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KMID : 1142820180020020065
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Bio, Ethics and Policy
2018 Volume.2 No. 2 p.65 ~ p.85
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Implications of Japanese 「Clinical Research Act」 on relevant regulation of Korea
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Kim Bo-Bae
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Abstract
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In Japan, the 「Clinical Research Act」, which was recently adopted to prevent misconduct in clinical research, was enacted on April 1, 2018. As social events related to clinical trials have been launched in succession, the existing professional self-regulation and government department guidelines alone are not enough. The act defines specific clinical studies as risky or funded by pharmaceutical companies and introduces a much stronger regulatory framework than general clinical studies. In addition to this, the act set standards for the conduct of clinical research, introduced a system for the approval of the clinical research examination committee, and strengthened management of economic conflicts of interest. In this paper, the main events, the legislative process, the subject of application, the main contents and characteristics were examined and implications for the related regulations in Korea were derived. This suggests that Korea`s 「Bioethics and Safety Act」 should differentiate the level of regulation by reflecting the characteristics such as the degree of risk on research subjects and ethical issues.
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KEYWORD
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Clinical Research Act, specific clinical studies, specific clinical studies, bioethics law, institutional bioethics committee
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