Thinking On Legal Problems Of Drugs?health Care Products Human Experiment

With the continuous development of science and technology,scientific and technical levels of medical and health services have also been advanced profoundly since modern times.While many difficult miscellaneous diseases have been cured completely,the contributions of human subject researches can not go unnoticed.Either the unpredictability and risks that human subject researches have or cases related to human subject research that have been increasingly exposed in recent years have reflected the serious situation of human subject research.It is particularly important to the question that how to regulate human subject research by using legal means,therefore we must conduct detailed studies in this respect to find out related solutions.This thesis consists of five parts,including the preface,three chapters of the main body and conclusion.The preface introduces the background significance of this selected topic,the exposition of the main research method used in this article,as well as the paper's innovation point and novelty.Chapter one is an overview of human subject research.Firstly,this chapter expounds the concept,classification,related subjects of human subject research,the rights and obligations of the sponsor researchers and subjects as well as the basis ethic principles stipulated by international norms of Nuremberg Code and Declaration of Helsinki that human subject research must follow.Secondly,this chapter expounds the development course of human subject research including human subject researches done by ancient and modern China,by Japan and Germany during the World War ? as well as human subject researches done by the Allies after the World War II.Finally,through comparing domestic and foreign current situations of legislation on human subject researches,this chapter concludes the reference and enlightenment of foreign legislative model to our country.Chapter two discusses the existing problems and reason analysis of legislation on human subject researches.Firstly,this chapter expounds the problem of legislation on human subject researches on the whole and analyzes problems from the three aspects including informed consent of subjects,ethical review and related legal responsibility of human subject research.Then,this chapter discusses the existing problems from the aspects of drug and health food.Finally,this chapter analyzes the specific reasons for problems of human subject research from the perspective of both domestic and abroad.Chapter three discusses the countermeasures and the suggestions of perfecting our country's legislation on human subject research.This chapter puts forward two solutions of establishing norms on human subject research and improving existing legal norms,expounds the concrete countermeasures from detailed inform obligation of subjects,ethical review mechanism,relief means and other aspects,and finally puts forward relevant suggestions on drugs and health food legislation and legislation on human subject research.