Policy

UK Research and Innovation policy on research and innovation involving animals

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UKRI
Published:

Policy statement

As a non-departmental public body and responsible funder, UK Research and Innovation (UKRI) has a responsibility to ensure that activities that UKRI funds are aligned with UK legislation and other guiding principles of ethical research practice. This policy sets out the approach of UKRI in ensuring that the commitments within the UKRI position statement on research and innovation involving animals are met in all funding activities involving animals, in the context of UKRI position statement on funding ethical research.

In addition, this policy supports UKRI’s position as a signatory to the Concordat on Openness on Animal Research and is consistent with the cross-funder guidance Responsibility in the use of animals in bioscience research which includes the principle of the ‘3Rs’: the replacement, reduction and refinement of the use of animals in research and innovation (R&I).

1. Purpose and scope

1.1 This policy sets out the principles for funding R&I involving animals across UKRI in line with the commitments of the UKRI public statement on R&I involving animals and the UKRI Statement of Ethics.

1.2 This policy primarily relates to the impact of R&I involving animals on animal welfare. Where appropriate, conservation impacts are brought within the policy.

1.3 The policy applies to all of UKRI.

1.4 This policy applies to all of the following:

1.4.1 UKRI funding applications and awards, including fellowships and studentships, and including research investments taking place overseas.

1.4.2 Organisations that apply for or receive funding or both from UKRI, including those based overseas, and those that apply for or receive funding or both from UKRI indirectly through a partner organisation.

1.4.3 Organisations when conducting work that benefits from UKRI funding, for example when using UKRI facilities or collaborating with individuals on UKRI-funded projects.

1.4.4 Individuals engaged in R&I activities at such organisations, whether directly employed by them or not, when using UKRI funds (either directly or indirectly, or when applying for UKRI funding).

1.4.5 Individuals employed by UKRI including those directly involved in research at centres, institutes, units and facilities.

1.4.6 Individuals while undertaking duties for UKRI such as assessing grant applications (‘assessors’), serving on a decision-making body on behalf of UKRI or providing strategic advice on issues related to R&I involving animals.

1.4.7 UKRI’s activities as a funder, including partnerships and collaborations with other funding partners; it also sets out our expectations for joint programmes co-funded with partners.

1.5 This policy references and is not intended to contradict existing guidance, particularly:

2. Definitions

2.1 For the purposes of this policy, the following definitions apply.

2.1.1 ‘Animals’ are taken to mean all invertebrates and vertebrates in the Kingdom Animalia, except where otherwise specified.

2.1.2 ‘ASPA-regulated research’ is defined in accordance with the Animals (Scientific Procedures) Act 1986 (ASPA) amended 2012, relating to species, life stages and procedures that are regulated by the Act.

2.1.3 ‘Non-ASPA research’ is that which involves the use, observation or interaction with animals that are not covered by Animals (Scientific Procedures) Act 1986; this may be regulated by other legislation.

2.1.4 The ‘3Rs’ principles are:

  • replacement: avoiding or replacing the use of animals in areas where they otherwise would have been used
  • reduction: minimising the number of animals used consistent with research aims and robust, reproducible findings
  • refinement: minimising the pain, suffering, distress or lasting harm that individual animals might experience

3. Principles

3.1 UKRI recognises the existence of relevant legislation regulating R&I involving animals, in particular but not limited to ASPA. UKRI is not a regulator and does not itself have a statutory compliance role within the legal responsibilities of parties conducting R&I using animals in the UK. Compliance with and enforcement of the relevant legislation is the responsibility of the parties or organisations named within it.

3.2 As a non-departmental public body and responsible funder in respect to the distribution of public funds, UKRI will ensure that funded R&I aligns with legislation and guiding principles.

3.3 UKRI is committed to only funding R&I using animals and procedures covered under ASPA where no scientifically acceptable non-animal alternatives exist.

3.4 UKRI supports the principles of the 3Rs, including by funding the development and dissemination of 3Rs approaches and technologies, including through the NC3Rs.

3.5 UKRI is committed to ensuring the highest possible standards of animal welfare throughout the R&I that we support.

3.6 UKRI expects those responsible for R&I involving animals to establish and maintain a culture of care that is upheld by all involved (including but not limited to project leads, technical and veterinary staff, and students).

