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 development of drugs and medical technologies that help to reduce suffering among humans and animals depends on the carefully regulated use of animals for research.

We respect the fact that people have strong ethical objections to the use of animals in scientific procedures. We have legislated so experimentation is only permitted when there is no alternative research technique and the expected benefits outweigh any possible adverse effects.

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

This guide gives details of the relevant laws and explains how to apply for licences to carry out tests involving animals.

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.

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 key stakeholders and the Animals in Science Committee

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

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.

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
4th floor Peel Building
2 Marsham Street
London
SW1P 4DF
Duty manager: 020 7035 0477

Swindon

Home Office
PO Box 1138
Swindon
SN1 2RZ

Authority to transfer protected animals

Download a PDF version of the application form for authority to transfer protected animals.

Wording is available from your local inspector which can be built into existing project licences and new applications on the current form which will remove the need for transfer forms for import/export of GA rodents.

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.

Declaring a conflict of interest

It is important that any named person responsible for animal welfare under ASPA 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.

Annual returns

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

The Return of procedures - animal use data 2014 (MS Excel Spreadsheet, 241KB) form should be completed according to the instructions document.

This form will be used for all procedures completed during 2014 (that is, those to be returned to the Home Office in January 2015) and for all those licences revoked during 2014.

All three documents will be kept under constant review and we recommend that users always refer to the documents on this website to ensure they are using the most up-to-date versions. We welcome feedback on the documents.

You can take a look at the annual return for 2013 and guidance notes.

Consultations

Draft code of practice for the care and accommodation of animals

A draft code of practice on the care and accommodation of animals was published on 15 February 2013. The code of practice sets out the standards which must be applied by all users, breeders and suppliers of animals from 1 January 2013 to 31 December 2016.

The closing date for responses was 8 May 2013.

Annual statistics on the use of animals for scientific purposes

This consultation document seeks your comments on proposed new arrangements for the collection and publication of data on the use of animals in scientific procedures required under Directive 2010/63/EU on the protection of animals used for scientific purposes (the Directive).

The closing date for responses was 8 May 2013

Publications

Annual report of the Animals in Science Regulation Unit

The 2012 annual report details how the unit has met its responsibilities under ASPA to regulate the use of animals, worked to support the delivery of the transposed directive and provided information about cases of non-compliance with ASPA and the outcomes of those cases.

You can also read the 2011 report.

Statistics

The full report of the 2012 statistics on scientific procedures on living animals was published on 16 July 2013.

You can also view the 2011 statistics.   

ASPA e-newsletters

These newsletters are for those with licences granted under the Animals (Scientific Procedures) Act 1986 and others with an interest in the use of animals in scientific research and testing.

You can download the April 2013 ASPA newsletter.

You can read previous editions of the newsletter.

If you would like to have the newsletters sent to you by email, please send your contact details to aspnewsletter@homeoffice.gsi.gov.uk

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.

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