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

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

Original Article

Clinical Value of Demonstration of Estrogen and Progesterone Receptors using Paraffin Wax Sections in Breast Carcinoma.: Hye Kyung Ahn, Yun Jung Kim, Young Euy Park; Korean J Pathol. 1996;30(2):89-93.

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Abstract PDF: This study aimed at assessing the usefulness of paraffin wax sections for demonstration of ER(estrogen receptor) and PR(progesterone receptor), using brief microwave processing rather than proteolytic predigestion. The receptor status of a breast cancer is often into consideration when planning treatment nowadays. As biochemical receptor assays require large amount of fresh tumor tissue and are not always available for all tumors, pathologists are now increasingly asked to provide a service for the assessment of the receptor status in tissue routine sections. Until recently, immunohistochemical demonstration of receptors was used in frozen sections. Therefore, routinely processed paraffin wax sections of 25 cases of breast carcinoma with known ER and PR concentrations, estimated by the standard DCC(dextran-coated charcoal) biochemical assay, were examined using the ABC immunoperoxidase technique. The results were assessed semiquantitably, using a five grade scoring system. Of the 25 cases examined, with DCC cutoff point being <10 fmol,71% and 75% in positivity of each ER, PR receptor is concordant. Statistic analysis demonstrates high relationship between scoring system of IH method and DCC value in ER (R=0.6061, p=0.001) and PR (R=0.5832, p=0.001). The IH method can provide easily assessed reliable positive information about ER, PR status of breast carcinoma using routinely processed paraffin wax sections.

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