Have you ever wondered how licences are granted by the Home Office for the purpose of animal research? Here we briefly explain what three licences must be in place for regulated scientific procedures on animal to be authorised.

Under the Animals (Scientific Procedures) Act 1986 (ASPA), three licences need to be held in order to conduct research on a protected animal. These are an establishment licence (PEL), personal licence (PIL) and a project licence (PPL). Licences are issued by the Home Office in England, Scotland and Wales, and by the Department of Health, Social Services and Public Safety in Northern Ireland.

Establishment licence

An establishment licence is required by any establishment where regulated procedures are carried out. This includes establishments that conduct the breeding and supply of laboratory animals. Establishments are mainly universities but can also be commercial organisations such as drug companies, contract research companies, non-profit making organisations, government departments or public health organisations. Under this licence, each establishment must have at least one named veterinary surgeon, named animal care and welfare officer, named training and competency officer, and named information officer.

Personal licence

A personal licence is required by anyone who wishes to conduct regulated animal research procedures. This type of licence is specific to the individual, and contains information on which procedures can be conducted, the species that can be used, the place in which the procedures can take place (which must hold an establishment licence), and any details of required supervision. Training should be conducted prior to applying for a personal licence to ensure proper research skills and knowledge. Further supervision by the project licence holder will take place when a licence is granted if necessary to ensure procedures are conducted competently.  A personal licence will only be authorised if the applicant has appropriate education and training and is competent in applying regulated procedures. They must also be able to appropriately handle and care for the laboratory animals being used.

Project licence

A project licence is required for any research requiring regulated procedures to be conducted. This licence specifies the work that can be conducted within the project, including any background information on the study, specific procedures that will be conducted and the establishment where the work is being conducted. The scientific rationale behind why animals are required for the study, and the number and species of animals required must also be included, with details of how procedures will have the minimum impact possible on the animals. Any amendments to the original project licence application must also be submitted to the Home Office for review.

The Home Office provides guidance to support project licence applications.

Before applications are sent to the Home Office for approval, the Animal Welfare Ethical Review Body (AWERB) for the establishment must scrutinise project licence applications to ensure the 3Rs have been thoroughly applied.