The Role of Ethical Review in Project Evaluation in Animal Research

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 moral justification.

Thus, the goal of this project was to analyze the benefit concept of the Directive and of published HBA methodologies. One of the key findings of this thesis is, that the generation of societal benefit (e.g. new vaccine, medical treatment, new technology) is attributed more (moral) weight on the scales of the HBA compared to the generation of knowledge. However, we demonstrate that the concept of prospectively evaluating societal benefit in animal research is based on logic, methodological and practical flaws from which follow serious moral and practical implications for applicants and authorizing bodies. Together, these flaws and implications turn the HBA into vague speculation and renders it an ill-suited method for scientific and ethical evaluation of animal research. In consequence, we develop the Harm-Knowledge-Analysis (HKA) as an alternative method for Project evaluation. On the project level in the HKA prospective evaluation of societal benefits is replaced by an evaluation of expected knowledge gain and an assessment of measures to maximize epistemic benefit e.g. strength of hypothesis, experimental design, 3V’s, etc. At the societal level, the main paradigm shift is to replace the balancing of harms against societal benefits with a retrospective assessment of societal benefits based on systematic reviews. We believe the HKA model to be an improvement from a systematic, practical, and ethical point of view. The HKA promises to support authorities and applicants in pursuit of reasonable, transparent and manageable prospective project evaluation. It also increases epistemic value at the project level and creates more transparency about the value of animal research at the societal level. In short, it overcomes serious limitations of the published HBA methodologies.
 

Animal research ethics, Harm-Benefit-Analysis, Project evaluation

Matthias Eggel

Messerli Foundation

2015 - 2018

Herwig Grimm and Matthias Eggel. (2017) White Paper and Colourful Language: Toward a Realistic View of Animal Research. ATLA 45, 101-103 
 *Authors contributed equally to this work

Herwig Grimm*, Matthias Eggel*, Anna Deplazes-Zemp and Nikola Biller Andorno (2017). The Road to Hell is Paved with Good Intentions: Why Harm-Benefit-Analysis and ist Emphasis on Practical Benefit Jeopardize the Credibility of Research. Animals, 7, 70
*Authors contributed equally to this work

Matthias Eggel and Herwig Grimm (2018). Necessary, but Not Sufficient. The Benefit Concept in the Project Evaluation of Animal Research in the Context of Directive 2010/63/EU. Animals, 8, 34. 

Matthias Eggel and Herwig Grimm (2018). The logic, methodological and practical flaws of the Harm-Benefit-Analysis (HBA) in Directive 2010/63/EU. 14th Congress of the European Society for Agricultural and Food Ethics