摘要
为抗击新型冠状病毒肺炎疫情,降低感染率和提高感染患者治愈率,有赖于快速掌握新型冠状病毒肺炎基本知识、研发有效冶疗药物和方法,急需高质量地开展临床研究。鉴于中国尚无专门针对重大传染病暴发下的伦理审查指南,伦理委员会审查新型冠状病毒肺炎临床研究面临诸多挑战,如伦理审查方式,临床研究与治疗的冲突,利益冲突的管理,试验性治疗的合法性及其伦理辩护。除常规伦理审查要点外,要重点关注研究设计、样本量估算、风险和受益评估、弱势群体、公平招募受试者、知情同意和数据共享等。最后提出从修订法律法规、国家层面预审、单中心伦理审查和远程视频会议审查模式等对策,以期为中国重大传染病暴发时临床研究的伦理审查能力建设提供参考。
In order to fight the COVID-19 epidemic,reduce the infection rate and increase the cure rate of infected patients,it is necessary to rapidly master the basic knowledge of COVID-19,develop effective treatment drugs and methods,and carry out high-quality clinical research urgently.In view of the fact that there is no specific ethical review guide for severe infectious diseases in China,the ethical committee is facing many challenges in reviewing the clinical research,such as ethical review methods,conflicts between clinical research and treatment,management of interest conflict,legitimacy of experimental treatment and ethical justification,etc.In addition to the main points of routine ethical review,these problems need to be focused on,including:study design,sample size estimation,risk and benefit assessment,vulnerable groups,fair recruitment of subjects,informed consent and data sharing,etc.Finally,some countermeasures are proposed,such as amending laws and regulations,the pre-examination at the national level,the single-center ethical review,the remote video conference review mode and others,so as to provide reference for the capacity building of ethical review in clinical research in the outbreak of severe infectious diseases in China.
作者
周吉银
ZHOU Jiyin(National Drug Clinical Trial Institution,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)
出处
《中国医学伦理学》
2020年第8期931-936,941,共7页
Chinese Medical Ethics
基金
2019年陆军军医大学人文社会科学基金重点项目“伦理倾销对我国的危害及防范研究”(2019XRW04)。
