IRB review points for studies utilizing paraffin blocks archived in the pathology laboratory
10.12701/yujm.2018.35.1.36
- Author:
Yong Jin KIM
1
;
Chang Rok JEONG
;
Jeong Sik PARK
Author Information
1. Department of Pathology, Kyungpook National University School of Medicine, Daegu, Korea. yyjjkim1@gmail.com
- Publication Type:Review
- Keywords:
Paraffin block;
The Bioethics and Safety Act;
IRB;
Human biological material;
Consent
- MeSH:
Anonyms and Pseudonyms;
Bioethics;
Ethics Committees, Research;
Humans;
Medical Records;
Paraffin;
Pathology;
Patient Selection;
Precision Medicine
- From:Yeungnam University Journal of Medicine
2018;35(1):36-39
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
