科学研究和医疗器械的伦理审查规范化探讨

Standardization of Ethic Approval on Medical Scientific Research and Medical Devices

本文通过介绍首都医科大学附属北京天坛医院医学伦理委员会的建立、会议制度、审查流程、工作的延伸以及持续提高伦理委员会审查能力的措施等五方面,就如何保证伦理委员会运行过程中关于医疗器械和科学研究的医学伦理审查规范化进行探讨。

By introducing the establishment of Medical Ethics Committee,its conference system,approving process,extension of the work and measures to improve the ability of ethical review in the Beijing Tiantan Hospital affiliated Capital Medical University,we discuss how to ensure standardization of the ethics approval on medical devices and medical scientific research during the operation of the Ethics Committee.