Li QY, Lv Y, An ZY, Dai NN, Hong X, Zhang Y, Liang LJ. Ethical review of off-label drugs during the COVID-19 pandemic. World J Clin Cases 2022; 10(17): 5541-5550 [PMID: 35979109 DOI: 10.12998/wjcc.v10.i17.5541]
Corresponding Author of This Article
Qiu-Yu Li, MD, Doctor, Department of Pulmonary and Critical Care Medicine, Peking University Third Hospital, No. 49 Huayuan North Road, Haidian District, Beijing 100191, China. liqiuyu00@bjmu.edu.cn
Research Domain of This Article
Medical Ethics
Article-Type of This Article
Minireviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Clin Cases. Jun 16, 2022; 10(17): 5541-5550 Published online Jun 16, 2022. doi: 10.12998/wjcc.v10.i17.5541
Ethical review of off-label drugs during the COVID-19 pandemic
Qiu-Yu Li, Ye Lv, Zhuo-Yu An, Ni-Ni Dai, Xue Hong, Yu Zhang, Li-Jun Liang
Qiu-Yu Li, Ni-Ni Dai, Department of Pulmonary and Critical Care Medicine, Peking University Third Hospital, Beijing 100191, China
Ye Lv, Advanced Institute for Medical Sciences, Dalian Medical University, Dalian 116044, Liaoning Province, China
Zhuo-Yu An, Peking University Institute of Hematology, Peking University People’s Hospital, Beijing 100191, China
Xue Hong, Yu Zhang, Li-Jun Liang, Department of Ethics Office, Peking University Third Hospital, Beijing 100191, China
Author contributions: Li QY and Lv Y contributed equally to this paper; Li QY and Ye L reviewed the literature and contributed to manuscript drafting and revising; An ZY, Dai NN, Hong X, Zhang Y and Liang LJ contributed to making a revision to the manuscript; Li QY also contributed to conceptualization, methodology, and funding acquisition; and All authors issued final approval for the version to be submitted.
Supported byNational Natural Science Foundation of China, No. 81900641; Peking University Health Center for Combating the Pandemic Programs, No. BMU 2021MX020, and No. BMU 2022MX008.
Conflict-of-interest statement: There is no conflict of interests to declare.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qiu-Yu Li, MD, Doctor, Department of Pulmonary and Critical Care Medicine, Peking University Third Hospital, No. 49 Huayuan North Road, Haidian District, Beijing 100191, China. liqiuyu00@bjmu.edu.cn
Received: February 7, 2022 Peer-review started: February 7, 2022 First decision: March 22, 2022 Revised: March 26, 2022 Accepted: April 9, 2022 Article in press: April 9, 2022 Published online: June 16, 2022 Processing time: 121 Days and 21.8 Hours
Abstract
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.
Core Tip: High-quality scientific research is very important in the attempt to effectively control the coronavirus disease 2019 epidemic and ensure people’s life health and safety. Chloroquine and hydroxychloroquine have received much attention.
