Simple SummaryThe European legislation on project evaluation of animal research has recently changed. Every procedure on live non-human vertebrates and cephalopods has to be approved in a project evaluation (harm–benefit analysis (HBA)) that weighs the inflicted harms on animals against potential prospective benefits. Recent publications on the HBA prioritise “societal benefits” that have a foreseeable, positive impact on humans, animals, or the environment over gaining knowledge (e.g., basic research). However, we argue that whether potential prospective societal benefits are realized is (a) impossible to predict and (b) exceeds the scope and responsibility of researchers. Furthermore, the emphasis on practical benefits has the drawback of driving researchers into speculation on the practical benefit of their research and, therefore, into promising too much. Repeated failure to deliver proclaimed practical benefits will lead to a loss of trust and credibility in research. The concepts of benefit and benefit assessment in the HBA, as well as the HBA itself, require re-evaluation in a spirit that embraces the value of knowledge in our society. Research projects should be measured by the quality of the research they perform and by the contributions they make to a specific field of research or research program. Only then can promises regarding benefits (in terms of knowledge) be kept and continued public trust ensured. Time and again, scientific knowledge has been utilized to great benefit for humans, animals, and the environment. The HBA, as it currently stands, tends to turn this idea upside down and implies that research is of value only if the resulting findings bring about direct practical benefits, which science itself can neither provide nor guarantee. The road to hell is, as the saying goes, paved with good intentions.AbstractIt is our concern that European Union Directive 2010/63/EU with its current project evaluation of animal research in the form of a harm–benefit analysis may lead to an erosion of the credibility of research. The HBA assesses whether the inflicted harm on animals is outweighed by potential prospective benefits. Recent literature on prospective benefit analysis prioritizes “societal benefits” that have a foreseeable, positive impact on humans, animals, or the environment over benefit in the form of knowledge. In this study, we will argue that whether practical benefits are realized is (a) impossible to predict and (b) exceeds the scope and responsibility of researchers. Furthermore, we believe that the emphasis on practical benefits has the drawback of driving researchers into speculation on the societal benefit of their research and, therefore, into promising too much, thereby leading to a loss of trust and credibility. Thus, the concepts of benefit and benefit assessment in the HBA require a re-evaluation in a spirit that embraces the value of knowledge in our society. The generation of scientific knowledge has been utilised to great benefit for humans, animals, and the environment. The...

Using animals for research raises ethical concerns that are addressed in project evaluation by weighing expected harm to animals against expected benefit to society. A harm–benefit analysis (HBA) relies on two preconditions: (a) the study protocol is scientifically suitable and (b) the use of (sentient) animals and harm imposed on them are necessary for achieving the study’s aims. The 3Rs (Replace, Reduce and Refine) provide a guiding principle for evaluating whether the use of animals, their number and the harm imposed on them are necessary. A similar guiding principle for evaluating whether a study protocol is scientifically suitable has recently been proposed: the 3Vs principle referring to the three main aspects of scientific validity in animal research (construct, internal and external validity). Here, we analyse the internal consistency and compatibility of these two principles, address conflicts within and between the 3Rs and 3Vs principles and discuss their implications for project evaluation. We show that a few conflicts and trade-offs exist, but that these can be resolved either by appropriate study designs or by ethical deliberation in the HBA. In combination, the 3Vs, 3Rs and the HBA thus offer a coherent framework for a logically structured evaluation procedure to decide about the legitimacy of animal research projects.