J Pathol Transl Med.  2018 May;52(3):141-147. 10.4132/jptm.2018.02.07.

Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent

• Kim YJ
• Park JS
• Ko K
• Jeong CR

• KMID: 2412925
• DOI: http://doi.org/10.4132/jptm.2018.02.07

Abstract

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.

Keyword

Paraffin block; Bioethics and Safety Act; Pathology research; Human biospecimen; Written consent

MeSH Terms

Bioethics
Ethics Committees, Research
Genetic Research
Humans
Informed Consent*
Korea
Linear Energy Transfer*
Paraffin*
Pathology
Precision Medicine
Public Health
Social Control, Formal
Translational Medical Research
Paraffin

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