医院伦理审查委员会建设的新思考

New Thoughts on the Construction of Hospital Ethics Review Committee

先进的科学技术在为患者带来福音的同时,也引发了一系列的伦理问题,受试者风险/受益评估是临床研究中伦理审查的核心。通过梳理中国伦理审查委员会发展现状,分析当前伦理审查中存在的问题,提出规范伦理审查委员会的设置和独立性、健全伦理审查委员会相关法律法规、建立伦理审查委员会行政准入及评估机制、建立多中心互认联盟、完善伦理审查委员会的标准化操作规程以及建立伦理人才培养体系、加强伦理审查委员会审查能力建设等建议,以期为委员会的审查工作提供新思路,从而更好地保护受试者权益,促进医学科学的发展。

Advanced technology not only brings good news to patients, but also causes a series of ethical issues. Subject risk/benefit assessment is the core of ethical review in clinical research. By combing the development status of China ethics review committee, analyzing the problems existing in the current ethical review, this paper proposed to standardize the establishment and independence of ethics review committee, improve the relevant laws and regulations of the ethics review committee, establish the administrative access and evaluation mechanism of the ethics review committee, build a multi-center mutual recognition alliance, improve the standardized operating procedures of the ethics review committee, set up an ethical personnel training system, and strengthen the review capacity building of the ethics review committee, so as to provide new ideas for the review work of the committee, then better protect the rights and interests of subjects and promote the development of medical science.