Guidelines to apply for ethical approval of animal experiments

Abstract

Animal welfare is a value of the European Union (EU) enshrined in Article 13 of the Treaty on the Functioning of the European Union (TFEU) [1]: "In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage." In order to eliminate disparities between laws and regulations of the Member States regarding the protection of animals used for scientific purposes, the EU passed the Directive 86/609/EEC in 1986. This directive aimed at ensuring that animals used for experimental or other scientific purposes are adequately cared for and no unnecessary pain or suffering is inflicted to them. These rules were refined with the adoption of Directive 2010/63/EU [2] in 2010. Directive 2010/63/EU harmonises animal research legislation across EU Member States and ensures high standards of animal welfare in scientific research. Directive 2010/63/EU was transposed into national law in each Member State by 2013 or 2014. Member States, which enacted more rigorous measures to protect experimental animals prior to the introduction of Directive 2010/63/EU, can maintain them as long as they do not hinder EU-wide scientific cooperation and trade. So national legislations to protect animals used for experimental or scientific purposes include EU standards as defined in Directive 2010/63/EU and possibly additional national standards. This chapter presents common aspects applying in all EU Member States and in the UK (since Directive 2010/63/EU was transposed into British law before Brexit), and gives the specifications that apply in each research institute of the SmartCow project. Methods in cattle physiology and behaviour research – Recommendations from the SmartCow consortium 10.5680/