MRC National Institute for Medical Research, London

Science for Health

Main navigation

Animals in research

Legislation and licensing

The UK has extremely stringent legislation governing the use of animals in research. This allows experimentation only in strictly controlled circumstances and ensures it is properly regulated and monitored.

This legislation is scrupulously observed at the Institute and encompasses the education and training of all staff who work with animals; the licensing of those staff and the projects they undertake; and the accommodation and care of animals (including regular inspections by the Home Office).

Before a project begins

Licence requirements

The Animals (Scientific Procedures) Act 1986 is the legislation that regulates the use of animals in scientific procedures in the UK. This legislation is enforced by the Home Office which demands that before any animal research study begins, three separate licences must be obtained:

Certificate of Designation (for the Institute)
- given to a laboratory or Institute with a properly built and run animal house that meets specified standards in:
  - staffing
  - veterinary care
  - properly trained animal technicians
  - animal accommodation, lighting, temperature, ventilation, etc
Project licence (for the research project)
- complete description of the project including:
  - why the research is important
  - why the animals are needed
  - why the information cannot be obtained without the use of animals
  - what experiments will be done
  - steps taken to reduce animal numbers
Personal licence (for the researcher)
- lists the techniques and species an individual may use and the establishment(s) at which they may work

Such licences are only granted if:

the research cannot be done using non-animal methods
the potential results of the research are important enough to justify the use of animals
the minimum number of animals will be used

Mandatory training

In addition, before any licence can be applied for or granted, evidence of successful completion of accredited, mandatory training for all involved in animal research, must be provided which covers:

Home Office legislation and the ethics of animal research
the basics of caring for animals
handling animals
ways of recognising illness or suffering

Licence approval

The licensing system is regulated by the Home Office and the system is policed by a team of special inspectors who are qualified vets or medical doctors. The Secretary of State gives final approval before a licence is granted.

Licensing staff assess proposals in detail and challenge applications to determine that they are necessary; that the quality and benefits of the proposed research outweigh any suffering; and that due consideration has been given to the guiding principles of the 3Rs. The process of applying for and receiving a Project Licence usually takes several months.

In judging whether to grant a licence application a number of sources of information may be consulted, for example:

laboratories with relevant expertise
databases
libraries
external experts

Internal project approval

Further, each project licence application is only considered for Home Office consideration if it has been scrutinised and approved by the local Ethical Review Panel.

During a project

Project review

Half-way through the lifetime of a Project Licence, NIMR's Local Ethical Review Process conducts a review of the achievements to date and ensures that the protocols used are still the most appropriate.

Project changes

During the course of a research project, results may lead to a significant change in the project plan. In these instances an official modification to the project licence must be applied for and approved before any further experiments can be carried out.

Licence compliance

As well as assessing applications for licences, the inspectors conduct regular inspections, often without warning, to ensure that work is being carried out strictly within the terms of the licence. Such inspections also examine whether animal facilities are being properly maintained.

At the end of a project

At the end of the lifetime of the licence if further research is still required, the process of application for a new Project Licence must begin. This will include a detailed retrospective review of the achievements of the last licence.