3.7 UKRI supports the Concordat on Openness on Animal Research, including through:

  • annual publication of data about the use of animals in UKRI-owned establishments
  • publication of a formal statement on the position of UKRI as funder with respect to R&I involving animals
  • active engagement and communication in support of funded R&I involving animals

3.8 UKRI is committed to ensuring R&I involving animals does not endanger vulnerable animal populations.

4. Responsibilities for ASPA-regulated R&I involving animals

4.1 This section sets out policy for UKRI as a funder, as a research-performing organisation and for organisations and individuals funded by UKRI, and assessors involved in the funding processes of UKRI.

4.2 ASPA regulates procedures carried out for scientific and educational purposes, that may cause pain, suffering, distress or lasting harm to living non-human vertebrates and living cephalopods (for instance, octopus, squid). In this section we describe the responsibilities of parties (as defined in the ‘Purpose and scope’ section), when R&I involves animals as regulated under ASPA or equivalent research in a country outside of ASPA regulations.

UKRI as a funder

4.2.1 As a funder, UKRI seeks to do the following.

UKRI will ensure R&I is conducted in an ethical way, in accordance with the UKRI position statement on funding ethical research by obtaining assurances from applicants that ethical and legal approvals from the relevant body or bodies are granted before work starts, for work conducted both in UK and overseas.

UKRI will collect sufficient information from applicants to enable assessors and decision-making bodies to review and determine the necessity and validity of the proposed work, including:

  • the robustness of the experimental or research design
  • consideration and application of alternatives to the use of animals
  • measures planned to improve animal welfare and avoid endangering animal populations

When selecting assessors, UKRI will ensure there is appropriate expertise within the full application process to assess the robustness of the experimental design, application of the 3Rs, and welfare implications of any proposed work involving animals, in accordance with UKRI principles of assessment and decision-making.

UKRI will provide training or guidance for assessors to aid them in assessing applications according to the principles outlined in the ‘Principles’ section.

UKRI will ensure additional review is conducted by NC3Rs for applications proposing use of certain species, including:

  • non-human primates
  • cats
  • dogs
  • equines
  • pigs

We will ensure compliance with the guidelines for Non-human primate accommodation, care and use guidelines and other relevant guidance (available on the Good Research Resource Hub).

UKRI will ensure that cross-council expertise is sought and made available for any funding opportunities led by a UKRI Council or body that does not have primary expertise in R&I involving animals in assessment processes.

UKRI will ensure the principles of responsible conduct in R&I involving animals as set out in this policy are reflected in the terms and conditions of grants awarded by UKRI.

In joint funding opportunities with other funders, UKRI will request the funding partner(s) include provisions to ensure that funding terms and conditions align with this policy.

UKRI will obtain assurances and evidence from organisations in receipt of UKRI funding that they comply with existing legislation and best practice.

UKRI will seek opportunities to apply and promote the principles of the 3Rs, including by encouraging applications with potential to advance the 3Rs.

When funding R&I involving non-human primates, UKRI will conduct periodic reviews as to the impact and outputs, in accordance with the recommendations of the Bateson Review of Research using Non-Human Primates (PDF, 1.5MB).

UKRI will conduct appropriate portfolio-wide evaluation of the use of animals in UKRI-funded R&I, including monitoring and analysis of animal use, and 3Rs practices.

Research-performing organisations, including UKRI

4.2.2 Organisations receiving funding from UKRI, or UKRI where it is an employer of researchers, shall:

  • support applicants to meet UKRI requirements, relevant legislation, and best practice, including via the provision of training for staff (training of students should meet the Statement of expectations for doctoral training and UKRI training grant terms and conditions)
  • ensure legislative compliance, a culture of care, and encourage organisational best practice, for example developing and implementing an organisation-wide 3Rs strategy to deliver active engagement on the 3Rs from all key stakeholder groups
  • exercise due diligence when selecting commercial suppliers and service providers
  • if requested, be able to provide assurance to UKRI that the requirements outlined above are met

Individuals and organisations funded by UKRI

4.2.3 Individuals or organisations conducting research funded by UKRI, or applying for UKRI funding in order to conduct ASPA-regulated research or innovation, shall be required to meet all the expectations set out in UKRI’s position statement on research and innovation involving animals and the Responsibility in the use of animals in bioscience research document.

