Business and enterprise – guidance

Research and testing using animals

Details of the law on scientific research and testing involving animals, and guidance on applying for licences.

Overview

The government is committed to the replacement, reduction, and refinement of the use of animals in research - the “3Rs”.

The use of animals in scientific research remains a vital tool in improving our understanding of how biological systems work both in health and disease, and in the development of new medicines, treatments and technologies. Underpinning this research is a strong commitment to maintaining a rigorous regulatory system which ensures that animal research is carried out only where no practicable alternative exists and under controls which keep suffering to a minimum. This is achieved through robustly applying the principles of the 3Rs to all research proposals involving the use of animals.

Implementing the 3Rs requires that, in every research proposal, animals are replaced with non-animal alternatives wherever possible; that the number of animals is reduced to the minimum needed to achieve the results sought; and that, for those animals which must be used, procedures are refined as much as possible to minimise their suffering. The government is committed to ensuring that any licence we grant under the Animals (Scientific Procedures) Act 1986 must rigorously and demonstrably apply the 3Rs principles.

In 2010, the coalition government made a commitment to work to reduce the use of animals in scientific research and a delivery plan has been published. The plan shows how alternative methods can deliver fast, high-quality research that also boosts economic growth. We have now published a delivery report which describes the progress made on actions set out in the delivery plan.

Animals (Scientific Procedures) Act 1986

The use of animals in experiments and testing is regulated under the Animals (Scientific Procedures) Act 1986 (ASPA). ASPA has recently been revised to transpose European Directive 2010/63/EU on the protection of animals used for scientific purposes. The revised legislation came into force on 1 January 2013.

We have prepared this document for our own internal purposes and are making it available for information. Please do not take the document to be a definitive statement of the law.

ASPA is implemented by the Home Office in England, Scotland and Wales and by the Department for Health, Social Security and Public Safety in Northern Ireland.

Guidance on the operation of the Animals (Scientific Procedures) Act 1986

Guidance on the Operation of ASPA was published on 13 March 2014.

The guidance is intended to be a reference document that explains how the act is administered and enforced and provides detailed guidance to holders of establishment licences, project licences and personal licences and new licence applicants. In developing the guidance we consulted widely with stakeholders and the Animals in Science Committee. Copies of the guidance can be purchased from TSO bookshop using the ISBN 9780108561290.

There are several topics on which we will wish to publish further advice such as guidance on the use of animals containing human material, re-use of animals, re-homing animals (especially cats and dogs) and use of wild animals and their return to the wild.

An explanatory memorandum was also laid in parliament.

Applying for licences

3 licences are required by the ASPA before testing on animals is permitted:

  • a personal licence for each person carrying out procedures on animals
  • a project licence for the programme of work
  • an establishment licence for the place at which the work is carried out

Before applying for a licence applicants are strongly advised to read the standard conditions for establishment licences, personal licences and project licences.

Application forms and guidance notes

Applications for personal licenses and amendments are made through our e-licensing system, ASPeL. Please read the ASPeL user guidance (PDF, 545KB, 63 pages) , named officials at establishments will be able to provide assistance in completing the application.

You can download:

Applicants are strongly advised to contact their local Home Office inspector before starting to complete the form. The project licence application form states the legal basis for the information we require to assess an application. It is intended to minimise unnecessary bureaucracy without compromising animal welfare. We are developing an online application process which will integrate with the new form.

It is important that any named person responsible for animal welfare under ASPA is aware that they should declare any conflict of interest. They must not be in a position where he or she does not put his/her overriding welfare obligations to the animals first. A person with a controlling financial interest or a substantial interest in the scientific outcome of a project might be presumed not to be suitable as such a named person in the absence of compelling circumstances to the contrary.

In order for the Secretary of State to determine whether an individual nominated to be such a named person is suitable, it is important to be fully aware of any real or perceived conflicts of interest which exist. A separate declaration should be completed by each person nominated by an establishment licence holder to be such a named person and should accompany the application for designation of an establishment, or the application for change(s), as appropriate.

Common errors in project applications

Note the following common errors in application forms:

  1. in section 18 (part d, plan of work, on new form) the protocols are described rather than discussed, and not discussed in relation to the objectives
  2. the justification for the choice of model, together with the choice of species and the consideration with the alternatives, is lacking in section 18 (part d, plan of work, on new form)
  3. consideration of reduction, refinement and replacement is not adequately handled.
  4. the objectives set out in section 17 (part c, purpose, on new form) are too vague and non-specific and the benefits are not realistically linked to the objectives
  5. the background described in section 17 (part c, purpose, on new form) fails to take account of the progress of others in the topic and to identify clearly what needs to be discovered.
  6. amendments are offered without an explanation or with an inadequate explanation or justification in section 18 (part d, plan of work, on new form)
  7. the 19b protocol (part e, protocols, on new form) contains too much text, much of which is either descriptive or restrictive
  8. clear end-points are not set in relation to predicted adverse effects
  9. the difference between re-use and continued use of animals is not appreciated

Where to send completed application forms

In the case of personal applications, completed forms should be sent via the applicant’s certificate-holder to the local office. Project application forms should be sent via the applicant’s establishment licence-holder to the local office. Correspondence should be addressed to the Home Office and not a named official.

