The legislation, regulation and oversight of animals used in research
The Home Office regulates and administers a licensing system under the Animals (Scientific Procedures) Act, 1986 incorporating the EU Directive 2010/63/EU. The University, as a licence holder, and its researchers are subject to inspection by the Home Office who examine all aspects of animal research, care and welfare.
The Home Office requires three levels of licensing that must all be in place before any regulated work is performed:
- An Establishment License (PEL). Where the premises that undertake research involving animals must be licensed to do so.
- A Project License (PPL). Where individual research projects are granted a license in order to undertake the proposed study.
- A Personal License (PIL). Where individual members of staff are required to hold a license to undertake research on animals. In each case the personal license holder will be trained to the accredited standard.
All research projects involving animals require approval by the University’s Animal Welfare and Ethical Review Board (AWERB), including projects not subject to Home Office licensing. Each project has to demonstrate a number of key requirements prior to local ethical approval, and submission to the Home Office for their consideration and the granting of a licence:
- That individuals involved in the research project are sufficiently experienced and trained in the use of animals in research.
- That there is no alternative to the use of animals in research.
- That the benefits of the research outweigh the potential adverse effects on the protected animals used.
AWERB also reviews animal projects that do not involve regulated procedures. This includes fieldwork research and observational studies, to ensure the natural habitats and environments of the subjects remain undisturbed by the research project.