Journal of Pathology and Translational Medicine

Review

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

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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.

Citations

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

Legal and Ethical Consideration in the Use of Human Biological Material.: Youngjoon Ryu, Bongkyung Shin, Baek Hui Kim, Aeree Kim, Hankyeom Kim; Korean J Pathol. 2010;44(2):111-116.; DOI: https://doi.org/10.4132/KoreanJPathol.2010.44.2.111

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Abstract PDF

Traditionally, pathologists have used human biological material primarily for diagnostic purposes. More recently, advances in biomedical technology and changes in the research environment have placed new demands on pathologists and their handling of human materials. Moreover, these technological advances have required pathologists to be not only experts in diagnosis, but also managers of biobanks storing human biological material. Consequently, pathologists might now be confronted with unanticipated legal and ethical questions. We investigated seven examples of South Korean legislation concerning human biological material, including "The Bioethics and Safety Act" (2005), and we considered possible conflicts of interest between donors and researchers. We also reviewed international bioethical guidelines and legal precedents from several countries with special regard to pathologic glass slides, paraffin blocks, remaining specimens and other guidelines. We conclude that a better understanding of the legal and ethical questions concerning human biological material leads pathologists to safer and more conscientious management of these samples.

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Citations to this article as recorded by

Proposal for the development of a human biological material management system for research hospitals
Young-Joon Ryu, Hankyeom Kim, Sejin Jang
Journal of the Korean Medical Association.2012; 55(3): 292. CrossRef

Original Articles

The Status of Pathology Specimen Bank in Other Countries.: Han Ik Bae, Ghil Suk Yoon; Korean J Pathol. 2005;39(6):379-383.

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Abstract PDF: Pathology specimen has been collected for purposes of education and research, particularly with respect to basic, developmental and translational studies in many areas of cancer research including molecular biology, immunology, and genetics. Even though no policy or ethical guideline drafted to regulate research tissue bank in Korea, advanced countries has been concerned ethical issues in the collections, storages, specimen transports and informatics for pathology specimen bank. Informed consent and confidentiality for protection of personal data records, which can be directly or indirectly associated with linked data from the donors' point of view, are the key to banking all over the world. The institutional review board (IRB) is important to ensure the scientific and ethical quality of pathologic specimen research. Increasing molecular genetic testing is also resulting in an increased demand of quality control for high quality nucleic acids. Most recently, the use of stored human tissue for education and research has become an object of increased ethical concern in Korea. Korean Association of Pathologists (KAP) has in urgent need of the policies and a standardized operating procedure, regulating a good collection practice of pathology specimen bank.

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.

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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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