Party and Government Office, the First Affiliated Hospital of Zhejiang University School of Medicine
Department of Science and Education, Zhangzhou Hospital Affiliated to Fujian Medical University

在新冠病毒感染(简称“新冠感染”)引发的突发公共卫生事件中,安全有效的药物对满足临床救治需求、恢复社会活动和经济发展有重要意义,而药物研发过程中存在着研究设计不科学、脆弱人群保护、利益冲突等方面的伦理挑战。本文着重讨论新冠感染临床试验可接受风险受益比、资源公正分配、加急伦理审查程序及标准等,由此建议突发公共卫生事件紧急应对时,临床试验应由政府引导、科研机构和社会力量协同攻关,对科研不诚信行为零容忍、维系伦理审查独立性、着实保护研究参与者权益,健全科技伦理治理体系。

Safe and effective drugs are of great significance to meet the needs of clinical treatment, restore social activities andeconomic development. The development of specific drugs under the COVID-19 epidemic has ethical challenges such as unscientificresearch design, protection of vulnerable groups, and conflicts of interest. This paper focuses on the acceptable risk-benefit ratio, fairallocation of resources, and procedures and standards for expedited ethical review in clinical trials of anti-COVID-19 drugs. Thepaper suggests that drug clinical trials in the emergency response to major public health emergencies should be coordinated by thegovernment, joint scientific research institutions and social forces, with zero tolerance for dishonesty in scientific research,maintaining the independence of ethical review, and protecting. rights and interests of research participants and improve the scientificand technological ethics governance system.During the public health emergency of international concern triggered by Corona Virus Disease 2019, which is commonly referredto as “COVID-19”, the significance of developing safe and effective drugs cannot be overstated. These drugs play a pivotal role inmeeting clinical treatment demands, restoring societal activities, and bolstering economic growth. However, the drug developmentprocess is riddled with ethical challenges, encompassing issues such as unscientific research design, significant vulnerability ofresearch participants, and prominent potential conflicts of interest.This study places a special emphasis on ethical considerations in the process of conducting clinical trials for COVID-19 infection. Itunderscores the critical importance of assessing the acceptable risk-benefit ratio, ensuring equitable resource allocation, expeditingethical review procedures, and upholding ethical standards. These multifaceted aspects are crucial in the landscape of public healthemergencies, where the ethical and scientific integrity of clinical trials must be preserved. First and foremost, the social and scientificvalue of the research is absolutely crucial. Even in the presence of conflicts, scientific integrity should not be compromised. Second,the equitable distribution of limited resources is of utmost significance. In the midst of a public health crisis, resources may beconstrained, thus underscoring the importance of fair allocation to address the most pressing needs. Next, expedited ethical reviewprocesses are indispensable, particularly during emergency situations. Ethical reviews must be conducted swiftly and efficiently,without compromising fundamental ethical standards of the research. Finally, assessing the risk-benefit ratio of research participants isindispensable. Research participants may face heightened risks in such emergency scenarios, necessitating the comprehensiveprotection of their rights and well-being, while simultaneously preserving the scientific validity of the research.Therefore, in the process of swiftly responding to public health emergencies, the following four ethical governance principles areworth considering, aiming to provide valuable insights for the establishment of a comprehensive technology ethics governanceframework. Firstly, a zero-tolerance approach towards research misconduct is essential, with a commitment to continuous researchintegrity. Secondly, it is crucial to maintain the independence of ethical review to ensure unbiased ethical judgments. Thirdly, there isa need to genuinely protect the rights of research participants and ensure a socially equitable and just orientation. Fourthly, clinicaltrials should be government-led, with collaborative efforts from research institutions and societal entities, ensuring multi-stakeholdercoordination.In conclusion, the COVID-19 pandemic has shed light on the critical importance of ethical considerations in clinical trials duringpublic health emergencies. Striking a balance between scientific urgency and ethical integrity is essential to address the uniquechallenges posed by such crises. By following the outlined recommendations and implementing a robust comprehensive ethicsgovernance system, we can better navigate these challenges, respond effectively to emergencies, and safeguard the well-being of allstakeholders involved in clinical research.

福建医科大学医学人文研究中心2020年开放课题(RW202002)

何玲玉, 蒋辉. 以新冠疫情为背景的临床试验伦理考量及治理机制探索[J]. 工程研究——跨学科视野中的工程, 2023, 15(4):290-298.

He L Y, Jiang H. Exploration of ethical considerations and governance mechanisms in clinical trials base on covid-19[J].Journal of Engineering Studies, 2023, 15(4): 290-298.