Research On The Clinical Trial Subjects' Right Of Informed Consent

Since the enactment of the Nuremberg Code after the Second World War,clinical trial subjects have entered into the public consciousness as a special group of people.The protection of the rights and interests of these subjects has gradually been noticed by the world because of the risks they face and their weak positions compared to researchers.The basic right of informed consent should be taken seriously.China put out a departmental regulation to standardize clinical trials in 1999.This regulation provided specific regulations for the protection to the right of informed consent of subjects.After nearly 20 years' development,regulations have been continuously improved.However,compared with developed countries such as the United States,our country still has its deficiencies in the formulation of laws and establishment of systems in this area,so we need to improve them.This thesis focuses on the subjects' right of informed consent and researches it from five parts.The first part defines the specific scope of this thesis as the human trials in the field of medical research.Through the presentation of several typical cases,this part introduces the situation in which the subjects' right of informed consent have been violated in practice and the deficiencies in the protection of subjects' right of informed consent in China.This part introduces the concept and stages of medical clinical trials.Then it introduces the occurrence and development of the clinical trial subjects' right of informed consent.It lays a foundation for further research on it below.The second part starts with the legal connotation of the subjects' right of informed consent.It introduces the normative expression of informed consent from the perspective of principles and rules.In addition,the legal relationship and legal responsibilities in the protection of informed consent are also introduced accordingly.In the third part,the subjects are divided into different types according to whether or not the people are sick and their autonomous decision-making abilities.Different types of subjects have different contents of informed consent.The fourth part is a comparative research of laws and systems at home and abroad.It compares the legal norms with those of the United States,and compares the ethics review committee system with those in the WHO guidelines.We need to find our shortcomings,and learn from others' advantages.The fifth part relates to the previous researches on the subjects' right of informed consent in all aspects in former contents and combines with a specific case,analyzes our current deficiencies in protection of subjects' right of informed consent and put forward relevant suggestions for this.The innovations in this thesis consists of innovation of content and innovation in perspective.This thesis focuses on the basic rights of a disadvantaged group.It combines the development of international ethical norms with legislation and regulations in China to take some researches.Many scholars in the past have proposed improvements in general directions.On this basis,this thesis,in conjunction with specific cases,proposes specific measures for the inadequacies of the protection of Chinese subjects' informed consent.