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

Kim, Yong-Jin; Jeong, Chang Rok; Park, Jeong Sik

doi:10.12701/yujm.2018.35.1.36

[국내논문] IRB review points for studies utilizing paraffin blocks archived in the pathology laboratory 원문보기

Yeungnam University Journal of Medicine = 영남의대학술지, v.35 no.1, 2018년, pp.36 - 39

Kim, Yong-Jin (Department of Pathology, Kyungpook National University School of Medicine) , Jeong, Chang Rok (Department of Ethics Education, Kyungpook National University Teachers College) , Park, Jeong Sik (Department of Philosophy, Kyungpook National University College of Humanities)

Abstract ▼ AI-Helper

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.

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가설 설정

When evaluating the study protocols utilizing paraffin blocks, not only bioethical aspects including consent forms, but also the fact that paraffin blocks are stored as a type of medical record, should be considered. Current “Medical Legislation Enforcement Regulations” article 15 (maintenance of medical records) indicates that paraffin blocks should be a type of medical record like radiologic imaging, and minimum of 5 years storage is mandatory.
In the study proposal, the investigators must agree that they will not use the block if ‘there is one last remaining block for the patient’ or they will obtain non-stainedglass slides if 'there is one last remaining block for the patient’.

참고문헌 (5)

Dry S. Who owns diagnostic tissue blocks? Lab Med 2009;40:69-73.

상세보기
Information Portal of Institutional Review Boards designated by the Ministry of Health and Welfare. 100 questions and 100 answers. 2013 to 2014 collection of open writings 30. Sejong: Ministry of Health and Welfare; 2015.
Department of Bioethics Policy, Ministry of Health and Welfare. Guidelines for understanding the conditions for waived consent when assessing study protocols utilizing remaining specimens to be discarded in the hospital [Internet]. Sejong: Ministry of Health and Welfare; 2017 [cited 2018 April 30]. https://bci.gilhospital.com/BlueAD/board.php?bbs_idgc_notice&bbs_no184&modeview&type6
Korean Society of Pathologists/Korean Society for Cytopatholgy. Pathology red book for quality assurance 2018 [Internet]. Seoul: Korean Society of Pathologists/Korean Society for Cytopatholgy; 2018. p. 25-6 [cited 2018 April 30]. http://www.pathology.or.kr/html/?pmodeboardview&MMC_pid251&seq18362
Kim YJ, Park JS, Ko K, Jeong CR. Let archived paraffin blocks be utilized for research with waiver of informed consent. J Pathol Transl Med 2018;52:141-7.

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