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

Abstract

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.

Statistical review of animal trials—A guideline

“…Overall, review boards work completely independent due to federal regulations without having unified criteria (Jörgensen et al., 2021). In general, missing of the latter complicates the work of reviewers and does not guarantee an unbiased review process upon known criteria for the applicants.…”

Influence of animal pain and distress on judgments of animal research justifiability among university undergraduate students and faculty

“…(Unfortunately, a retrospective harm-benefit analysis indicates that even existing harm-benefit guidelines are not followed in some studies [ 44 ]). At the present time, however, recommendations to include even this level of quantification [ 43 ] have not been adopted in the United States and implementation in the European Union remains problematic [ 56 ]. As noted above, without such quantification, review remains qualitative and largely subjective between IACUCs [ 52 ], and even within a single IACUC, especially over time as membership changes.…”

Brexit: A Boon or a Curse for Animals Used in Scientific Procedures?

“…While this is true, the EU have reported that no Member State has initiated a safeguard clause since the Directive took effect in January 2013 [24]. The issue with severity limits across Member States, however, is the lack of guidance and definition of these terms, particularly what 'cannot be ameliorated' means and the level of suffering that has to take place for it to be 'severe' [25]. As there is little guidance, and what does exist is general rather than detailed and specific, there are concerns that there is 'considerable variation' as to how severity limits are applied [26].…”

“…For example, research from Sweden reviewing applications for projects using animals in procedures found they were mainly not completed adequately and in line with the Directive. As for the project evaluation by the Swedish Animal Ethics Committees, only 4 out of 18 application reviews were deemed to satisfactorily mention harm and benefit and none included mention of the 3Rs [25].…”