摘要
通过对近10年我国临床医学研究人员忽视知情同意现状的分析,以《纽伦堡法典》、《赫尔辛基宣言》等国际公认的法规和准则,以及1998年以来我国相继颁布、完善、实施的《涉及人的生物医学研究伦理审查办法(试行)》、《药物临床试验质量管理规范》、《临床药理基地管理指导原则》、《中华人民共和国执业医师法》等相关的法律、法规、原则、规范以及伦理道德为依据,探讨生物医学期刊如何在临床试验知情同意督查中发挥应有的作用。
This article using current situation analyzes the clinical research staffs neglect of informed consent in clinical trials to investigate how the biomedical journals play a role in clinical trial supervision of informed consent, based on the international laws and regulation, such as Nuremberg Code, the Helsinki Declaration,as well as the relative laws, regulations, principles, standards concerning ethics and morality having been issued by Chinese government since 1998.
出处
《医学与哲学（A）》
CSSCI
北大核心
2009年第6期24-26,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词
生物医学期刊
临床试验
伦理学
知情同意督查
biomedical journals, clinical trials, ethics, supervision of informed consent
