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医疗市场中的流行病学、质量控制与消费者获取:澳大利亚人类基因技术监管格局的变化

Epidemiology, quality control and consumer access in the medical marketplace: the changing landscape of human genetic technology regulation in Australia.

作者信息

Savard Jacqueline

机构信息

Centre for Values, Ethics and the Law in Medicine (VELiM), School of Public Health, The University of Sydney.

出版信息

J Law Med. 2013 Mar;20(3):595-603.

PMID:23600191
Abstract

Advances in genetics, genetic therapeutics and the application of genetic technologies to many aspects of human life have challenged the capacity of regulatory authorities and legislative processes the world over. In Australia, developments in the "new genetics" prompted the government to initiate a major inquiry into the protection of human genetic information, resulting in the production and publication of Report 96, titled "Essentially Yours: The Protection of Human Genetic Information in Australia" in 2003. This article examines the recommendations set out in this report and how they have provided Australia with a framework to deal with the advances in human genetic technologies, using the examples of direct-to-consumer personal genome testing and whole-genome sequencing.

摘要

遗传学、基因治疗学的进展以及基因技术在人类生活诸多方面的应用,对全球监管机构的能力和立法程序构成了挑战。在澳大利亚,“新遗传学”的发展促使政府对人类基因信息的保护展开重大调查,最终于2003年出台并发布了第96号报告,题为《完全属于你:澳大利亚的人类基因信息保护》。本文以直接面向消费者的个人基因组检测和全基因组测序为例,审视了该报告中提出的建议,以及这些建议如何为澳大利亚提供了一个应对人类基因技术进展的框架。

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Epidemiology, quality control and consumer access in the medical marketplace: the changing landscape of human genetic technology regulation in Australia.医疗市场中的流行病学、质量控制与消费者获取:澳大利亚人类基因技术监管格局的变化
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The Australian joint inquiry into the Protection of Human Genetic Information.澳大利亚对人类遗传信息保护的联合调查。
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