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It is our concern that European Union Directive 2010/63/EU with its current project evaluation of animal research in the form of a harm–benefit analysis may lead to an erosion of the credibility of research. The HBA assesses whether the inflicted harm on animals is outweighed by potential prospective benefits. Recent literature on prospective benefit analysis prioritizes “societal benefits” that have a foreseeable, positive impact on humans, animals, or the environment over benefit in the form of knowledge. In this study, we will argue that whether practical benefits are realized is (a) impossible to predict and (b) exceeds the scope and responsibility of researchers. Furthermore, we believe that the emphasis on practical benefits has the drawback of driving researchers into speculation on the societal benefit of their research and, therefore, into promising too much, thereby leading to a loss of trust and credibility. Thus, the concepts of benefit and benefit assessment in the HBA require a re-evaluation in a spirit that embraces the value of knowledge in our society. The generation of scientific knowledge has been utilised to great benefit for humans, animals, and the environment. The HBA, as it currently stands, tends to turn this idea upside down and implies that research is of value only if the resulting findings bring about immediate societal benefit.

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.

Animal research ethics and animal welfare in science have become progressively tightly regulated, and ethical integrity and scientific quality, as well as social responsiveness and responsibility have become key requirements for research to be approved, funded, published, and accepted. The multitude of factors to contemplate has in some instances not only become complex, requiring a team approach, but often perceived as confusing and overwhelming. To facilitate a process of simplistic yet comprehensive conceptualization, we developed the 12 Rs Framework to act as a mind map to guide scientists, oversight structures, and other stakeholders through the myriad of ethical considerations. It unfolds into three domains of twelve encompassing ethical principles, values, and other considerations, including the animal welfare, social values, and scientific integrity domains, whilst also recognizing the diversity of local context, legal requirements, values, and cultures around the globe. In the end, it can be seen as a unifying ethical framework to foster and promote animal research ethics.

The use of nonhuman animals in biomedical research is regulated under stringent conditions, not only in response to societal attitudes towards animal experimentation but also because ethical responsibility in scientific research requires researchers and veterinarians to be more invested and aim to improve the welfare of animals used for experiments. Analyses of animal research oversight reveal the frequent approval of experiments, and the approval of some experiments has raised and continues to raise public concerns. Societal compliance is required for a consensus-based approach to animal research policy, prompting the need to have transparent discussions about oversight and the frequency of approvals. We discuss how frequent approval may be perceived and why it seems problematic from a societal perspective: the regulatory process exists to approve only legitimate experiments. Although some experiments remain unacceptable irrespective of their harm–benefit ratios, almost all experiments are approved. We explain some possible legitimate reasons for frequent approval and how the review process could be leading to the approval of illegitimate studies. To ensure transparency and improve public trust and understanding of oversight, we propose the adoption of a platform to inform society about how unethical experiments are screened out.

Background Scientific research projects involving animals are required to undergo ethical evaluation, generally known as harm-benefit analysis (HBA) , to ensure that they address important ethical concerns related to animal welfare and the scientific quality of the research to maximize the likelihood of their potential benefits. Research continuously shows the challenges encountered by decision-makers, prompting researchers to review how HBA is conducted and to propose tools to aid decision-making. However, the extent to which such resources are currently available, their jurisdictions of applicability, and how they guide decision-making are not entirely clear. Method Through a Scoping Review methodology, a systematic literature search was conducted in PubMed, Scopus and Web of Science for publications in Europe and North America (USA and Canada) from 1985 to 2023. Title and abstract, full-text, and reference screenings, followed by data charting, respectively, were carried out for retrieved publications using pre-developed and registered review protocol. Results 17 resources that can guide HBA and decision-making were identified. They discussed what should constitute harm to animals and benefits of research, and how these two interests can be balanced to make a decision. Some adopt mathematical calculations, some propose guidelines for committee discussions, while others propose the combination of different approaches to decision-making. Conclusions Decision-making based on deliberation among committee members should be supported over the use of scoring approaches. Additionally, making ethical decisions on a case-by-case basis is preferable to accuracy, which may not be realistically practicable.

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.

Can nonhuman animals be used for the benefit of humans in a scientifically and morally justified manner and, if yes, how? Based on our own experiences as scholars from various academic backgrounds, we argue that this question can only be answered as an interdisciplinary and international endeavor, considering insights from research ethics and animal ethics as well as scientific and legal aspects. The aim of this article is to contribute to the foundation of the emerging field of animal research ethics. In doing so, we describe the following seven phases of animal research experiments: ethical, legal and social presumptions (phase 0), planning (phase I), review (phase II), conduct of experiments (phase III), publication/dissemination (phase IV), further exploitation of results (phase V), and evaluation (phase VI). In total, 20 key ethical, legal, and practical challenges that an ethical framework for the use of animals in research needs to address are identified and analyzed. Finally, we characterize the following four meta-challenges and opportunities associated with animal research ethics as a field: (1) moral pluralism, (2) the integration of views and positions outside the laboratory, (3) international plurality of conduct, standards, and legal norms, and (4) interdisciplinary education.

The practical application of harm-benefit analysis (HBA), a requirement mandated by European Union Directive 2010/63/EU, has been extensively examined. However, reviewing bodies can access only sparse and often incomplete HBA guidance. This study develops a composite HBA method composed of the relevant and useful elements from current guidance documents and provides instructions on conducting such an analysis. It redefines HBA approaches, eliminating redundant aspects while meeting the Directive's requirements. This novel compound HBA method includes a clear procedural methodology to guide project applicants, reviewing bodies, and authorities in transparent and coherent decision-making.

The use of animals in research requires careful ethical consideration of whether the burden on the animals is justified. As one important part of the project evaluation, a harm–benefit analysis (HBA) must be carried out in order to approve projects in line with the EU Directive 2010/63/EU. This implies that harms and benefits must be assessed prospectively beforehand in order to weigh them. Although there are different methods of weighing, it is clear that an assessment of prospective harms and benefits is a precondition for any weighing procedure. In this context, projects that use genetically altered (GA) lines raise new issues. A unique challenge when using GA lines is the significant lack of knowledge in this context, making it difficult and sometimes impossible to estimate harm prospectively with sufficient certainty, since it is not predictable what sort of harm—if at all—the animals are going to experience. Therefore, this contribution aims to deal with the challenges of harm assessment in GA animals and their implications for welfare assessment and the HBA. A practical guideline is presented herein to serve as guidance for relevant harm factors and address the main challenges, particularly when dealing with uncertainties in the process of HBA.

In order to assess the extent to which the legally prescribed training for the acquisition of animal experimentation expertise provides scientific personnel with the necessary competence and expertise to carry out a correct harm-benefit analysis in the context of animal experimentation applications, we conducted an interactive stress assessment concerning the basic animal experimentation expertise course. First, before the practical part of the course and then, after the practical part, the participants assessed images and video material of healthy and stressed animals. The results were assessed comparatively and showed a significant increase in performance in all categories (p-value < 0.001). In addition, the results were comparatively assessed against those of scientists already experienced in animal experiments and experienced animal caretakers in research and clinics. In all groups, the vast majority of participants were able to recognise stress in laboratory animals. A significant proportion of the participants were also able to rate the level of stress correctly according to three degrees of severity: mild, moderate and severe. Nevertheless, a small number of participants were unable to distinguish between healthy and stressed animals and thus, the stress in the individual groups was assigned very differently from the different degrees of severity. The results of this study illustrate, on the one hand, the high significance that training must have in order to acquire the expertise, and, on the other hand, how strongly the assessment of stress is influenced by subjectivity.