IRB와 HRPP의 개념과 운영에 대한 제언

Abstract

A hospital is a place where clinical trials are conducted in accordance with the Phar- maceutical Affairs Law, and human subject research is performed in accordance with the Bioethics and Safety Act. In accordance with the Bioethics and Safety Act and the Phar- maceutical Affairs Law, the Institutional Review Board (IRB) is integrated and operated within the institution to protect human subjects. In addition, domestic clinical trials have recently been activated and have increased rapidly in a relatively short period of time. As a result, as part of a comprehensive development plan to position the country as a leader in clinical trials, the Ministry of Food and Drug Safety (MFDS) has implemented the Korean model of the Human Research Protection Program (HRPP) through operational guidelines. Although the term IRB is widely known in relation to research ethics, the term HRPP has only been in use for a relatively short period of time. However, there appears to be confusion surrounding the concept of HRPP, as multiple understandings coexist. In order to help understand and operate HRPP compared to the IRB, the relat- ed content is summarized in comparison to the situation in the United States, and the following suggestions are made. First, it is necessary to harmonize and reach a consensus with the stakeholders regarding the relationship between the IRB and the HRPP. Second, it is required to consult and cooperate with the Ministry of Health and Welfare and the MFDS on the IRB and HRPP. Third, it is necessary to discuss the future direction of the Korean model of HRPP promoted by the MFDS.