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作 者:李继红[1] 陈航 年宏蕾 陈静 Li Jihong;Chen Hang;Nian Honglei;Chen Jing(Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)
机构地区:[1]首都医科大学附属北京世纪坛医院,北京100038
出 处:《中华医学科研管理杂志》2024年第5期402-408,共7页Chinese Journal of Medical Science Research Management
摘 要:目的探索建立系统性循序渐进性的标准化伦理委员培训内容及路径,持续保持和提升伦理审查质量和效率,为未来制定委员培训方向和建立培训体系提供参考。方法本文通过文献研读、问卷调查等方法,具体分析了机构伦理委员培训过程中的困境及成因,并对培训内容、时机和途径等进行了重点探索。结果建议从伦理委员会及其办公室、医疗机构和上级政府部门等3个维度着手,通过制定培训计划、评估培训效果、完善培训内容、建立培训体系、储备培训师资、发挥专家委员会培训职能、促进信息交流平台建设及加强国际交流等方式加强伦理委员培训。结论加强伦理委员培训,可助力提高委员胜任力,从而提升伦理委员会审查质量,进一步保障研究参与者的合法权益。ObjectiveThis article aimed to explore and establish a systematic,progressive and standardized training content and path for ethics committee members,and also wants to continuously maintain and improve the quality and efficiency of ethical review,and at last wants to provide reference for the future formulation of ethics committee members training direction and system.MethodsThis article analyzed the dilemma and the causes in the training process for ethics committee members through literature review,questionnaire survey,and policy researches,and at last focused on exploring the training content,timing,and methods.ResultsWe should begin with 3 dimensions:the ethics committee and its office,medical institutions,and higher government departments.We should also strengthen the training of ethics committee members through developing training plans,evaluating training effectiveness,improving training content,establishing training systems,reserving training teachers,leveraging the training functions of expert committees,promoting the construction of information exchange platforms,and strengthening international exchanges.ConclusionsIt is imperative to strengthen training of ethics committee members,improve their competence,so as to improve the review quality of each ethics committee,and ultimately to safeguard the legitimate rights and interests of research participants.
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