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Animal research in the UK: Regulation, implementation, welfare and development of new approach methodologies.

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Abstract
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Use of animals in biomedical research is still considered essential by many in academia, industry and regulatory authorities. Therefore, it is important that legal, governance and welfare procedures are in place to ensure that only necessary procedures using animals are carried out and that this occurs within a framework with animal welfare at its core. Animal research in the United Kingdom is conducted under the Animals (Scientific Procedures) Act 1986 and animal research in the United Kingdom has long been seen as a flag bearer for high quality-high welfare research. An example of the leading role taken in supporting animal welfare in research was establishment of the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) to support reducing the scale and impact of animal research. Here, we provide an overview of governance and licensing procedures of animal research in the United Kingdom, coupled with explanations of how excellent welfare underpins high quality research, and examine the development of new approach methodologies.

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Video analysis is a popular and frequently used tool in animal behavior and welfare research. In addition to the actual object of research, video recordings often provide unforeseen information about the progress of the study, the animals or the people involved. Conflicts can arise when this information is weighed against the original intention of the recordings and broader social expectations. Uncertainty may prevent the video observers, often less experienced researchers, to properly address these conflicts, which can pose a threat to animal welfare and research quality and integrity. In this article, we aim to raise awareness of the interrelationship of variables characteristic for video-based animal studies and the potential conflicts emerging from this. We propose stepping stones for a framework which enables a culture of openness in dealing with unexpected and unintended events observed during video analysis. As a basis, a frame of reference regarding privacy and duty of care toward animals should be created and shared with all persons involved. At this stage, expectations and responsibilities need to be made explicit. During running and reporting of the study, the risk of animal welfare and research integrity issues can be mitigated by making conflicts discussible and offering realistic opportunities on how to deal with them. A practice which is outlined and guided by conversation will prevent a mere compliance-based approach centered on checklists and decision trees. Based on these stepping stones, educational material can be produced to foster reflection, co-creation and application of ethical practice.

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  • Supplementary Content
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Judgment bias tasks (JBTs) are considered as a family of promising tools in the assessment of emotional states of animals. JBTs provide a cognitive measure of optimism and/or pessimism by recording behavioral responses to ambiguous stimuli. For instance, a negative emotional state is expected to produce a negative or pessimistic judgment of an ambiguous stimulus, whereas a positive emotional state produces a positive or optimistic judgment of the same ambiguous stimulus. Measuring an animal’s emotional state or mood is relevant in both animal welfare research and biomedical research. This is reflected in the increasing use of JBTs in both research areas. We discuss the different implementations of JBTs with animals, with a focus on their potential as an accurate measure of emotional state. JBTs have been successfully applied to a very broad range of species, using many different types of testing equipment and experimental protocols. However, further validation of this test is deemed necessary. For example, the often extensive training period required for successful judgment bias testing remains a possible factor confounding results. Also, the issue of ambiguous stimuli losing their ambiguity with repeated testing requires additional attention. Possible improvements are suggested to further develop the JBTs in both animal welfare and biomedical research.

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The costs of animal research: origins and options.
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Animal-based research comprises almost half of the portfolio of the National Institutes of Health (NIH). It is vital to the biomedical community but is encountering unprecedented challenges to its continued success. These challenges are related to technological advances in science and to specific aspects of the regulatory climate and costs of animal research. These are not abstract issues for the individual scientist. The costs for animal research may determine in which institution a scientist pursues his/her research and with whom he/she can, or cannot, collaborate. The National Allergy and Infectious Disease Advisory Council outlined many of these challenges in a resolution forwarded to NIH Director Varmus in February 1996. As scientists who deal with this issue daily, we highlight the origins and the potential solutions.

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