Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent
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. Curr...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Korean Society of Pathologists & the Korean Society for Cytopathology
2018-05-01
|
| Series: | Journal of Pathology and Translational Medicine |
| Subjects: | |
| Online Access: | http://www.jpatholtm.org/upload/pdf/jptm-2018-02-07.pdf |
| _version_ | 1811241334886891520 |
|---|---|
| author | Yong-Jin Kim Jeong Sik Park Karam Ko Chang Rok Jeong |
| author_facet | Yong-Jin Kim Jeong Sik Park Karam Ko Chang Rok Jeong |
| author_sort | Yong-Jin Kim |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T13:34:48Z |
| format | Article |
| id | doaj.art-8cdc0a7c279e4ea48d39a56187e9536d |
| institution | Directory Open Access Journal |
| issn | 2383-7837 2383-7845 |
| language | English |
| last_indexed | 2024-04-12T13:34:48Z |
| publishDate | 2018-05-01 |
| publisher | Korean Society of Pathologists & the Korean Society for Cytopathology |
| record_format | Article |
| series | Journal of Pathology and Translational Medicine |
| spelling | doaj.art-8cdc0a7c279e4ea48d39a56187e9536d2022-12-22T03:31:03ZengKorean Society of Pathologists & the Korean Society for CytopathologyJournal of Pathology and Translational Medicine2383-78372383-78452018-05-0152314114710.4132/jptm.2018.02.0716761Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed ConsentYong-Jin KimJeong Sik Park0Karam Ko1Chang Rok Jeong2 Department of Philosophy, College of Humanities, Kyungpook National University, Daegu, Korea Korea Study Group for Biomedical Ethics, Seoul, Korea Department of Ethics Education, Teachers’ College, Kyungpook National University, Daegu, KoreaAdvances 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.http://www.jpatholtm.org/upload/pdf/jptm-2018-02-07.pdfParaffin blockBioethics and Safety ActPathology researchHuman biospecimenWritten consent |
| spellingShingle | Yong-Jin Kim Jeong Sik Park Karam Ko Chang Rok Jeong Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent Journal of Pathology and Translational Medicine Paraffin block Bioethics and Safety Act Pathology research Human biospecimen Written consent |
| title | Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent |
| title_full | Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent |
| title_fullStr | Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent |
| title_full_unstemmed | Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent |
| title_short | Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent |
| title_sort | let archived paraffin blocks be utilized for research with waiver of informed consent |
| topic | Paraffin block Bioethics and Safety Act Pathology research Human biospecimen Written consent |
| url | http://www.jpatholtm.org/upload/pdf/jptm-2018-02-07.pdf |
| work_keys_str_mv | AT yongjinkim letarchivedparaffinblocksbeutilizedforresearchwithwaiverofinformedconsent AT jeongsikpark letarchivedparaffinblocksbeutilizedforresearchwithwaiverofinformedconsent AT karamko letarchivedparaffinblocksbeutilizedforresearchwithwaiverofinformedconsent AT changrokjeong letarchivedparaffinblocksbeutilizedforresearchwithwaiverofinformedconsent |