An overview of the regulation of genetically altered animals in research

This chapter presents existing legal and regulatory structures and some of the overarching governance practices that apply to “genetically modified” animals in what are considered “research” settings in selected countries or geopolitical units around the world. It incorporates the ethics of animal use by reference and concentrates on the statutory regulation and softer governance systems in situations in which animals that are clones (or their offspring) or that have intentional genomic alterations that fit within the rubric of “techniques of modern biotechnology” as defined by the WHO and FAO are used for research purposes. The chapter defines ‘What is an animal?’, the meaning of “modified” or “altered” and of “research”, then delves into the nuances around terms such as “regulation” and “governance”. It looks at the special case of non-human primates before providing a detailed compendium of the laws, regulations, and standards pertaining to research involving genetically modified animals in all major regions of the world.