方案违背的伦理审查与管理  

Ethic Review and Management of Program Violation

作　　者：訾明杰[1] 李晓玲[2] 母双[3] 盛艾娟[4] ZI Mingjie;LI Xiaoling;MU Shuang;SHENG Aijuan(Medical Ethics Committee,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Medical Ethics Committee,Peking University People’s Hospital,Beijng 100044,China;Medical Ethics Committee,Beijing YouAn Hospital,Capital Medical University,Beijing 100069,China)

机构地区：[1]中国中医科学院西苑医院医学伦理委员会,北京100091 [2]首都医科大学宣武医院药剂科,北京100053 [3]北京大学人民医院伦理审查委员会,北京100044 [4]首都医科大学附属北京佑安医院医学伦理委员会,北京100069

出　　处：《中国医学伦理学》2020年第2期165-168,共4页Chinese Medical Ethics

基　　金：国家科技重大专项“体现中药特点的重大疾病新药临床评价技术平台建设”(2017ZX09304003)

摘　　要：临床试验的依从性是指临床试验参与各方遵守与临床试验有关的所有要求,包括《药物临床试验质量管理规范》和适用的管理要求。依从方案是保证临床试验结果真实、科学、可靠的前提,是保证临床试验质量、保障受试者健康及安全的关键。但在临床试验的实施过程中,由于诸多方面的原因,不依从方案的情况难以避免。偏离方案或者违背方案可能会造成非预期的不良事件,乃至严重不良事件,并且可能造成受试者的损害,无论是研究者、伦理委员会、研究机构都应重视方案违背或偏离,研究机构的受试者保护体系应该从管理、培训、伦理审查等多角度加强依从性的管理,以期减少或避免方案违背,尽可能减少或降低损害的发生。Compliance in relation to trials refers to the compliance of all parties involved in the clinical trials with all requirements related to the clinical trials,including Good Clinical Practice(GCP)and applicable management requirements.Compliance program is the premise to ensure the authenticity,science and reliability of clinical trial results,and the key to ensure the quality of clinical trials and the health and safety of subjects.However,in the implementation of clinical trials,due to many reasons,it is difficult to avoid the situation of non-compliance with the program.The deviation or violation of program may cause the unanticipated adverse event,even serious adverse event,and may cause damage to the subject.Researchers,ethics committees and research institutions should pay attention to the violation or deviation of program.The human research protection program in research institutions should be strengthen the management of compliance from the perspectives of management,training and ethical review,so as to reduce or avoid the program violation,and to minimize or reduce the occurrence of damage.

关 键 词：临床试验的依从性 方案违背 伦理审查 伦理监管 受试者保护体系 

分 类 号：R-052[医药卫生]