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KMID : 1142820170010020055
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Bio, Ethics and Policy
2017 Volume.1 No. 2 p.55 ~ p.72
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Consideration of consent exemption standard for research of collected human materials
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Cha Seung-Hyun
Ha Dae-Cheong
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Abstract
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Recent medical trends have changed the value of human-derived materials as a resource. Accordingly, there is a strong voice that a system should be set up to facilitate the use of human derivatives. In our "Law on Bioethics and Safety (hereinafter referred to as the" Bioethics Law "), apart from human subject research, the" consent exemption "clause is specified as an exception to the" consent "clause and the principle of research use of human derivatism is. However, there is controversy over the interpretation of the application of the provision, and due to this controversy.
In accordance with Article 37 (3) of the current Bioethics Act, Article 16 (3), which is the consent exemption standard for human subjects, is also applied to the study of human derivation. The term "practically impossible", "serious" Low "and so on. Ambiguous standards enable arbitrary interpretation. Therefore, researchers of human derivatives can not expect the consistency of the application of the law, and they are more likely to lose legal stability.
In this article, we review international norms such as the Helsinki Declaration, the Taipei Declaration, the CIOMS Guidelines, and the amendment standard of 45CFR46 in the United States, as well as the consent exemption criteria in the case of human derivatives research. . The three criteria of "reality", "minimum risk" and "public interest value of research" are considered to be valid criteria in judging the exemption of consent of human body research. Therefore, I would also like to consider the desirable direction of the interpretation of the requirement for the exemption of consent.
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KEYWORD
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BIOETHICS AND SAFETY ACT, Human Materials Research, Consent Exemption, Impracticability, Minimal Risk, Public value of research
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