摘要
通过论证未成年人参与药物临床试验的必要性,介绍与比较英国、德国、美国和澳大利亚等国对未成年人参与药物临床试验的立法规制,对我国相关立法状况进行分析,认为我国应修改《药物临床试验质量管理规范》等法律文件,要求研究者考察未成年受试者同意能力的发展状况、明确伦理审查的标准和引入风险利益评估体系。
This is to discuss the necessity of enlisting the minor into the drug clinical trial, introduce and compare the legislation of the drug clinical trial involved minor subjects in UK, Germany, USA, Australia. It analyzed our country＇s corresponding legislation and concluded that the Chinese legislation should amend the Good Clinical Practice and the corresponding legal documents： the {nvestigator should evaluate the status of developmental consent capacity of the minor; the standard of ethical review should be defined in the law,the risk and benefit evaluation system should be adopted.
出处
《医学与哲学（A）》
CSSCI
北大核心
2009年第2期48-50,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
基金
江苏省教育厅高校哲学社会科学基金指导项目"临床试验中受试者权益保障的法律制度研究"
项目编号:07SJD820013
关键词
未成年人
药物临床试验
受试者保护
比较法研究
minor, drug clinical trial, protection of subjects, study of comparative law
