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The EU adopted Directive 2010/63/EU, thereby creating an instrument for legally implementing effective measures to regulate animal experimentation. In this framework, the 3Rs principle for replacement, reduction, and refinement of animal experiments proposed by Russell and Burch (1959) is of paramount importance. The highest goal of the 3Rs can be understood as a Culture of Care (CoC), entailing complete renunciation of sentient beings as test subjects. The implementation of a CoC is explicitly mentioned in Recital 31 of the EU-Directive. This article elaborates on historical underpinnings of the CoC concept and uses qualitative social research to trace its characteristics. Data were based on non-standardized survey procedures (topic-oriented, guideline-based expert interviews) and were collected at the management, scientific, supervisory and care levels in relation to animal experimentation. The goal of the qualitative approach is to understand contexts, conditions, strategies, and consequences of the CoC and depict them as a theoretical model. [ABSTRACT FROM AUTHOR]

Simple Summary: Scientific experiments that use animals are strictly regulated, mainly as a result of public concerns about animal testing. Examination of the regulation of animal experiments shows that most of the experiments submitted for authorization are approved. But what could be the reasons for this high approval? Since public understanding is needed in order to reach a common agreement that will shape animal research policy, it is important to have a transparent discussion about what leads to the frequent approval of animal experiments. The aim of this article is to discuss why frequent approval of experiments is a problem: the regulatory process has been put in place to authorize only acceptable experiments. Even though some experiments, such as cosmetic testing on animals, are prohibited in many countries irrespective of harm–benefit ratios, most types of animal experiments are approved. Further, we explain some possible genuine reasons for frequent approval, but at the same time, we also discuss how the regulatory process could be leading to the approval of unacceptable studies. To ensure transparency, gain public trust, and improve the understanding of the regulation of animal testing, we propose that regulators publish their experiment evaluations on an accessible online platform, explaining how they reached their decisions. 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. [ABSTRACT FROM AUTHOR]

In mammalian research, the implementation of the 3Rs is ubiquitous. However, the adaptation of procedures for experimental work on fish seems less extensive in comparison, even though fish model organisms are common in a broad range of research fields already. To strengthen animal welfare in experimental research, we provide an overview of current research results, including studies on the nociception of fishes. Furthermore, we describe the potential of implementing the 3Rs in fish experimental research. In the context of "Reduction", we show alternative research methods to lethal sampling. Considering "Refinement", we point out possibilities to improve fish handling and indicate that adaptations to the individual species ecology are necessary. Under the aspect of "Replacement", we describe the high potential of cell cultures that can be obtained from fish tissue and give an overview of the already extensive use in ecotoxicology and virology. In addition, we illustrate that cell cultures could also be increasingly used for basic research. [ABSTRACT FROM AUTHOR]

The use of novel tools and technologies is transforming our approaches to study wild animal behaviour. Yet, from disturbance of natural habitats through field experiments to tagging, there is much ground for researchers to provide clear ethical assessment of their research practices and how they can affect wild animals.In this perspective, I review the current trends in field animal behaviour research, with a focus on studies on sociality, and investigate the forms under which such practices can impact animals. I focus particularly on the notions of disturbance and invasiveness.I build a parallel with the legal classifications in terms of degrees of severity found in the Swiss law and aimed at protecting animal well‐being, inspired by the principles of the 3R (Replace, Refine, Reduce) used in invasive animal research.I highlight how the impact of research can be assessed and monitored, particularly through behavioural and physiological means, identifying areas where such monitoring is critical, but also acknowledging the theoretical and practical limitations to such tools.I hope to trigger discussions on an ethical use of new tools and technologies, which can both inspire new research while limiting the disturbance to wild animals. [ABSTRACT FROM AUTHOR]

Government authorities often view the 3Rs of "replace, reduce, refine" popularized by Russell and Burch as both a regulatory principle and a governance principle aimed at reducing the total amount of animal distress in science. They thus expect that the 3Rs should, in time, result in changes in total animal experimentation numbers. Communications by Swiss authorities provide stark examples of this expectation. But the 3Rs do not aim at affecting animal experimentation at the level of total numbers; rather, they focus on study design in the individual case. While the underlying philosophy of the 3Rs indeed included a principle of seeking feasible overall reforms, this notion is completely absent in the 3Rs framework itself. Authorities need to stop treating the 3Rs as a means to reduce total distress and should instead invest resources into developing feasible and effective strategies for transformative governance in animal research. [ABSTRACT FROM AUTHOR]

