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结论:基因组和健康数据在研究中的共享协调:一个不可能的梦想?

Conclusion: harmonisation in genomic and health data sharing for research: an impossible dream?

机构信息

Department of Health, Ethics and Society, and CAPHRI (Care and Public Health Research Institute), Maastricht University, Maastricht, The Netherlands.

出版信息

Hum Genet. 2018 Aug;137(8):657-664. doi: 10.1007/s00439-018-1924-x. Epub 2018 Aug 17.

Abstract

There are clear benefits from genomics and health data sharing in research and in therapy for individuals across societies. At the same time, citizens have different expectations and fears about that data sharing. International legislation in relation with research ethics and practice and, particularly, data protection create a particular environment that, as is seen in the articles in part two of this special issue, are crying out for harmonisation both at a procedural but at fundamental conceptual levels. The law of data sharing is pulling in different directions. This paper poses the question, 'harmonisation, an impossible dream?' and the answer is a qualified 'no'. The paper reflects on what can be seen in the papers in part two of the special issue. It then identifies three major areas of conceptual uncertainty in the new EU General Data Protection Regulation (not because it has superiority over other jurisdictions, but because it is a recent revision of data protection law that leaves universal conceptual questions unclear). Thereafter, the potential for Artificial Intelligence to meet some of the shortcomings is discussed. The paper ends with a consideration of the conditions under which data sharing harmonisation might be achieved: an understanding of a human rights approach and citizen sensitivities in considering the 'public interest'; social liberalism as a basis of solidarity; and the profession of 'researcher'.

摘要

基因组学和健康数据在研究和个体治疗中的共享带来了明显的益处,但同时,公民对数据共享有不同的期望和担忧。与研究伦理和实践相关的国际立法,特别是数据保护立法,创造了一个特殊的环境,正如本特刊第二部分的文章所表明的那样,在程序和基本概念层面都迫切需要协调。数据共享法正在朝不同的方向发展。本文提出了“协调,一个不可能的梦想?”这个问题,答案是有条件的“否”。本文反思了特刊第二部分的文章中所看到的内容。然后,它确定了新的欧盟一般数据保护条例(不是因为它比其他司法管辖区优越,而是因为它是对数据保护法的最新修订,使普遍的概念问题不明确)中的三个主要概念不确定性领域。此后,讨论了人工智能在满足某些缺点方面的潜力。本文最后考虑了实现数据共享协调的条件:在考虑“公共利益”时,理解人权方法和公民敏感性;社会自由作为团结的基础;以及“研究人员”的职业。

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