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指导基因组研究:澳大利亚人类研究伦理行为国家声明。

Guiding Genomic Research: Australia's National Statement on Ethical Conduct in Human Research.

机构信息

Australian Centre for Health Law Research, School of Law, Queensland University of Technology, Brisbane, Australia.

Graduate, School of Law, Queensland University of Technology, Brisbane.

出版信息

J Law Med. 2021 Mar;28(2):462-474.

Abstract

With advances in genomic research playing an important role in the development of clinical applications, it is important that ethical guidance for researchers is contemporary and relevant. In this article we analyse the relevant provisions in Australia's National Statement on Ethical Conduct in Human Research (revised in 2018) and consider the guidance it provides for contemporary genomics research. We analyse four key areas: genomic information; biobanking and use of human tissue; consent to participation in genomic research, including specific issues related to participation by children; and return of findings. We conclude that Australia's National Statement is well-placed to provide guidance to Australian researchers on issues relating to genomics, although there is scope for additional guidance on some issues related to consent.

摘要

随着基因组研究的进展在临床应用的发展中发挥着重要作用,为研究人员提供符合时代要求且具有现实意义的伦理指导十分重要。本文分析了澳大利亚《人类研究伦理行为国家声明》(2018 年修订版)中的相关规定,并探讨了其为当代基因组学研究提供的指导。我们分析了四个关键领域:基因组信息;生物库和人类组织的使用;参与基因组研究的同意,包括与儿童参与相关的具体问题;以及研究结果的返还。我们得出结论,澳大利亚的《国家声明》为澳大利亚的研究人员提供了与基因组学相关问题的指导,尽管在与同意相关的某些问题上还需要进一步的指导。

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