Guidance on determining indispensability and balancing potential benefits of animal experiments with costs to the animals with specific consideration of EU directive 2010/63/EU.

Within the context of a workshop, a concept and practical guidance were developed that seek to balance potential benefits of animal experiments to humans, other animals, and the environment against the pain, suffering, and distress caused to the experimental animals. The aim was to achieve transparent decisions that can be communicated in a concise manner that is accessible to a layperson and is in accordance with German national law and EU Directive 2010/63/EU. The steps of the resulting decision process deal with the classification of procedures into the four severity levels, the consideration of humane endpoints, determination of the indispensability of the procedure on the basis of sound scientific argument, classification into applied or basic research, determination of the probability of success in the case of applied research, and the cost-benefit analysis, culminating in a decision on the approval or denial of the procedure.