首页|《涉及人的生命科学和医学研究伦理审查办法》对高等学校伦理审查及其管理的新要求

《涉及人的生命科学和医学研究伦理审查办法》对高等学校伦理审查及其管理的新要求

New requirements for ethical review and ethical management of colleges and universities set forth by the Ethi-cal Review Measures of Life Science and Medical Research Involving Human Participants

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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 in-stitutional responsibilities set forth by the Ethical Review Measures of Life Science and Medical Research Involving Human Par-ticipants(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 Meas-ures 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 fa-cilitate ethical review reliance and coordinate more streamlined review of cooperative research,and improve the quality and effi-ciency of ethical review promptly.

Ethical reviewColleges and universitiesInstitutional responsibilityEthical review relianceEthi-cal review efficiency

宋艳双、张海洪

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北京大学医学部,北京 100191

伦理审查 高等学校 机构主体责任 委托审查 审查效率

海南省博鳌乐城先行区真实世界研究专项计划项目

HNLC2022RWS009

2024

中华医学科研管理杂志
中华医学会

中华医学科研管理杂志

CSTPCD
影响因子:0.515
ISSN:1006-1924
年,卷(期):2024.37(3)