协和医学杂志

2019, v.10(01) 77-80

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生物样本库知情同意书规范化设计
Standardized Design of Biobank's Informed Consent Form

满秋红;薛江莉;杨亚军;
MAN Qiu-hong;XUE Jiang-li;YANG Ya-jun;The People's Hospital of Suzhou National New & Hi-tech Development Zone;Taizhou Insititue of Health Sciences,Fudan University;School of Life Sciences,Fudan University;

摘要(Abstract):

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。
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.

关键词(KeyWords): 生物样本库;知情同意书;规范
biobank;informed consent form;standard

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基金项目(Foundation): 国家重点研发计划(2016YFF0202301、2016YFC1201701)

作者(Author): 满秋红;薛江莉;杨亚军;
MAN Qiu-hong;XUE Jiang-li;YANG Ya-jun;The People's Hospital of Suzhou National New & Hi-tech Development Zone;Taizhou Insititue of Health Sciences,Fudan University;School of Life Sciences,Fudan University;

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