医学院校生物医学研究伦理审查常见问题分析  

Analysis of Common Ethical Review Issues in Biomedical Research in Medical Universities

作　　者：蒋辉 黄慧娴 陈旻[3] JIANG Hui;HUANG Huixian;CHEN Min(Department of Science and Education,Zhangzhou Hospital Affiliated of Fujian Medical University,Zhangzhou 363000,China;Research and Teaching Department,Xiamen Haicang Hospital,Xiamen 361028,China;School of Health Man-agement,Fujian Medical University,Fuzhou 350108,China)

机构地区：[1]福建医科大学附属漳州市医院科教科,福建漳州363000 [2]厦门市海沧医院科研教学部,福建厦门361028 [3]福建医科大学卫生管理学院,福建福州350108

出　　处：《医学与哲学》2025年第3期35-37,41,共4页Medicine and Philosophy

基　　金：2020年福建医科大学医学人文研究中心开放课题(RW202002)。

摘　　要：针对医学高校生物医学研究伦理审查中存在的问题进行深入分析,涉及研究设计的科学性、知情同意的规范性、研究团队的可行性、申报审查的合规性、登记管理的合法性以及成果分享的公平性等多个方面。通过对这些问题的梳理,提出了针对性的改进措施,包括提高伦理意识、落实管理责任、完善伦理审查流程、接受公众监督等。同时,文章强调医学科技活动应严格遵循国际伦理规范,以推动我国伦理法治建设和社会文明的进步,为生物医学研究领域的健康发展提供有力保障。This paper conducts an in-depth analysis of the issues existing in the ethical review of biomedical research in medical universities,covering various aspects such as the scientific validity of research design,the standardization of informed consent,the feasibility of research teams,the compliance of application reviews,the legality of registration management,and the fairness of research outcome sharing.By sorting out these issues,the paper proposes targeted improvement measures,including enhancing ethical awareness,implementing management responsibilities,perfecting the ethical review process,and accepting public oversight.Additionally,the article emphasizes that medical scientific activities should strictly adhere to international ethical standards to promote the development of ethical governance and social progress in China,ensuring the healthy advancement of biomedical research.

关 键 词：医学院校 生物医学研究 伦理审查 

分 类 号：R-05[医药卫生]