突发传染病临床研究伦理审查专家共识  

Expert Consensus on Ethics Review of Clinical Research of Emerging Infectious Diseases

作　　者：周吉银 曹欢欢 尹梅[3] 关健 张新庆[5] 陈旻[6] 梁立智[7] 刘星 张海洪[9] 张金钟[10] 王明旭 ZHOU Jiyin;CAO Huanhuan;YIN Mei;GUAN Jian;ZHANG Xinqing;CHEN Min;LIANG Lizhi;LIU Xing;ZHANG Haihong;ZHANG Jinzhong;WANG Mingxu(National Drug Clinical Trial Institution,The Second Affiliated Hospital of Army Medical University,Chongqing 400037,China;Chinese Medical Ethics Editing Department,Xi’an 710061,China;College of Humanities and Social Sciences,Harbin Medical University,Harbin 150081,China;Peking Union Medical College Hospital,Chinese Academy of Medical Science,Beijing 100010,China;School of Humanities and Social Sciences,Peking Union Medical College Hospital,Chinese Academy of Medical Science,Beijing 100730,China;Research Center of Medical Humanities/School of Humanities,Fujian Medical University,Fuzhou 350122,China;School of Medical Humanities,Capital Medical University,Beijing 100069,China;Office of Medical Ethics Committee,Xiangya Hospital,Central South University,Changsha 410008,China;Office of Peking University Human Research Protec tion Program,Beijing 100191,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;School of Public Health,Xi’an Jiaotong University Health Science Center,Xi’an 710061,China)

机构地区：[1]陆军军医大学第二附属医院国家药物临床试验机构,重庆400037 [2]《中国医学伦理学》杂志编辑部,陕西西安710061 [3]哈尔滨医科大学人文社会科学学院,黑龙江哈尔滨150081 [4]中国医学科学院北京协和医院,北京100010 [5]中国医学科学院北京协和医学院人文和社会科学学院,北京100730 [6]福建医科大学医学人文研究中心/人文学院,福建福州350122 [7]首都医科大学医学人文学院,北京100069 [8]中南大学湘雅医院医学伦理委员会办公室,湖南长沙410008 [9]北京大学受试者保护体系办公室,北京100191 [10]天津中医药大学,天津301617 [11]西安交通大学医学部公共卫生学院,陕西西安710061

出　　处：《中国医学伦理学》2020年第4期501-506,共6页Chinese Medical Ethics

摘　　要：突发传染病严重威胁人类健康,需采取紧急处理措施。如新型冠状病毒肺炎已成世界大流行状态,尚无特效治疗药物、疗法或疫苗。因此,急需开展突发传染病的临床研究,有助于疫情防控。我国目前无突发传染病临床研究的伦理准则,相关国际伦理指南对一些细节操作问题缺乏明确指导。为此,我们制定具有指导意义的突发传染病临床研究伦理审查专家共识,明确其伦理审查范围和要点,以供医疗机构、药物和医疗器械企业、医务工作者参考。其伦理审查要点包括研究团队资质及分工协作,前期研究基础、研究方案、纳入排除和提前退出标准等研究方案的设计与实施,风险受益评估,受试者公平招募,书面的知情同意书、预先考虑数据共享等知情同意,跟踪审查,数据共享和结果发表。该专家共识有助于保障突发传染病临床研究受试者的安全和权益,提高其临床研究质量。Emerging infectious diseases seriously threaten human health and urgent measures need to be taken.For example,COVID-19 has become a world pandemic,and there are no effective treatment drugs,therapies or vaccines.Therefore,there is an urgent need to carry out clinical research on emerging infectious diseases to help prevent and control the epidemic.There are currently no ethical guidelines for clinical research on emerging infectious diseases in China,and relevant international ethical guidelines lack clear guidance on some detailed operational issues.To this end,we have formulated an expert consensus on ethics review of clinical research of infectious diseases with guiding significance,and clarified the scope and points of ethics review for reference by medical institutions,drug and medical device companies,and medical workers.The key elements of its ethics review include the research team qualifications and division of labor and collaboration;design and implementation of research protocol,including preliminary research basis,research protocol,inclusion exclusion and early exit criteria,and others;risk and benefit evaluation;fair recruitment of participants;informed consent,including written informed consent,advance considering data sharing;continuing review;data sharing;results published.The expert consensus will help to protect the safety and rights of participant in clinical research of emerging infectious diseases and improve the quality of their clinical research.

关 键 词：突发传染病 新型冠状病毒肺炎 临床研究 伦理审查 专家共识 

分 类 号：R-052[医药卫生]