Wildlife must be protected from crime and trade for the sake of public and planetary health.

COVID-19 most likely had its origins in wildlife, and hundreds of thousands of new viruses could spill over from wildlife to humans. We are struggling to combat climate change, and we are staring down the loss of a million species. It's time to change course.

A brief history of the animals' scientific research, international rules and Brazilian regulations.

Several countries and non-governmental organizations have discussed the use of animals in industry and biomedical areas. This work shows the progression of animal' rights for scientific purposes in Brazil and how Brazilian Councils have advanced to follow worldwide regulations. Since the first rules about animals' usage in Ireland in 1635, the British Cruelty to Animals Act in 1876, and the Brazilian animal protection rules in 1924 and 1934, most worldwide actions culminated in the Universal Declaration of Animal Rights (1978). In 1979, the Brazilian Law 6.638 displayed directives for didactic-scientific practice of vivisection. In 2008, the Arouca Law 11.794 filled regulatory gaps and created the National Council for the Control of Animal Experimentation (CONCEA). In 2014, the CONCEA incorporated the 3R's philosophy and recognized substitute techniques, but only in 2023 it prohibited vertebrate animals in scientific research, development and control of personal hygiene products, cosmetics and perfumes. It is clear current Brazilian and international rules are unable to cover all aspects of animal wellbeing, even for regulations of commercial issues. Certainly, innovative tools, as organ-on-chip, in vitro techniques and bioinformatical advancements will provide a crucial animal welfare and new laws will minimize animal pain and distress, including for disregarded invertebrates.

Refining animal research: The Animal Study Registry.

The Animal Study Registry (ASR; www.animalstudyregistry.org) was launched in January 2019 for preregistration of animal studies in order to increase transparency and reproducibility of bioscience research and to promote animal welfare. The registry is free of charge and is designed for exploratory and confirmatory studies within applied science as well as basic and preclinical research. The registration form helps scientists plan their study thoroughly by asking detailed questions concerning study design, methods, and statistics. With registration, the study automatically receives a digital object identifier (DOI) that marks it as intellectual property of the researcher. To accommodate the researchers concerns about theft of ideas, users can restrict the visibility of their registered studies for up to 5 years. The full content of the study becomes publicly accessible at the end of the embargo period. Because the platform is embedded in the infrastructure of the German Federal Government, continuity and data security are provided. By registering a study in the ASR, researchers can show their commitment to transparency and data quality to reviewers and editors, to third-party donors, and to the general public.

International primate neuroscience research regulation, public engagement and transparency opportunities.

Scientific excellence is a necessity for progress in biomedical research. As research becomes ever more international, establishing international collaborations will be key to advancing our scientific knowledge. Understanding the similarities in standards applied by different nations to animal research, and where the differences might lie, is crucial. Cultural differences and societal values will also contribute to these similarities and differences between countries and continents. Our overview is not comprehensive for all species, but rather focuses on non-human primate (NHP) research, involving New World marmosets and Old World macaques, conducted in countries where NHPs are involved in neuroimaging research. Here, an overview of the ethics and regulations is provided to help assess welfare standards amongst primate research institutions. A comparative examination of these standards was conducted to provide a basis for establishing a common set of standards for animal welfare. These criteria may serve to develop international guidelines, which can be managed by an International Animal Welfare and Use Committee (IAWUC). Internationally, scientists have a moral responsibility to ensure excellent care and welfare of their animals, which in turn, influences the quality of their research. When working with animal models, maintaining a high quality of care ("culture of care") and welfare is essential. The transparent promotion of this level of care and welfare, along with the results of the research and its impact, may reduce public concerns associated with animal experiments in neuroscience research.

A cross-sectional study of associations between herd-level calf mortality rates, compliance with legislation on calf welfare, and milk feeding management in Norwegian dairy herds.

