Oversight on the Bioethical Compliance of National R&D Projects or Research Personnel

ABSTRACT

BACKGROUND: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. METHODS: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. RESULTS: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. CONCLUSION: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.