ArticleEuropean journal of human genetics : EJHG2016
Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach.
Article in European journal of human genetics : EJHG, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 44 papers, 1 of them a synthesis that pooled it.
What it found
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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
44 citing papers in PubMed, 1 synthesis or guideline 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
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- Research progress in agitation early warning monitoring and new technologies for critically ill patients: a narrative review.Frontiers in medicine · 2026Review
- Emerging and evolving values in the changing landscape of genomics.Frontiers in genetics · 2025Article
- Data altruism and the "consent" question: a study into the "consent" models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data.Frontiers in medicine · 2024Review
- Privacy-preserving analysis of time-to-event data under nested case-control sampling.Statistical methods in medical research · 2024Article
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- Data-driven sudden cardiac arrest research in Europe: Experts' perspectives on ethical challenges and governance strategies.Resuscitation plus · 2023Review
- Towards trust-based governance of health data research.Medicine, health care, and philosophy · 2023Article
- Electronic health records to capture primary outcome measures: two case studies in HIV prevention research.Trials · 2023Article
- Reproducibility and Scientific Integrity of Big Data Research in Urban Public Health and Digital Epidemiology: A Call to Action.International journal of environmental research and public health · 2023Article
- Patients' and Publics' Preferences for Data-Intensive Health Research Governance: Survey Study.JMIR human factors · 2022Article
- Practices and Attitudes of Bavarian Stakeholders Regarding the Secondary Use of Health Data for Research Purposes During the COVID-19 Pandemic: Qualitative Interview Study.Journal of medical Internet research · 2022Article
- What ethical approaches are used by scientists when sharing health data? An interview study.BMC medical ethics · 2022Article
- Decision-Making under Risk: Conditions Affecting the Risk Preferences of Politicians in Digitalization.International journal of environmental research and public health · 2022Article
- You Can't Have AI Both Ways: Balancing Health Data Privacy and Access Fairly.Frontiers in genetics · 2022Article
- Ephemeral data handling in microservices with Tquery.PeerJ. Computer science · 2022Article
- Of Screening, Stratification, and Scores.Journal of personalized medicine · 2021Review
- Reflections on dynamic consent in biomedical research: the story so far.European journal of human genetics : EJHG · 2021Article
- Research under the GDPR - a level playing field for public and private sector research?Life sciences, society and policy · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Medical research is increasingly becoming data-intensive; sensitive data are being re-used, linked and analysed on an unprecedented scale. The current EU data protection law reform has led to an intense debate about its potential effect on this processing of data in medical research. To contribute to this evolving debate, this paper reviews how the dominant 'consent or anonymise approach' is challenged in a data-intensive medical research context, and discusses possible ways forwards within the EU legal framework on data protection. A large part of the debate in literature focuses on the acceptability of adapting consent or anonymisation mechanisms to overcome the challenges within these approaches. We however believe that the search for ways forward within the consent or anonymise paradigm will become increasingly difficult. Therefore, we underline the necessity of an appropriate research exemption from consent for the use of sensitive personal data in medical research to take account of all legitimate interests. The appropriate conditions of such a research exemption are however subject to debate, and we expect that there will be minimal harmonisation of these conditions in the forthcoming EU Data Protection Regulation. Further deliberation is required to determine when a shift away from consent as a legal basis is necessary and proportional in a data-intensive medical research context, and what safeguards should be put in place when such a research exemption from consent is provided.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.