BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSION: 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.
