Research

Regulation and policy

1. Regulation
1.1 UK legislation
1.2 European Directive 

2. Policy
2.1 Responsibility for the use of animals in bioscience research
2.2 Expectations for the use of animals in research
2.2 Openness about Animal Research
2.3 Informing public policy

Regulation

UK legislation

The Animals (Scientific Procedures) Act 1986

Controls on the use of animals in research have existed in the UK since 1876. These were revised and strengthened with the introduction of the Animals (Scientific Procedures) Act (ASPA) in 1986.  In 2013, ASPA was amended to bring UK law into line with the requirements of EU Directive 2010/63, and new codes of practice and guidance have been introduced.  UK regulations are widely regarded as some of the strictest in the world. Full details of the law on scientific research and testing involving animals can be accessed here.

Scientific procedures and licences

The Home Office licenses all scientific procedures in the UK under ASPA.  The term ‘procedure’ refers to any act that may cause an animal a level of pain, suffering or distress equivalent to or greater than the introduction of a hypodermic needle. Research involving animals can only be undertaken when all three of the below licenses have been granted:

  • Research can only take place in research institutes or companies which have appropriate animal accommodation and veterinary facilities, and have been granted an establishment licence.
  • Research can only be done as part of an approved research or testing programme which has been given a project licence.
  • Research can only be carried out by people with sufficient training, skills and experience as shown in their personal licence.

An annual report providing statistics relating to scientific procedures performed on living animals is produced by the Home Office Animals in Science Regulation Unit. These reports can be accessed here.

Species

Animals protected by the law include all living vertebrates, including those most commonly used in scientific procedures, such as mice, rats (and other rodents) and fish. Other species used include amphibians, reptiles and birds. Horses, cats, dogs and non-human primates are specially protected species under ASPA. Invertebrate animals such as the fruit fly, Drosophila, and worms (which are also commonly used in biomedical research) are not protected by the law.

Scientific procedures performed on living animals is produced by the Home Office Animals in Science Regulation Unit. These reports can be accessed here.

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European directive

UK law has adhered to European directives on the protection of animals used for scientific purposes since 1986. The most recent directive, 2010/63/EU, came into force in November 2010 and was implemented into UK law on 1 January 2013.

Along with other medical research and bioscience organisations, the MRC contributed to Home Office consultatons on the implementation of the Directive into UK law. The MRC was keen to ensure that the resultant legislation prioritised animal welfare and the application of the 3Rs (reduction, refinement and replacement of animals in research), harmonisation of standards across the European Union, the promotion of public confidence in humane animal research, and the reduction of unnecessary bureaucracy that does not directly promote animal welfare.

The MRC, together with leading biomedical research organisations, learned societies, industry representatives, universities and patient groups, has signed a pan-European statement supporting the European Directive 2010/63/EU on the protection of animals used for scientific purposes. For more information on this statement, please visit the European Animal Research Association’s website.

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Policy

Responsibility for the use of animals in bioscience research: Expectations of the major research council and charitable funding bodies

The MRC expectations are set out in Responsibility for the use of animals in bioscience research

This document provides general guidance to researchers and associated veterinary and animal care staff using vertebrates (live animals or animal products) in bioscience research. It sets out the expectations of the funding bodies for the use of such animals in research and is therefore also useful to ethics committees, referees and Panel/Committee/Board members involved in reviewing research proposals. Implementation of the principles in this guidance is a condition of receiving funds from the funding bodies.

The guidance covers:

  • A summary of the legal controls on animal use
  • The responsibilities of the relevant parties
  • The principles and procedures of the funding bodies
  • The requirements for research or collaborations outside of the UK.

This includes a requirement to follow the NC3Rs’ ARRIVE guidelines, which lay out criteria that should be met in reporting animal studies in order that their results and conclusions can be properly evaluated and utilised. 

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Expectations for the use of animals in research

This section gives an overview of the expectations of the MRC with regard to the responsibility of the use of animals in bioscience research. Full details can be found in the MRC’s Guidance for applicants, in particular the additional guidance provided for proposals involving animal use.

In accordance with the legal obligations under the Animals (Scientific Procedures) Act 1986, the Home Office will only authorise project licences to carry out scientific procedures following comprehensive project evaluation, and require the implementation of the principles of replacement, reduction and refinement (the 3Rs) in those projects. Furthermore, the principles of the 3Rs also extend to the breeding, accommodation and care of protected animals. More information on the 3Rs can be found here .

Experiments using animals funded by the MRC must comply with the Animals (Scientific Procedures) Act 1986 in:

  • Using the simplest possible, or least sentient, species of animal appropriate
  • Ensuring that distress and pain are avoided wherever possible
  • Employing an appropriate design and using the minimum number of animals consistent with ensuring that scientific objectives will be met.

