伦理审查委员会在伦理审查管理实践中的建设与发展  

Ethical Review Committee in the Ethical Review Management in the Practice of the Construction and Development

作　　者：张彤群[1] 李卫彬[1] 李燕申[1] 

机构地区：[1]首都医科大学附属北京胸科医院伦理委员会,北京101149

出　　处：《医学信息》2012年第12期36-37,共2页Journal of Medical Information

基　　金：国家科技重大专项（项目编号：2008ZX09312-013、2012zx09303002）

摘　　要：伦理审查委员会在药物临床试验日常伦理管理工作中通过完善制度和标准操作规程来加以规范和提高自身的伦理审查能力，将伦理原则及规范要求运用于对临床试验方案设计、知情同意、跟踪审查及项目实施中，才能最大限度保护受试者的安全与权益。完成一项高质量的临床试验离不开伦理审查委员会的形式审查和过程管理，而跟踪审查的缺失或不完善将无法及时、准确地了解项目研究的进展、内容修订、受试者等方面的真实情况，使伦理审查委员会难以真正发挥对研究项目的伦理审查作用。因此，建立规范的管理审查机制对提高临床试验质量和保障受试者权益具有重要作用。Through improving the system and standard operating procedures,Ethics review committee can regulate and improve its ethics review capacity in daily clinical trial work and maximize the protection of subjects＇ safety and interests by using the ethical principles and specifications in clinical trial design, informed consent, tracking review and project implementation. The form reviewed and the process managed by the hospital ethics review committees are indispensable to accomplish one clinical trial with high quality. The deficiency or imperfection of tracking projects will make it difficult to understand the project progress, content editing, subjects and other aspects of reality timely and accurately and play role on the research project of the ethical regulation for the hospital ethics review committees. Therefore, to establish a standardized management system and tracking review system is important to improve the quality of clinical trials, protect the rights and interests of the subiects.

关 键 词：伦理审查委员会 伦理审查 管理实践 

分 类 号：R-052[医药卫生]