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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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첨단재생의료 관련 법적 기준 마련의 의의와 향후과제: 첨단재생의료 임상연구를 중심으로

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Type
Academic journal
Author
Erei Yoon (이화여자대학교) Eunae Kim (이화여자대학교)
Journal
Korea National Institute for Bioethics Policy Bio, Ethics and Policy Vol.6 No.2 KCI Accredited Journals
Published
2022.10
Pages
1 - 24 (24page)

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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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Abstract· Keywords

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The 「Act on the Safety and Support for Advanced Regenerative Medicine and Advanced 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 advanced 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 regenerative 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 protection 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.
#첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률(첨단재생바이오법) #첨단재생의료 임상연구 #환자접근성 #기관생명윤리위원회 #심의 #동의 #Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products(Advanced Regenerative Bio Act) #clinical research on advanced regenerative medicine #patient accessibility #Institutional Review Board #research protocol review #informed consent

Contents

요약
Ⅰ. 들어가며
Ⅱ. 첨단재생의료 임상연구 관련 법적 기준의 주요 내용과 의의
Ⅲ. 첨단재생의료 임상연구 규제 관련 법적 쟁점
Ⅳ. 마치며
참고문헌
ABSTRACT

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