Do Ethical Reviews of Animal Research Serve the Animals? Empirical Insights from the Swedish System

On January 27^th, Svea Jörgensen gave an interesting talk at the Messerli Research Institute entitled “Struggling to Balance the Scales: Empirical Insights from the Ethical Review of Animal Research in Sweden.” Svea outlined details of her PhD project, which investigates the ethical review process of applications for animal research in Sweden.

There are six regional Animal Ethics Committees (AECs) in Sweden that are tasked with the transparent ethical reviews of animal research projects. Their work is informed by the European Union (EU) Directive 2010/63/EU which regulates the use of animals for scientific purpose and ultimately aims to replace animal testing with alternative methods. AECs are legally obliged to perform a harm-benefit analysis and ensure an application’s compliance with the 3Rs – ethical guidelines that aim to reduce, replace, and refine the use of animals in research. Svea’s research has, however, found that there are serious flaws in the current decision-making process of AECs, prompting her to suggest that the review process requires a robust, and transparent ethical review.

 Svea’s analysis of 44 applications and decisions from 2020 yielded some worrisome results. She assessed each of the applications on the quality and completeness of information they included related to harms & benefits as well as the 3R principle. She then considered whether the decisions made by the AECs’ were informed by the 3Rs and performance of a harm benefit analysis (HBA). She found that applications regularly lacked essential information regarding harms & benefits as well as the 3Rs and that the legislation was, at times, ambiguous, failing to give clear guidance for interpretation.

In short, she found that projects are routinely approved without proper ethical evaluation, meaning the ethical review system fails to live up to the goals and requirements set by legislation.

Svea has gained additional insights into the process by sitting in on the committees’ plenary meetings and conducting a survey with researchers and AEC members on their perceptions of the review process. Her results have been sobering. She found that both committee member and researcher respondents ranked animal interests as of the highest priority “in theory” but only ranked them as 2^nd priority “in practice.” All respondents ranked the interests of the applying researcher as 5^th (i.e. last) priority “in theory” with committee members and researchers respectively ranking them as 3^rd and 4^th priority “in practice.”

In essence, animals’ interests are less prioritised in practice than in theory, while the applying researcher’s interests are prioritised higher in practice than is theoretically intended.

Moreover, according to the respondents’ applications often lack important information needed for the ethical review, the AEC members’ ability to assess the 3Rs is questionable, actual ethical deliberation is missing from the ethical review, and the mandatory harm-benefit analysis is not always performed. Shockingly, despite all of this, almost all projects receive ethical approval.

In light of these findings, Svea aims to revise the process so that they can better fulfil its legal and ethical requirements, safeguard the welfare of the animals used, and increase the scientific validity of approved projects. That is, the final stage of her project will review how the system can be improved so as to ensure that ethical guidelines (such as the 3R Principle) are properly integrated and the EU legislation can be lived up to. To do this she will conduct a literature review, across countries, on the known issues in the ethical review system while also developing an alternative model to the HBA which is currently viewed by some experts as an inadequate tool for ethical decision-making.

A lively discussion followed Svea’s talk and there was a general sense of concern about the fact that the vast majority of applications are approved despite serious shortcomings. The causes of this discrepancy were debated and some suitable starting points for a revision of the review process were considered. Overall it was an interesting and enlightening discussion into the back-of-house processes that enable animals to be tested on and used in research, highlighting just how much systemic change is needed to bring it to an end.

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Svea Jörgensen holds a degree in veterinary medicine from the Swedish University of Agricultural Sciences (SLU) and has undertaken studies in law at Lund University. She is currently a PhD candidate in animal ethics at the SLU, where she is affiliated with the Department of Applied Animal Science and Welfare.