TY - JOUR
T1 - OECD workshop consensus report
T2 - Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines
AU - Jacobs, Miriam N.
AU - Bult, Jan M.
AU - Cavanagh, Kevin
AU - Chesne, Christophe
AU - Delrue, Nathalie
AU - Fu, Jianan
AU - Grange, Emma
AU - Langezaal, Ingrid
AU - Misztela, Dominika
AU - Murray, Jenny
AU - Paparella, Martin
AU - Stoddart, Gilly
AU - Tonn, Torsten
AU - Treasure, Carol
AU - Tsukano, Masaaki
AU - Versteegen, Rosemary
N1 - Publisher Copyright:
Copyright © 2023 Jacobs, Bult, Cavanagh, Chesne, Delrue, Fu, Grange, Langezaal, Misztela, Murray, Paparella, Stoddart, Tonn, Treasure, Tsukano and Versteegen.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - animal-free
KW - ethics
KW - human derived reagents
KW - human platelet lysate
KW - human serum
KW - human serum albumin
KW - in vitro test methods
KW - xenofree
UR - http://www.scopus.com/inward/record.url?scp=85151536477&partnerID=8YFLogxK
U2 - 10.3389/ftox.2023.1140698
DO - 10.3389/ftox.2023.1140698
M3 - Article
AN - SCOPUS:85151536477
SN - 2673-3080
VL - 5
JO - Frontiers in Toxicology
JF - Frontiers in Toxicology
M1 - 1140698
ER -