These include, but are not limited to:

  • securing ethics approval before starting any work
  • conducting R&I in compliance with legislation
  • considering and applying the principles of the 3Rs
  • ensuring that research teams have appropriate training and competence
  • when reporting the results of the research, doing so in accordance with the ARRIVE guidelines

In the event of work being contracted to third-party suppliers and service providers, or carried out overseas or by an overseas partner, the individuals and organisations will ensure that the work is performed in accordance with this policy.

The individuals and organisations will ensure a culture of care, familiarise themselves with best practice and relevant guidance in their discipline, and seek continuing professional development (for example, by attending training provided by funders, research organisations, and other bodies).

The individuals and organisations will exploit opportunities to reduce and refine the use of genetically altered animals by sharing and archiving strains (for instance, embryos or sperm) in accordance with the principles set out in ‘Sharing and archiving of genetically altered mice’.

The individuals and organisations will notify and consult with UKRI before any substantive changes are made to experimental plans where this affects animals involved in the R&I.

Assessors involved in the funding processes of UKRI

4.2.4 Assessors, including reviewers and panel members, involved in assessing R&I involving animals shall understand and continually develop their knowledge of principles of good research practice involving animals, including:

  • experimental design
  • application of the 3Rs
  • principles of good welfare

5. Responsibilities for R&I involving or impacting animals that is not regulated under ASPA

5.1 UKRI also undertakes and funds a number of activities not regulated under ASPA which involve or may impact upon animals. For example, this would include:

  • behavioural observation studies of animals in the wild
  • non-invasive wildlife surveys
  • some research that impacts agricultural animals
  • studies on cultural practices involving animals
  • research involving invertebrates other than cephalopods

The requirements in the following section also cover the use of animal materials such as tissues and primary cells. We describe responsibilities of parties (as defined in the ‘Purpose and scope’ section), when R&I involves animals and is not regulated by ASPA.

5.1.1 As a funder, UKRI shall do the following.

When sentient animals are involved (as defined under in Animal Welfare (Sentience) Act 2022), UKRI will seek assurance of ethical approval before work starts, for work conducted both in the UK and internationally, or otherwise seek justification on why this is not appropriate.

UKRI will collect sufficient information on the 3Rs from applicants to enable assessors and decision-making bodies to review and determine the necessity and validity of the proposed work, including:

  • the robustness of the experimental or research design
  • consideration and application of alternatives to the use of animals
  • measures planned to improve animal welfare

When selecting assessors, UKRI will ensure there is appropriate expertise to assess the robustness of the experimental design, application of the 3Rs, and welfare implications of any proposed work involving animals within the application process.

UKRI will ensure additional reviews are conducted by NC3Rs for applications proposing use of non-human primates, cats, dogs, equines, and pigs. We will ensure compliance with the guidelines for ‘Non-human primate accommodation, care and use’ and other relevant guidance (available on the Good Research Resource Hub).

UKRI will provide training or guidance for peer reviewers, grant assessors, and panel members to aid them in assessing applications according to the principles outlined in the ’Principles’ section.

Research performing organisations, including UKRI

5.1.2 Organisations receiving funding from UKRI, and UKRI where it is an employer of researchers, shall support applicants to meet UKRI requirements, relevant legislation and best practice, including via the provision of training for staff. Training of students should meet the Statement of expectations for doctoral training and UKRI training grant terms and conditions.

Individuals and organisations funded by UKRI

5.1.3 Individuals or organisations conducting research funded by UKRI or applying for UKRI funding in order to conduct non-ASPA-regulated R&I, including outside of the UK, should meet expectations as set out in UKRI’s position statement on research and innovation involving animals and the Responsibility in the use of animals in bioscience research guidelines. These include:

  • securing ethics approval before starting any work requiring approval
  • conducting R&I in compliance with other relevant legislation
  • considering and applying the principles of the 3Rs
  • considering impact on non-target species
  • when reporting the results of the research, doing so in accordance with ARRIVE

The individuals and organisations will:

  • ensure they and their team have appropriate training and expertise (for example, in animal handling, capture, and release)
  • familiarise themselves with best practice and relevant guidance in their discipline
  • seek continuing professional development (for example, by attending training provided by funders, research organisations, and other bodies)

Assessors involved in the funding processes of UKRI

5.1.4 Assessors, including reviewers and panel members, involved in assessing R&I involving animals should understand principles of good research practice involving animals, including 3Rs knowledge and application.

