简易伦理审查程序在实践中的困境分析  

Analysis of the dilemmas of the simplified ethical review procedure in practice

作　　者：胡本泽 黄宇虹[1] 谷旭放[1] 郭卫华 胡思源[3] 杨雅清 HU Benze;HUANG Yuhong;GU Xufang;GUO Weihua;HU Siyuan;YANG Yaqing(Ethics Committee Office,the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300250,China;School of Marxism,Tianjin Normal University,Tianjin 300382,China;Clinical Trial Center,the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;School of Medical Humanities,Tianjin Medical University,Tianjin 300070,China)

机构地区：[1]天津中医药大学第二附属医院伦理委员会办公室,天津300250 [2]天津师范大学马克思主义学院,天津300382 [3]天津中医药大学第一附属医院临床试验中心,天津300193 [4]天津医科大学医学人文学院,天津300070

出　　处：《中国医学伦理学》2025年第1期46-51,共6页Chinese Medical Ethics

基　　金：科技部国家重点研发计划项目(2021YFC1712900)。

摘　　要：2023年9月《科技伦理审查办法(试行)》发布,其第三章第三节修订了有关伦理审查简易程序的条款。对这一条款的修订,为进一步优化伦理审查工作、确保伦理审查程序有章可循、提高科研效率提供制度保证。“简易程序”并不意味着降低审查质量和要求,而是在始终遵循国际公认的伦理准则,并强调不违反国家法律法规的基础上,提升伦理审查和后续研究工作开展的效率,促进推动涉及人的生命科学和医学研究的开展。其在实际工作中为伦理审查能力的提升带来诸多新的机遇与挑战,如对伦理委员会判断力和决定力带来的新考验、如何确保简易审查程序相关条件的可靠性和可控性、如何确定可以采取简易审查程序进行审查的基本条件等。因此,为了积极应对简易程序审查所带来的挑战和可能风险,应当努力实现三个“统一”:研究者的道德自律与相关部门实施监管的他律相统一,简易程序审查标准制定与审查工作实际的统一,伦理责任与法律责任的统一。In September 2023,the Measures for Scientific and Technological Ethics Review(Trial Implementation)was issued,revising the provisions related to the simplified procedure for ethical review in Chapter 3,Section 3.This revision of these provisions provides systematic guarantees for further optimizing ethical review work,ensuring that ethical review procedure is well-regulated,and improving scientific research efficiency.The“simplified procedure”does not mean reducing the quality and requirements of the review.Instead,based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations,improving the efficiency of ethical review and subsequent research work,and promoting the development of life sciences and medical research involving humans.In practical work,it introduces numerous new opportunities and challenges for the improvement of ethics review ability,such as new tests on the judgment and decision-making power of ethics committees,how to ensure the reliability and controllability of the conditions related to the simplified review procedure,and how to determine the basic conditions for adopting the simplified review procedure for review.Therefore,to actively respond to the challenges and possible risks brought by the simplified procedure review,efforts should be made to achieve three“unifications”,including the unification of researchers’moral autonomy and the heteronomy of supervision implemented by relevant departments;the unification of the standard formulation of the simplified procedure review and the review work in practice;and the unification of ethical responsibility and legal responsibility.

关 键 词：科技伦理 伦理审查 简易程序审查 自律与他律 

分 类 号：R-052[医药卫生]