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KMID : 1172020120130010025
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Journal of Korean Bioethics Association
2012 Volume.13 No. 1 p.25 ~ p.39
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Challenges on Institutional Review System and Responses from Developed Countries
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Choi Eun-Kyung
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Abstract
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Since emergence and expansion of large-scale, multi-site research, concerns raised that institutional review system can’t handle increased workload. Institutional review system has been criticized for limited expert resource, inadequate initial and continuous review, repetitive and meaningless work, conflict of interest, and limited activity for quality improvement. Further, in response to enlargement and standardization of medical research, expansion of ethics review system and standardization of review activity has been needed. Also, current review system is needed to effectively include non-traditional research activity like human material research, genetic research.
Each country has been made its own effort to introduce various systems and pursue reforms. In U.S and Canada, accreditation system and central IRB system were initiated, and regional review system is argued now. In UK, Europe and New Zealand where regional and multi-site ethics review system has been settled, central research ethics authority is established to organize and coordinate ethics review activities. In general, these countries try to centralize a part of institutional or local boards’ work and restrict their autonomy and authority.
This paper shows these developed countries’ efforts to reform current institutional review system. Centralization of institutional review system is welcomed for improved efficiency of ethics review activity, but it is also worried to make another bureaucracy, excess of central work. The outcome of centralization of ethics review system is not certain yet, but these efforts are still expected to solve the challenges on institutional review system.
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KEYWORD
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research ethics review system, IRB, multi-site research, accreditation, central review board, centralization of ethics review
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