Approved Ambiguities: An Analysis of Applications for the Ethical Review of Animal Research in Sweden-Focusing on Harm, Benefit, and the 3Rs.

This study examines regulatory requirements concerning the ethical review of animal research in Sweden, in particular legal obligations placed on applicants, and to some extent on Animal Ethics Committees (AECs). It focuses on what information applying researchers are required to provide, to what extent submitted applications reflect the fulfilment of these requirements, and how the AECs handle the information they receive. The study emphasizes areas of concern critical for an ethical evaluation. By examining a selection of submitted applications, the study has found information about harm, benefit, and the 3Rs is often insufficient or occasionally altogether missing, thus hindering the AECs' performance of a harm-benefit analysis (HBA) and an assessment of how the applying researcher has considered the 3Rs in their project. The authors underscore the necessity for applying researchers to include detailed, relevant, complete, and accurate information to facilitate a thorough ethical review. To facilitate a shift towards a more thorough project evaluation, the authors suggest nine action points to improve the ethical review process for the sake of applicants, evaluators (AECs), and the animals used in research. This approach will also help enhance research quality, promote transparency, and build public trust in the ethical review process.