Research Ethics Challenges in Pandemic Korea and Their Implications for the Revised 2024 Declaration of Helsinki.

BACKGROUND

The pandemic significantly impacted research ethics, vastly magnifying existing challenges. This study examines challenges for research ethics in Korea during coronavirus disease 2019 (COVID-19) and their implications for the 2024 revised Declaration of Helsinki.

METHODS

As a literature search method, we applied the scoping review protocol using six databases, search keywords related to research ethics and COVID-19, then analyzed key themes against the revised Helsinki Declaration.

RESULTS

We reviewed the literature on research ethics during the COVID-19 pandemic in the Republic of Korea, identifying ten key themes: 1) participant safety; 2) national governance; 3) community engagement; 4) global cooperation; 5) reliable research; 6) rapid Institutional Review Board reviews; 7) consent adaptation; 8) fair inclusion of vulnerable groups; 9) ethics of human challenge trials; and 10) use of human materials without consent. The revised Helsinki Declaration of 2024 newly introduces: 1) ethical principles in public health emergencies; 2) meaningful community engagement; 3) scientific rigor; and the Declaration reframes 4) addressing vulnerability; and 5) informed consent for biological materials.

CONCLUSION

By analyzing the relevance and implications of the challenges identified in this literature review in relation to the revisions made to the Declaration of Helsinki in 2024, we demonstrate that the updated Declaration addresses most of the ethical challenges posed by research in pandemic Korea. This paper highlights that the 2024 revision underscores the significance of research ethics during pandemic situations and proposes approaches to enhance the research environment and ecosystem in the 21st century post-pandemic.