Sadly, just after the Animals (Scientific Procedures) Act 1986 had been amended1 to bring into force in the UK the new European Directive 2010/63/EU on the protection of animals used for scientific purposes,2 allegations were made about the abuse of laboratory animals at one of the country’s leading academic research establishments.3 Nothing more must be said about that, pending the outcome of various investigations. However, it raises the question of who is responsible for ensuring that animals are used properly, and who is culpable, when things go wrong.
In the UK, we have long experience of the clearly-defined responsibilities of the Home Office ministers and officials, including the Animals in Science Regulation Unit (ASRU) Inspectorate, and various named persons in the breeding or user establishment, including the certificate holder, the day-today care person, the veterinary surgeon, the project licensees and the personal licensees. The former EU Directive, Directive 86/609/EEC, said relatively little about specific responsibilities, but the new Directive says far more in several of its articles, as follows:
Article 23 requires Member States to ensure the competence of all staff, by seeing that all staff are adequately educated and trained before they perform any of their functions.
Article 24 spells out the specific requirements for personnel to be responsible for overseeing the welfare and care of the animals in the establishment, ensuring that the staff dealing with animals have access to information specific to the species housed in the establishment, and ensuring that the staff are adequately educated, competent and continuously trained, and supervised until they have demonstrated the requisite competence, whilst also ensuring that projects are carried out in accordance with the project authorisation.
Article 25 requires Member States to ensure that each establishment has a designated veterinarian with expertise in laboratory animal medicine, charged with advisory duties in relation to the well-being and treatment of the animals.
Article 26 lays down the requirement for an animal welfare body, while Article 27 outlines its tasks in relation to the welfare of the animals, the application of the Three Rs, the internal establishment and review of operating procedures with regard to monitoring, reporting and follow-up, including the development and outcomes of projects and their further contributions to the Three Rs.
Article 30 requires the Member States to ensure that all establishments keep records of the number and species of animals involved, their origins, their use and their death or re-homing.
Article 34 specifies that the competent authorities of the Member States must carry out regular inspections, to verify compliance with the requirements of the Directive, taking into account the number and species of animals involved, the record of the establishment in complying with the requirements of this Directive, the number and types of projects carried out, and any information that might indicate noncompliance.
Article 35 states that, when there is due reason for concern, the Commission shall undertake controls of the infrastructure and operation of national inspections in Member States, and the competent authority of the Member State concerned shall undertake measures to take account of the results of the control.
There are, of course, other individuals and organisations with responsibilities. These include the research funding bodies and the peer reviewers who assess research grant proposals, as discussed in a useful booklet, Responsibility in the use of animals in bioscience research,4 published by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). Also of importance are the editors and editorial boards of the journals which publish articles which involve the use of laboratory animals, as was considered in a thoughtful article by Helen Galley.5
Given the clarity of the legislation and the specified responsibilities of so many different kinds of people, how can things go so wrong, as happens, as far as we know, on relatively rare occasions? First of all, human beings are involved, and whether those involved are doctors, lawyers, airline pilots, other professionals or even parents, we are a fallible
species and sometimes do wrong things, accidentally or deliberately. We need rules within which to work, and people in place to try to ensure that we do so, but they can’t watch all of us all of the time. In the end, it all depends on personal integrity, and, in the case of performing potentially-harmful experimental procedures on living vertebrates, the ultimate and inescapable responsibility must rest with those who actually perform the procedures. That is where the buck stops.
1 Anon. (2012). The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012. Statutory Instrument No. 3039, 57pp. London, UK: The National Archive. Available at: http://www.legislation.gov.uk/uksi/2012/3039/contents/made (Accessed 23.05.13).
2 Anon. (2010). Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Official Journal of the European Union L276, 20.10.2010, 33–79.
3 Woolf, M. & Jacobson, S. (2013). Inquiry into ‘abuse’ of lab rats at college. The Sunday Times, 14 April 2013, p. 8.
4 Anon. (2013). Responsibility in the use of animals in bioscience research, 24pp. London, UK: NC3Rs. Available at: http://www.nc3rs.org.uk/downloaddoc.asp? id =719 (Accessed 23.05.13).
5Galley, H.F. (2010). Mice, men and medicine. British Journal of Anaesthesia 105, 396–400.