Regulatory and Ethical Considerations

This chapter addresses the issue of legislative frameworks applicable to the use of animals for scientific purpose. After a short introduction on the rationale of law and regulations, a first part covers the latest European Directive (2010/63/UE), which enforces the implementation of the 3Rs principle (Replacement, Reduction, Refinement) as well as the US Animal Welfare Act, which is a reference for all others laws, policies, and guidelines. Effective January 1, 2013, the new European Directive notably mandates that every research, testing, or teaching project involving animals obtain an authorization delivered by a competent authority after a thorough evaluation by an Ethics Committee. In addition, the new organizational scheme is described that creates animal welfare bodies in charge of following up research projects, establishing and reviewing operational procedures, and advising the staff dealing with animals on matters related to animal welfare. A second part of the chapter covers the preparation of an animal license protocol, with detailed explanations and recommendations on the items commonly found in protocol forms: the prospective assessment of pain and distress, the measures to alleviate them, the experimental design and the number of animals, the experimental and humane endpoints, the description of the surgical procedure itself, and the compliance with the 3Rs principle. Beyond the practical aspect of filing an animal license form, the aim of the chapter is to provide essential knowledge on the current legislation and elements of thought in order to promote the responsible use of animals in research, testing, or teaching.