摘要
目的:为我国药物临床试验相关立法的完善以及受试者人权的保护提供参考。方法:介绍药物临床试验中知情同意权保护的现状,对知情同意权的构成要素进行阐释,并对我国知情同意权保护实践中存在的问题及原因进行分析。结果与结论:我国尚须进一步完善药物临床试验的立法,加强对研究人员的法制教育,加强对违法侵权行为的法律监督。
OBJECTIVE： To provide the reference for the improvement of GCP （good clinical practice） regulations and protection of subject＇s human rights. METHODS： The status quo of the protection of subject＇s right of informed consent and the elements for the right of informed consent and the existing problems in its practice in China were analyzed. RESULTS ＆ CONCLUSIONS： China should further promote the legislation of clinical trials, reinforce the legal education of researchers, and emphasize the supervision on the illegal tort act.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第28期2163-2166,共4页
China Pharmacy
关键词
受试者
临床试验
知情同意权
Human subject
Clinical trial
Informed consent
