临床研究项目风险识别与评价  

Risk Identification and Evaluation of Clinical Research Projects

作　　者：李红英[1] 柴华旗[2] 徐溢涛[1] 

机构地区：[1]苏州大学附属第一医院伦理委员会,江苏苏州215006 [2]苏州市立医院本部,江苏苏州215000

出　　处：《中国医学伦理学》2015年第1期39-43,共5页Chinese Medical Ethics

基　　金：2009年苏州市科技局专项科研课题:医院伦理委员会运作现状及策略探讨;课题编号:YJS0911;2013年苏州大学附属第一医院院课题:机构伦理委员会普德培训职能探讨(编号:31010303330034)

摘　　要：临床研究存在相应风险,在研究期间有时可造成患者/受试者直接的身心健康损害甚至生命安全,也有的在研究结束后一定时期或在子代才反映出其远期不良效应。论述了临床研究项目风险的分类方法,依据其影响因素将风险分为自身性和人为性两类,并从自身性风险、研究者风险、申办者问题和受试者问题这四个方面详细探讨了风险的识别及其评价。在此基础上提出了规避风险的策略:构建临床研究和伦理管理运作监管平台,加强对研究项目风险的外部监督,申办者或研究者各司其职,加强机构伦理委员会能力建设,充分发挥机构伦理委员会职能,风险转移,降低研究风险。Clinical studies remain the corresponding risk, during the study period can sometimes cause pa-tients/subjects health damage directly or even life safety;also some at the end of the study after a certain period or in the offspring can reflect the long-term adverse effects. Clinical research project risk classification method is dis-cussed, according to the influencing factors of risk can be divided into two categories, their sexual and artificially, and from their sexual risk, the researchers risk, the sponsor problems and subjects of the four aspects of risk identi-fication and evaluation is discussed in detail. Based on this, advances the tactics of risk aversion： construction of clinical research and regulation of ethical management platform,To strengthen the external supervision of research project risk, The sponsor or researchers do their job, To strengthen the construction of institutional ethics committee ability, Give full play to the institutional ethics committee functions,Risk transfer and reduce the risk.

关 键 词：临床研究 风险 识别与评价 机构伦理委员会 

分 类 号：R-052[医药卫生]