Authorization of animal research proposals – a comparison of harm concepts in different European regulations

Meeting the professional responsibilities of veterinarians in animal research has been described by the German Federal Chamber of Veterinary Surgeons (Bundestierärztekammer, BTK) as a “special ethical challenge”. Veterinarians are involved in animal research, not only as researcher and animal welfare officers, but also as members of ethical review committees and as such require a unique set of skills to provide a wide range of services and practices. Animal research in Europe is strictly regulated. The harm-benefit analysis (HBA) is one of the legal corner stones in project authorization and as such has to be carried out within a specific legal framework. Hence, veterinarians (and other members of ethical review committees) require an understanding of the normative foundation of animal research legislation in order to fulfill their role and responsibilities. Against this background, it is the goal of this article (1) to introduce the rationale and role of the harm concept and the HBA in project evaluation of animal research. (2) We then outline the different harm concepts which the European and the Swiss legislation are based on and (3) elaborate on the moral significance that is given to different forms of harm within the HBA in these legal frameworks. (4) Last, we demonstrate potential practical implications of these conceptually different normative frameworks for project evaluation in animal research with the practical example of genetically disenhancing the ability of rodents to feel pain and to suffer