Drug Clinical Trial Subjects Research On Legal Issues Of Rights Protection Tort Liability

Drug clinical trials are an indispensable procedure for medical research,which is used to develop new drugs and develop new prevention and treatment methods.In recent years,the demand for drug clinical trials has increased day by day,but these drugs to be tested are like "blind boxes".No one can predict whether the subjects will be improved or more severely damaged.It is inevitable that adverse effects of varying degrees will occur.React to events.At the same time,participants in drug trials are mostly subjects who have received certain financial benefits or are suffering from serious illnesses that cannot be treated with existing drugs.However,whether it is the previous Tort Liability Law or the newly implemented Civil Code of the People’s Republic of China(hereinafter referred to as " The Civil Code did not provide specific provisions on the tort of drug clinical trials,resulting in inconsistent judgment results in judicial practice,and the legal rights and interests of the subjects could not be protected after damage.Dissertation mainly explores the legal issues of drug clinical trials from the perspective of tort liability,and proposes legislative suggestions for the protection of the rights and interests of subjects in drug clinical trials in my country.The main content of the paper is divided into six parts.The first part is introduction.Introduce the research background of the thesis,literature review at home and abroad,research ideas and methods.The second part is the current status and legal issues of tort liability for drug clinical trials in my country.The author discusses the status quo of the legislation of drug clinical trials in my country,and puts forward the dilemma of the legislation in my country.A total of 38 relevant judicial cases were searched through the search on the Peking University Magic Treasure and Judgment Documents website with the term "drug clinical trial".The author selects three typical cases to focus on the legal issues encountered in clinical trials of drugs: difficulty in determining liability for infringement,exemption for serious consequences of adverse events,inconsistent application of the imputation principle,and simpler identification of causality,The compensation period is short,and the compensation system for mental comfort money is not uniform.The third part is an overview of drug clinical trials.This part mainly discusses the concept of drug clinical trials,the legal relationship of drug clinical trials,the civil rights of subjects,and the characteristics of drug clinical trials that are different from hospital diagnosis and treatment.The fourth part is the legal theory analysis of tort liability for drug clinical trials in my country.This part focuses on the in-depth analysis of the principles of imputation,causality,and exemptions for drug clinical trials.To lay the foundation for proposing a tort liability system for drug clinical trials adapted to the development of our country.The fifth part is the legal protection system for the rights and interests of subjects in clinical trials of drugs outside the territory.It mainly introduces the international drug clinical trial norms and the informed consent system of American subjects,the French drug clinical trials use different imputation principles according to different situations,the Dutch equivalent causality theory,and the complete compensation system of the European Union system.And then look for a drug clinical trial tort liability system that can meet the localization.The sixth part is suggestions for perfecting tort liability in drug clinical trials.It is suggested that the tort liability for drug clinical trials should be included in the "Civil Code" tort liability,and the application of highly probable causality is more conducive to the subject’s claim of rights.In the event of a serious adverse reaction,the injury above cannot be exempted by signing the "Informed Consent Form".Continuously improve the detailed compensation system and the insurance system for drug clinical trials,and establish a special fund system at the same time.