Where a proposal involves multiple experiments – for example a pilot study, tissue supply or treatment comparison – the level of detail shown below should be included for each type of experiment.
|Information||Details||Location and guidance section|
|Procedure severity||Confirmation of the use of animals (this should be ticked as yes even if the animal costs are not requested as part of the proposal) and details of any procedures categorised as moderate or severe in accordance with the maximum prospective severity rating in the Home Office licence under which the work will be carried out.||Animal research section of the Je-S form – section 4.4.1.|
|The need to use animals and the choice of species||
A sound scientific reason for the use of animals and an explanation why there are no realistic non-animal alternatives. An explanation of how the choice of species complies with ASPA.
Relevant information about the animals to be used – for example species, strain, sex, developmental stage, weight.
|Animals species section of the Je-S form under ‘Supporting Information’ for each species – sections 4.1 and 4.4.2.|
|Experimental approach||The number of experimental and control groups, the total number of animals used in each experiment and the number of animals in each experimental group, and the number of times each animal will be measured; the number of independent replications of each experiment indicated; any steps taken to minimise the effects of bias when allocating animals to treatment – for example randomisation procedure – and when assessing results – for example, blinding.||Reproducibility and statistical design annex – sections 220.127.116.11 and 4.4.3|
|Sample size||An explanation of how the number of animals was arrived at, including power calculations if appropriate or other supporting information to demonstrate that the findings will be robust. Details of any statistical advice sought or available.||Reproducibility and statistical design annex – sections 18.104.22.168 and 4.4.3.|
|Planned statistical analyses||An overview of the planned statistical analyses in relation to the choice of sample size, along with details of any statistical advice available.||Reproducibility and statistical design annex – sections 22.214.171.124 and 4.4.3.|
|Objectives and experimental outcomes||The primary and any secondary objectives of the study, or specific hypotheses being tested. The primary and secondary experimental outcomes to be assessed – for example, cell death, molecular markers, behavioural changes.||Reproducibility and statistical design annex – sections 126.96.36.199 and 4.4.3.|
|Justification of the choice of species/model||An explanation of how and why the animal species and model being used can address the scientific objectives and the relevance to human biology. Relevant information about the animals to be used – for example species, strain, sex, developmental stage, weight.||Reproducibility and statistical design annex – sections 188.8.131.52 and 4.4.3.|
|Justification of the experimental design and statistical framework||A scientific justification of why the numbers of animals to be used, the experimental design chosen, and planned statistical analyses are appropriate to enable the objectives of the study to be met.||Reproducibility and statistical design annex – sections 184.108.40.206 and 4.4.3.|
|Funding requested||The total number of animals requested and the associated purchase and upkeep costs listed.||Animal costs section of the Je-S form – sections 220.127.116.11 and 4.4.4.|
|Explanation of funding requested||Overview of how the figure for funding requested was reached. No experimental or statistical details should be included in this section, however a breeding plan may be included to demonstrate how the total number of animals requested was determined.||
Animal costs section of the Je-S form – sections 18.104.22.168 and 4.4.4 – and justification of resources attachment – section 4.4.5 and 2.2.4.