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Simple Summary: Monitoring vitals sign such as the respiratory rate, heart rate, or temperature is of high importance to medical and biological research. Using camera-based methods, we monitored the respiratory rate of unconstrained laboratory rats by analyzing the visible breathing movement in the thorax. We hope this is a further step to enabling the non-invasive monitoring of rodent in an experimental environment without using implanted sensors, reducing the stress and pain within an otherwise unneeded operation. Animal research has always been crucial for various medical and scientific breakthroughs, providing information on disease mechanisms, genetic predisposition to diseases, and pharmacological treatment. However, the use of animals in medical research is a source of great controversy and ongoing debate in modern science. To ensure a high level of bioethics, new guidelines have been adopted by the EU, implementing the 3R principles to replace animal testing wherever possible, reduce the number of animals per experiment, and refine procedures to minimize stress and pain. Supporting these guidelines, this article proposes an improved approach for unobtrusive, continuous, and automated monitoring of the respiratory rate of laboratory rats. It uses the cyclical expansion and contraction of the rats' thorax/abdominal region to determine this physiological parameter. In contrast to previous work, the focus is on unconstrained animals, which requires the algorithms to be especially robust to motion artifacts. To test the feasibility of the proposed approach, video material of multiple rats was recorded and evaluated. High agreement was obtained between RGB imaging and the reference method (respiratory rate derived from electrocardiography), which was reflected in a relative error of 5.46%. The current work shows that camera-based technologies are promising and relevant alternatives for monitoring the respiratory rate of unconstrained rats, contributing to the development of new alternatives for a continuous and objective assessment of animal welfare, and hereby guiding the way to modern and bioethical research. [ABSTRACT FROM AUTHOR]

Copyright of Revista Colombiana de Bioetica is the property of Universidad El Bosque and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Findings from animal experiments are often difficult to transfer to humans. In this perspective article I discuss two questions. First, why are the results of animal experiments often so difficult to transfer to humans? And second, what can be done to improve translation from animal experiments to humans? Translation failures are often the result of poor methodology. It is not merely the fact that low statistical power of basic and preclinical studies undermine a "real effect," but the accuracy with which data from animal studies are collected and described, and the resulting robustness of the data is generally very low and often does not allow translation to a much more heterogeneous human condition. Equally important is the fact that the vast majority of publications in the biomedical field in the last few decades have reported positive findings and have thus generated a knowledge bias. Further contributions to reproducibility and translation failures are discussed in this paper, and 10 points of recommendation to improve reproducibility and translation are outlined. These recommendations are: (i) prior to planning an actual study, a systematic review or potential preclinical meta-analysis should be considered. (ii) An a priori power calculation should be carried out. (iii) The experimental study protocol should be pre-registered. (iv) The execution of the study should be in accordance with the most recent ARRIVE guidelines. (v) When planning the study, the generalizability of the data to be collected should also be considered (e.g., sex or age differences). (vi) "Method-hopping" should be avoided, meaning that it is not necessary to use the most advanced technology but rather to have the applied methodology under control. (vii) National or international networks should be considered to carry out multicenter preclinical studies or to obtain convergent evidence. (viii) Animal models that capture DSM-5 or ICD-11 criteria should be considered in the context of research on psychiatric disorders. (ix) Raw data of publication should be made publicly available and should be in accordance with the FAIR Guiding Principles for scientific data management. (x) Finally, negative findings should be published to counteract publication bias. The application of these 10 points of recommendation, especially for preclinical confirmatory studies but also to some degree for exploratory studies, will ultimately improve the reproducibility and translation of animal research. [ABSTRACT FROM AUTHOR]

