随着医学研究的不断深入以及精准医学与转化医学等发展的需要,规范化高标准的生物样本库建设是必需的.而目前国内尚无有关生物样本库的统一伦理规范与标准.基于此,概述了生物样本相关伦理指南法规与伦理委员会审查与监督,并论述了生物样本库相关知情同意的问题:即知情同意的告知信息,生物样本的采集、保存与使用需要获得捐赠者的明确同意,知情同意的模式问题,以期为将来制定标准与规范奠定基础.%With the constant deepening of medical research and the need of translational medicine,it is neces-sary to normalize the construction of biobank with high - standard. However,there are no issued ethical guideline and standard for biobank in China at present. Based on this,this paper expounded the related ethical guidelines for biological samples and the review and supervision of ethics committee,and deeply expounded the issues of informed consent related to biobank,that is,the informed information of informed consent,the need to get explicit consent from the donor when collect,preserve and use the biological samples and the mode of informed consent,in order to lay the foundation for the future development of standards and norms.
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