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保护无法给予知情同意的受试者:迈向“最小”风险的更好标准。

Protecting subjects who cannot give consent: toward a better standard for "minimal" risks.

作者信息

Wendler David

机构信息

Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institute of Health, USA.

出版信息

Hastings Cent Rep. 2005 Sep-Oct;35(5):37-43.

PMID:16295263
Abstract

When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than "minimal" risks, according to guidelines accepted around the world. We need a new standard for what "minimal" risks are, however--one that recognizes that participating in non-beneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.

摘要

根据全球公认的指导方针,当儿童和无行为能力的成年人参与对他们没有直接益处的研究时,他们所面临的风险不得超过“最小”风险。然而,我们需要一个关于什么是“最小”风险的新标准——一个认识到参与无益处的研究就如同参与慈善活动的标准。这样一个标准似乎有可能为这些弱势群体提供更严格的保护。

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