The aim of the present inquiry was to design an overview about the non-technical summaries available on the web page of the National Sanitary Veterinary and Food Safety Agency (Romania). We analyzed the compliance to the requirement of replacement, reduction and refinement (the 3R’s). 56 projects were found, the most of them (48), were assigned as “basic research”, 2 as “translational and applied research”, 2 as “regulatory use and routine analysis”, while 4 projects targeted “higher education or training”. The most common animals species used were rats, and mice, followed by rabbits, pigs, hamsters, guinea pigs and frogs (Rana sp.). According to cumulative severity of the project, 20 projects were classified as “severe”, six as “moderate”, three “mild”, and three as “non-recovery”. 24 projects had nor a severity assessment, neither a proper description of the level of severity. In our opinion, the number of projects classified as “severe” is too high; at least for some of them, the level of severity could be reduced using appropriate pain control techniques and / or human end-points. Overall, our recommendation is further improving the knowledge and skills of the personal involved in authorization and execution of the projects and of the authority inspectors that authorized the projects.

Toxicity studies in mammals continue to be the most appropriate model for predicting risk in humans, but they tend to be expensive and time-consuming. In the aftermath of the genetic sequencing of zebrafish (Danio rerio), this species is highly genetically homologous to humans. The use of the zebrafish model to assess food toxicity is already a reality as it is capable of biological processes difficult to reproduce in vitro. Studies of complex mechanisms of absorption, distribution, metabolism, and excretion as well as cellular and tissue interactions are of great information value resulting in time, space and cost savings, when compared to studies with rodents. This review addresses the relevance of zebrafish model in food safety research, both in the use of ingredients and approved and generally recognized as safe food additives as well as for establishing levels of safe food contaminant residues present in the environment. Toxicological screening using the zebrafish model integrate the evaluation of teratogenicity, cardiotoxicity, hepatotoxicity, genotoxicity, neurotoxicity, endocrine toxicity, reproductive and behavioral aspects. These are important endpoints for food safety assessment, which take substantially less time than in mammalian tests. Furthermore, it serves well as a screening test follow-up for validating favorable results in murine models, hence accelerating the risk assessment process of products submitted for approval and registration, prioritizing safe compounds and reducing unnecessary costs in subsequent mammalian studies. In conclusion, the zebrafish model can be a useful tool for food safety tests; however, additional studies are needed to further validate this model for registration of new food ingredients and additives. [ABSTRACT FROM AUTHOR]

Animals used for scientific purposes are protected by EU legislation. Social animals should be kept in stable groups that enable species-typical social behavior and provide individuals with social comfort. However, when group-housing male mice, aggression within the homecage is a common husbandry and welfare problem. Excessive fighting and injuries due to aggression can cause pain and stress, resulting in individuals being euthanized or housed individually. In addition, stress can alter physiological parameters, risking scientific validity and generating larger sample sizes. Mouse aggression, and the consequences thereof, thus opposes the 3R goals of Refining the methods to minimize potential pain and suffering and Reducing the number of animals used. Animal technicians, veterinarians, and scientists using animals have valuable information on how these problems are experienced and handled in practice. We assembled these experiences from laboratory animal facilities in Sweden, mapping problems observed and identifying strategies used to prevent mouse aggression. In line with current literature, less aggression was perceived if mice were grouped before sexual maturity, re-grouping avoided and nesting material transferred at cage cleaning. Preventing aggression will minimize pain and suffering and enable housing of stable groups, leading to more reliable scientific outcomes and is thus of high 3Rs relevance.

Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine, and the principle that the quality of subsequent batches is the consequence of the application of consistent production of batches monitored by a GMP quality system. Efforts to implement the consistency approach are supported by several drivers from industry, government, and research, but there are also several barriers that must be overcome. A workshop entitled “Consistency Approach, Drivers and Barriers” was organized, which aimed to discuss and identify drivers and barriers for the implementation of the 3Rs in the consistency approach from three different perspectives/domains (industry, regulatory and science frameworks). The workshop contributed to a better understanding of these drivers and barriers and resulted in recommendations to improve the overall regulatory processes for the consistency approach. With this report, we summarise the outcome of this workshop and intend to offer a constructive contribution to the international discussion on regulatory acceptance of the consistency approach. [ABSTRACT FROM AUTHOR]

