4. Proposals involving animal use - MRC

Contents

4.4 Peer review

Information relating to the use of animals will be subject to careful scrutiny, and will carry substantial weight when the scientific strength of the proposal is assessed. Guidance on where each aspect should be addressed in Je-S is given below.

This information must be provided for all proposals involving animals, regardless of whether or not the animal costs are requested as part of the proposal.

4.4.1 Je-S section on animal research

If applicants are contracting out animal research or proposing to undertake any animal experiments as part of collaborative programmes outside the UK, please see section 4.5.

4.4.2 Je-S section on animal species’

Sound scientific reasons for the use of animals and an explanation of why there are no realistic alternatives must be given, with an explanation of how the choice of species complies with ASPA – see section 4.1.

In this section please include the following information:

  • sound scientific rationale for the use of animals
  • explanation of why there are no realistic non-animal alternatives
  • how the choice of species complies with the Animals (Scientific procedures) Act (1986). For knockout or transgenic lines briefly include information on the sources these may be obtained from and relevant information to demonstrate the verification of lines selected.
  • relevant information about the animals to be used – for example, species, strain, sex, developmental stage, weight.

Applicants are encouraged to provide other supporting information regarding experimental design and statistical analyses, for example, in the reproducibility and statistical design annex to the case for support – see section 2.2.3.5 – and not in the Je-S application form. Please note that you are not required to duplicate information presented elsewhere in the application.

Section 4.4.3 provides more detail about the information required in the annex for proposals requesting the use of animals. A summary of where to put all required information regarding the use of animals in your proposal is at section 4.8.

4.4.3 Case for support – reproducibility and statistical design annex

The scientific case underpinning the choice of animal model and the experimental plans should be detailed in the one-page annex to the case for support – reproducibility and statistical design annex – see section 2.2.3.5 for more detail. There is no requirement to duplicate information.

The experimental design should be outlined, including a justification of the total numbers of animals to be used and, where appropriate, the frequency of measurements or interventions required on each animal. Planned procedures to minimise experimental bias – for example, randomisation protocols, blinding – should be outlined or an explanation included as to why such procedures are not appropriate. Each experiment does not need to be described in detail, but sufficient information must be included that reviewers are readily able to understand the experimental plan.

Researchers must provide a properly constructed justification of how the numbers of animals to be used were determined. In general, it would be expected that professional statistical advice will be sought in putting this section together.

In many instances this section will include statistical power calculations based on justifiable and explicit assumptions about the anticipated size of the experimental effects. If statistical power calculations are not given, applicants should provide a principled explanation of the choice of numbers. Power calculations can be used to calculate the minimum sample size required so that one can be reasonably likely to detect an effect of a given size, or to calculate the minimum effect size that is likely to be detected in a study using a given sample size. In general, explanations based solely in terms of usual practice will not be considered adequate. An overview of the planned statistical analyses and their relation to the choice of sample size should be included.

An explanation should be provided of how and why the animal species and model being used can address the scientific objectives and the relevance to human biology. For knockout or transgenic lines this should include information on the sources these may be obtained from and relevant information to demonstrate the verification of lines selected.

It is essential that the case is clearly made as to how the chosen design – with reference to the information regarding the numbers of animals and planned statistical analyses provided – will enable the stated objectives of the study to be achieved.

In addition to the usual background and specification of the primary and secondary objectives of the study, or specific hypotheses being tested, the primary and secondary experimental outcomes to be assessed should be clearly defined – for example cell death, molecular markers, behavioural changes. Each experiment does not need to be described in detail, but sufficient information must be included that reviewers are readily able to understand the design rationale and make robust judgements on the scientific case.

4.4.4 Je-S section on resources – animal costs

The costs of both the animals themselves and their maintenance may be requested and should be listed in the resources – animal costs section of the Je-S form. See section 3.2.2.3 for additional information. Where experiments involve genetically altered animals, examples of the breeding strategies may be included in the justification of resources section to support the total number of animals requested.

Applicants contemplating the use of animals purchased from commercial suppliers should, wherever possible, use UK suppliers, to minimise the risk of suffering during transport. For cats, dogs and primates, Home Office-approved suppliers must be used.

If applicants are contracting out animal research or proposing to undertake any animal experiments as part of collaborative programmes outside the UK, please see section 4.5.

Applicants planning research using rhesus macaques should obtain animals from the MRC Centre for Macaques, who will advise on costs.

4.4.5 Proposal attachment justification of resources

A detailed justification of the costs incurred should be given in the justification of resources attachment – see section 2.2.4 for further information. This should detail the animal costs requested, and may outline breeding programmes if appropriate to support the number of animals required. No experimental or statistical details should be included in this section; these details must be included in the animal species section of the Je-S form and case for support.

4.4.6 Use of animals overseas

From 1 September 2017, if your project involves the use of animals overseas you must submit a signed statement uploaded as a Letter of Support to the Je-S application, from both UK and overseas PIs that:

  • they will adhere to all relevant national and local regulatory systems in the UK and overseas
  • they will follow the guidelines laid out in the NC3Rs ‘Responsibility in the use of animals in bioscience research’ document and ensure that work is carried out to UK standards
  • before initiation of the proposed research work, appropriate approvals from institutional or central animal ethics committees will be obtained for experimental protocols to be adopted in their projects. Successful proposals may be expected to provide copies of these permissions before funding is released
  • details on where the animal research will take place – UK or overseas – and through which funder the resources are being sought.

If the research involves the use of rodents overseas, rather than in the UK, please also complete the additional questions on the use of rodents overseas’ (DOCX, 117KB) form, and attach as a letter of support in Je-S.

Last updated: 20 August 2021

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