摘要
目的 :探讨在我国建立药物临床试验赔偿机制的必要性。方法 :从媒体报道的海宁市“韩国人参丸事件”入手 ,分析药物临床试验的法律属性 ,阐述受试者与研究者的特别权利义务关系 ,及目前我国药物临床试验中存在的问题。结果与结论 :随着药物临床试验项目在我国的陆续开展及扩大 ,相关部门应通过立法对药物临床试验受试者予以强制保险 ,实行无过错归责制度 ,以确保受试者的合法权益得到保障。
OBJECTIVE:To discuss the necessity of compensation system in clinical trial of medicine in China.METHˉODS:The legal attributes of clinical trial of medicine were analyzed based on the report of'Korean Ginseng Bolus Event'in Haining,the relation of rights and obligations between the subjects and researchers and the current problems in clinical trial in China were discussed.RESULTS&CONCLUSIONS:With the development of clinical trial of medicine in China,laws should be established to enforce compulsory insurance for the subjects and carry out no fault responsibility in order to ensure their legal rights.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第10期724-727,共4页
China Pharmacy
