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

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.

In vitro evaluation of the carcinogenic potential of perfluorinated chemicals

“…Efforts to develop non-animal-derived alternatives for FCS are ongoing and motivated by concerns regarding animal welfare and the need for more standardized and defined culture conditions. Although some progress has been made in the development of serum-free or defined media formulations that utilize recombinant growth factors and synthetic substitutes, the complete replacement of FCS remains a challenging task (Lang et al, 2018;Subbiahanadar Chelladurai et al, 2021;Jacobs et al, 2023;Colacci et al, 2023). Despite advancements in cell culture technology, non-animal-derived alternatives often fail to fully replicate the growth-promoting properties of FCS, resulting in suboptimal cell growth, reduced cell viability, and altered cellular behavior (Colacci et al, 2023).…”

The Cell Transformation Assay: A Historical Assessment of Current Knowledge of Applications in an Integrated Approach to Testing and Assessment for Non-Genotoxic Carcinogens

“…However, from animal welfare perspectives, the use of FBS is criticized, as is the use of human serum [ 217 ]. Moreover, the recognized need to reduce the carbon footprint of cattle farms means that bovine serum provisioning may become more limited in the future.…”

Avoiding a reproducibility crisis in regulatory toxicology—on the fundamental role of ring trials

“…In the context of past validation studies, following the principles of GIVIMP, in particular, with respect to the test system characterization (which includes identity and contamination checks and sufficiently detailed documentation), would have circumvented many of problems listed in the table above. The OECD workshop report with respect to needs for human serum use (Jacobs et al 2019 , 2023 ) provides additional supplementary information for the GIVIMP in relation to reporting on human serum use and is intended as a checklist for test method developers to ask of their suppliers, to stimulate better practise.…”