Department of the History of Medicine and Medical Humanities, Seoul National University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2024 Apr 1;39(12):e116. doi: 10.3346/jkms.2024.39.e116.
Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government's pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic.
We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020-February 2021) and the second phase (March 2021-February 2023) for long-term preparedness.
The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training).
As a result of South Korea's commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.
尽管政府在大流行期间需要进行越来越多的临床研究伦理政策改革，但以前的文献范围仅限于韩国政府的大流行应对策略或机构和学术协会层面的研究伦理反思。本文考察了韩国政府在应对 2019 年冠状病毒病（COVID-19）大流行期间医疗产品快速开发和紧急供应的紧迫性所带来的研究伦理挑战和问题时，主动进行政策改革和做出响应。
我们使用与 COVID-19 大流行期间研究伦理和诚信相关的预定关键词，对各种政府文件进行了检索。仅包括政府或公共机构发布的文件。共选择了 24 份文件进行分析。它们分为两个阶段：紧急响应阶段（2020 年 1 月至 2021 年 2 月）和长期准备阶段（2021 年 3 月至 2023 年 2 月）。
韩国政府建议采取几项研究治理措施，以加快 COVID-19 相关研究的伦理审查，将审查时间缩短至不到一周：机构审查委员会（IRB）的联合运作、特别审查委员会的豁免或加速审查、紧急审查指南以及指定韩国医学科学院为临床试验安全支持机构以及中央 IRB 的监督机构。它允许临时采用非面对面的知情同意程序（电话解释和原始签名同意书的照片）和临床试验（电话咨询和处方、代理处方以及向临床试验参与者提供药物和供应，以及在线伦理培训）。
由于韩国在大流行应对中坚持伦理原则，医疗系统在大流行期间没有崩溃，并且进行了谨慎考虑伦理问题的大流行研究。2015 年中东呼吸综合征流行期间的大流行伦理免疫为政府的迅速行动奠定了基础，确保了大流行研究伦理和大流行应对伦理。
