论中医药研究伦理审查的整体原则--中医药研究伦理审查特点研究（四）

摘要

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.%在中医药研究伦理审查中强化整体观念、坚持整体原则的依据是，在关注受试者权益的同时关注研究项目的目的、设计，是伦理委员会的职责；整体观念是中医药学的本质特征；坚持整体原则，才能保障受试者安全。落实整体原则，要审查试验药物是否对“证”、审查试验药物方剂配伍的整体性、审查试验药物毒副作用的防范，要加强伦理委员会建设。