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本文引用的文献

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Bystander risk, social value, and ethics of human research.旁观者风险、社会价值与人体研究伦理
Science. 2018 Apr 13;360(6385):158-159. doi: 10.1126/science.aaq0917. Epub 2018 Apr 12.
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Pricing Externalities to Balance Public Risks and Benefits of Research.为平衡研究的公共风险和利益而定价外部性。
Health Secur. 2017 Jul/Aug;15(4):401-408. doi: 10.1089/hs.2016.0118. Epub 2017 Aug 2.
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The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens.功能获得性研究中生物安全考量的伦理问题,该研究导致了潜在大流行病原体的产生。
J Med Ethics. 2015 Nov;41(11):901-8. doi: 10.1136/medethics-2014-102619. Epub 2015 Aug 28.
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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
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The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.《关于群组随机对照试验的伦理设计和实施的渥太华声明》。
PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20.
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A framework for risk-benefit evaluations in biomedical research.生物医学研究中风险-效益评估的框架。
Kennedy Inst Ethics J. 2011 Jun;21(2):141-79. doi: 10.1353/ken.2011.0007.
7
Missing the forest: further thoughts on the ethics of bystander risk in medical research.只见树木,不见森林:关于医学研究中旁观者风险伦理的进一步思考
Camb Q Healthc Ethics. 2007 Fall;16(4):483-90. doi: 10.1017/s0963180107070648.
8
Third-party risks in research: should IRBs address them?研究中的第三方风险:机构审查委员会应处理这些风险吗?
IRB. 2007 May-Jun;29(3):1-5.
9
Protecting third parties in human subjects research.在人体研究中保护第三方。
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Medical research, risk, and bystanders.医学研究、风险与旁观者
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临床试验中对旁观者的调控影响:一个尚未解决的前沿领域。

Regulating impact on bystanders in clinical trials: An unsettled frontier.

作者信息

Eyal Nir, Kimmelman Jonathan, Holtzman Lisa G, Lipsitch Marc

机构信息

Center for Population-Level Bioethics, Rutgers University, New Brunswick, NJ, USA.

Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, Montreal, QC, Canada.

出版信息

Clin Trials. 2019 Oct;16(5):450-454. doi: 10.1177/1740774519862783. Epub 2019 Aug 1.

DOI:10.1177/1740774519862783
PMID:31368813
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6742522/
Abstract

This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders.

摘要

本文非正式地回顾了关键的研究伦理准则和法规、学术成果以及研究性研究,发现它们在如何看待医学研究中对旁观者(即研究虽未将其作为参与者,但却使其面临风险的非参与者)的风险方面存在很大差异。这些关键来源中,有些对旁观者未作考虑或极少考虑,而另一些则给予他们最大程度的保护(比给予研究参与者的保护还要大)。这一尚未解决的前沿领域将受益于对保护研究旁观者伦理的更深入调查。