日本药物临床试验知情同意发展状况及启示

Development of Informed Consent of Drug Clinical Trials in Japan

通过归纳分析日本药物临床试验中知情同意的发展内容,为中国药物临床试验发展提供借鉴经验。通过内容分析法,对日本医学中央杂志收录的有关药物临床试验知情同意相关文献信息进行摘录、归类与分析。总结日本药物临床试验中知情同意的概念与重要性、受试者的认知与决策、问题、内容、团队建设及优化措施六大主题内容。提出我国药物临床试验应借鉴日本的情况在完善补偿制度,知情同意书内容改善以及教育培养方面需要重点关注,如何本土化发展日本经验是今后进一步研究的重点。

This paper summarized the development of informed consent of drug clinical trials in Japan in order to provide reference for the development of clinical trials in China.Through content analysis,the relevant literature about informed consent of drug clinical trials collected by the Japanese Medical Central Journal were extracted,categorized and analyzed.The six themes of the concept and importance of informed consent,subject cognition and decision making,problems,content,team building and optimization measures were analyzed.In conclusion,China should draw lessons from Japan in improving compensation mechanism,improving the content of informed consent and education and training.How to localize the development of Japanese experience should be the focus of further research in the future.