对我国伦理审查委员会建设的探讨

On the Development of IRB in China

我国伦理审查委员会已初具规模,但需要进一步完善。为加强伦理审查委员会建设,从以下六个方面进行探讨:性质、功能和职责;组成、成员聘用和要求;设置、报批和注册;审查的依据、目的和原则;审查的范围和程序以及对其监管。

Institutional Review Board （IRB）has developed and formed its initial shape in our country, but further perfection is still required. In order to improve the quality and function of IRB, this paper discusses issues related to IRB in china from the following aspects： orientation of its nature, functions and responsibilities; its constitution and qualification requirements for IRB members; the procedure of installation, application and registration; the basis, objective and principle of reviewing; the scope and procedure of reviewing and its supervision and management.