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KMID : 1011120160090030185
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Bioethics Policy Studies
2016 Volume.9 No. 3 p.185 ~ p.221
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A study on the research related conflict of interest as seen through the Dan Markingson case in U.S.A.
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Kim Eun-Ae
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Abstract
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If the research related persons and organizations having the multiple interests can’t consider the primary interest appropriately or can be effected by the secondary interest, the professional judgment by these persons and organizations can cause problems. The conflict of interest (hereinafter COI) of the research related persons and organizations such as the researcher, the member of IRB, the research institution can have a negative effect on ensuring the research validity and integrity as well as protecting the research participant’s right and welfare. So, the research related international norms such as 〈Declaration of Helsinki〉, 〈CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects〉 emphasizes the importance of its disclosure, minimization, management. But, for the fulfillment of these actions to prevent the problems and negative effect by the COI, understanding of these actions’ necessity and importance must be supported. Therefore, in this article, I introduced one real example ‘the Dan Markingson case in U.S.A.’ that clearly showed the problems and negative effect by the COI of the research related persons and organizations and analyze the major issues of this case focusing on the COI. And, to confirm the present legal and political condition as well as the problems, I review the research related Korean laws such as 「Bioethics and Safety Act」, 「Pharmaceutical Affairs Act」, 〈Korean Good Clinical Practice〉 and Korean policies announced by the research related government ministry. Also, I suggest the way to improve or complement them for the appropriate handling of the COI.
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KEYWORD
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conflict of interes, Dan Markingson case, research, clinical trial, protection of research participant, Institutional Review Board
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