Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

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

국가 R&D 과제의 생명윤리 관리체계 구축에 대한 고찰

  • Jang, Seong Mi (College of Pharmacy, Chungang University) ;
  • Jeong, Kyeong Hye (College of Pharmacy, Chungang University) ;
  • Kim, Bo Yeon (College of Pharmacy, Chungang University) ;
  • Kim, Young Nam (Department of Pharmacy, Chungang University Hospital) ;
  • Cho, Hyeon In (Department of institutional Review Board, Samsung Medical Center) ;
  • Kim, Eun Young (College of Pharmacy, Chungang University) ;
  • Huh, Woo Sung (Department of Nephrology, Samsung Medical Center, Sungkyukwan University School of Medicine)
  • 장성미 (중앙대학교 약학대학) ;
  • 정경혜 (중앙대학교 약학대학) ;
  • 김보연 (중앙대학교 약학대학) ;
  • 김영남 (중앙대학교병원 약제부) ;
  • 조현인 (삼성서울병원 기관윤리 심의국) ;
  • 김은영 (중앙대학교 약학대학) ;
  • 허우성 (성균관대학교 의과대학 삼성서울병원 신장내과)
  • Received : 2015.12.30
  • Accepted : 2016.02.16
  • Published : 2016.03.31
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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.

Keywords

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