Our aim was to investigate the associations between management factors, compliance with current legislation, and herd-level calf mortality. In a national calf welfare audit, veterinary inspectors from the Norwegian Food Safety Authority assessed compliance with current legislation on calf welfare (n = 912 herds). Nine criteria were assessed and rated as satisfactory (1) or not satisfactory (0): housing, natural behavior, single pens, colostrum feeding, feeding, water, surveillance, illness/injuries, and <5% mortality rate. In addition, a short questionnaire on milk feeding management for 3-wk-old calves was distributed to all national calf welfare audit herds, and data on mortality and disease recordings were obtained from the Norwegian Dairy Herd Recording System (NDHRS). A herd welfare compliance score (WCS) for each farm was constructed, summarizing the results for the individual criteria. Most herds had a high WCS (median 9.0, range 2-9). Fifty-six percent of the national calf welfare audit herds (508/912) responded to the questionnaire. We performed a cross-sectional study using a data set from 431 herds with available data on recorded disease and mortality events from the NDHRS, recordings from the national calf welfare audit, and the questionnaire. A mixed-effects negative binomial model with Norwegian Food Safety Authority district as the random effect was fitted to the data. Of the 416 herds with available data on calf mortality, 108 (25.9%) reported no mortality in 2016, and the median 6-mo mortality rate was 0.064 (interquartile range 0-0.11) dead calves per 6 calf-months at risk, based on NDHRS recordings. Calf mortality rates were higher in herds whose calves did not have free access to water (incidence rate ratio 1.29; 95% confidence interval 1.02-1.64) and higher in herds that had reported calf disease events (incidence rate ratio 1.31; 95% confidence interval 1.09-1.54). Neither the WCS nor any of the calf milk feeding management factors were associated with mortality, but more than half of producers (59.6%) fed less milk than currently recommended for 3-wk-old calves (8 L/d first 3 to 4 wk). These results indicate that a lack of access to water was associated with higher calf mortality rates. Herds with registered calf disease events had a higher incidence rate ratio of mortality. This finding may be linked to suboptimal calf management, leading to more calf diseases and mortality; or it may be that veterinary consultancy occurs too late or only for the worst cases. There is room for improvement in Norwegian dairy calf management, and water should be provided to young calves.

Rethinking 3R strategies: Digging deeper into AnimalTestInfo promotes transparency in in vivo biomedical research.

In the European Union (EU), animal welfare is seen as a matter of great importance. However, with respect to animal experimentation, European citizens feel quite uninformed. The European Directive 2010/63/EU for the protection of laboratory animals aims for greater transparency and requires that a comprehensible, nontechnical summary (NTS) of each authorised research project involving animals is published by the respective Member State. However, the NTSs remain sleeping beauties if their contents are not easily and systematically accessible. The German web-based NTS database AnimalTestInfo is a unique channel for scientists to communicate their work, and provides the opportunity for large-scale analyses of planned animal studies to inform researchers and the public. For an in-depth meta-analysis, we classified the duly completed NTSs submitted to AnimalTestInfo in 2014 and 2015 according to the International Classification of Diseases and Related Health Problems (ICD) system. Indexing the NTSs with ICD codes provided a fine-grained overview of the prospective uses of experimental animals. Using this approach, transparency, especially for highly controversial animal research involving, for example, nonhuman primates, is fostered, as it enables pinpointing the envisaged beneficiary down to the level of the addressed disease. Moreover, research areas with many planned projects involving animals can be specified in detail. The development of 3R (replacement, reduction, and refinement) measures in these research areas may be most efficient, as a large number of experimental animals would benefit from it. Indexing NTSs with ICD codes can support governments and funding agencies in advancing target-oriented funding of 3R research. Data drawn from NTSs can provide a basis for the development, validation, and implementation of directed 3R strategies as well as guidance for rethinking the role of animal research models.

A Belmont Report for Animals?

Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability.

Effect of milking stall dimensions on upper limb and shoulder muscle activity in milkers.

Increasing societal awareness for animal welfare can promote changes in legislation. Some of these changes may also affect the person that interacts with the animal in a shared workspace, such as in milking stalls. Swiss milking stalls were designed many years ago, when cows were smaller than they are today. A recent animal-based study indicated that welfare decreased in cows exposed to restricted space allowance in milking stalls, which had resulted from increasing body size without adjustment of milking stall dimensions. However, changing the milking stall dimensions without considering the milker may be detrimental. For many years, health issues, particularly of the upper limb and shoulders, have affected milking personnel. The current study investigated the effect of large and standard milking stall dimensions on muscle activity in milkers (as a measure of workload) during milking. This assessment is fundamental to ensure that legislation improving animal welfare does not jeopardize human health. The study took place in an experimental milking parlor that allowed for size adjustment of the individual milking stall. Nine milkers performed 2 shifts of milking in a herringbone and 2 shifts in a side-by-side milking parlor. The milking stall dimensions were large on one side and standard on the other side of the parlor; the 2 sides were switched between milking shifts. We used surface electromyography to monitor bilateral muscle activity of forearm (flexor carpi ulnaris), arm (biceps brachii), and shoulder (deltoideus anterior; upper trapezius) muscles. Statistical analysis was performed separately for the herringbone and the side-by-side parlor for each muscle using mean and maximum muscle activity as the target variables in a linear mixed-effects model. The analysis showed that the different milking stall dimensions did not consistently affect activity of the measured muscles. Our results suggest that milking stall dimensions are not a primary risk factor for poor ergonomics in parlor workers.

Ensuring due process in the IACUC and animal welfare setting: considerations in developing noncompliance policies and procedures for institutional animal care and use committees and institutional officials.

