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生物样本库建设过程中的知情同意问题 被引量:8

Informed Consent in the Governance of Biobank
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摘要 生物样本库的特殊性给传统的知情同意模式提出了严峻挑战,如何选择合适的知情同意模式已经引起了学术界的广泛讨论。首先,讨论生物样本库的建设情况以及实施知情同意的特殊性,并以英国生物样本库为例阐述知情同意在生物样本库中的实践。接着,论述生物样本库建设中采用的几种典型的知情同意模式,并分析其优缺点。最后,从知情同意的理论演变、中国的伦理治理现状和相关经验研究等角度出发进行分析,论证了我国生物样本库建设中,采用多层次知情同意模式的合理性。 The particularity of biobank poses a severe challenge to the traditional informed consent.How to choose the appropriate pattern of informed consent has aroused extensive discussions among scholars.This paper firstly discussed the construction of biobanks in China and its particularity in terms of implementing informed consent.Secondly,by taking the UK as an example,it examined the practice of informed consent in biobank.Thirdly,several typical patterns of informed consent and their advantages and disadvantages were analyzed.Finally,based on the analysis of the evolution of informed consent theory,the ethical governance and relative empirical studies of biobanks in China,this paper proposed that the multi-layered informed consent model of biobank should be applied in China.
作者 杨成尚 YANG Cheng-shang(School of Marxism, Fudan University, Shanghai 200433, Chin)
出处 《医学与哲学(A)》 北大核心 2017年第2期26-30,共5页 Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词 生物样本库 知情同意 多层次知情同意模式 biobank informed consent multi-layered informed consent
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