Research On The Civil Rights Protection Of Subjects In Drug Clinical Trials

Drug clinical trials are a necessary stage and necessary procedure before a new drug is approved for marketing.Due to the complexity of the human body,the pharmacology of the new drug,and the uncertainty of the drug's drug properties,the civil rights of the subjects are vulnerable to infringement during the trial.At present,my country has no special legislation on the protection of the rights and interests of the subjects.There are many deficiencies in the protection of the civil rights and interests of the subjects.This article intends to use differentiated thinking to legally clarify the specificity of drug clinical trials,the differences between different stages of the trial,and the differences in the cognitive abilities of the subjects.It is recommended that legislation be made to clarify various measures for the protection of the civil rights of the subjects.This article is divided into four chapters as well as introduction and conclusion.The first chapter mainly introduces the topic of civil rights protection of subjects in drug clinical trials through the analysis of typical cases of subject infringement in the field of pharmaceutical clinical trials,and analyzes the existence of civil rights protection of subjects in China from the case.The problem is mainly reflected in the difficulty of determining the tort liability of the trial party in drug clinical trials,the right of the subject to know is not guaranteed,the ethics committee cannot fully exercise its review and supervision function,and the subject's civil rights relief system is incomplete.The second chapter mainly introduces the legislative status of the protection of the civil rights of the subjects in the clinical trials of drugs in our country.At this stage,there is no specific legislative guarantee for the protection of the civil rights of the subjects.The legal level is low.The regulations are not operable,and the relevant laws and regulations have not been harmonized.There are many problems in the protection of the civil rights of the subjects.The lack of special legislation and the lag of legislation coexist.Institutional guarantees,lack of compulsory insurance and compensation and relief systems for test drug damage of subjects.The third chapter mainly expounds the institutional mechanisms of foreign countries in the civil protection of drug clinical trial subjects' rights and its reference to China,including the ethical review and supervision mechanism of the United States and the compensation mechanism for trial drug candidates,the German insurance system,and Japanese ethics Review mechanism and Lithuania's principle of no-faultliability.When perfecting the legislation to protect the civil rights and interests of the subjects in my country,we can learn from the countries and regions outside the region to learn the mature system of civil rights and interests protection of the subjects under the premise of fully considering the actual situation in my country.The fourth chapter is mainly aimed at the shortcomings and problems of the current legislation on the protection of the civil rights of drug testers in my country,to coordinate the relevant laws and regulations of drug clinical trials,and to improve the right relief.Under the premise of ensuring the healthy and orderly development of small and medium-sized pharmaceutical enterprises,use differentiated thinking to clarify the responsibility identification and division of responsibility for the infringement of the civil rights and interests of the subjects,as well as the forms and methods of guaranteeing the subject's right to informed consent.At the same time,improve the ethical review system for the protection of the civil rights of the subjects,and establish a compulsory insurance system and compensation and relief system for test drugs.This article focuses on the subjects of different stages of drug clinical trials,and separately states the characteristics of each stage of drug clinical trials and the specific measures for the protection of the civil rights and interests of the subject groups at this stage.Whether it is out of consideration for the protection of citizens' individual rights,or from the perspective of long-term human health,it is necessary and feasible to protect the civil rights and interests of subjects in clinical trials of drugs in the form of legislation.