Legal Analysis and Advice on Clinical Trial of Medicine from"Korean Ginseng Bolus Event"
- VernacularTitle:从“韩国人参丸事件”反思我国药物临床试验中的法律问题
- Author:
Yue WANG
- Publication Type:Journal Article
- Keywords:
Clinical trial of medicine;
Informed consent;
No fault responsibility;
Law
- From:
China Pharmacy
2001;0(10):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To discuss the necessity of compensation system in clinical trial of medicine in China.METH?ODS: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.
