기관생명윤리위원회(IRB)의 공무수탁사인 해당 여부

Clinical researchers are required to go through a review by an Institutional Review Board (“IRB”) to ensure the proposed research provides adequate protection to the research subjects. IRBs are responsible not only for reviewing the ethical and scientific validity of research proposals but also for processing information disclosure requests from research subjects. Due to this multifaceted nature of an IRB’s role, difficulties arise in understanding the nature of its primary function of reviewing clinical research proposals. In a court case that recognized an IRB's standing as a defendant in an information disclosure dispute, the court also asserted that the IRB holds the status of a regulatory agency performing duties specifically entrusted by the government. However, considering that the review process is governed by the institution’s autonomous standards, that there is no legal provision explicitly delegating such authority, and that the IRB lacks any power to affect a researcher’s legal status through its decisions, the IRB cannot be regarded as an entrusted regulatory agency. Instead, the review function of IRBs should be understood as a mechanism for institutions to fulfill their supervisory duties over affiliated researchers. IRBs operate as private experts ensuring research involving human subjects aligns with public standards through a system of self-regulation.