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KMID : 1025620200230010019
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Korean Journal of Medical Ethics
2020 Volume.23 No. 1 p.19 ~ p.37
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A Study on Policy Measures for Non-compliance with Institutional Bioethics Committees
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Chung Eun-Joo
Baik Su-Jin
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Abstract
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Since 2013, with the expansion of Institutional Bioethics Committees (IBCs), the ethical review and management of research on human subjects has greatly increased throughout South Korea. During this same time, a number of ethical lapses, including certain researchers failing to comply fully with the law or making false statements on their IBC applications, have attracted media attention. Although these scandals have helped to highlight the importance of ethical guidelines in research on human subjects, they have been quickly forgotten and have not led to any lasting changes or solutions. In order to prevent these incidents from occurring, new policy proposals are needed. Among these should be a plan to improve the IBC review/approval process in order to ensure that all research-related activities, from the beginning to the end of the research cycle, follow proper guidelines. Toward that goal, this article examines, and makes recommendations concerning the IBC review/approval process, which is the starting point of responsible research. The article examines the purpose and limitations of the Bioethics and Safety Act, reviews domestic and foreign laws and policies on IBC review duties, with a focus on 45CFR46 in the US, and finally suggests measures that could be adopted to better manage IBC non-compliance in Korea. On this last point, this article makes three recommendations: (1) a preventative measure for strengthening IBC education and related capacities through an IBC governance organization; (2) a measure to link and activate existing policies for research funding at academic institutions; and (3) a measure for registering and sharing research and IBC approval information.
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KEYWORD
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research ethics, bioethics, Institutional Bioethics Committee (IBC), Institutional Review Board (IRB), non-compliance, Bioethics and Safety Act, IRB review and approval
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