Table 1.
Topic | Recommendation |
---|---|
(A) Formulation of the study | |
1. Literature searches | □ Form a clear hypothesis, with primary and secondary outcomes. |
□ Consider the use of systematic reviews. | |
□ Decide upon databases and information specialists to be consulted, and construct search terms. | |
□ Assess the relevance of the species to be used, its biology and suitability to answer the experimental questions with the least suffering, and its welfare needs. | |
□ Assess the reproducibility and translatability of the project. | |
2. Legal issues | □ Consider how the research is affected by relevant legislation for animal research and other areas, e.g. animal transport, occupational health and safety. |
□ Locate relevant guidance documents (e.g. EU guidance on project evaluation). | |
3. Ethical issues, harm–benefit assessment and humane endpoints | □ Construct a lay summary. |
□ In dialogue with ethics committees, consider whether statements about this type of research have already been produced. | |
□ Address the 3Rs (replacement, reduction, refinement) and the 3Ss (good science, good sense, good sensibilities20). | |
□ Consider pre-registration and the publication of negative results. | |
□ Perform a harm–benefit assessment and justify any likely animal harm. | |
□ Discuss the learning objectives, if the animal use is for educational or training purposes. | |
□ Allocate a severity classification to the project. | |
□ Define objective, easily measurable and unequivocal humane endpoints. | |
□ Discuss the justification, if any, for death as an endpoint. | |
4. Experimental design and statistical analysis | □ Consider pilot studies, statistical power and significance levels. |
□ Define the experimental unit and decide upon animal numbers. | |
□ Choose methods of randomization, prevent observer bias, and decide upon inclusion and exclusion criteria. | |
(B) Dialogue between scientists and the animal facility | |
5. Objectives and timescale, funding and division of labour | □ Arrange meetings with all relevant staff when early plans for the project exist. |
□ Construct an approximate timescale for the project, indicating the need for assistance with preparation, animal care, procedures and waste disposal/decontamination. | |
□ Discuss and disclose all expected and potential costs. | |
□ Construct a detailed plan for division of labour and expenses at all stages of the study. | |
6. Facility evaluation | □ Conduct a physical inspection of the facilities, to evaluate building and equipment standards and needs. |
□ Discuss staffing levels at times of extra risk. | |
7. Education and training | □ Assess the current competence of staff members and the need for further education or training prior to the study. |
8. Health risks, waste disposal and decontamination | □ Perform a risk assessment, in collaboration with the animal facility, for all persons and animals affected directly or indirectly by the study. |
□ Assess, and if necessary produce, specific guidance for all stages of the project. | |
□ Discuss means for containment, decontamination, and disposal of all items in the study. | |
(C) Quality control of the components in the study | |
9. Test substances and procedures | □ Provide as much information as possible about test substances. |
□ Consider the feasibility and validity of test procedures and the skills needed to perform them. | |
10. Experimental animals | □ Decide upon the characteristics of the animals that are essential for the study and for reporting. |
□ Avoid generation of surplus animals. | |
11. Quarantine and health monitoring | □ Discuss the animals' likely health status, any needs for transport, quarantine and isolation, health monitoring and consequences for the personnel. |
12. Housing and husbandry | □ Attend to the animals' specific instincts and needs, in collaboration with expert staff. |
□ Discuss acclimatization, optimal housing conditions and procedures, environmental factors and any experimental limitations on these (e.g. food deprivation, solitary housing). | |
13. Experimental procedures | □ Develop refined procedures for capture, immobilization, marking, and release or rehoming. |
□ Develop refined procedures for substance administration, sampling, sedation and anaesthesia, surgery and other techniques. | |
14. Humane killing, release, reuse or rehoming | □ Consult relevant legislation and guidelines well in advance of the study. |
□ Define primary and emergency methods for humane killing. | |
□ Assess the competence of those who may have to perform these tasks. | |
15. Necropsy | □ Construct a systematic plan for all stages of necropsy, including location, and identification of all animals and samples. |
A more detailed discussion, with references and links, is available at https://norecopa.no/PREPARE, together with a downloadable pdf version of this checklist in several languages.