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扩大同意范围——以及稀释伦理准则?

Broadening consent--and diluting ethics?

作者信息

Hofmann B

机构信息

Faculty of Health Care and Nursing, University College of Gjøvik, Blindern, Gjøvik, Norway.

出版信息

J Med Ethics. 2009 Feb;35(2):125-9. doi: 10.1136/jme.2008.024851.

Abstract

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people's autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material.

摘要

生物样本库研究可能成果丰硕。有人认为,对于生物材料的未来研究,广泛同意是可以接受的,原因如下:a) 益处很大;b) 尊重了人们的自主权;c) 与当前做法一致;d) 风险很低。此外,如果信息得到安全处理、人们可以撤回同意,并且扩大后的研究应由伦理审查委员会批准,那么就应该允许广泛同意。然而,这些论点存在缺陷,广泛同意的标准要么限制过严,以至于无法进行任何研究,要么未能解决生物样本库研究面临的重要挑战。生物样本库研究的广泛同意可能掩盖重大的伦理挑战,并威胁对研究的信任。这并不意味着应该放弃生物样本库研究,也不意味着人们不能授权对捐赠的生物材料进行未来研究。

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