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KMID : 1142820200040010029
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Bio, Ethics and Policy
2020 Volume.4 No. 1 p.29 ~ p.47
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Roles and Tasks of Institutional Bioethics Committees as Self-regulatory Organizations in Ethical Research
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Baik Su-Jin
Kim Hyeon-Cheol
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Abstract
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The Institutional Bioethics Committee System authorized by the Bioethics Act was designed to be implemented in research institutes for the management and oversight of ethical conduct of research, including review of research plans and protection of research subjects within the institutes. In other words, the research institute itself adopts a system of self-regulation that manages the conduct of internal research through the institutional committee. While self-regulation has the advantage of affording oversight and management of ethical issues at a close distance to the site where the research is conducted, internal interests may influence the institution’s regulatory capacity through the institutional committee. Nevertheless, with adequate independence and expertise within the institutional committees, research institutions can ensure the freedom of researchers to conduct independent research while assuring ethical principles and maintaining trust in the research process. In this article, I examine the limitations of the institutional committee system and suggest ways to improve the current situation. First, in the Bioethics Act, there are no provisions to ensure that the institutional committee achieves the status to supervise all of the institution’s research. Second, the requirement to establish an institutional committee within all research institutions is hindered by a lack of clarity regarding the actual research environment of many institutions. Third, practical considerations further limit system development because of a shortage of qualified institutional committee chairpersons, members, and administrative personnel with the expertise to deliberate and manage the institutional committee effectively. To address these concerns, I present a plan to improve the institutionalization of research ethics committees and strengthen competency management plans for specific institutional committees and members.
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KEYWORD
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Institutional Bioethics Committee, self-regulation, research ethics, ethical framework, ethical governance
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