Every institution that is involved in research with animals is expected to have in place policies and procedures for the management of allegations of noncompliance with the Animal Welfare Act and the U.S. Public Health Service Policy on the Humane Care and Use of Laboratory Animals. We present here a model set of recommendations for institutional animal care and use committees and institutional officials to ensure appropriate consideration of allegations of noncompliance with federal Animal Welfare Act regulations that carry a significant risk or specific threat to animal welfare. This guidance has 3 overarching aims: 1) protecting the welfare of research animals; 2) according fair treatment and due process to an individual accused of noncompliance; and 3) ensuring compliance with federal regulations. Through this guidance, the present work seeks to advance the cause of scientific integrity, animal welfare, and the public trust while recognizing and supporting the critical importance of animal research for the betterment of the health of both humans and animals.-Hansen, B. C., Gografe, S., Pritt, S., Jen, K.-L. C., McWhirter, C. A., Barman, S. M., Comuzzie, A., Greene, M., McNulty, J. A., Michele, D. E., Moaddab, N., Nelson, R. J., Norris, K., Uray, K. D., Banks, R., Westlund, K. N., Yates, B. J., Silverman, J., Hansen, K. D., Redman, B. Ensuring due process in the IACUC and animal welfare setting: considerations in developing noncompliance policies and procedures for institutional animal care and use committees and institutional officials.

Animal maltreatment: Implications for behavioral science professionals.

Despite the widespread belief among the public and an increasing number of law enforcement personnel that individuals who harm animals often harm other people, the subject of animal maltreatment has received little attention from behavioral scientists. Advances in comparative neuroanatomy have highlighted the ability of animals to feel physical and emotional pain, including complex psychological reactions to traumatic events. These advances, and recent studies (however sparse) that support the notion that perpetrators of crimes against animals often commit other crimes, have arguably created an ethical and practical imperative for behavioral scientists to undertake a serious examination of animal maltreatment and potential mechanisms for responding to it. In addition, the close and complex relationships many Americans have with animals and the advancements in animal protection law in the past two decades necessitate expertise on the part of forensic psychologists and psychiatrists, who will increasingly be called upon to evaluate animal maltreatment offenders and consult on related policy and legislation.

Bestiality: An introduction for legal and mental health professionals.

Bestiality, or human-animal intercourse, has been a concern of the legal and mental health communities for many years. Ancient legal codes delineated punishments for those who engaged in the behavior, denoting a moral and general societal concern surrounding bestiality dating to ancient times. Despite this longstanding interest in and legal efforts to punish humans for having sex with animals, there has been little research on the behavior. Current available research has largely been siloed based on the populations studied, making it difficult to render any firm conclusions about bestiality's prevalence, frequency, and the risk posed by those who have sex with animals. It is important for clinicians to know the legal status of the behavior in their jurisdictions, to understand possible medical and psychiatric complications and comorbidities, and to know how to evaluate and treat individuals who engage in bestiality or have the related diagnosis of zoophilic disorder. This article provides an overview of the terminology and research pertaining to bestiality, summarizes legal and ethical considerations, and describes clinically relevant information for the evaluation and management of individuals engaged in sex with animals.

Assignment of culpability to animals as a form of abuse: Historical and cultural perspectives.

How the law regards animals reflects cultural trends that have varied widely from antiquity to the present. This article argues that cultural views of animals have shaped laws, attitudes, and practices worldwide. Whereas ancient (biblical and Mesopotamian) practices turned on economics, medieval concepts of animal culpability aligned with Christian beliefs of the primacy of humans. In medieval Europe, pets, farm animals, vermin, and insects could be held accountable for damage to persons and property. Considered entitled to due process, they were represented, tried, and punished - sometimes in public executions. Centuries of regarding animals as property subordinated to humans gave way to animal cruelty laws. It was not until the 19th century that respect for animal welfare, apart from economics, assumed legal significance. Presently, animals are not considered capable of criminal intent but can be "executed" for dangerousness. However, they may possess legal standing as civil complainants in animal rights cases. Contemporary trends include animal rights activism and courts conferring legal personhood to animals. The discussion concludes that there will be disparate approaches worldwide, based on prevailing views of animal sentience, spiritually based concepts and values, litigation arguing property and environmental law, and economics.

Animal hoarding: The challenge for mental health, law enforcement, and animal welfare professionals.

