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KMID : 1142820220060020001
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Bio, Ethics and Policy
2022 Volume.6 No. 2 p.1 ~ p.24
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Significance and Future Tasks of Establishing Legal Standards for Advanced Regenerative Medicine: Focusing on the Advanced Regenerative Medicine Clinical Research
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Yoon E-Rei
Kim Eun-Ae
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Abstract
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The 「Act on the Safety and Support for Advanced Regenerative Medicine and Ad- vanced Biological Products」 enacted on August 27, 2019 (hereinafter referred to as the “Advanced Regenerative Bio Act”) has been in effect since August 28, 2020. Before ad- vanced regenerative medicine can actually be implemented as a new technology, advanced regenerative medicine clinical research must be properly conducted, and its safety and effectiveness must be confirmed. In addition, since this clinical research is also conducted on humans, the protection of research subjects who are subject to advanced regenera- tive medicine in the research stage as patients and human material donors who provide human cells, etc., used in clinical research on advanced regenerative medicine should be emphasized above all else. Therefore, in this thesis, we will analyze the significance of establishing legal standards for advanced regenerative medicine under the 「Advanced Regenerative Bio Act」 with an emphasis on advanced regenerative medicine clinical research. Specifically, we would like to compare the legal standards governing the protec- tion of advanced regenerative medicine clinical research subjects, the review of research protocols by the IRB, and the obtaining of informed consent from subjects in advanced regenerative medicine clinical research under the 「Advanced Regenerative Bio Act」 with the legal standards governing the clinical trial subjects and human material donors, the clinical trial protocol and human material research protocol review by the IRB, and obtaining informed consent from the clinical trial subjects and human material donors. In addition, we would like to propose future tasks pertaining to matters to be considered in order to make the already established legal standards for advanced regenerative medicine clinical research more meaningful. We would also like to propose future tasks related to the consideration of limited treatment as part of a method to overcome the limitations in improving patient accessibility.
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KEYWORD
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Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products(Advanced Regenerative Bio Act), clinical research on advanced re- generative medicine, patient accessibility, Institutional Review Board, research protocol review, informed consent
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