摘要
通过分析我国医学伦理委员会在临床研究项目审查工作中存在的问题,阐述了完善伦理审查机制的必要性,从临床研究项目的申请注册、运行程序、档案管理、信息化平台建设等方面入手,构建了科学、规范、可操作性强的伦理审查工作机制。
Through analyzing the problems existing in Chinese MEC＇s review of clinical research projects, this paper expounds the necessity of perfecting the ethical review mechanism, and from the aspects of the application for registration,operational procedure, archives management, and information platform construction, etc. of clinical research projects,constructs a scientific and normative ethical review mechanism with stronger maneuverability.
出处
《山西科技》
2016年第4期22-26,共5页
Shanxi Science and Technology
基金
山西省软科学研究计划资助项目(编号:2015041004)
关键词
医学伦理委员会
伦理审查机制
运行程序
信息化平台
MEC
ethical review mechanism
operational procedure
archives management
information platform
