Korean J Clin Pharm.  2016 Mar;26(1):77-83. 10.0000/kjcp.2016.26.1.77.

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

Affiliations
  • 1College of Pharmacy, Chungang University, Seoul 06973, Republic of Korea. eykimjcb777@cau.ac.kr
  • 2Department of Pharmacy, Chungang University Hospital, Seoul 06973, Republic of Korea.
  • 3Department of institutional Review Board, Samsung Medical Center, Seoul 06351, Republic of Korea.
  • 4Department of Nephrology, Samsung Medical Center, Sungkyukwan University School of Medicine, Seoul 06351, Republic of Korea. wooseong.huh@samsung.com

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.

Keyword

National R&D projects; ethical oversight system; multilateral approaches

MeSH Terms

Academies and Institutes
Certification
Compliance*
Ethics Committees, Research
Germany
Humans
Korea
Research Personnel*
Social Control, Formal
Writing
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