Correspondence

Letter from Lord Sharpe of Epsom responding to the ASC forced swim test report (accessible)

Published 5 March 2024

This was published under the 2022 to 2024 Sunak Conservative government

Lord Sharpe of Epsom OBE
Parliamentary Under Secretary of State
2 Marsham Street
London
SW1P 4DF

Professor David Main
Chair of the Animals in Science Committee
Animals in Science Committee Secretariat
40 Wellesley Road
London
CR9 2BY

01 March 2024

Dear Professor Main,

Response to review of the use of the forced swim test

Thank you for your letter of 29 June 2023 enclosing the Animals in Science Committee’s report on the use of the forced swim test ^{[footnote 1]}. The report responds to a commission from the Home Office of 22 August 2022 ^{[footnote 2]}.

The Animals in Science Committee (ASC) was asked for advice on “the evidence of alternative methods and appropriate justification for the use of the forced swim test under the Animals (Scientific Procedures) Act 1986, with due consideration to the legitimate requirements of science and industry and to the protection of animals” and to provide recommendations on how the 3Rs (replacement, reduction, refinement) should be applied regarding the forced swim test.

I am grateful to the committee for its work, including examining relevant licences and considering a range of stakeholder views before coming to its recommendations. The report helpfully suggests a primary audience for each recommendation.

As the Minister responsible for the regulation of animals in science in Great Britain, I accept the committee’s recommendations. The Home Office will further restrict the use of the forced swim test, as recommended by the committee, and apply enhanced scrutiny to any proposal to use the forced swim test.

I have requested the animals in science Regulator to implement the relevant recommendations to regulation through making changes to operational processes and guidance to applicants and regulated establishments, as appropriate.

However, I intend to go further. I aim to completely eliminate the use of the forced swim test. This will require the validation of suitable appropriate alternatives. I have therefore written to the Minister for Science, Research and Innovation at the Department for Science, Innovation and Technology (DSIT) and the Chief Executive of UK Research and Innovation (UKRI) to request that they consider what actions they can take to enable a complete ban on the use of the forced swim test in the near future.

The detail of all actions that my department will take to implement the committee’s recommendations is attached to this letter. Most actions will be completed by the end of March 2024, unless otherwise indicated.

I am grateful to the committee for their work and for the clarity of the report and recommendations. Through the adoption of the committee’s recommendations on the forced swim test by the Home Office, DSIT, UKRI and the science sector, we will promote better protections for animals and better science.

Yours Sincerely,

[signed]

Lord Sharpe of Epsom OBE

Parliamentary Undersecretary of State

Home Office

Implementation of the ASC’s recommendations on the use of the forced swim test

1. Formal evaluation of project licence applications should include a consideration of the specific scientific justification for use of the forced swim test (FST), including relevance to the diagnostic features of human illness of interest or specific induced physiological changes that are being investigated.

• The Animals in Science Regulation Unit (ASRU) will require specific justification for use of the FST in project licence applications. ASRU will communicate this requirement to establishments. This action will be completed by end of March 2024.

• ASRU will review current licences, and liaise with licence holders where necessary, to ensure scientific justification is adequate, in line with the report’s recommendations. If scientific justification is not considered by ASRU to be adequate, authorisation to use the FST will be revoked. This action will be completed by end of March 2024.

2. The use of the FST in project applications should be rejected if it is being proposed as a ‘model’ of depression (including in the phenotyping of genetically altered mice) or for studies of anxiety and its treatment.

• ASRU will reject project applications where use of the FST is sought as a model of depression. ASRU will communicate this to establishments. This action will be completed by end of March 2024.

• ASRU will review current licences, and liaise with licence holders where necessary, to ensure the FST is not used as a model of depression, in line with the report’s recommendations. If required, authorisation to use the FST will be revoked. This action will be completed by end of March 2024.

3. The processes of local project review should ensure that the proposed purpose for using the FST has been clearly explained and assessed and opportunities for adoption of the 3Rs fully explored.

