ABSTRACT
In the traditional Chinese medicine research ethics review, the basis of strengthening the overall concept and adhering to the overall principle is that paying attention to the rights and interests of the subjects at the same time focusing on the study objective and the study design, which is the ethics committee′s responsibility. The overall concept is the essential characteristic of traditional Chinese medicine. Only when sticking to the overall prin-ciple, the safety of subjects can be ensured. The implementation of the overall principle should review all of the fol-lowings:whether the investigational drug is certificated, the integrity of the test drug prescriptions, the prevention of drug side effect, and strengthen the construction of ethics committee.