注重审查项目的临床基础——中医药研究伦理审查特点研究(一)

Attaching Importance to Clinical Basis: Features of Ethical Review on Traditional Chinese Medicine Study(Ⅰ)

中医药研究伦理审查既要遵循医药学伦理审查的原则、规范,又要遵循中医药研究的规律,重视自身的特点。注重对项目既往临床基础的审查是中医药研究伦理审查的一个显著特征。审查项目临床基础的目的是保护受试者安全。审查项目的临床基础要和落实《药品注册管理办法》结合在一起。

Ethical review on traditional Chinese medicine study should not only follow the principles ot mecllcal ethics review, but also should comply with the laws of traditional Chinese medicine study and attach importance to its own characteristics. Paying attention to the review of clinical basis is a significant feature of ethics review on traditional Chinese medicine study. Review on the clinical basis is aimed to protect the safety of the subjects. Reviewing on the clinical basis should carry out with the ＂The Administration of Drug Registration＂.