6. Additional responsibilities and expectations

Research outside of the UK

6.1 When UKRI funds R&I outside the UK that involves animals, including as part of international collaborations, UKRI requires that funded individuals and organisations establish and demonstrate that the welfare standards are no less stringent than those required in the UK.

6.1.1 When seeking or receiving funding for such applications, applicants (whether based in the UK or overseas) shall be required to:

  • provide additional information at the application stage regarding any animal facilities and care provided overseas
  • provide assurance that the international researcher or organisation complies with all relevant local and national regulatory systems
  • ensure that work will be conducted to welfare standards at or above those expected if the work were performed in the UK
  • seek ethical review approval prior to starting work from both the UK and the relevant overseas ethical review body, as appropriate

Animal welfare

6.2 UKRI expects and supports the provision of excellent care and welfare standards for animals used in R&I, according to best practice and up to date guidance. UKRI expects that funded activities take account of UK societal values and considers animal welfare implications of research and innovation.

6.2.1 Where there are deviations from expectations on animal welfare, as set out in the ‘Responsibility in the use of animals in bioscience research’ document and other relevant guidance, approval should be sought by the applicant during the application process and agreed by UKRI.

6.2.2 In accordance with the relevant guidance, UKRI requires funded individuals and organisations to take a proactive approach to refinement of husbandry and scientific procedures, considering opportunities for improving welfare, including those featured in the NC3Rs resource library. UKRI encourages funded individuals and organisations to publish and report (for example through ResearchFish) refinement and positive welfare activities.

6.2.3 UKRI expects consideration of animal welfare through the life of the animal from sourcing through to humane endpoints set out in the ‘Responsibility in the use of animals in bioscience research’ document.

6.2.4 UKRI expects the consideration of broad ethical aspects where the research may have direct or near-term implications for animal welfare, for example in genome editing, or farming practices.

Robust and reproducible research

6.3 UKRI is committed to funding robust and reproducible research. Individuals or organisations conducting research funded by UKRI or applying for UKRI funding are expected to:

  • describe the experimental design and analysis plans in proposals (the Experimental Design Assistant can provide support in planning experiments)
  • provide appropriate information on animal characteristics (for instance sex, genetic background, age) and meet the requirements on the inclusion of sex in experimental design where required by the funding council
  • make use of measures to reduce the risk of bias, including but not limited to randomisation, blinding (masking), sample size calculations, and inclusion and exclusion criteria
  • publish the results of all experiments that have been conducted (including so-called negative results)
  • publish their protocols and methodologies allowing the research to be reproduced
  • report any animal research in adherence with the ARRIVE guidelines including the source of animals in an officially recognised nomenclature
  • publish datasets and make research data as open as possible

UKRI encourages the use of research practices that support rigorous and reproducible research, and the application of best practice such as Registered Reports and pre-registration.

Reporting requirements

6.4 As a signatory to the Concordat on Openness on Animal Research, UKRI is committed to the principle of transparency in funding research and innovation involving animals.

6.4.1 When acting in its role as a research-performing organisation, UKRI will publicly release the figures of ASPA-regulated procedures on animals annually, including severity of the procedure and species of animal involved, in addition to reporting to the Home Office. Historical data will be maintained for five years, and thereafter archived in the National Archives.

6.4.2 As a funder, UKRI will collect and publish available summary information about the use of animals in grants awarded to external organisations. This includes the proportion of grants involving animal usage, species information and 3Rs uptake.

6.4.3 UKRI encourages individuals (notably researchers) to be transparent about the involvement of animals in their R&I, for example by clearly identifying the use of animals in project summaries. UKRI encourages individuals to consider public engagement in planning research and innovation, where appropriate, in accordance with the Concordat on Openness on Animal Research.

6.4.4 UKRI will handle other information about R&I involving animals with sensitivity and due respect to the individuals involved, including by seeking permission before publishing information that may identify individuals.

7. Approval and review

7.1 The UKRI Simpler Better Funding (SBF) Policy Advisory Group recommended this policy for approval with final approval at the UKRI SBF Programme Board.

7.2 Associate Director of UKRI Funding Policy will act as policy owner.

7.3 Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and NC3Rs representatives to UKRI Animal Policy Forum will act as policy writers and lead policy monitoring and evaluation.

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