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KMID : 1011120220150020027
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Bioethics Policy Studies
2022 Volume.15 No. 2 p.27 ~ p.46
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Problems of Legal Standards related to Human Subject Research and Solution to Them: Focusing on the definition of human subject research, the criteria for exemption of IRB review, and the criteria for obtaining informed consent
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Yoo Su-Jung
Kim Eun-Ae
Choi Kyung-Suk
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Abstract
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The Bioethics and Safety Act(hereinafter referred to as the “Bioethics Act”) was fully revised in 2012, and regulations on human subject research and human material research were introduced in 2013. Since then, it is very important for both human subject researchers and institutional review board to determine what specific human subject research is, what its scope is, and when IRB review is exempt. However, there are unclear and ambiguous parts in the definition and scope of human subject research, and the criteria for the exemption of IRB review. Thus, there are many complaints about them. In light of the fact that the purpose of review, investigation, and supervision of human subject research is to protect the research subjects, this paper identifies what regulations that need to be specified and provides cases where the expression in the law is somewhat improper and unreasonable. This paper reviews the problems of the legal standards related to human research under the current Bioethics Act, focusing on the definition of human subject research, the criteria for exemption of IRB review, and the criteria for obtaining informed consent. The paper suggests concrete legal phrases as solutions to overcome these problems.
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KEYWORD
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Bioethics and Safety Act, Institutional Review Board, human subject research, exemption of IRB review, informed consent
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