Simple Summary: Due to the implementation of a landing obligation in fisheries in the European Union (EU), with an exemption for species with "high survival", discard survival studies (henceforth DSSs) have become one of the most politically prioritized fisheries research areas in European fisheries. In contrast to most fisheries science research areas, DSSs are embedded by the EUs animal research welfare directive. This is a challenge, and there has not been any focus on how to implement animal welfare (AW) regulations experimentally in DSSs. This paper focuses on AW regulations in relation to conducting DSSs, but the outreach is much broader. We investigate experimental procedures by bringing in relevant examples, using the output results, and relating this information to relevant AW guidelines and regulations by focusing on implementing 3R principles. Globally, it is estimated that around 10% of the fish that are caught are discarded. This is considered to be a wasteful human marine activity since these fish are often dead or dying. To reduce the high discard rates of commercial fisheries, the European Union (E.U.) has enacted a landing obligation that includes the ability to exempt "species for which scientific evidence demonstrates high survival rates". Therefore, discard survival studies (henceforth DSSs) have become one of the most politically prioritized fisheries research areas in European fisheries. International expert groups have produced guidance reports to promote best practices and to harmonize the methodologies. Nevertheless, there has not been any focus on how to implement animal welfare (AW) regulations experimentally. Discard survival studies are "frontrunners" in fisheries science research areas that are embedded by animal research welfare requirements and are expected to be more restrictive in the future because of an increased public focus on fish welfare. This paper focuses on AW regulations in relation to conducting DSSs, but the outreach is much broader. We investigate experimental procedures by bringing in relevant examples, using output results, and relating this information to relevant AW guidelines and regulations by focusing on implementing 3R principles. [ABSTRACT FROM AUTHOR]

Sacrificing model animals is required for developing effective drugs before being used in human beings. In Japan today, at least 4,210,000 mice and other mammals are sacrificed to a total of 6,140,000 per year for the purpose of medical studies. All the animals treated in Japan, including test animals, are managed under control of "Act on Welfare and Management of Animals". Under the principle of this Act, no person shall kill, injure, or inflict cruelty on animals without due cause. "Animal" addressed in the Act can be defined as a "vertebrate animal". If we can make use of invertebrate animals in testing instead of vertebrate ones, that would be a remarkable solution for the issue of animal welfare. Furthermore, there are numerous advantages of using invertebrate animal models: less space and small equipment are enough for taking care of a large number of animals and thus are cost-effective, they can be easily handled, and many biological processes and genes are conserved between mammals and invertebrates. Today, many invertebrates have been used as animal models, but silkworms have many beneficial traits compared to mammals as well as other insects. In a Genome Pharmaceutical Institute's study, we were able to achieve a lot making use of silkworms as model animals. We would like to suggest that pharmaceutical companies and institutes consider the use of the silkworm as a model animal which is efficacious both for financial value by cost cutting and ethical aspects in animals' welfare. [ABSTRACT FROM AUTHOR]

Models to measure potency in vaccine research and development and preclinical testing are frequently based on an immunization--challenge procedure in laboratory animals. These models have proven to be very instrumental in scientifically underpinning the correlation of protection of selected vaccine antigens and their efficacy. In vivo models in vaccine research and development are, for the time being, irreplaceable, although significant progress has been made in using in vitro prescreening tests to evaluate particular immunological parameters. For a long time, in vivo potency tests have been similarly relevant for routine vaccine lot-release testing. The design of a potency test, defined in most pharmacopeias, relied on a direct or indirect-challenge procedure in laboratory animals. For various reasons, there now is an increased interest in the development of alternatives to the current in vivo potency tests. Animal models have their limitations, with respect to their relevance, reliability, costs and moral acceptability. All alternative approaches have in common that they ultimately result in a refinement, reduction or replacement in the use of animals. The new models range from modifications of the existing in vivo test procedure (e.g., use of humane end points or serology instead of challenge) to in vitro antigen-quantification tests. A new paradigm in quality control of vaccines is the consistency approach. This approach is state-of- the-art in quality control of the new-generation vaccines and it is now finding its way into the quality control of traditional vaccines. The consistency approach implies the use of a set of parameters to constitute a product profile, which is monitored throughout production, and which guarantees that each lot released is similar to a manufacturer-specific vaccine of proven clinical efficacy and safety. Consistency relies heavily on the implementation of quality systems, such as good manufacturing practice and quality assurance, and on the use of in vitro analytical tools, such as immunochemical and physicochemical tests. [ABSTRACT FROM AUTHOR]

