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• W2896838885 abstract "Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of ‘their’ data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of research—absent in the GDPR—which can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational self-determination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy." @default.
• W2896838885 created "2018-10-26" @default.
• W2896838885 creator A5082237867 @default.
• W2896838885 date "2018-11-01" @default.
• W2896838885 modified "2023-10-04" @default.
• W2896838885 title "Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate" @default.
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• W2896838885 doi "https://doi.org/10.1016/j.ejca.2018.09.032" @default.
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