Addressing potential ethical issues regarding the supply of human-derived products or reagents in in vitro OECD Test Guidelines

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Miriam N. Jacobs
Rosemary J. Versteegen
Carol Treasure
Jennifer Murray

Abstract

The number and scope of Organisation for Economic Cooperation and Development (OECD) in vitro test guidelines (TGs) are increasing in an effort to both improve human relevance and replace in vivo animal testing. In vitro test methods being developed for TG use are increasing the use of human based reagents in combination with or replacing animal derived reagents, and demand for human reagents is likely to grow in the near future. There are a range of issues asso­ciated with the ethical use of human reagents, particularly human serum, in the adaptation and development of in vitro TGs, especially to ensure that there is no human exploitation, legal requirements are adhered to, and that the origin of the reagent is assured. To address these concerns, the OECD has instigated a workshop on ethics, sources, availability, and traceability of human based reagents for TG purposes, to be held in March 2019. The focus is to provide guidance on acceptable sources of human serum for use in in vitro TGs, in terms of donor ethics and informed consent regarding commercial use, and quality control for safety and consistent performance, with a view to providing guidance to support the adaptation and/or development of in vitro TGs using human reagents, and to ensure that in reporting the test results to regulators, clearly defined ethical and traceability aspects are adequately addressed, for the Mutual Acceptance of Data principle to be accepted in all OECD member countries. This thought-starter provides a discussion basis to achieve those objectives.

Article Details

How to Cite
Jacobs, M., Versteegen, R., Treasure, C. and Murray, J. (2019) “Addressing potential ethical issues regarding the supply of human-derived products or reagents in in vitro OECD Test Guidelines”, ALTEX - Alternatives to animal experimentation, 36(2), pp. 163-176. doi: 10.14573/altex.1901281.
Section
Food for Thought ...
Author Biographies

Miriam N. Jacobs, Department of Toxicology, Centre for Radiation, Chemical and Environmental Hazards, Public Health England, Chilton, OXON, UK

Miriam Jacobs is the UK National Coordinator (Human Health) to the OECD Test Guideline Programme. She is a toxicologist with a multidisciplinary background.

Rosemary J. Versteegen, International Serum Industry Association, McHenry, MD, USA

CEO of International Serum Industry Association

Carol Treasure, XCellR8 Ltd, Daresbury, Cheshire, UK

Founder XCellR8

Jennifer Murray, Life Science Group Ltd, Wilden, Bedfordshire, UK

JM is Director of a company manufacturing both serum and serum-free products.