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摘要: 知情同意书的签署是生物样本库伦理建设的核心, 其结构包括"知情告知"和"自主同意"两部分主体内容。本文依据现阶段生物样本库的特点, 提出生物样本库知情同意书的规范化设计, 具体描述从"生物样本库完备告知"到"捐赠者充分知情"两部分核心内容和要求, 以供生物样本库实践者参考和借鉴。Abstract: The signing of the informed consent is the core of the ethical construction of biobank. Based on the characteristics of current biobank construction, this paper proposed the standardized design, or the example template, of biobank's informed consent. The consent is comprised of two main contents, namely "the informed consent" and "the independent consent". This paper delineated in detail both of these two parts, i.e., "fully informing the donors " and "complete informing the biobank". This paper presented a list and related requirements, hopefully, to provide a reference for practitioners of the biobank.
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Key words:
- biobank /
- informed consent form /
- standard
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[1] 沈铭贤.五个层面的挑战与三大理论难题——试论基因伦理[J].医学与哲学(人文社会医学版),2008,29:10-14. [2] Vaught J.Biobanking comes of age:the transition to biospecimen science[J].Annu Rev Pharmacol Toxicol,2016,56:211-228. [3] 世界中医药学会联合会.HRPS/CR 01-2017涉及人的生物医学研究伦理审查体系要求[EB/OL].http://xycme.csu.edu.cn/info/1075/1503.htm. [4] 刘闵.生物样本库及其伦理问题简介[J].生命科学,2012,24:1318-1324. [5] 郜恒骏.中国生物样本库——理论与实践[M].北京:科学出版社,2017:200-208. [6] 国务院办公厅.国务院办公厅关于促进和规范健康医疗大数据应用发展的指导意见[EB/OL].http://www.gov.cn/zhengce/index.htm. [7] 郜恒骏,周学迅,张小燕,等.生物样本的法律和伦理问题[J].中国医药生物技术(增刊),2018,13:60-66.
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