The Establishment And Mechanism Of Chinese Ethics Review Committees System

The complex ethical issues of research involving human subjects in the Biomedical Sciences and Clinical Trial are becoming the focus in the academic community. As a mechanism, a platform that handling with these ethical issues in order to protect the human subjects' rights and welfare, the Ethics Review Committee (ERC) is a hot topic. With the dramatic development of biomedical research in China, how to truly perform the ERCs' functions by the establishment of the ERCs system which showing Chinese characteristics and meeting international standards? This is both an urgent practical and a theoretical problem needing further exploration or research. The thesis is trying to make an overall study of this problem based on the comparison between IRBs system in U.S.A and ERCs system in China as well as the combination of theory and practice.As the saying goes, the good research method is a gold key for the success of research. The study followed the guidance "improving the medical ethics research method" which was put forward by famous medical ethicists ZhizhengDu and BenfuLi. The basic methods are adopted, such as: 1) literature analytical method;2) the combination of comparative method and historical analytical method;3) the combination of questionnaire and interview method.In the introduction, by defining the meaning of ERC, and summarizing the progress and limitation of research on Chinese ERC over past two decades, the necessity and significance of the establishment of Chinese ERCs system is stated.In chapter 1, the history and status quo of IRBs in U.S.A and those of Chinese ERCs are introduced.In chapter 2, a questionnaire survey aimed to explore the ERCs' current status is conducted in three-level hospitals of Tianjin. Then the existing questions and reasons of ERCs in China are analyzedChapter 3 lays the foundation for the establishment of Chinese ERCs system through expounding that the support and retardation of government's relative policies and regulations, the international ethical guidance's role and limitation, and the way of learning the useful experiences from IRBs system in U.S.A.In chapter 4, the mechanisms for operation, management, and surveillance on IRBs in U.S.A and those on ERCs in China are compared and analyzed. And according to the special situation of China, the plan of adopting good experiences to perfect those mechanisms on Chinese ERCs is conceived.Chapter 5 demonstrates the content, importance and significance of the ERCs' four activities, including: self-education, research and intercommunication, self-assessment;information opening and public participation. And the suggestion of forming Chinese ERCs network is offered.In chapter 6, by the way of popularizing research ethics education, strengthening ethical consciousness of all level governors on bioscience, cultivating responsible biomedical researcher, healthcare worker, and enlightening the public on their right and duty, the favorable atmosphere for ERCs' operation is created.