摘要
为了保护受试者的合法权益,药物临床试验的伦理审查必须规范化进行。通过走访哈尔滨医科大学附属医院伦理委员会了解到,伦理审查程序缺乏相对完整性,特别是跟踪审查程序还在完善过程中,没有形成统一具体的操作规程。对此,结合我国实际情况,借鉴国外先进经验,提出构建药物临床试验跟踪审查程序的建议。
In order to protect the legitimate rights and interests of subjects, drug clinical trials of ethical review must be standardized. The author visited Harbin Medical University Ethics Committee,have known that ethics review process lack of relative integrity, in particular, the track review is still in the process of improvement, there is no unified and specific pro- cedures. With this regard,based on China＇ s actual situation,learning from the advanced experience from abroad, the build recommendations is proposed to track review procedures of clinical trials.
出处
《医学与哲学（A）》
北大核心
2012年第8期16-18,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
基金
黑龙江省教育厅课题"人体实验伦理审查程序正当化问题研究"
项目编号:11552166
关键词
药物临床试验
伦理审查
跟踪审查
drug clinical trials, ethics review, track review
