Holm Søren, Ploug Thomas
Centre for Social Ethics and Policy, School of Law, Williamson Building, University of Manchester, Manchester, M13 9PL, UK.
Centre for Applied Ethics and Philosophy of Science, Aalborg University Copenhagen, AC Meyers Vænge 15, S 2450, København, Denmark.
J Bioeth Inq. 2017 Dec;14(4):515-525. doi: 10.1007/s11673-017-9810-0. Epub 2017 Oct 4.
Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests.
丹麦是一个已经朝着大数据和学习型医疗保健系统迈进的社会。常规医疗保健数据已集中登记多年，有一个全国性的组织库，还有许多关于教育、就业、住房、污染等方面的其他可用登记处。这使得丹麦研究人员能够在大量人群中研究暴露因素、基因与疾病之间的联系。将公共登记处用于科学研究相对没有争议，并得到了便利法规的支持，该法规允许在未经数据主体同意的情况下使用数据。然而，未来大部分数据将不由公共当局持有，而是由私人公司持有。这种转变对数据研究用途的治理有何影响？本文将论证，研究伦理委员会需要更多参与，研究人员需要更好地接受培训；并且必须重新引入某种形式的同意。将讨论四种不同的同意模式：退出同意、宽泛/全面同意、动态同意和元同意。将论证，一种包括公民进行元选择可能性的治理模式能在个人利益和公共利益之间达成最佳平衡。