Animal hoarding has been considered a significant problem by animal welfare and law enforcement professionals for over a century. However, it has only been recognized as an indication of a mental disorder in the last decade. I review the different forms that animal hoarding can take and the current understanding of the prevalence, demographics and possible etiology of this disorder. Conventional animal cruelty laws have often been inadequate to respond to animal hoarding cases until they reach levels that may involve serious harm to animals and people. I document how prosecution of such cases can be difficult and often does not adequately consider the mental health issues underlying the problem or the high likelihood of recidivism. Attempts to solve these problems by enacting new laws specifically addressing animal hoarding have been controversial and ineffective. I explore new approaches that coordinate a variety of community resources in response to hoarding cases that offer the best opportunity to respond to both the human and animal problems associated with animal hoarding.

Where to draw the line? Should the age of protection for zebrafish be lowered?

Zebrafish are not protected by legislation in many countries until they reach the first feed stage, typically at five days post-fertilisation. If they exhibit similar responses to adults when responding to pain and other stimuli should they be given more protection?

Phase 0, including microdosing approaches: Applying the Three Rs and increasing the efficiency of human drug development.

Phase 0 approaches, including microdosing, involve the use of sub-therapeutic exposures to the tested drugs, thus enabling safer, more-relevant, quicker and cheaper first-in-human (FIH) testing. These approaches also have considerable potential to limit the use of animals in human drug development. Recent years have witnessed progress in applications, methodology, operations, and drug development culture. Advances in applications saw an expansion in therapeutic areas, developmental scenarios and scientific objectives, in, for example, protein drug development and paediatric drug development. In the operational area, the increased sensitivity of Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), expansion of the utility of Positron Emission Tomography (PET) imaging, and the introduction of Cavity Ring-Down Spectroscopy (CRDS), have led to the increased accessibility and utility of Phase 0 approaches, while reducing costs and exposure to radioactivity. PET has extended the application of microdosing, from its use as a predominant tool to record pharmacokinetics, to a method for recording target expression and target engagement, as well as cellular and tissue responses. Advances in methodology include adaptive Phase 0/Phase 1 designs, cassette and cocktail microdosing, and Intra-Target Microdosing (ITM), as well as novel modelling opportunities and simulations. Importantly, these methodologies increase the predictive power of extrapolation from microdose to therapeutic level exposures. However, possibly the most challenging domain in which progress has been made, is the culture of drug development. One of the main potential values of Phase 0 approaches is the opportunity to terminate development early, thus not only applying the principle of 'kill-early-kill-cheap' to enhance the efficiency of drug development, but also obviating the need for the full package of animal testing required for therapeutic level Phase 1 studies. Finally, we list developmental scenarios that utilised Phase 0 approaches in novel drug development.

Toward a harmonized approach to animal welfare law in Canada.

Animal protection law in Canada varies across the country. Federal animal protection law exists in the Criminal Code, in regulations for the transport of animals, and in regulations for humane handling and slaughter at abattoirs that are inspected by the Canadian Food Inspection Agency. Provincial animal protection laws often include provisions that i) describe a duty of care toward animals; ii) prohibit causing or permitting animal "distress;" iii) specify exemptions from prosecution; and iv) reference various national and other standards. Inconsistencies lead to duplication of effort, create difficulty in working across jurisdictions, and may erode public trust. A more consistent approach might be achieved by i) referencing a common suite of standards in provincial statutes; ii) citing the federal transport and humane slaughter regulations in provincial regulations; iii) establishing agreements so provincial authorities may enforce federal regulations; iv) wider and more uniform adoption of enforcement tools that require people to take immediate action to protect animal welfare; v) developing new standards; and vi) national consultation to define frequently used terms.

Vers une harmonisation législative du bien-être animal au Canada. La réglementation applicable en matière de protection animale est variable au Canada. Au niveau fédéral, on retrouve des règles de protection au sein du Code criminel, de la réglementation sur le transport et de celle sur la manipulation et l'abattage lorsque ce dernier a lieu dans les abattoirs inspectés par l'Agence Canadienne d'Inspection des Aliments. Les règles de protection animale applicables au niveau provincial prévoient généralement i) la définition d'un devoir de diligence envers les animaux, ii) l'interdiction de causer ou de permettre une 'détresse' chez l'animal, iii) des dispenses à l'exercice de poursuites, et iv) la description de standards, notamment nationaux. L'absence d'uniformisation des textes nuit à l'efficacité des efforts réalisés, complique la compréhension et l'application des textes existants et peut alimenter la méfiance du public. Une approche plus rationnelle pourrait être appliquée en, i) adoptant une liste commune de standards au sein des lois provinciales, ii) citant les normes fédérales régulant le transport et l'abatage des animaux dans les lois provinciales, iii) établissant des accords visant à faire appliquer les lois fédérales par les provinces, iv) élargissant et uniformisant l'adoption d'outils juridiques permettant de prendre des actions immédiates afin de protéger le bien-être des animaux, v) en développant de nouveaux standards et vi) à travers une consultation nationale visant à définir les termes fréquemment utilisés.(Traduit par les auteurs).