Necessary, but Not Sufficient. The Benefit Concept in the Project Evaluation of Animal Research in the Context of Directive 2010/63/EU

According to Directive 2010/63/EU, project proposals involving experiments on animals have to be approved in a harm-benefit-analysis (HBA) that weighs the potential benefits of the experiment against the harm inflicted on animals. Only if the benefit outweighs the harm, will the project be approved. However, it is unclear what counts as a valid benefit. In this paper, we analyze the underlying premises of the HBA and its consequences for the project evaluation process. We come to the conclusion that knowledge, as such, is considered a low benefit and that only knowledge applied to benefit society, e.g., new cancer treatment or potent vaccine, etc., is considered to be a high benefit. However, we demonstrate that benefit of this kind cannot be assessed prospectively for research proposals due to the inherent uncertainties of research and the difficulty of determining extra-scientific factors that are crucial for the generation of societal benefit. As a consequence, we advocate a reevaluation of current project evaluation and propose to develop an alternative model for project evaluation