新型冠状病毒肺炎疫情下临床研究伦理审查工作的实践与思考

Practice and thinking on ethical review of clinical researches under COVID-19 pandemic

疫情爆发以来,以新型冠状病毒肺炎(COVID-19)为研究对象的临床研究迅速增加,由于其重大公共卫生事件的特点,此类研究对伦理审查工作也提出了更高的要求。本文阐述了本次疫情下伦理审查工作面临的挑战,并以上海中医药大学附属曙光医院的实际经验为例,提出了应对策略与建议,以期保障特殊时期受试者和研究人员的健康和安全,保障临床研究规范有序的开展。

Since the outbreak of the pandemic, there has been a rapid increase in clinical researches of coronavirus disease 2019(COVID-19). As a major public health event, the related research work has higher requirements for ethical review. We expounded the challenges faced by the ethical review work under pandemic, and also proposed countermeasures and suggestions by learning from the practical experience of Shuguang Hospital of Shanghai University of Traditional Chinese Medicine for the purpose of ensuring the health and safety of subjects and researchers during the special periods as well as the standardized and orderly development of clinical research.