable, and Reusable Data Principles in Health Data Stewardship: Scoping Review.Journal of medical Internet research · 2023Article
- Comparing Decentralized Learning Methods for Health Data Models to Nondecentralized Alternatives: Protocol for a Systematic Review.JMIR research protocols · 2023Article
- Accelerating action to reduce anemia: Review of causes and risk factors and related data needs.Annals of the New York Academy of Sciences · 2023Review
- Returning study results to research participants: Data access, format, and sharing preferences.International journal of medical informatics · 2023Article
- Patients' knowledge, preferences, and perspectives about data protection and data control: an exploratory survey.Frontiers in pharmacology · 2023Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The General Data Protection Regulation (GDPR) came into force in May 2018. The aspiration of providing for a high level of protection to individuals' personal data risked placing considerable constraints on scientific research, which was contrary to various research traditions across the EU. Therefore, along with the set of carefully outlined data subjects' rights, the GDPR provides for a two-level framework to enable derogations from these rights when scientific research is concerned. First, by directly invoking provisions of the GDPR on a condition that safeguards that must include 'technical and organisational measures' are in place and second, through the Member State law. Although these derogations are allowed in the name of scientific research, they can simultaneously be challenging in light of the ethical requirements and well-established standards in biobanking that have been set forth in various research-related soft legal tools, international treaties and other legal instruments. In this article, we review such soft legal tools, international treaties and other legal instruments that regulate the use of health research data. We report on the results of this review, and analyse the rights contained within the GDPR and Article 89 of the GDPR vis-à-vis these instruments. These instruments were also reviewed to provide guidance on possible safeguards that should be followed when implementing any derogations. To conclude, we will offer some commentary on limits of the derogations under the GDPR and appropriate safeguards to ensure compliance with standard ethical requirements.
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