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KMID : 1172020190200010063
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Journal of Korean Bioethics Association
2019 Volume.20 No. 1 p.63 ~ p.82
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Interpretation of Exemption of RB Review Under Bioethics and Biosafety Act & Proposal for Improvement in Practice
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Lee Gang-Mi
Lee Won-Bok
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Abstract
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The Bioethics and Biosafety Act of Korea requires that a research involving human subjects or human biospecimen must obtain prior consent from the subject (or donor) as well as review by an institutional review board (“IRB”). The law also provides exemption from these consent and IRB review requirements. There is question as to who can decide whether a proposed research is eligible for exemption from IRB review. The relevant government ministry and agency appear to be of the view that an IRB has the authority to determine the eligibility. However, a strict construction of the statutes brings into question whether an IRB has the legal basis to determine whether a proposed research will pose minimal risk to the subject (or donor) or the general public, or to determine whether a proposed research falls into one of the many exempted types of research. To the contrary, a strict reading of the statutes will reveal that an IRB has no legal authority to determine whether a proposed research is eligible for exemption. From policy perspective, the narrow and specific statutory exemptions from IRB review under Korean law are amenable to self-determination by the investigator for some exemptions. The authors propose a flowchart by which the investigator of a research can self-determine the eligibility for exemption from IRB review when it is appropriate.
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KEYWORD
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Bioethics and Biosafety Act, institutional review board, exemption from review, human research, human biospecimen research, Common Rule
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