Yeungnam Univ J Med.  2018 Jun;35(1):36-39. 10.12701/yujm.2018.35.1.36.

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

• Kim YJ
• Jeong CR
• Park JS

• KMID: 2415731
• DOI: http://doi.org/10.12701/yujm.2018.35.1.36

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.

Keyword

Paraffin block; The Bioethics and Safety Act; IRB; Human biological material; Consent

MeSH Terms

Anonyms and Pseudonyms
Bioethics
Ethics Committees, Research*
Humans
Medical Records
Paraffin*
Pathology*
Patient Selection
Precision Medicine
Paraffin

Reference

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2. 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.

3. 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_id=gc_notice&bbs_no=184&mode=view&type=6.

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