临床检验血样本科研再利用的伦理考量

Ethical Considerations on the Reuse of Clinical Laboratory Blood Samples in Research

通过查阅目前国内外的相关法规指南,从临床废弃样本处理、科研生物样本管理等相关的国内外法规和流程入手,分析总结方案设计阶段的伦理注意点,并结合样本库与临床检验剩余样本研究的差异及样本的归属权等焦点问题进行分析,为伦理委员会在以后审查此类研究提供理论依据。

By referring to the domestic and foreign relevant regulatory guidelines,this paper analyzed and summarized the ethical point in the design phase in the perspective of relevant regulations of clinical waste sample management and biological sample management. It also analyzed the focus problems including the difference in sample library and clinical laboratory remaining sample as well as the ownership of the sample,to provide theoretical basis for ethics committee to review this kind of protocols.