The Social&Ethic Problem And Regulatory Mode Of Human-derived Biological Samples

Scientific experiments of medicine which promote the development of medical technology is an important power in the21st century, especially human-derived biological samples is an important bridge which can connect medical experiments to clinical diagnosis and treatment technology. But the more wide application of human-derived biological samples they are, the more disadvantages about the lack of regulatory and imperfect management system will be appeared. In recent years, government stepped up to construct the infrastructure of biological information science and technology, especially construction and application of the biological sample library. Then how to keep the personal interests of donor from harm while medical science and technology develop steady is a problem urgently to be solved in the current.Ethics and legal system have always been reviewed by community from human trails primitively to experiments of human-derived biological samples currently. So we first define the concept of "human-derived biological samples" in detail from the above aspects, and then discuss the social ethical issues about the human-derived biological sample which are used for scientific research objectively. We argue that the fundamental reason of these problems is that the ethical attributes and legal nature of human-derived biological samples is not clear. In view of this, we will comb the attribute of human-derived biological samples systematically.In this paper, we sketch the domestic and foreign regulatory mode of human-derived biological samples basing on previous documentary study and interview study. Compared to relatively mature ethical regulation pattern of some countries, Medicine Ethics Committee starts later in China. Existing studies show that scientific research institutions have not enough understanding about the necessity of ethical review and supervision work, which led to the difficulties of practical work. We hope to summary the valuable regulation strategy through the analysis of the regulatory mode of abroad. On the basis of the theory study, the author interviewed doctors and researchers about the troubles and problems which<Involves People of Biomedical Research Ethics Review Method (try out)> and<Human Genetic Resources Management Interim Measures> confront in practical work. These studies show that the specific problems of management and application of biological samples is due to the weak functions of the medical ethics committee and the oversight of relevant rules and norms.We have Known the actual situation about the management of human-derived biological samples at present in our country, and the existing international code of ethics, and foreign regulatory experiences. So we put forward to the preliminary conception which strengthen supervision and management in aspect of human-derived biological samples. It embodies the important value of medical ethics. We try to construct the pattern of mutual supervision between administrative department. We should ensure the donor’s personal interests in the first place. Apart from that, we ought to make the supervision function of medical ethics committee clear, and integrate regional biological samples, and improve the distribution of samples effectively. By this way, the ethics problems of human-derived biological samples faced by society can be solved scientifically. Finally the regulatory mode adapt to the demands of the development of biological science and technology in our country.