中国医学伦理学Issue(1)：39-43,5.
临床研究项目风险识别与评价∗
Risk Identification and Evaluation of Clinical Research Projects
摘要
Abstract
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Key words
Clinical Study/Risk/Identification and Evaluation/Institutional Ethics Committe分类
医药卫生引用本文复制引用
李红英,柴华旗,徐溢涛..临床研究项目风险识别与评价∗[J].中国医学伦理学,2015,(1):39-43,5.基金项目
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) （编号:31010303330034）
