样本库中临床剩余生物样本的伦理问题  

Ethical issues in the process of inclusion of residual tissue in biobank

作　　者：崔焱[1,2,3] 张允[1,2,3] 辛有清[1,2,3] 

机构地区：[1]首都医科大学附属北京友谊医院科研办 [2]首都医科大学附属北京友谊医院医学伦理办公室 [3]国家消化系统疾病临床医学研究中心,北京100050

出　　处：《临床和实验医学杂志》2015年第21期1763-1766,共4页Journal of Clinical and Experimental Medicine

基　　金：国家科技重大专项"十二五"计划(2013ZX10002004);北京市科委科技计划重大项目(D12110000391203);北京市医院管理局临床医学发展专项(ZYLX201308)

摘　　要：生物样本库中纳入的临床生物样本中,既往留存的临床剩余样本是其中很重要的组成部分。对于这类样本的入库及管理面临一系列伦理问题,主要包括:剩余生物样本纳入样本库是否需要伦理审查;是否需要取得捐献者签署的知情同意书;以及样本采集、保存、管理的标准化和信息保密问题。文章对这些问题进行分析整理,阐述伦理要点及关注点,为生物样本库建设及运作过程的伦理问题提供解答及指导。Residual biological materials are important components of human tissue specimens incorporated in the biobank. A range of ethi-cal issues are involved in the incorporation of such samples and their management including ethical review necessity for residual biological materials incorporation,whether the informed consent form required to sign by donors and the standardization and information confidentiality of the sampling, storage,management and related data of samples. Here we analyze these issues and expound key ethical points for providing answers and guidance to the ethical questions in the process of biobank construction and operation.

关 键 词：临床剩余生物样本 样本库 知情同意 隐私保密 

分 类 号：R-052[医药卫生]