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JPTM > Ahead-of Print

doi: https://doi.org/10.4132/jptm.2018.02.07    [Epub ahead of print]
Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent
Yong-Jin Kim1, Jeong Sik Park2, Karam Ko3, Chang Rok Jeong4
1Department of Pathology, School of Medicine, Kyungpook National University, Daegu, Korea
2Department of Philosophy, College of Humanities, Kyungpook National University, Daegu, Korea
3Korea Study Group for Biomedical ethics, Seoul, Korea
4Department of Ethics Education, Teachers’ College, Kyungpook National University, Daegu, Korea
Corresponding Author: Chang Rok Jeong ,Email: canthos@hanmail.net
Received: January 5, 2018;  Accepted: February 7, 2018.  Published online: April 5, 2018.
ABSTRACT
Advances in biomedical and genetic research have contributed to more effective public health improvement via bench to bed research and the emergence of personalized medicine. This has certainly showcased the importance of archived human tissues, especially paraffin-embedded blocks in pathology. Currently in Korea, undue legislative regulations of the Bioethics and Safety Act suspend and at times discourage studies from taking place. In this paper, the authors underline the value of paraffin blocks in the era of personalized and translational medicine. We discuss detailed clauses regarding the applicability of paraffin blocks from a legal perspective and compare our regulations with those of other countries. The necessity for allowing waived consent and Institution Review Board (IRB) approval will be argued throughout. The authors suggest that researchers declare the following to obtain IRB approval and waiver of informed consents: 1) research would not be practically carried out without a waiver of consent, 2) proposed research presents no more than minimal risk of harm to subjects and the waiver of consent will not adversely affect the rights and welfare of subjects, 3) research shall not utilize a tissue block if only one is available for each subject to allow future clinical use such as re-evaluation or further studies.
Key Words: Paraffin block, Bioethics and Safety Act, pathology research, human biospecimen, written consent
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