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“相较于黑白,它更偏向灰色地带”:临床遗传学家对欧洲消费者基因检测监管的看法。

'It's much more grey than black and white': clinical geneticists' views on the oversight of consumer genomics in Europe.

作者信息

Kalokairinou Louiza, Borry Pascal, Howard Heidi C

机构信息

Department of Public Health & Primary Care, Centre for Biomedical Ethics & Law, University of Leuven, Leuven, Belgium.

Centre for Research Ethics & Bioethics, Uppsala University, Uppsala, Sweden.

出版信息

Per Med. 2020 Mar;17(2):129-140. doi: 10.2217/pme-2019-0064. Epub 2020 Mar 10.

Abstract

Direct-to-consumer (DTC) genetic tests (GT) have created controversy regarding their risks and benefits. In view of recent regulatory developments, this article aims to explore the attitudes of European clinical geneticists toward the oversight of DTC GT. Fifteen semi-structured interviews were performed with clinical geneticists based in ten European countries. The transcripts were thematically analysized in an iterative process. Respondents strongly supported quality standards for DTC GT equal to those applied within the healthcare setting. Despite participants unanimously considering the involvement of healthcare professionals to be important, mandatory medical supervision was controversial. In this regard, promoting education and truth-in-advertising was considered as being key in maintaining a balance between protecting consumers and promoting their autonomy.

摘要

直接面向消费者(DTC)的基因检测(GT)在其风险和益处方面引发了争议。鉴于近期的监管发展,本文旨在探讨欧洲临床遗传学家对DTC GT监管的态度。对来自欧洲十个国家的临床遗传学家进行了15次半结构化访谈。对访谈记录进行了反复的主题分析。受访者强烈支持DTC GT的质量标准应与医疗环境中应用的标准相同。尽管参与者一致认为医疗保健专业人员的参与很重要,但强制医疗监督存在争议。在这方面,促进教育和广告真实性被认为是在保护消费者和促进其自主性之间保持平衡的关键。

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