突发公共卫生事件临床研究伦理指南  

Ethical guidelines for clinical research related to public health emergencies

作　　者：无 刘星 张欣[2,3] 

机构地区：[1]湖南省医学会医学伦理学专业委员会 [2]中南大学湘雅医院 [3]中南大学医学人文研究中心

出　　处：《中南大学学报（医学版）》2020年第8期881-885,共5页Journal of Central South University ：Medical Science

基　　金：中南大学新型冠状病毒感染的肺炎防控首批应急项目(160260007)。

摘　　要：临床研究是应对突发公共卫生事件,降低疫情危害,保护公众健康和生命安全的重要环节。然而,不同于一般情况下的临床研究,突发公共卫生事件临床研究存在诸多不确定性和知识缺口,全球关于突发公共卫生事件临床研究伦理尚无统一标准,这对我国伦理研究实践提出了新的挑战。本文结合我国突发公共卫生事件临床研究伦理经验,提出突发公共卫生事件临床研究伦理指南应包括快速高效的伦理审查机制,科学合理的研究方案,风险与受益的合理权衡,坚持生命伦理的基本价值,确保充分知情同意,保护受试者个人隐私,以及公正合理地招募受试者等内容,进一步强调了保证公共卫生和临床应急处理的优先性,即在疫情暴发的情境下,各类公共卫生事件临床研究不能影响疫情防控和临床支持性治疗措施的优先性。Clinical research is an important part in responding to public health emergencies,reducing epidemic hazards,and protecting public health and life safety.However,different from the general clinical research,there are many uncertainties and knowledge gaps in the clinical research of public health emergencies,and there is no unified standard for the clinical research ethics of public health emergencies in the world,which poses a new challenge to the practice of ethical research in China.In this article,we will combine with the ethical experience of clinical research on public health emergencies in China,propose the ethical guidelines for clinical research related to public health emergencies,including fast and efficient ethical review mechanism,scientific and reasonable research design,a reasonable balance of risk and benefit,adhere to the fundamental value of bioethics,to ensure that fully informed consent,to protect the subject's privacy,and recruiting fairly and reasonably.Further emphasized the prioritizing of public health and clinical emergency treatment,that is,under the situation of outbreak,all kinds of relevant public health clinical research can’t affect the priority of epidemic prevention and control and clinical supportive treatment measures.

关 键 词：突发公共卫生事件 临床研究 伦理指南 

分 类 号：R-052[医药卫生]