伦理委员会针对2020版《药物临床试验质量管理规范》变化的应对措施  

Response Measures of the Ethics Committee to the Changes of the 2020 Version of Pharmaceutical Clinical Trial Quality Management Standards

作　　者：隋广嶷[1] 柳萍[1] 胡洪涛[1] 唐铭凡 赵长宏[1] SUI Guangyi;LIU Ping;HU Hongtao;TANG Mingfan;ZHAO Changhong(Ethics Committee,Harbin Medical University Cancer Hospital,Harbin 150081,China)

机构地区：[1]哈尔滨医科大学附属肿瘤医院伦理委员会,黑龙江哈尔滨150081

出　　处：《中国医学伦理学》2021年第10期1296-1301,共6页Chinese Medical Ethics

摘　　要：对2020版《药物临床试验质量管理规范》(GCP)与2003版进行比对性审视。从强化受试者权益保护的角度,进一步明确伦理委员会、研究者/临床试验机构、申办者都具有保护受试者的职责;从优化安全性信息报告的角度,伦理委员会的审查程序和内容也需要进行较大的调整。针对以上变化并结合医院伦理委员会实际工作,伦理委员会应该从伦理审查文件、审查意见与用词、安全性信息报告的标准路径时限、知情同意的特殊情况、方案偏离等方面着手,修订工作流程、管理制度、标准操作规程和工作表格,以更好地落实2020版GCP的要求,保障受试者的权益与安全。A review of the 2020 version of the Pharmaceutical Clinical Trial Quality Management Standards(GCP)and the 2003 version was compared.From the perspective of strengthening the protection of the rights and interests of subjects,further clarify that the ethics committee,investigators/clinical trial institutions,and sponsors all have the responsibility to protect the subjects.From the perspective of optimizing the safety information report,the review procedures and content of the ethics committee also need to be adjusted significantly.In response to the above changes and combined with the actual work of the hospital ethics committee,the ethics committee should revise the work process,management system,standard operating procedures and work forms from the aspects of ethics review documents,reviewing opinions and terms,standard path time limit for safety information reporting,special circumstances of informed consent,deviations from the plan,etc.,to better implement the requirements of the 2020 version of GCP and protect the rights and safety of subjects.

关 键 词：伦理委员会 伦理审查 安全性信息报告 受试者权益保护 

分 类 号：R-052[医药卫生]