This checklist aims to help ensure that nothing has been forgotten. It could be printed and presented to the IACUC or Ethical Review Committee to indicate that the design and practicalities have been well thought out. |
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Item to be considered | Comment |
Name of investigator and date
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Name or designation of the experiment
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Objectives: State clearly the objective of the experiment
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Is there an in-vitro alternative?
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Will the experiment be legal? Is the species protected, and have all necessary certificates, licenses etc. been obtained?
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Local ethical review: Has the proposal been before the local review committee?
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Human health and welfare considerations. Are hazardous materials going to be used (biological or chemical) and if so are adequate precautions in place?
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Species & strain. What species and why was it chosen?
If mice or rats are to be used, will an isogenic strain be chosen, and if so which one (maybe several strains need to be compared to pick the best one)? If not, why not?
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Type of experiment: Pilot, exploratory, confirmatory, to estimate parameters (e.g. means, dose-response), survey
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What is the experimental unit? (two experimental units must be able to receive different treatments).
How will the animals be housed?
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Treatments: What factors will be studied and at how many levels? Would it be useful to study two or more factors (e.g. treatment, sex, strain, time following treatment etc.) using a factorial design? Might two drugs potentiate one-another? What factors would be or interest?
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Outcomes: what will be measured or counted and how will it be done? Does this require the experiment to be split into “mini-experiments” using a blocked design? Can a measurement outcome rather than a count be used?
Do any planned surgical procedures with anaesthesia and analgesia conform with best practice? Have humane end-points been chosen? |
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Animals. Are uniform animals likely to be available (e.g. narrow age/weight range, isogenic) or do they need to be stratified using a blocked design? Do they have some natural structure, such as coming in litters which would make a blocked design appropriate?
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Refinement: What specific steps are being taken to minimise pain, distress or lasting harm?
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How will the randomisation be done? Is it a completely randomised design, or is the randomisation restricted by blocks? Is there provision for randomisation throughout the experiment, not just in the allocation to animals?
Who will supervise it? |
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Is blinding considered to be necessary, and if so how will it be done.? Has provision been made for coded caging labels and samples?
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Sample size. How will this be determined? Has an estimate been done using either Power Analysis or the Resource Equation Method. If not, why not?
Are the suggested numbers the minimum possible consistent with achieving the objective of the study? |
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Has the formal design of the experiment now been decided (e.g. between-subject, randomised block, factorial design etc.)?
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Statistical analysis. Has the method of statistical analysis of the resulting data been determined? What methods will be used?
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Staff-1: has the experiment been discussed with the Director of the animal facilities?
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Staff-2: What staff will be needed, do they have the required skills or will they need training?
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Have SOPs and written protocols been developed?
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Facilities: Are suitable cages, racks, animal rooms and supplies available
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Finance: Is there a sufficient budget to complete the project, taking into account costs of housing, purchase of animals, purchase of supplies.
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