生物样本库的伦理审查  

Ethical Review of Biobank

作　　者：赵励彦[1] 范贞[2] 刘瑞爽 张玉梅[4] 宋艳双[1] ZHAO Liyan;FAN Zhen;LIU Ruishuang;ZHANG Yumei;SONG Yanshuang(Biomedical Ethics Committee,Peking University,Beijing 100191,China;Beijing Bairui Law Firm, Beijing 100097, China;Public Education Department, Peking University Health Science Center, Beijing 100191, China;Shool of Public Health,Pering University Health,Sicence Center, Beijing 100191,China)

机构地区：[1]北京大学生物医学伦理委员会,北京100191 [2]北京市百瑞律师事务所,北京100097 [3]北京大学医学部公共教学部,北京100191 [4]北京大学医学部公共卫生学院,北京100191

出　　处：《中国医学伦理学》2020年第3期345-348,共4页Chinese Medical Ethics

基　　金：北京大学科研管理课题“公众对生物样本库及其知情同意模式的态度、参与意愿及影响因素的研究”(PKU-8)。

摘　　要：建立生物样本库的目的是采用专业的方法保存生物样本和数据用于将来的研究。生物样本库的伦理审查是加强生物样本库管理和保护、促进其有效开发利用的关键环节。针对生物样本库可能涉及的三种情况,从生命伦理学的基本原则出发分析了不同情况的伦理审查要点,审查生物样本库相关研究是否符合相关伦理法规和管理要求,以确保生物样本库的正常运行,推进生物样本库的维护和使用。生物样本库在我国正逐渐向着规范化、系统化方向运行,希望可以为生物样本库的伦理审查提供参考。The purpose of establishing the biobank is to use professional methods to preserve biological samples and data for future research.The ethical review of biobank is a key link to strengthen the management and protection of biobank and promote its effective development and utilization.In terms of the three situations that may be involved in the biobank,this paper analyzed the key points of the ethical review in different situations from the basic principles of bioethics,and examined whether the relevant research of the biobank conforms to relevant ethical regulations and management requirements,so as to ensure the normal operation of the biobank and promote the maintenance and use of the biobank.Biobank is gradually moving towards standardized and systematic direction in China,which is expected to provide reference for the ethical review of biobank.

关 键 词：生物样本库 伦理审查 泛化知情同意 二次使用 

分 类 号：R-052[医药卫生]