摘要
目的探讨《涉及人的生命科学和医学研究伦理审查办法》(以下简称"《办法》")政策背景下高等学校履行机构主体责任面临的挑战,论证规范高等学校伦理审查和伦理管理的工作重点和难点,为相关工作实践提供参考。方法在政策文本研究的基础上,结合笔者所在机构的伦理审查与伦理管理工作经验,论证存在的问题并提出可行的实践建议。结果《办法》通过强化机构主体责任,加强对涉及人的生命科学和医学研究的伦理审查规范。高等学校将面临诸多挑战,需要更加系统的伦理审查及伦理管理制度设计。结论高等学校的伦理审查和伦理管理工作需进一步强化系统性布局,明确工作优先性排序,创新探索委托审查、合作研究伦理审查协作等机制,持续提升伦理审查质量和效率。
Objective This study aimed to explore the challenges faced by colleges and universities in performing their institutional responsibilities set forth by the Ethical Review Measures of Life Science and Medical Research Involving Human Participants(hereinafter referred to as the Measures),demonstrate the key points and main challenges in standardizing the ethical review and ethical management of colleges and universities,to provide a possible reference for daily working practices.Methods Based on the interpretation of the policy document,combined with practical experiences in ethical review and ethical management,this paper summarized identified problems faced and proposed feasible practical suggestions.Results The Measures strengthen the ethical review norms for life science and medical research involving human participants by reaffirming the responsibility of institutions.Colleges and universities might face some challenges and more systematic design is needed.Conclusions The ethical review and ethical management work at colleges and universities need further consideration,top-down design model should be developed,to set work priorities,and at the same time,more innovative ways should be adopted to facilitate ethical review reliance and coordinate more streamlined review of cooperative research,and improve the quality and efficiency of ethical review promptly.
作者
宋艳双
张海洪
Song Yanshuang;Zhang Haihong(Peking University Health Science Center,Beijing 100191,China)
出处
《中华医学科研管理杂志》
2024年第3期187-191,共5页
Chinese Journal of Medical Science Research Management
基金
海南省博鳌乐城先行区真实世界研究专项计划项目(HNLC2022RWS009)。
关键词
伦理审查
高等学校
机构主体责任
委托审查
审查效率
Ethical review
Colleges and universities
Institutional responsibility
Ethical review reliance
Ethical review efficiency
