国内外临床试验保险实施现状研究

采用文献分析法,了解、分析比较包括中国、日本、印度、美国等22个国家在内的国内外临床试验保险法律、法规,实施现状及制度细则。发现我国临床试验保险制度并不完善,未能很好地发挥保障受试者权益的作用。通过逐步设立临床试验保险相关法律条例,持续提升临床试验机构与伦理委员会的审查能力,构建第三方损害评定机制,不断强化各方的自我保护意识与维权意识、法律意识等举措,加强对受试者的保护,进一步完善我国临床试验保险制度。

Status Quo of Clinical Trials Insurance Practice at Home and Abroad

Through literature review, we investigate and compare the clinical trial insurance laws,regulations,implementation status and system in 22 countries,including China,Japan,India,the United States and so on.It is found that the insurance system of clinical trials in China is not perfect and fails to play agood role in protecting the rights and interests of subjects.The strategies to improve the clinical trial insurance system are proposed,including gradually establishing the relevant laws and regulations of clinical trial insurance,continuously improving the review ability of clinical trial institutions and their ethics committees,building the third-party damage assessment mechanism,continuously strengthening the self-protection awareness,rights protection awareness,and legal awareness of all parties,which are aimed to strengthen the protection of subjects in clinical trials.