日本《临床研究法》对我国的启示

Enlightenment of Japanese Clinical Trials Act to China

日本《临床研究法》适用于日本《药事法》规定的临床试验以外的、在人体开展药物和医疗器械的有效性或安全性研究。它明确了实施临床研究的程序,规范了经认证的临床研究审查委员会的审查过程,并完善了临床研究资金等信息的公布制度。通过研究日本《临床研究法》的立法背景和相关法律要求,梳理临床研究实施中的各方责任,笔者提出制定高阶的专门法律、建立伦理委员会认证机构、加强受试者的保护、提高研究经费透明度等建议。

Japanese Clinical Trials Act is applicable to the research on the effectiveness or safety of drugs and medical devices in human body,except for the clinical trials regulated by the Japanese Pharmaceutical Affairs Law.It defines the procedures for the implementation of clinical researches,standardizes the review process of the certified clinical research review committee,and improves the disclosure system of clinical research funds and other information.By studying the legislative background and relevant legal requirements of Japanese Clinical Trials Act and combing the responsibilities of all parties in the implementation of clinical research,we put forward some suggestions in this paper,such as formulating high-level special laws,establishing the certificate authority of ethics committee,strengthening the protection of subjects,and improving the transparency of research funds.