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临床试验中对旁观者的风险:一场研讨会。

Risk to bystanders in clinical trials: A symposium.

作者信息

Eyal Nir

机构信息

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

出版信息

Clin Trials. 2019 Oct;16(5):447-449. doi: 10.1177/1740774519862758. Epub 2019 Aug 1.

DOI:10.1177/1740774519862758
PMID:31368795
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6742523/
Abstract

This symposium takes a critical look at the ethics of impact on "bystanders" to clinical research. By that we mean study non-participants who nevertheless are at risk of being affected by the study in some way. This introduction suggests some questions to consider while reading through the symposium contributions, and gives a précis of each.

摘要

本次研讨会批判性地审视了临床研究对“旁观者”的影响所涉及的伦理问题。我们所说的“旁观者”是指那些并非研究参与者,但却有可能以某种方式受到研究影响的人。本引言提出了一些在阅读研讨会论文时需要思考的问题,并对每篇论文做了内容摘要。

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Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants.最小化还是合理?考虑到对不同意的旁观者进行研究的伦理门槛以及对不同意的参与者的影响。
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本文引用的文献

1
A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection.一项在感染早期开始接受抗逆转录病毒治疗的 HIV 感染者中进行的治疗性疫苗接种的随机对照安全性/疗效试验。
Sci Transl Med. 2017 Dec 6;9(419). doi: 10.1126/scitranslmed.aan8848.
2
Ethics of maternal vaccination.孕产妇疫苗接种的伦理学
Science. 2017 Oct 27;358(6362):452-453. doi: 10.1126/science.aao4219.
3
Ethics of Internet research trigger scrutiny.
Nature. 2017 Oct 3;550(7674):16-17. doi: 10.1038/550016a.
4
Interrupting antiretroviral treatment in HIV cure research: scientific and ethical considerations.艾滋病治愈研究中抗逆转录病毒治疗的中断:科学与伦理考量
J Virus Erad. 2017 Apr 1;3(2):82-84. doi: 10.1016/S2055-6640(20)30287-9.