摘要
通过对文献以及日本相关法律制度的梳理,发现日本在补偿责任的界定以及强制性上都有法律明确规定,具体的补偿内容完备,覆盖面广。我国药物临床试验补偿责任的规定在法律框架、补偿责任保险、补偿制度方面都存在不足。借鉴日本的补偿制度,我国需要进一步确立临床试验补偿责任的法律地位,完善补偿责任的内容设计,构建我国健康受试者的损害救济制度。
Based on the analysis of literature and the relevant Japanese legal system,it was found that regulations on the definition of compensation liability and mandatory are clear in Japan.And the specific compensation content is complete and a wide range was covered.The provisions on the compensation responsibility for drug clinical trials in China are insufficient in legal framework,compensation liability insurance,and compensation system.Drawing on the compensation system of Japan,the legal status of compensation for clinical trials should be established,the content design of compensation responsibility should be improved,and a damage relief system should be constructed for healthy subjects in China.
作者
马大力
邓蕊
MA Da-li;DENG Rui(College of Humanities and Social Sciences,Shanxi Medical University,Taiyuan 030001,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第23期2808-2813,共6页
Chinese Journal of New Drugs
基金
山西省软科学研究项目(2018041036-3)
山西省高等学校人文社会科学重点研究基地项目资助(20190115)
山西省研究生教育改革课题(2019JG098)
关键词
日本
药物Ⅰ期临床试验
补偿责任
受试者权益
救济制度
Japan
drug phase I clinical trial
compensation responsibility
subject rights
relief system