• ASRU will communicate to licensed establishments to ensure animal welfare ethical review bodies (AWERB) are aware of the need to appropriately scrutinise proposals to use the FST, in line with the report’s recommendations, at the AWERB review stage prior to application. This action will be completed by end of March 2024.

• This will be in addition to any steps taken by the Animals in Science Committee to share best practice on this issue with AWERBs.

4. Further research should be conducted into non-animal methods for studying depression, antidepressants and other areas of research where the FST is currently used. Funders should consider specific funding calls in these areas.

• The Home Office has written to DSIT, as the department responsible for the promotion of non-animal scientific methods, and UKRI, which supports research and innovation in the UK, to highlight the recommendation and consider the actions they can take to eliminate the need for the forced swim test.

5. When it is proposed to use the FST in a programme of work, details of the experimental design and the number of animals to be used in the test should be included in the licence.

• ASRU will ensure details of the experimental design and the number of animals to be used for the FST are included in the project licence. ASRU will communicate this requirement to establishments. This action will be completed by end of March 2024.

• ASRU will amend its electronic licensing system to incorporate this requirement at the next available opportunity.

• ASRU will review current licences to ensure details of the experimental design and number of animals to be used for the FST are included. If necessary, ASRU will require licence holders to submit a request for amendment to their licence. This action will be completed by end of March 2024.

6. An optimum water temperature should be identified for both mice and rats, aiming for the water to be at a temperature that minimises the risk of hypothermia while achieving the scientific aims of the study. In addition, as a further refinement, the water should be changed between each animal and the equipment cleaned.

• ASRU will require details and justification of these refinements in project licence applications to use the FST. ASRU will communicate this requirement to establishments. This action will be completed by end of March 2024.

• ASRU will review current licences to ensure details of these refinements for the FST are included. If necessary, ASRU will require licence holders to submit a request for amendment to their licence. This action will be completed by end of March 2024.

• The Home Office will notify the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) of these recommended refinements to consider good practice regarding water temperature.

7. Applicants should provide robust, scientific justification for the typical and maximum length of swim time, and this should be reduced to the minimum necessary, commensurate with reliable evaluation of animals’ behaviour in the test.

• ASRU will require justification for the swim time for the FST in project licence applications. ASRU will communicate this requirement to establishments. This action will be completed by end of March 2024.

• ASRU will review current licences, and liaise with licence holders where necessary, to ensure scientific justification is adequate, in line with the report’s recommendations. If justification is not considered by ASRU to be adequate, establishments will be required to submit a request for amendment to their licence. This action will be completed by end of March 2024.

• The Home Office will notify the NC3Rs of these recommended refinements to consider good practice regarding swim time.

8. All protocols proposing use of the FST should provide details of how the animals will be monitored during the procedure and cared for after the test has been completed.

• ASRU will require details and justification of these refinements in project licence applications to use the FST. ASRU will communicate this requirement to establishments. This action will be completed by end of March 2024.

• ASRU will review current licences to ensure details of these refinements for the FST are included. If necessary, ASRU will require licence holders to submit a request for amendment to their licence. This action will be completed by end of March 2024.

• The Home Office will notify the NC3Rs of these recommended refinements to consider good practice regarding animal monitoring and care during and after the test.

9. We recommend that applicants assess the severity of their intended procedure in the light of the relevant guidance note (Home Office, 2014).

• ASRU will communicate to establishments the relevant guidance on severity in the Guidance on the operation of the Animals (Scientific Procedures) Act 1986, 2014. This action will be completed by end of March 2024.

10. The AWERB should review the NTS and ensure that the FST is included and clearly described as a potential procedure if it is listed in the protocols.

• ASRU will communicate to licensed establishments to ensure AWERBs are aware of the recommendation for the FST to be clearly described in the non-technical summary where applicable, at the AWERB review stage prior to application. This action will be completed by end of March 2024.

• This will be in addition to any steps taken by the Animals in Science Committee to share best practice on this issue with AWERBs.

1. Advice on the use of the forced swim test ↩

2. Use of the forced swim test under the Animals (Scientific Procedures) Act 1986 ↩