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KMID : 1011120150090020025
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Bioethics Policy Studies
2015 Volume.9 No. 2 p.25 ~ p.56
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A Study on Criteria for Social Behavioral Research : Analysis of Common Rule and Standard Operating Procedure of the University Institutional Review Board in U.S.
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Kim Si-Hyeong
Choo Jung-Wan
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Abstract
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This study examines criteria for Social Behavioral Research (SBR) based on the amended Bioethics and Safety Act to stabilize Institutional Review Boards (IRBs) established within each university. Although there exists a well-instituted IRB by medical laws and policies for studies in the field of medical science, it is difficult to directly apply the IRB for SBR. This is because the IRB does not include guidelines and standard operation procedures (SOPs) for SBR. In addition, regarding that most universities do not have their own guidelines and SOPs for SBR in South Korea, the establishment of SOPs is necessary. Therefore, to this end, this study analyzes an IRB accredited by AAHRPP in the U.S. Particularly, common rule (CR) and SOPs are examined in terms of risks, benefits, privacy, and confidentiality. Then, the analyzed results are compared with an existing SOP of the public IRB in South Korea to find limitations of the existing SOP for SBR. As a result, this study provide us an insight in improving and developing SOPs of IRB in South Korea.
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KEYWORD
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Institutional review board, Bioethics and Safety Act, Common rule, Standard operating procedure, Social behavioral research, Risk, Privacy
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