2019冠状病毒病大流行期间对超说明书用药的伦理审查
Ethical review of off-label drugs during the COVID-19 pandemic.
作者信息
Li Qiu-Yu, Lv Ye, An Zhuo-Yu, Dai Ni-Ni, Hong Xue, Zhang Yu, Liang Li-Jun
机构信息
Department of Pulmonary and Critical Care Medicine, Peking University Third Hospital, Beijing 100191, China.
Advanced Institute for Medical Sciences, Dalian Medical University, Dalian 116044, Liaoning Province, China.
出版信息
World J Clin Cases. 2022 Jun 16;10(17):5541-5550. doi: 10.12998/wjcc.v10.i17.5541.
High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019 (COVID-19) pandemic and ensure people's health and safety. Chloroquine (CQ) and hydroxychloroquine (HCQ) have received much attention. This article comprehensively investigates the ethical review of off-label CQ and HCQ research during the COVID-19 pandemic with regard to strictly abiding by review standards, improving review efficiency, ensuring the rights and interests of subjects and that ethics committees conduct independent reviews, and achieving full ethics supervision of research conducted during an emergency. Research must be both rigorous and prudent to ensure the best outcome, with the maximization of benefits as the core principle. Standardization of the application, implementation and ethical review processes are needed to prevent unnecessary risk.
高质量的科学研究对于有效控制2019冠状病毒病（COVID-19）大流行以及保障人们的健康和安全至关重要。氯喹（CQ）和羟氯喹（HCQ）备受关注。本文全面探讨了在COVID-19大流行期间，针对氯喹和羟氯喹的非标签研究进行伦理审查的相关问题，包括严格遵守审查标准、提高审查效率、保障受试者权益以及确保伦理委员会进行独立审查，从而实现对紧急情况下开展的研究进行全面伦理监督。研究必须严谨审慎以确保最佳结果，以利益最大化为核心原则。需要对应用、实施及伦理审查过程进行规范，以防止不必要的风险。
Zotero 插件