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OECD workshop consensus report: Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines

Authors :
Miriam N. Jacobs
Jan M. Bult
Kevin Cavanagh
Christophe Chesne
Nathalie Delrue
Jianan Fu
Emma Grange
Ingrid Langezaal
Dominika Misztela
Jenny Murray
Martin Paparella
Gilly Stoddart
Torsten Tonn
Carol Treasure
Masaaki Tsukano
Rosemary Versteegen
Source :
Frontiers in Toxicology, Vol 5 (2023)
Publication Year :
2023
Publisher :
Frontiers Media S.A., 2023.

Abstract

The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD in vitro test guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries. These include informed donor consent terminology, a checklist of human serum information requirements to be included with the Good Laboratory Practise report, and suitable sources for human serum to ensure waste supplies are used, that can no longer be used for medical purposes, ensuring no competition of supply for essential medical use.

Details

Language :
English
ISSN :
26733080
Volume :
5
Database :
Directory of Open Access Journals
Journal :
Frontiers in Toxicology
Publication Type :
Academic Journal
Accession number :
edsdoj.64e648c9e6894018be64557ad5a4ea22
Document Type :
article
Full Text :
https://doi.org/10.3389/ftox.2023.1140698