Risk Identification and Evaluation of Clinical Research Projects / 中国医学伦理学

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.