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若要使研究被允许,它就必须造福人类受试者吗?

Must research benefit human subjects if it is to be permissible?

作者信息

Wikler Daniel

出版信息

J Med Ethics. 2017 Feb;43(2):114-117. doi: 10.1136/medethics-2015-103123. Epub 2016 Aug 29.

Abstract

Must medical experiments with human subjects offer them a 'favourable risk-benefit ratio', that is, more expectation of benefit than harm or burden, if they are to be judged as ethically justified? Ethical justification is easier for experiments that do offer net benefit to subjects, but ethical justification is possible also for some experiments that do not. Basic science experiments with healthy volunteers and 'Phase I' drug trials that seek to determine tolerable dosage levels are routinely approved by ethical review committees; moreover, guidance they receive from government funding agencies specifically asks them to weigh risks to subjects against benefits to subjects and also benefits to those who may benefit from the knowledge gained in the experiment. If a puzzle remains, it is why there remains any assumption that research ethics requires a 'favourable risk-benefit ratio' for the individual research subject.

摘要

涉及人类受试者的医学实验若要被判定在伦理上是合理的,就必须为他们提供“有利的风险效益比”,即预期的益处多于伤害或负担吗?对于确实能给受试者带来净益处的实验来说,伦理合理性更容易论证,但对于一些不能带来净益处的实验来说,伦理合理性也是有可能的。涉及健康志愿者的基础科学实验以及旨在确定可耐受剂量水平的“一期”药物试验通常会得到伦理审查委员会的批准;此外,它们从政府资助机构获得的指导特别要求它们权衡受试者面临的风险与受试者获得的益处,以及那些可能从实验中获得的知识中受益的人所获得的益处。如果仍存在一个疑问,那就是为什么仍然存在这样一种假设,即研究伦理要求为单个研究受试者提供“有利的风险效益比”。

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