가습기 살균제 연구의 교훈과 의생명과학연구에서의 적용 가능성 ― 연구 관련 이해상충의 해결을 중심으로 ― = Lessons of Humidifier Disinfectants Scandal and Applicability in Biomedical Research - Focusing on resolving conflicts of interest related to biomedical research -

다국어 초록 (Multilingual Abstract)

It has been over a decade since Hwang Woo-suk's stem cell research, which showed the problem of conflict of interest(COI) in scientific research. However, there is still no system for management of COI. This study starts from recognizing the possibility that the study of humidifier disinfectants can be distorted by COI. The purpose of this study is to review the COI related to the study of humidifier disinfectants and to examine whether the lessons learned here can be applied to biomedical research.
The problem of COI in the study of humidifier disinfectants was found to occur in all the research stages (study design, performance, analysis of results, and presentation of results) except the hypothesis setting in the five stages of the study. In order to solve these problems, we analyze the laws and institutions of the United States, which have been aware of COI related to researches from the earliest awareness and have managed policy conflicts. In the United States, an independent organization called the ‘Conflict of Interest Committee’ and ‘Conflict of Interest Officers’ were established to make concrete plans for management of COI in the design phase of the study and to manage them accordingly. Procedures for managing COI include supervision to resolve issues that may arise from COI at the pre-research stage, such as design, performance and reporting of research, and ways to sanction violations of regulations regarding conflicts of interest . In the case of South Korea, where there is little conflict of interest in scientific research, the US policy is worthy of reference.
In addition, this study examines how COI are managed in South Korea's biomedical research centered on the role of the Institutional Review Board(IRB), which is a characteristic institution of biomedical research and the Bioethics and Safety Act. In legal issues, the lack of objective criteria and definition of COI has been recognized as a problem, and the IRB has been partially responsible for managing conflicts of interest, but has not exercised its influence throughout the all stages of the study. Therefore, this study suggests a method to maintain the protection of the subjects and enhance the reliability of the biomedical research through the regulation of the definition of COI and the strengthening IRB’s role.