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Full Text: 
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¿µ³²ÀÇ´ëÇмúÁö Yeungnam Univ J Med 2018;35(1):36-39
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REVIEW ARTICLE
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IRB review points for studies utilizing paraffin blocks archived
in the pathology laboratory |
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Yong-Jin Kim1, Chang Rok Jeong2, Jeong Sik Park3
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1Department of Pathology, Kyungpook National University School of Medicine; 2Department of Ethics Education, Kyungpook National
University Teachers College; 3Department of Philosophy, Kyungpook National University College of Humanities, Daegu, Korea
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Corresponding Author: Yong-Jin Kim, Department of
Pathology, Kyungpook National University School of
Medicine, 130, Dongdeok-ro, Jung-gu, Daegu 41944,
Korea
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Tel: +82-53-200-5250, Fax: +82-53-426-1525
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E-mail: yyjjkim1@gmail.com
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Received: April 5, 2018, Revised: June 10, 2018
Accepted: June 11, 2018
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Abstract
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In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases
has come into the limelight. This archived material with clinical data will reduce the research time
and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating
the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made
the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent,
and alternatively to get the same before starting an experiment. Written consent may be waived off in studies
using paraffin blocks with anonymous status or conditions not linked to personal information by applying
the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers
to preserve the blocks as medical records of patients in long-term archives.
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Key Words: Keywords: Paraffin block; The Bioethics and Safety Act; IRB; Human biological material; Consent
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