摘要
在应对新冠肺炎疫情突发公共卫生事件的紧急背景下,医疗机构科学规范地开展临床研究,对于保护受试者权益,确保临床研究质量至关重要。伦理委员会及办公室作为保护受试者权益、确保临床研究规范开展的职能机构;伦理委员会健全的管理制度、SOP是规范工作的基础,为适应突发公共卫生事件防控需要,及时调整工作机制,有利于促进临床科研工作的顺利开展,为突发公共卫生事件防控相关的临床研究保驾护航。
Under the emergency background of responding to public health emergencies of COVID-19,it is of vital importance for medical institutions to carry out clinical research in a scientific and standardized way to protect the rights and interests of subjects and ensure the quality of clinical research.The ethics committee and office are the functional institutions that protect the rights and interests of subjects and ensure the standardized development of clinical research.The sound management system and SOP of the ethics committee are the basis for standardized work.In order to adapt to the needs of the prevention and control of public health emergencies,the working mechanism should be adjusted in time,which is conducive to promoting the smooth development of clinical scientific research and escorting clinical research related to the prevention and control of public health emergencies.
作者
田晓花
周运翱
TIAN Xiaohua;ZHOU Yun’ao(Ethics Committee,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)
出处
《中国医学伦理学》
2020年第11期1349-1353,共5页
Chinese Medical Ethics
基金
北京市属医院科研培育计划项目“基于健康受试者参加临床试验动机调查探索受试者权益保护的策略研究”(PG2020033)。
