Poster #105 - The Hidden Costs of Clinical Trial Deregulation in South Korea

• In Event: Friday Poster Reception

Abstract

South Korea has rapidly emerged as a global hub for clinical trials, driven by regulatory reforms aimed at expediting drug approvals and attracting pharmaceutical investment. While these changes have enhanced national competitiveness, they have also led to unintended consequences—most notably, a rise in adverse events among trial participants and a growing number of lawsuits. Together, these developments raise urgent concerns about how deregulation is reshaping the governance of labor, risk, and accountability in biomedical research.
This study addresses two core questions. First, how has the deregulation of clinical trials reshaped institutional and material arrangements of governance—particularly in terms of labor relations and risk distribution? Second, what ethical and political consequences have these transformations produced for trial participants?
Using a qualitative case study approach, the research draws on interviews with trial participants and regulatory actors, alongside document analysis of clinical trial policies, litigation cases, and media reports. The analysis is grounded in Actor-Network Theory (ANT) and Foucault’s concept of governmentality. ANT maps the heterogeneous networks—linking policymakers, sponsors, institutions, and regulatory agencies—to trace how deregulation operates and where it generates structural tensions. Governmentality reveals how participants are responsibilized as autonomous, risk-bearing subjects in the name of scientific progress.
The analysis reveals three key findings. First, deregulation has shifted the regulatory regime from the protection of vulnerable subjects to the optimization of biomedical productivity, reflecting a paradox of modern governance. Second, building on Melinda Cooper’s concept of clinical labor, the study shows how participants’ exposure to risk is reframed as a form of therapeutic altruism and as a contribution to biomedical productivity. Third, extending Giorgio Agamben’s concept of Homo Sacer, the analysis identifies a new form of exclusion—participants who are legally included in research protocols but denied ethical protection when harm occurs.
This research contributes to public administration, bioethics, and critical policy studies by illuminating how deregulation produces systemic vulnerability through biopolitical mechanisms. It calls for a rethinking of clinical trial governance that centers justice and accountability.

Author

• Youngdal Son, Sungkyunkwan University
  Presenting Author