Study On The Protection System Of The Rights And Interests Of The Human Subjects Of Clinical Trials In Japan

The development of medicine can not be separated from the early support of clinical trials,which are the golden standard to verify the effectiveness and safety of new drugs and medical devices.The role of subjects in clinical trials is crucial.Although medical clinical trials have many positive effects on reducing the risk of being used by society after new drugs are put into market,since the subjects of clinical trials are mainly healthy volunteers or patients,they need to take a high risk in clinical trials.Because once the clinical trials failed,the subjects will pay the price of health and even their lives.Therefore,how to promote the development of medical research under the premise of ensuring the legitimacy of medical clinical trials and the rights and interests of subjects has become an important topic of our research.As a member of the ICH and one of the enacting countries of the ICH-GCP,Japan has established a legal system ranging from clinical trial implementation norms and clinical research ethics principles to specialized laws.It mainly includes the "Ethical Guidelines for Human Medical Research" jointly issued by GCP,MHLW and MEXT in2014 and the "Clinical Research Law" implemented in 2018.Although Japan has formulated different laws and regulations according to different types of clinical trials,its basic concepts are derived from the ethical principles of clinical research established in the "Declaration of Helsinki".The core content of "Clinical Research Law" includes three aspects: specific clinical research implementation procedures,ethical review of the certified clinical research review committee,and information publicity of clinical research funding.The “Ethical Guidelines for Human Medical Research” takes into account the various forms of medical research on human subjects,so it only proposes the basic principles of clinical trials,emphasizes that the heads of research institutions,researchers and all relevant members of the ethics review committee should have a high ethical outlook,and clarifies the responsibilities and obligations of the heads of research institutions and researchers.The thesis defines and outlines the concept of Japanese medical clinical trials and the applicable legal norms for different types of clinical trials,and introduces the main contents of the main legal texts of Japanese medical clinical trials.Meanwhile,it systematically evaluates the main contents of Japanese human medical test legislation in terms of the protection of subjects’ rights and interests from the perspective of conflict of interest,informed consent and ethical review.In order to truly integrate into the international drug regulatory system,the China Drug Administration officially joined ICH on June 7,2018.In view of the current situation of legal norms of clinical trials in China,combined with the legislative experience of Japanese medical clinical trials,this thesis gives corresponding suggestions in balancing the legalization and development of clinical trials,establishing conflict-of-interest management mechanisms,enriching informed consent and establishing an independent ethical review committee,expects to provide useful experience to the perfection of law on clinical trials and the protection of the rights and interests of subjects in our country.