【摘要】 在中医药研究伦理审查中,审查项目的辨证论治内容是检验项目是否符合中医规律和理论,其目的不是检验项目的科学性,而是为了保护受试者的安全。在这其中,要坚持伦理审查与科学审查的统一,更要注重中医药本身发展研究的特点和规律,不能简单的套用审查西医西药的方法。在审查辨证论治内容的实践操作层面,应当注意:对辨证论治内容的审查,要纳入中医药研究伦理审查标准操作规程。在保护患病受试者安全的审查上,要坚持证候标准,要审查既往临床应用证候与研究中患病受试者证候是否一致。对辨证论治的审查,要重视理法方药的内在逻辑关系,要充分发挥熟悉项目研究内容的中医药专家的作用。在强调审查辨证论治内容的同时,要注重审查项目的其他内容,形成伦理审查的合力,防止片面性。更多还原

【Abstract】 In ethical review on traditional Chinese medicine(TCM) research,treatment based on syndrome differentiation is the point that whether it conform to the law and the theory of TCM,its purpose is not to test the scientific nature of the project,but in order to protect the safety of the subjects.It should stick to the unity of ethical review and scientific scrutiny,should notice more itself characteristics and law of development and research of TCM,it cant simply to review western medicine the method of western medicine.In examination and treatment based on syndrome differentiation of practice level,it should be noted:the contents should be in TCM research ethics review standard operating procedures.On the review to protect the safety of ill subjects,insist on syndrome standards,to review previous clinical syndrome and disease subjects in the study of syndrome.It also should attach great importance to the internal logic relations of medicine,to give full play to be familiar with the project research content of the role of TCM experts.At the same time,it also should pay attention to review other content of the project,form a confluence of ethical review,preventing one- sidedness.更多还原