Richter Gesine, Borzikowsky Christoph, Lesch Wiebke, Semler Sebastian C, Bunnik Eline M, Buyx Alena, Krawczak Michael
Institute of Experimental Medicine, Division of Biomedical Ethics, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany.
Institute of Medical Informatics und Statistics, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany.
Eur J Hum Genet. 2021 Mar;29(3):495-502. doi: 10.1038/s41431-020-00735-3. Epub 2020 Oct 1.
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.
为医学研究提供常规临床护理数据需要获得足够的同意,以使其使用和交流合法化。虽然公众对支持医学研究的兴趣日益增加,但个人通常难以主动允许研究人员访问其数据。除了广泛同意之外,(无同意)数据捐赠的想法也被引入,作为使医学数据的二次研究使用合法化的另一种方式。然而,在实施广泛同意政策或数据捐赠的同时,还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)和代表性德国公民(n=1006)中进行了两项实证研究。荷兰患者广泛接受广泛同意(92.3%),这与之前在德国患者中发现的结果一致(93.0%)。此外,28.8%的荷兰患者普遍同意将二次数据用于非学术研究,42.3%将根据所涉机构的类型做出决定。在德国针对普通民众的调查中,78.8%赞成在没有明确同意的情况下将数据捐赠作为合法化的替代模式,其中大多数赞成者(96.7%)允许将捐赠的数据用于大学和公共研究机构。这种支持意愿与以下事实形成鲜明对比,即只有 16.6%的人允许行业访问数据。因此,我们的发现不仅为关于广泛同意和数据捐赠的辩论提供了经验证据,还表明在这种情况下,有必要就行业在医学研究中的作用进行广泛的公众讨论和教育。
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