London

Home Office
Animals in Science Regulation Unit
1st floor Peel Building, North East Quarter
2 Marsham Street
London
SW1P 4DF
Duty manager: 020 7035 0477

Swindon

Home Office
PO Box 1138
Swindon
SN1 2RZ

Dealing with disagreements

Referral processes

We aim to deal with disputes or disagreements fairly and openly. The process for requesting a second opinion on decisions, which can be started by an Animals in Science Regulation Unit (ASRU) inspector or an individual, is described in our ‘route map’ document.

When this approach is unsuitable or has not worked, it may be necessary to use the formal appeals process as described in section 12 of ASPA. It is intended to be used when the Secretary of State proposes to refuse, vary or revoke an authorisation.

Annual returns: 2015

The documents in this section and the form to provide data are frequently reviewed and we ask users to always check this webpage to ensure they are using the most up-to-date versions. We welcome feedback on the documents and the form.

Before submitting your annual return, please read through these documents:

2015 form

Please do not use this form to provide data for 2014 (the 2014 form is provided further down this page). This form should only be used for procedures completed during 2015 (those due to be reported to the Home Office in January 2016) and for all those licences expiring or revoked during 2015.

The Return of procedures - animal use data 2015 (XSLM, 225KB) should be completed according to the instructions document - after clicking on the link for the form, click ‘save’, choose an appropriate folder and click ‘save again’. This will ensure that macros are automatically enabled, which will in turn ensure that the form validates properly.

Annual returns: 2014 (for outstanding returns from 2014 only)

Before submitting your annual return, please read through these documents:

2014 form

Please do not use this form to provide data for 2015 (the 2015 form is provided further up this page). This form should only be used for procedures completed during 2014 (that is, those to be reported to the Home Office in January 2015) and for all those licences expiring or revoked during 2014.

The Return of procedures - animal use data 2014 (MS Excel Spreadsheet, 585KB) should be completed according to the instructions document - after clicking on the link for the form, click ‘save’, choose an appropriate folder and click ‘save again’. This will ensure that macros are automatically enabled, which will in turn ensure that the form validates properly.

Publications

Code of practice for the care and accommodation of animals

The code of practice sets out the standards of care and accommodation of animals required by ASPA, and provides advice about the way in which those responsible under ASPA may comply with those requirements.

The intention of the code is to ensure that the design, construction and function of the installations and equipment of licensed establishments – along with their staffing, care and practices – provides for scientific procedures to be carried out as effectively as possible.

The code is in 3 sections covering both general and species specific indications:

  • section 1 describes the legal minimum standards applicable until 31 December 2016
  • section 2 describes the legal minimum standards applicable from 1 January 2017
  • section 3 provides non-mandatory advice to assist licensees to comply with the standards and covers a broader range of subjects than sections 1 and 2 alone.

The full version and the short guide to the code are available to download. Personal copies of the Code of Practice can be purchased from TSO bookshop TSO bookshop using the ISBN 9780108560316.

The code of practice is also available to download split by species:

You can read the Explanatory memorandum: code of practice for the care and accommodation of animals (PDF, 75.6KB, 3 pages) or (print-ready version) (PDF, 68.6KB, 4 pages) .

Transparency going forward

In the 2013 annual report of the Animals in Science Regulation Unit, we set out details of plans to start publishing anonymised reports of substantial investigations.

The publication of such investigations may be triggered by a number of factors including, but not limited to:

  • an exposé making allegations in the public domain
  • a cluster of non-compliances or ‘near misses’ triaged by an inspector to ASRU management
  • a non-compliance apparently involving significant animal harm
  • a published paper that appears to describe unjustified pain, suffering or distress
  • concern raised by inspectors or others that a particular procedure may not optimally implement the 3Rs

We believe the early publication of these investigations is in the interests of transparency and openness. We believe that this will also help ensure that all stakeholders can learn from the outcomes of these investigations as early as possible and enable them to address any potential weaknesses in their own management systems, creating a cycle of continuous improvement. These reports will also provide the public with an insight into this important aspect of ASRU’s work.

You can read anonymised reports of the ASRU investigations into compliance.

Animals in Science Committee

The government’s response to the Animals In Science Committee’s review on investigations into non-compliance.

Annual report of the Animals in Science Regulation Unit

The 2013 annual report describes the work of the unit during 2013 in regulating work under the Animals (Scientific Procedures) Act 1986 (ASPA) as amended in 2012.

You can also read previous annual reports in the Animals in Science Regulation Unit annual reports collection.

Statistics

The full report of the 2013 statistics on scientific procedures on living animals was published on 10 July 2014.

You can also view previous reports in the Statistics of scientific procedures on living animals collection.   

Non-technical summaries (abstracts)

You can view the collection of non-technical summaries from licences granted under ASPA during 2013.

Publication of non-technical summaries is a legal requirement under Article 43 of EU Directive 2010/63. This mandatory requirement will help put the debate on the use of animals in research and testing on a much better informed footing.

Details of project licences granted under ASPA in 2010 to 2012 are available on The National Archives.

Abstracts before March 2010 are on the archived version of the Animals in Scientific Procedures website.