Study On The Mechanism Of The Legal Ethical Review Of Medical Ethics Committee In China

Biomedical research involving human subjects is essential for the development of medicine, and it is the foundation of the medicine serving for the health of human beings. Biomedical research involving human subjects is obviously a kind of medical research which needs human subjects to participate in, and it may be with some hazards to subjects. It is a big ethical problem that how to conduct the sound development of medical research, and at the same time how to effectively protect the subjects and their securities and rights. Medical Ethics Committee (MEC) is an organization to deal with the above problems.MEC has been discussed with a short history of nearly twenty years in our country. And the history of its foundation is just more than ten years in China. The foundation and development of MEC has promoted the solutions of medical dilemmas, but no-doubly speaking, the development of MEC is just away from scratch line, which is with a series of problems. The root or essential problem between them is that the mechanism of ethical review of MEC in China is not as perfect as in other countries. And this problem has blocked the development of MEC review work.The thesis mainly studies on the mechanism of the legal ethical review of MEC in China.The discussion, foundation and development of MEC and its review work are closely related to the history and the scandals of biomedical research involving human subjects, and moreover the development of international ethical guidelines and national laws and regulations. So we first take a summary to the above aspects, and mainly discuss the definition and significance of MEC, classification, its functions and roles, the development situation of it at home and abroad, and the development of our laws and regulations pertaining to MEC and its review work.Investigating to the MECs in Shandong Province of China, we get a general overview of MEC establishment, MEC members' composition, MEC review works, and existing problems about MEC and ethical review.Basing on previous documentary study and investigation study, the thesis totally concludes and analyses the problems, and points out that the deficiency of the mechanism of the legal ethical review of MEC is the key root of the problems.Focusing on the root problem, on the basis of international ethical guidelines and national laws and regulations, the thesis not only studies deeply on the mechanism of the legal ethical review of MEC, but also conceives the perfecting methods of the mechanism. The study concretely discusses the foundation of MEC (including establishment condition, application to establish, register and management, sub-MEC establishment, working condition, MEC members, software supports, financing and charge); modes of review (including exemption review, expedited review and full review); procedure of review (including application to review, preliminary review, notice to preliminary review result, review meeting, notice to review determination, follow-up review and changed review/renewal review, completion/termination report, review of multiple center research projects and international cooperative research projects); and management of related documents and files. The thesis also frames a rule of MEC, hoping to resolve the existing problems and improve the development of MEC and its review work.