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Secondary research use of personal medical data: attitudes from patient and population surveys in The Netherlands and Germany
European Journal of Human Genetics ( IF 5.2 ) Pub Date : 2020-10-01 , DOI: 10.1038/s41431-020-00735-3
Gesine Richter 1 , Christoph Borzikowsky 2 , Wiebke Lesch 3 , Sebastian C Semler 3 , Eline M Bunnik 4 , Alena Buyx 5 , Michael Krawczak 2
Affiliation  

Making routine clinical-care-data available for medical research requires adequate consent to legitimize use and exchange. While, public interest in supporting medical research is increasing, individuals often find it difficult to actively enable researchers to access their data. In addition to broad consent, the idea of (consent-free) data donation has been brought into play as another way to legitimize secondary research use of medial data. However, flanking the implementation of broad consent policies or data donation, the attitude of patients, and the general public toward different aspects of these approaches needs to be assessed. We conducted two empirical studies to this end among Dutch patients (n = 7430) and representative German citizens (n = 1006). Wide acceptance of broad consent was observed among Dutch patients (92.3%), corroborating previous findings among German patients (93.0%). Moreover, 28.8% of the Dutch patients generally approved secondary data-use for non-academic research, 42.3% would make their decision dependent upon the type of institution in question. In the German survey addressing the general population, 78.8% approved data donation without explicit consent as an alternative model of legitimization, the majority of those who approved (96.7%) would allow donated data to be used by universities and public research institutions. This willingness to support contrasted sharply with the fact that only 16.6% would allow access to the data by industry. Our findings thus not only add empirical evidence to the debate about broad consent and data donation, but also suggest that widespread public discussion and education about the role of industry in medical research is necessary in that context.



中文翻译:

个人医疗数据的二次研究使用:荷兰和德国患者和人口调查的态度

为医学研究提供常规临床护理数据需要获得充分的同意才能使使用和交换合法化。虽然公众对支持医学研究的兴趣正在增加,但个人经常发现很难让研究人员主动访问他们的数据。除了广泛同意之外,(无需同意)数据捐赠的想法已被用作使医学数据的二次研究使用合法化的另一种方式。然而,在实施广泛的同意政策或数据捐赠方面,需要评估患者和公众对这些方法不同方面的态度。为此,我们在荷兰患者(n  = 7430)和具有代表性的德国公民(n = 1006)。在荷兰患者(92.3%)中观察到广泛接受广泛同意,证实了之前在德国患者中的发现(93.0%)。此外,28.8% 的荷兰患者普遍同意将二级数据用于非学术研究,42.3% 的患者会根据所讨论的机构类型做出决定。在针对一般人群的德国调查中,78.8% 的人批准在没有明确同意的情况下捐赠数据作为合法化的替代模式,大多数批准者(96.7%)将允许大学和公共研究机构使用捐赠的数据。这种支持意愿与只有 16.6% 的受访者允许按行业访问数据的事实形成鲜明对比。因此,我们的研究结果不仅为关于广泛同意和数据捐赠的辩论增添了经验证据,

更新日期:2020-10-02
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