All proposals using animals should explain not only why the use animals is necessary and the ethical implications of the planned experiments, but also clearly describe how the planned experimental design is appropriate to give robust results. In explaining the latter, applicants are expected to detail how the number of animals to be used was decided, plans to minimise experimental bias, and provide information on statistical aspects of the study including statistical power and appropriate statistical analysis.

The MRC also expects applicants to ensure that best practice in relation to animal husbandry and welfare is followed. Applications which propose the use of non-human primates, cats, dogs or equines, which are specially protected species under ASPA, are subject to additional review by the NC3Rs.

The MRC strongly encourages the archiving and sharing of genetically altered mouse strains as a means of both reducing and refining animal use. The MRC supports a central repository of mouse strains, the MRC Mouse Frozen Embryo and Sperm Archive (FESA) at MRC Harwell. FESA aims to ensure that valuable mouse strains are safeguarded, that the need to maintain colonies of live mice for long periods of time is reduced, and that the significant investment in producing genetically altered strains is capitalised upon fully.  All those funded to create new mouse strains should consider archiving these.

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Openness about Animal Research

The MRC is committed to openness about the use of animals in research.  We believe we have a duty to explain to the public – who fund our research – why and how animals are used. Alongside other research councils, universities, industry, charities, umbrella bodies and learned societies, the MRC helped to draw up the Concordat on Openness on Animal Research and was one of the first signatories.

The Concordat, launched in 2014, commits those who signed to:

  1. Be clear about when, how and why we use animals in research
  2. Enhance our communications with the media and the public about our research using animals
  3. Be proactive in providing opportunities for the public to find out about research using animals
  4. Report on progress annually and share our experiences.

The Concordat is overseen by Understanding Animal Research (UAR), an organisation supported by the MRC whose aim is to achieve a broad understanding of the humane use of animals in medical, veterinary, scientific and environmental research in the UK. More information about the use of animals in research can be found here.

Informing public policy

The MRC plays a key part in shaping public policy and legislation. The MRC calls upon the  expertise of animal researchers, animal facilities managers and technicians, named animal care and welfare officers (NACWOs) and policy officers to respond to various government,  European Commission and other consultations on the wider issues relating to the use of animals in research. Examples of this can be found below. 

Non-human primates

In conjunction with other funding organisations, the MRC has commissioned reports into the use of non-human primates in research: 

The use of non-human primates in research: a working group report chaired by Sir David Weatherall (December 2006)

The Weatherall report examined the scientific case for the use of non-human primates for research into the prevention or treatment of disease, or for fundamental research that has the long-term potential of achieving the same end.  The group concluded that there was a scientific case for careful, meticulously regulated non-human primate research, provided that it was the only way of solving important questions and high standards of welfare are maintained.

Review of research using non-human primates: report of a panel chaired by Professor Sir Patrick Bateson (July 2011)

This review followed the recommendation of the Weatherall report that the major funding organisations should undertake a systematic review of the outcome of all their research using non-human primates supported over the previous decade. The Bateson review panel concluded that, in many cases, the use of non-human primates was justifiable even in the context of current understanding of animal welfare and advances in knowledge that might now render some work on living animals unnecessary.

However, the panel did raise concern with the small number (approximately 9%) of research programmes from which no clear scientific, medical or social benefit had emerged. The MRC, in collaboration with the BBSRC and Wellcome Trust have begun to make progress against the recommendations made in the report.

EU directive 2010/63/EU

The MRC has made an important contribution to the development of the new European directive (2010/63/EU) on the ‘protection of animals used for experimental and other scientific procedures’ and its integration into UK law.

  • The MRC contributed to the UK Bioscience Sector Coalition response (PDF, 217KB) to the Home Office Consultation on the Transposition of European Directive 2010/63/EU (September 2011).
  • The MRC and Biotechnology and Biological Sciences Research Council (BBSRC) also submitted a joint response (PDF, 62KB) to this consultation; to comment on areas where the MRC/BBSRC community had additional expertise and experience (September 2011).
  • The MRC signed up to the UK Bioscience Sector Coalition response (PDF, 476KB) to the Home Office Consultation on EU proposals for a new directive on the protection of animals used for scientific purposes (July 2009).
  • The MRC signed up to the UK Bioscience Sector Coalition response (PDF, 639KB) to the House of Lords European Union Committee inquiry into the Revision of the Directive on the Protection of Animals Used for Scientific Purposes (86/609/EEC) (May 2009).

The MRC submitted a response (PDF, 43KB) to the consultation on the outline for the revision of Directive 86/609 on the protection of animals used for experimental and other scientific purposes (January 2007).
 

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