1. Researchers must perform a harm-benefit analysis of the research project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and whether it ultimately benefits human beings, animals or the environment.
2. The design of experimental protocols must comply with the requirement of replacement, reduction and refinement:
2.1. Replacement: a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure. Also, animals experiencing a lower level of harm for the same procedure (e.g. domestic animals) should also be used as an alternative.
2.2. Reduction: the number of animals used in projects must be reduced to a minimum without compromising the objectives of the project.
2.3. Refinement: Protocols of breeding, accommodation and care, and of methods used in procedures, should be designed in ways that eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to the animals.
Researchers will make an effort to foresee the specific ways in which procedures will negatively affect animal welfare and fitness by collecting sufficient information about their protocols and study animals and will adhere to approved general and specific guidelines for the use of animals in research.
3. When designing a research project, researchers are required to:
3.1. Assess the severity of the procedures and to classify them accordingly.
3.2. Plan the use of anaesthesia, analgesia and other pain relieving methods.
3.3. Reduce, avoid and/or alleviate any form of animal suffering, from birth to death where appropriate.
3.4. Determine the use of humane end-points (termination of procedures) according to specific welfare indicators and supervision protocols. The methods selected should avoid, as far as possible, death as an end-point due to the severe suffering experienced during the period before death. Where possible, it should be substituted by more humane end- points using clinical signs that determine the impending death, thereby allowing the animal to be killed without any further suffering.
Where death as the end-point is unavoidable, the procedure shall be designed so as to: (a) result in the deaths of as few animals as possible; and (b) reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death.
Where an animal is to be kept alive (e.g. released into its habitat), it shall receive appropriate care.
3.5. Avoid any unjustified duplication of procedures.
3.6. Comply with prevailing legal requirements (e.g. being licensed by the competent authority) before undertaking any procedures. Researchers are responsible for ensuring that the conditions of the licence are complied with.
3.7. Ensure the competence of persons involved in the project. Researchers are responsible for ensuring that the staff are adequately educated, competent and continuously trained and that they are supervised until they have demonstrated the requisite competence.