Research On The Protection Of Informed Consent Rights Of Subjects In Multi-center Drug Clinical Trials In My Country

With the development trend of pharmaceutical biology globalization,it is an inevitable trend to carry out international multi-center clinical trials actively.Over the past decade,data from multi-center clinical trials in China have been increasing,and China ranks among the top 10 countries in the world in terms of the number of participants(the top 10 countries include the United States,China,India,Brazil,Russia,Japan,Mexico,Germany,Turkey and Thailand).Clinical trials are an important part.of the development of medical progress,in which subjects play a huge role,but also bear the greatest health risks.Therefore,attention should be paid to the protection of subjects’ rights and interests,in which informed consent right is the core of subjects’ rights,and also the premise and basis for realizing other rights.As for the regulation of subjects’ informed consent right,many laws and regulations in China have standardized it,including Drug Administration Law,Quality Management Practice of Drug Clinical Trials,Guidelines for International Multicenter Drug Clinical Trials(Trial),and Ethical Review Measures for Biomedical Research Involving People,etc.However,international multi-center clinical trials are more complicated than routine clinical trials because they involve many countries and regions.Due to cultural and language barriers,uneven educational background,different versions of informed consent and other reasons,it is more difficult to protect the informed consent of participants in multi-center clinical trials.The focus of this study is how to effectively protect IMCT subjects’ right to know and self-determination from the legal level,so as to avoid them becoming victims of seeking medical progress and economic benefits due to deception,coercion and other reasons.This paper focuses on the protection of informed consent of subjects in international multicenter clinical trials from the following four partsThe first part introduces the current situation of international multi-center clinical trials in China.By defining the concepts of clinical trial,drug clinical trial and multi-center clinical trial,and summarizing the characteristics of multi-center clinical trial,the advantages and significance of carrying out international multi-center clinical trial in China are expounded,which lays a foundation for the discussion of subjects’ rights and interests in international multicenter clinical trial in the following sections.The second part expounds the legal connotation of informed consent of subjects in international multi-center clinical trials from three aspects:the basic content of informed consent of subjects,the rules of informed consent and the legal relationship of the protection of informed consent right of subjects in multi-center clinical trials.In addition,this paper also discusses the basis of subjects’ right to claim damages when their informed consent is infringed,analyzes the constituent elements of tort liability in multi-center clinical trials,and discusses the range of subjects’ right to claim damages in different situations.The third part is a comparative study of Chinese and foreign legal norms,comparing the supervision of the subject’s informed consent right in multi-center clinical trials in China with the current legal norms in Japan and the United States,finding out the current deficiencies of China,and actively drawing on the advanced experience of Japan and the United States,which are developed pharmaceutical countries.The fourth part is related to the above,aiming at the deficiency in the protection of informed consent of subjects in multi-center clinical trials in China,and combining with international advanced experience,relevant suggestions are put forward in accordance with the actual situation in China.