ABSTRACT
The modernization of Traditional Chinese Medicine (TCM) is urgent need of the modern theory of TCM, is a consensus. But, How to establish and what kind of modern TCM theory, is far from a consensus. Based on the summarization of the common law in the construction of scientific theory, we are trying to give a answer that are expected to form a consensus. Firstly, we have illustrated the trend that the development of TCM theory should learn from the life and medical sciences theory function and value; Secondly, we have proven that TCM and TCM theory belongs to the traditional medicine and theory and pointed out the limitation of the traditional medicine, TCM and its theory. And then we have revealed the inevitable trend of traditional medicine, TCM and its theory development at home and abroad, logically obtained the inevitable choice of constructing the modern TCM basic theory; Lastly, we have analyzed the different discipline new theory construction process and method at home and abroad and discovered the common five steps rule, put forward three principles and five steps of constructing modern TCM basic theory, demonstrated its important role during the theoretical revolution promoting Chinese Medicine theory from phenomenon description to mechanism clarification and the scientific value of Chinese Medicine theory in the domestic and foreign development trend.
ABSTRACT
The ethics of medical research is an important area of physician ethics. Physicians are called to respect the life, health, and personality of human subjects. In contrast to other ethical fields, physician ethics, including the ethics of medical research, does not rely on the good faith of physicians alone; ethics and the law are intermingled. While respecting international norms related to medical ethics, individual countries have expanded legal interventions into medical research. The United States has regulated the research of human subjects receiving federal funding through the Common Rule. In Korea, legal interventions for human subjects protection have been applied to a limited extent in clinical trials under the Pharmaceutical Affairs Act and the Medical Devices Act in Korea. On January 29, 2004, the Bioethics and Safety Act was enacted, requiring embryo research institutes, gene banks, and gene therapy institutions to establish Institutional Review Boards. On February 1, 2012, the Bioethics and Safety act was completely revised, which was a significant turning point in medical ethics in Korea. Structural differences between the Common Rule of the United States and the Bioethics and Safety Act of Korea are as follows. First, the Bioethics and Safety Act shall be applied regardless of the presence or absence of government funding. Thus the Bioethics and safety act has a more comprehensive and compulsory effect than the Common Rule. Second, under the Bioethics and Safety Act, the Ministry of Health and Welfare has direct supervision over institutional review boards, rather than supervision of the research organization itself. This differs from the Common Rule, which regards the research organization as the counterpart to the government. Third, the Bioethics and Safety Act regulates the study of derivatives of human bodies, in addition to research on human subjects. The Bioethics and Safety Act has the following problems. First, it mandates that researchers, instead of IRBs, record and store data concerning medical research. Second, the Act does not provide a specific definition of "minimal risk". Third, as the Act does not allow the exemption of informed consent of children under the age of 18 even if specific prerequisites are met as in the case of adults, research involving children will atrophy significantly in Korea.