How to tip the Harm-Benefit-Scales in gene editing – and why legal regulations always trump personal and public beliefs in project evaluation in animal research

Abstract

Directive 2010/63/EU on the protection of animals used for scientific purposes (henceforth “the Directive”) mandates that every project proposal in EU member states involving procedures on living non-human vertebrates and cephalopods must be approved in a project evaluation which includes a harm-benefit-analysis assessing “whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations and may ultimately benefit human beings, animals or the environment”. This project evaluation is carried out by competent authorities, with the advice of committees whose composition varies across Europe. The committees usually include scientific and veterinary/animal welfare expertise. They also often have experts in legal and ethical issues, advisors on alternatives to animal experiments, and sometimes also lay people. This invites the question: How do committee members understand “ethical considerations”, and how does this influence their evaluation and their advice to competent authorities? This is important, for decision-making in project evaluation is restricted and must fall within the boundaries of the applicable legal regulation. We argue that committee members are not always aware of this restriction. Genetic enhancement (e.g. for better modelling of human diseases in larger animals) and disenhancement (e.g. genetically reducing research animals’ ability to suffer) are controversial procedures in animal research. Where these two procedures are concerned, the mainly consequentialist and pathocentric legal framework of the Directive will potentially contradict the personal beliefs of some committee members, and indeed some members of the public, about what is morally permissible in animal research. Both genetic enhancement and genetic disenhancement could be classified as a valid benefit by the Directive, but some committee members might consider them morally unacceptable as a result of their personal beliefs. We use this potential conflict to address the question of what happens when committee members are of different opinions; we explain how, under these circumstances, a standardised understanding of “ethical consideration” can be achieved. We argue that, since project evaluation must comply with the normative framework of the Directive, the law always trumps objections based on personal and public beliefs that are in turn based on non-pathocentric and non-consequentialist moral theory. Our argument and its implications can be summarised as follows: First, the authorising committee’s benefit evaluation, “taking ethical considerations into account”, is restricted to by limits given in the regulation. However, second, it is far from clear that committee members understand what this means. Third, genetic disenhancement and genetic enhancement are arguably two paradigmatic cases where the personal beliefs of committee members will potentially contradict the Directive, and thus where there is real risk of illegal project evaluation. To minimise this risk, committee members should be trained and educated about their role and responsibilities in project evaluation. Only then will it be safe to assume that they are carrying out their authorising role appropriately.