摘要
对药物临床试验的方案、知情同意书以及实施情况的伦理审查在药物临床试验中具有举足轻重的作用,对伦理审查的科学管理是药物临床试验实施的伦理性和科学性的重要保证。以伦理审查、药物临床试验为关键词,对药物临床试验伦理审查相关文献进行分析,并结合管理学中的沟通理论以及某三甲医院伦理审查工作的实际,探讨了沟通对伦理审查管理的积极作用以及管理中存在的沟通问题,并讨论医院应如何在实践中有效运用沟通理论来提高伦理审查管理的效率。
The ethical review to trial design, informed consent and its implementation occupies a pivotal position in drug clinical trials. And appropriate management of ethical review can ensure the ethical and scientific characteristic in the drug clinical trials. Through literature review about ethical review, combining with management theory and the situation of ethical review in hospital, it proved that the problems existed in management of ethical review and the smooth communication were positive in ethical review. And it discussed how to improve the efficiency of management of ethical review by better communication based on hospital practice.
出处
《医学与哲学（A）》
北大核心
2015年第2期33-36,共4页
Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词
伦理审查
沟通理论
药物临床试验
ethical review, communication theory, drug clinical trials
