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- Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent
- Yong-Jin Kim, Jeong Sik Park, Karam Ko, Chang Rok Jeong
- J Pathol Transl Med. 2018;52(3):141-147. Published online April 5, 2018
- DOI: https://doi.org/10.4132/jptm.2018.02.07
- 7,594 View
- 135 Download
- 3 Web of Science
- 3 Crossref
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Abstract
PDF - 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 Korea’s regulations with those of other countries. The necessity for allowing waived consent and Institutional 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: research could not be practically carried out without a waiver of consent; the 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; and research will not utilize a tissue block if only 1 is available for each subject, to allow future clinical use such as re-evaluation or further studies.
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Citations
Citations to this article as recorded by
- NaV1.7 channels are expressed in the lower airways of the human respiratory tract
Everardo Hernández-Plata, Ana Alfaro Cruz, Carina Becerril
Respiratory Physiology & Neurobiology.2023; 311: 104034. CrossRef - Expression Profiles of GILZ and SGK-1 in Potentially Malignant and Malignant Human Oral Lesions
Mahmood S. Mozaffari, Rafik Abdelsayed
Frontiers in Oral Health.2021;[Epub] CrossRef - IRB review points for studies utilizing paraffin blocks archived in the pathology laboratory
Yong-Jin Kim, Chang Rok Jeong, Jeong Sik Park
Yeungnam University Journal of Medicine.2018; 35(1): 36. CrossRef
- NaV1.7 channels are expressed in the lower airways of the human respiratory tract
Original Article
- Management and Ethics of Biobank; Biorepository.
- Bong Kyung Shin, Jung Woo Choi, Hyunjuu Lee, Aree Kim, Insun Kim, Han Kyeom Kim
- Korean J Pathol. 2005;39(6):372-378.
- 1,842 View
- 35 Download
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Abstract
PDF
- Research access to a large number of high-quality biospecimen, adequately annotated and ethically acquired, is critical to an improved understanding of disease and ultimately new development of effective diagnostic markers and therapeutic targets. Therefore, the importance of biobanking is widely recognized within the life science and healthcare communities. Resolution of the ethical issues, including informed consent, confidentiality and institutional review board approval, are probably the most important task to every biobank or biorepository. In Korea, the new, very strict ethical act on research, issued in 2005, requires researchers as well as biorepositories to know how they use or run a biorepository ethically without damaging the right of human subjects who gave the repository their biospecimen.
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