With the implementation of Directive 2010/63/EU in 2013 every research proposal in EU member states that includes experiments on living vertebrates and cephalopods became subject to authorization. Central to the authorization is an evaluation process that includes a Harm-Benefit-Analysis (HBA) that evaluates the projected harm to the animals and the potential benefits of the study and requires ethical considerations to be taken into account. Only if the potential benefits outweigh the inflicted harm on the animals, a proposal will be approved; and according to the Directive, only then is an animal experiment morally acceptable.
The concept of harm and the evaluation of harm inflicted on research animals, together with methodologies on how to weigh animal harm against potential benefits have widely been discussed in the scientific literature. Interestingly, only few scientific papers deal with the concept of benefit. However, a clear understanding of the benefit concept and what actually constitutes benefit is of paramount importance for the practicability of the HBA and for ethical review of animal research and its ethical justification.
Thus, the goal of this project is to 1) analyze the benefit concept of the Directive and of published HBA methodologies 2) evaluate their strength and limitations and c) if necessary, to develop a benefit concept that overcomes current challenges and limitations.
Harm-Benefit analysis (HBA), animal research ethics, project evaluation
Prof. Herwig Grimm, Messerli Research Institute in Vienna, Austria