【摘要】 根据2017年国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》的精神,为了进一步抓好伦理审查的关键环节,提升伦理审查的效率和质量,就目前伦理委员会会议审查工作进行总结;提出需要优化会议审查流程和方式,制定一套合理的伦理委员会会议审查制度和标准,通过管控伦理审查过程中的关键点,包括主审委员的初审、独立顾问的选聘等,提高整体审查水平,更好地保护受试者权益。其中,针对在行政主导下的伦理委员会如何使专家更好地发表意见,鼓励非医学背景的人员为受试者发声提出了建议和看法,希望为我国医院伦理委员会的建设提供借鉴。更多还原

【Abstract】 According to the spirit of"Regulation on Deepening the Reform of Examination and Approval System and Encouragement the Innovation of Medical Devices"issued by the General Office of the State Council in 2007 in China,this paper summarized the problems and strategies of board meeting review to further grasp the key procedure of ethical review and improve the efficiency and quality of ethical review.It discussed the optimization of board meeting review standard operational procedures and review system,including the preparation of the board meeting,initial review of primary reviewers,invitation of independent consultant,improvement of ethical review quality and better protection of human subjects.Meanwhile,suggestions and strategies on how to make members freely express their opinions under the administrative guidance of institutional review board and how to encourage non-medical members to speak up for the subjects were put forward,so as to provide reference for the construction of institutional review board in China.更多还原