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Ǵм Yeungnam Univ J Med 2018;35(1):36-39


IRB review points for studies utilizing paraffin blocks archived in the pathology laboratory

Yong-Jin Kim1, Chang Rok Jeong2, Jeong Sik Park3
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
Corresponding Author: Yong-Jin Kim, Department of Pathology, Kyungpook National University School of Medicine, 130, Dongdeok-ro, Jung-gu, Daegu 41944, Korea
Tel: +82-53-200-5250, Fax: +82-53-426-1525
E-mail: yyjjkim1@gmail.com

Received: April 5, 2018, Revised: June 10, 2018 Accepted: June 11, 2018


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.

Key Words: Keywords: Paraffin block; The Bioethics and Safety Act; IRB; Human biological material; Consent