Reviewing the Review: A Pilot Study of the Ethical Review Process of Animal Research in Sweden

Simple Summary The use of research animals is regulated within the EU through Directive 2010/63/EU on the protection of animals used for scientific purposes, as well as through national legislations and guidelines. However, the ethical review process, which all animal research must undergo, has been heavily criticized. This pilot study has analyzed the ethical review process in Sweden, focusing on how well legislative demands are fulfilled by researchers and animal ethics committees. After developing a score sheet, 18 documents (including both applications and decisions) were thoroughly reviewed, and the requests in the application form were compared to legal demands. The results revealed a number of issues concerning how HBA (harm-benefit analysis) was conducted by the committees, application, and review of the 3Rs (Replace, Reduce, Refine), as well as how humane end-points, severity assessment, and the "upper limit" of suffering were implemented and assessed. The study further indicates disconcerting discrepancies between the Swedish application forms for project evaluation, national legislation, and the directive as well as a lack of transparency throughout the review process. These findings risk compliance with the directive, animal welfare, research validity, and public trust. Therefore, a number of suggestions for improvements are provided, and the need for further research is emphasized. The use of animals in research entails a range of societal and ethical issues, and there is widespread consensus that animals are to be kept safe from unnecessary suffering. Therefore, harm done to animals in the name of research has to be carefully regulated and undergo ethical review for approval. Since 2013, this has been enforced within the European Union through Directive 2010/63/EU on the protection of animals used for scientific purposes. However, critics argue that the directive and its implementation by member states do not properly consider all aspects of animal welfare, which risks causing unnecessary animal suffering and decreased public trust in the system. In this pilot study, the ethical review process in Sweden was investigated to determine whether or not the system is in fact flawed, and if so, what may be the underlying cause of this. Through in-depth analysis of 18 applications and decisions of ethical reviews, we found that there are recurring problems within the ethical review process in Sweden. Discrepancies between demands set by legislation and the structure of the application form lead to submitted information being incomplete by design. In turn, this prevents the Animal Ethics Committees from being able to fulfill their task of performing a harm-benefit analysis and ensuring Replacement, Reduction, and Refinement (the 3Rs). Results further showed that a significant number of applications failed to meet legal requirements regarding content. Similarly, no Animal Ethics Committee decision contained any account of evaluation of the 3Rs and a majority failed to include harm-benefit analysis as required by law. Hence, the welfare may be at risk, as well as the fulfilling of the legal requirement of only approving "necessary suffering". We argue that the results show an unacceptably low level of compliance in the investigated applications with the legal requirement of performing both a harm-benefit analysis and applying the 3Rs within the decision-making process, and that by implication, public insight through transparency is not achieved in these cases. In order to improve the ethical review, the process needs to be restructured, and the legal demands put on both the applicants and the Animal Ethics Committees as such need to be made clear. We further propose a number of improvements, including a revision of the application form. We also encourage future research to further investigate and address issues unearthed by this pilot study.