실질적인 임상시험 대상자 보호를 위하여: 한국 내 임상시험 대상자 보호 프로그램도입의 현황과 한계*,**

Abstract

Korea has witnessed rapid growth in the clinical trial industry in past 10 years. Public concern regarding the rights and safety of human research participants has been a major issue in the field. As the need for a more effective system of protection for human subjects grows, one which surpasses the scope of the Institutional Review Board (IRB), the Korean Ministry of Food and Drug Safety (MFDS) has issued its “Operation Guidelines for Human Research Protection Program (HRPP)” in 2014. It is the first government-initiated adoption of a HRPP in the world. This study shows that there is great deal of variation in clinical trial institutes in terms of their size and systems of operation and that many small- to medium-sized clinical trial institutes are not willing to adopt HRPP. The current MFDS HRPP policy does not reflect the differences in the various clinical trial institutes, which leads to a low adoption rate in HRPP in Korea. Furthermore, the government-initiated HRPP policy may puts more burdens on smaller organizations. Despite the limitations of the current HRPP policy, it is argued in this article that strong leadership to promote HRPP by the Korean government can improve clinical trial participant protection and the quality of clinical trials in Korea. Future policy for establishing and promoting HRPP in Korea should encompass considerations of the variability in the characteristics of clinical trial institutes as well as measures for enhancing the understanding of HRPP in the research community.