RESUMEN
At the end of February 2023, the new Notice on the Issuance of Ethical Review Measures for Life Science and Medical Research Involving Humans was issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the State Administration of Traditional Chinese Medicine. It adheres to the basic principles and institutional framework of the Ethical Review Measures for Biomedical Research Involving Humans , and combines with the actual situation of domestic ethical work to optimize and improve the details and procedures of the review. Based on the Ethical Review Measures for Biomedical Research Involving Humans, the Ethical Review Measures for Life Science and Medical Research Involving Humans have expanded the scope of application of ethical review. Different experts in the field have discussed in detail the changes in the scope of review, and proposed review procedures that may need to be corresponding adjustments based on the changes for the readers’ reference.
RESUMEN
According to the common standard of ethic review for clinical research , it is equal to each kind of research program whether western medicine or Traditional Chinese Medicine .It should be reviewed the ethic and scientific issues in the same time .However, on account of the two majority characteristics of Traditional Chinese Medicine , it would be concerned more evidence , such as the safety data before clinic , the syndrome differentiation and treatment of target disease , drug combination , dosage and course of treatment , the methods of outcome meas-urement, admixture of the drug, the selection of control drug including placebo and so on .