样本库受试者隐私保护管理的现状分析  

Status Analysis of Subjects' Privacy Protection Management in Sample Bank

作　　者：陈晓云[1] 王思洁[1] 高洁[1] 姜维洁[2] CHEN Xiaoyun WANG Sifie GAO Jie JIANG Weifie(Ethics Committee, the Affiliated Longhua Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200126, China The Experiment Center, the Affiliated Longhua Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200126, China)

机构地区：[1]上海中医药大学附属龙华医院医学伦理委员会,上海200126 [2]上海中医药大学附属龙华医院中心实验中心,上海200126

出　　处：《中国医学伦理学》2017年第1期74-77,共4页Chinese Medical Ethics

基　　金：上海市卫计委中医药新三年行动计划助项目。编号:ZY3-RCPY-3-1058 ZY3-CCCX-2-1002;Fogarty International Center of the US NIH(美国国立卫生研究院基金(NIH))

摘　　要：总结了国内外样本库隐私保护方面的法规和指南,分析了国内样本库隐私保护方面的受试者是否从真正意义上"去标识化"和隐私是否会被泄露等问题。在此基础上,结合我国国情提出相应的建议,以期通过建立完善的去标识化流程,加强访问权限以及生物样本库系统的监管,并加强对研究者隐私规则的培训,加强相关监督和质控管理等措施改善目前的状况。This paper summarized the domestic and foreign laws and guidelines of privacy protection in sample bank and analyzed the problems that whether the subjects were in the real sense of ＂no identification＂ and whether the privacy would be leaked. Based on this and combined with Chinese conditions, it put forward the corresponding suggestions to improve the current situation, through establishing a thorough process of no identification, strengthening the access permission and the supervision of biological sample bank system, strengthening the training of researchers＇ privacy rules ,strengthening the related supervision and management of quality control, and so on.

关 键 词：生物样本库 隐私保护 医学临床科研 科研伦理 

分 类 号：R-052[医药卫生]