Objective: The ongoing translational and reproducibility crisis dominates preclinical research today as results from animal studies often disappoint when transferred to human clinical studies. This problem is especially relevant in the field of brain diseases and translational neuropsychiatry. Methods: Here, we discuss if the 3R concept could be part of the translational crisis. Results: The focus has been on the second R, which is to reduce the variation between the experimental animals, so that the number of animals per study can be reduced. However, the risk of obtaining false results has also increased. We, therefore, recommend that researchers use a broader perspective as also suggest by Russell and Burch who founded the 3Rs when considering the 3R concept, which involves the translational aspects described in detail in their 3R book from 1959. Conclusion: This may together with systematic reviews and well-designed and well-performed animal studies and accurate reporting of the results indeed contribute to solving the translational crisis in preclinical research. [ABSTRACT FROM AUTHOR]

Simple Summary: Stereotaxic surgery techniques are commonly used today in research laboratories by a range of students, technicians, and researchers. Over the past twenty years, technical and scientific progress has been made in neurosurgery to meet the evolving requirements imposed by international legislation, and to promote the implementation of 3R rules. These improvements were motivated by a greater awareness of animal welfare and the necessary effort in the reduction of the number of animals used in experiments. The data presented in the present study show that technical and methodological improvements brought to our surgical procedures from 1992 resulted in reproducible stereotaxic neurosurgeries and in a significant reduction in experimental errors and animal morbidity. The effects of these improvements include a decrease in the final number of animals used in our experiments as well as better management of pain during and after surgery and the use of appropriate aseptic techniques. Correct stereotaxic surgical approaches are precisely described throughout the text. Techniques of stereotaxic surgery are commonly used in research laboratories by a range of students, technicians, and researchers. To meet the evolving requirements imposed by international legislation, and to promote the implementation of 3R rules (replacement, reduction, and refinement) by reducing experimental error, animal morbidity, and mortality, it is essential that standard operating procedures and proper conduct following such complex surgeries be precisely described and respected. The present report shows how refinements of our own neurosurgical techniques over decades, have significantly reduced the number of animals (rats) used in experiments and improved the animals' well-being during the post-surgical recovery period. The current pre-, per-, and post-surgical procedures used in our laboratory are detailed. We describe the practical aspects of stereotaxic neurosurgery that have been refined in our laboratory since 1992 and that cover various areas including appropriate anesthesia and pain management during and after surgery, methods to determine the stereotaxic coordinates, and the best approach to the target brain structure. The application of these optimal surgical methods that combine reliable and reproducible results with an acute awareness of ethics and animal welfare leads to a significant reduction in the number of animals included in experimental research in accordance with ethical and regulatory rules as required by the European Directive on laboratory animal welfare. [ABSTRACT FROM AUTHOR]

Simple Summary: In the EU, the breeding of genetically modified laboratory animals is defined as an animal experiment, if the animals may experience pain, suffering or harm due to the genetic modification. In most cases, modifications of the immune system do not lead to pain, suffering, or harm given the animals are kept under specific pathogen-free housing conditions. Nevertheless, the EU working group on genetically altered animals defined SPF housing conditions as "Refinement". According to this working group, applied refinement strategies for breeding genetically modified animals do not exclude them from project licensing. Thus, theoretical suffering, pain or harm is assumed without applying methods of actual burden assessment. Furthermore, the definition of SPF as a refinement strategy rather than a standard husbandry procedure leads to incomprehension among the scientific community in the EU. Here, we discuss the ethical basis of animal experiments as well as the current legal situation for immunodeficient animals. Furthermore, we discuss potential pain, suffering, or harm of immunodeficient animals from an immunological perspective. Finally, we briefly outline an animal welfare-oriented approach to severity assessment of immunodeficient mice. In the EU, the breeding of genetically modified laboratory animals is, by definition, an animal experiment if the offspring may experience pain, suffering, or harm. In order to determine the actual burden of genetically modified mice, established methods are available. However, the breeding of immunodeficient mice is considered an experiment requiring a permit, even if no pain, suffering or harm is observed under scientifically required defined hygienic housing conditions, as determined by established methods of severity assessment. This seems contradictory and leads to uncertainty among scientists. With this commentary, we would like to shed light on this topic from different perspectives and propose a solution in terms of individualized severity assessment and approval procedures. [ABSTRACT FROM AUTHOR]

