摘要
文章描述了受试者在临床研究中面临风险的特点,从伦理委员会组织机构与人员设置、培训、跟踪审查及伦理监管等方面列举了伦理审查风险的表现形式,剖析原因,并提出应通过加强监管、改进组织机构设置、加大培训力度、加强实地访查、完善跟踪验收机制、建立独立数据和安全监查委员会等措施规避风险。
Describe the features of risk for subjects in clinical studies cited the risk manifestations of ethical review：the personnel organization of ethical review boards,and the composition of the ethical review board members.as well as ehical training,follow-up review and ethical regulatory.To avoid these risks,an analysis is made on the causes of ethical review risks,and recommendations are proposed on Strengthen supervision,refom of ethicaI review board setup,greater efforts on training,strengthen field visits,improving mechanism of tracking and acceptance,establishment of an independent data and safety monitoring board.
出处
《世界中医药》
CAS
2017年第4期917-919,共3页
World Chinese Medicine
基金
新疆医科大学人文社科基金(编号:2013XYSK60)
关键词
临床医学
伦理审查
风险
防范
机制
Clinical Medicine
Ethical review
Risk
Prevention
