MLC Foundation, Dagelijkse Groenmarkt 2, 2513 AL Den Haag, the Netherlands.
Eur J Cancer. 2018 Nov;104:70-80. doi: 10.1016/j.ejca.2018.09.032. Epub 2018 Oct 15.
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.
癌症发病率和生存率、生活方式和环境因素的影响以及治疗方案与结果的相互作用在很大程度上取决于观察性研究、来自医疗保健系统和参与队列研究的志愿者的患者数据，这些数据通常是非选择性的。自 2018 年 5 月 25 日起，欧洲通用数据保护条例（GDPR）适用于此类数据。GDPR 侧重于对“其”数据的主体进行更多的个人控制。然而，GDPR 之前有过一场旷日持久的辩论。研究界在这场辩论中积极参与，因此，GDPR 也有研究豁免。其中一些直接适用；其他豁免需要纳入国家法律。这些豁免将与 GDPR 的概述一并讨论。我提出了一个 GDPR 中不存在的研究的实质性定义-这可以保证其在 GDPR 中的特殊地位。辩论还没有结束。大多数法律文本都存在歧义，并在价值背景下进行解释。在这种情况下，这些价值可以概括为信息自主与团结以及自主权的更深层次含义。价值也将指导国家的实施及其解释。个人控制或信息自主的价值应该通过在医疗保健中相互依存的微妙视角来平衡，因为这是一个不断学习的系统，特别是在基于欧洲团结的医疗保健系统中。良好的研究治理可能是摆脱同意或匿名二元论的一种方式。
