临床试验中医患矛盾的预防和避免  

Prevention and Avoidance of Doctor-patient Contradiction in Clinical Trials

作　　者：王晶[1] 李欣慧[2] 刘东国[2] 信彬[1] WANG Jing;LI Xinhui;LIU Dongguo;XIN Bin(Ethics Committee,Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010,China;Doctor-Patient Relations Coordination Office, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院伦理委员会,北京100010 [2]首都医科大学附属北京中医医院医患关系协调办公室,北京100010

出　　处：《中国医学伦理学》2019年第9期1113-1116,共4页Chinese Medical Ethics

基　　金：北京市医院管理中心2018年度(第四批)“青苗”计划专项经费资助项目“基于中医医联体模式的市属中医院区域伦理委员会建设与研究”(QML20181004)

摘　　要：通过分析归纳临床试验潜在的医患矛盾类型,提出伦理委员会针对识别潜在医患矛盾群体、注重试验方案的科学性、规范研究知情告知流程等措施,达到预防医患纠纷的目的。同时,在伦理委员会对临床试验监管方面,提出了随访流程的人性化管理、畅通受试者抱怨的渠道、加强伦理委员会实地访查等,避免医患纠纷。伦理委员会通过充分的伦理初始审查以及持续跟踪审查,有效监管临床试验的各环节,预先发现并解决潜在的医患矛盾。By analyzing and summarizing the potential types of doctor-patient contradictions in clinical trials,this paper put forward some measures to prevent doctor-patient disputes,such as identifying potential groups of doctor-patient contradictions,paying attention to the scientificity of the experimental scheme,and standardizing the process of informed research.At the same time,in the aspect of ethics committee's supervision of clinical trials,this paper put forward humanized management of follow-up process,unblocked channels for complaints of subjects,and strengthened on-site visits by ethics committee,so as to avoid doctor-patient disputes.Through adequate initial ethical review and continuous follow-up review,the ethical committee effectively supervised all aspects of clinical trials,and discovered and resolved potential doctor-patient conflicts in advance.

关 键 词：临床研究 医患关系 伦理审查 伦理监管 

分 类 号：R-052[医药卫生]