Defending Informed Consent: Civil Society's Victory Against Emergency Research Deregulation in South Korea.

Abstract

Informed consent is both a foundational principle of research ethics and a human right grounded in self-determination and bodily integrity. During the COVID-19 pandemic, legislative attempts were made in South Korea to bypass informed consent and ethics review requirements for research involving patients with infectious diseases. Framed as emergency measures to accelerate biomedical innovation, the proposals sparked resistance from a broad coalition of civil society actors, including human rights advocates, patient organizations, labor unions, medical professionals, and bioethics scholars. This coalition, drawing on international bioethics norms and lessons from past research ethics controversies, mounted a coordinated public response, warning that such deregulation could erode fundamental ethical safeguards and set a concerning precedent. Their efforts helped prevent the proposed legislation from advancing in the parliamentary process. This defense of informed consent must be understood within the context of South Korea's post-authoritarian democratic evolution. Decades of civic struggle-from resistance to military dictatorship to the response to a constitutional crisis triggered by a martial law declaration in 2024-have shaped a politically conscious and ethically engaged public. This case study illustrates how informed consent can function not simply as a technical or procedural requirement but as a hard-won civil right anchored in democratic participation. South Korea's experience offers globally relevant insights into the role of civic vigilance in safeguarding human rights, especially during public health crises and emergency rule.