ABSTRACT
Clinical studies remain the corresponding risk, during the study period can sometimes cause pa-tients/subjects health damage directly or even life safety;also some at the end of the study after a certain period or in the offspring can reflect the long-term adverse effects. Clinical research project risk classification method is dis-cussed, according to the influencing factors of risk can be divided into two categories, their sexual and artificially, and from their sexual risk, the researchers risk, the sponsor problems and subjects of the four aspects of risk identi-fication and evaluation is discussed in detail. Based on this, advances the tactics of risk aversion: construction of clinical research and regulation of ethical management platform,To strengthen the external supervision of research project risk, The sponsor or researchers do their job, To strengthen the construction of institutional ethics committee ability, Give full play to the institutional ethics committee functions,Risk transfer and reduce the risk.
ABSTRACT
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 .