Simple Summary: The chorioallantoic membrane of an avian embryo is a simple, low-cost, low-maintenance, and well-available in vivo animal model with many advantages in the field of scientific experimentation and a multitude of ways of its application. Our review addresses the avian species that are less known as suitable for the chorioallantoic membrane model (CAM) assay than the most commonly used chicken embryo. We describe and compare the characteristics of the quail, turkey, and duck CAM assays, each species offering different advantages for research and opening more possibilities for working methods. The chorioallantoic membrane model (CAM) of an avian embryo is used as an experimental model in various fields of research, including angiogenesis research and drug testing, xenografting and cancer research, and other scientific and commercial disciplines in microbiology, biochemistry, cosmetics, etc. It is a low-cost, low-maintenance, and well-available in vivo animal model that is non-sentient and can be used as an alternative for other mammal experimental models. It respects the principles of the "3R" rule (Replacement, Reduction, and Refinement)—conditions set out for scientific community providing an essential framework for conducting a more human animal research, which is also in line with constantly raising public awareness of welfare and the ethics related to the use of animal experimental models. In this review, we describe the chorioallantoic membrane of an avian embryo, focusing on its properties and development, its advantages and disadvantages as an experimental model, and the possibilities of its application in various fields of biological research. Since the most common chicken CAM model is already well known and described in many publications, we are particularly focusing on the advantages and application of less known avian species that are used for the CAM model—quail, turkey, and duck. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Simple Summary: The mouse is the most commonly used mammal in scientific research, and housed in research facilities around the world. Mice are a social species, but when housing male mice together in a confined environment in the laboratory, aggression is often observed and can be problematic. Fighting or trying to avoid fighting can be stressful. Furthermore, fighting can lead to injuries which can sometimes be fatal. Mouse aggression is therefore a significant welfare problem and has implications on the 3Rs (Replacing, Reducing, and Refining animal use in scientific procedures and education). In this study, we used a survey and workshops to collect the experiences of animal technicians, veterinarians, and researchers at Swedish research animal facilities relating to mouse aggression and what methods of preventing aggression they practice. Both group housing and single-housing as a consequence of aggression was perceived as problematic and stressful for the animals. In line with current recommendations from the literature, participants perceived that aggression occurred less if mice were grouped with litter mates at an early age, that nesting material was transferred at cage cleaning, and disturbance was kept to a minimum. Experience from practice will play a valuable part in developing guidelines for group-housed male mice. Animals used for scientific purposes are protected by EU legislation. Social animals should be kept in stable groups that enable species-typical social behavior and provide individuals with social comfort. However, when group-housing male mice, aggression within the homecage is a common husbandry and welfare problem. Excessive fighting and injuries due to aggression can cause pain and stress, resulting in individuals being euthanized or housed individually. In addition, stress can alter physiological parameters, risking scientific validity and generating larger sample sizes. Mouse aggression, and the consequences thereof, thus opposes the 3R goals of Refining the methods to minimize potential pain and suffering and Reducing the number of animals used. Animal technicians, veterinarians, and scientists using animals have valuable information on how these problems are experienced and handled in practice. We assembled these experiences from laboratory animal facilities in Sweden, mapping problems observed and identifying strategies used to prevent mouse aggression. In line with current literature, less aggression was perceived if mice were grouped before sexual maturity, re-grouping avoided and nesting material transferred at cage cleaning. Preventing aggression will minimize pain and suffering and enable housing of stable groups, leading to more reliable scientific outcomes and is thus of high 3Rs relevance. [ABSTRACT FROM AUTHOR]