Better be prepared -on the importance of planning animal experiments

Is the use of animals in a project absolutely necessary? Are there suitable, animal-free methods to achieve my project goal? How is the the highest possible level of animal welfare and a low level of severity classification guaranteed? These are all questions that researchers need to address in the planning a project. Detailed and accurate planning of an experiment is necessary to ensure the highest possible quality and reproducibility. In the case of an experiment that requires the use of animals, apart from the ethical or moral motivations, there are also legal obligations that prescribe the detailed preparation of a project.

According to the current EU Directive on animal experiments (RL 2010/63/EU), projects involving the use of laboratory animals must be reviewed by the authorities with regard to "the expected scientific benefit or educational value", the "fulfilment of the requirement of replacement, reduction and refinement", the severity assessment carried out and the harm-benefit analysis. This information must be submitted by the applicant in the form of a non-technical project summary along with the animal experiment application. By addressing all of the factors to be specified, researchers are required to think through and plan the experiment carefully and to address the issue of animal welfare in more detail. This way, on the one hand, the 3R principle (Replace-Reduce-Refine) is integrated into the planning and, on the other hand, the expected benefits are analyzed. The goal of the harm-benefit analysis is to evaluate "whether the harm to animals in the form of suffering, pain, and distress is justified by the expected outcome, taking into account ethical considerations, and may ultimately benefit humans, animals, or the environment".​​​​​​¹

According to the Animal Experiments Criteria Catalogue Ordinance (TVKKV) valid in Austria, the applicant is obliged to submit a criteria catalog to the authority together with the animal experiment application. The content of the criteria catalog is identical to that of the non-technical project summary required by EU law.²

A non-binding guide to planning an animal experiment is provided by the so-called PREPARE Guidelines, which were developed in a collaborative project between Norecopa and the RSPCA (Royal Society for the Prevention of Cruelty to Animals). PREPARE stands for Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. Topics covered in the PREPARE Guidelines include:

• Literature research
• Legal framework
• Ethical obligations (harm-benefit analysis, humane endpoints)
• Experimental design and statistics,
• Planning/timing of the project involving all persons involved
• Evaluation and selection of an appropriate laboratory animal facility
• Preparatory training
• Hazard analysis
• Description of substances and procedures used
• Know-how on the selected animal species
• Quarantine and health monitoring
• Species-appropriate animal husbandry
• Experimental activities
• Humane killing methods/reuse/disposal
• Necropsy and sampling

These checklists provide helpful guidance on what all would need to be considered in advance of an animal experiment.³

Precise planning of the experiment thus offers, among other things, the opportunity to deal with all factors that contribute to guaranteeing the highest possible level of animal welfare. The non-technical project summary and the criteria catalog represent the obligatory project planning, whereas the PREPARE Guidelines offer voluntary assistance, which can also be used.
 

Sources: 
1) RL 2010/63/EU
2) TVKKV
3) https://norecopa.no/prepare/; accessed on 28.07.2023