Coordination Funds

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With implementation of the EU Directive 2010/63/EU, the 3R principle and the principle of stringent severity assessment - the prerequisite for refinement - have become statutory guidelines in animal experimentation. All scientific procedures have to be categorized as to whether they induce a mild, moderate or severe condition of pain, distress, suffering or lasting harm on the animals. Accordingly, evidence-based validated methods and practical guidance were needed. In order to identify and develop those methods, FOR 2591 “Severity Assessment in Animal-Based Research” was launched in April 2017 encompassing 15 groups within 7 Institutions in Germany and 1 in Switzerland. The aim of the first funding period was the evaluation of parameters and the development of new, innovative techniques allowing for an objective severity assessment in a comprehensive yet concise set of animal models. The evaluation of parameters focused on assessing the objectivity, scalability, applicability, degree of invasiveness and sensitivity.Application of more than 65 methods on 55 model systems revealed a core set of applicable parameters. In addition, multimodal assessment strategies turned out to be essential as animals experience more than a single dimension of severity during experiments including pain, anxiety, suffering, harm and the affective internal state. Utilizing the measured variables for severity assessment required Data Science approaches. These facilitated mining, selection and non-redundant combination of parameters, as well as objective grading of severity. Besides, the ground has been laid for automation systems enabling an observer-independent, non-invasive and broadly applicable severity assessment.During the 2nd funding period, it is planned to develop validated parameter-based composite scoring systems and to utilize them for comparing models, animals and methods and evaluating evidence-based refinement methods. Ideally, these systems should be independent of human judgement concerning acquisition, analysis and evaluation of data. Consequently, parameters as well as scoring systems and their underlying algorithms need to be validated and evaluated concerning generalisation and robustness. Home-cage monitoring systems will be developed to enable routine, automated and contactless assessment of the animals in real-time. Finally, normative requirements for the implementation of evidence-based severity assessment in the statutory framework will be defined.Therefore, FOR2591 will continue to follow the concept of being a multidisciplinary team with strong synergy. Biomedical research will be joined with engineering, pharmacokinetics and ethical/legal expertise. Research quality and validity will be advanced by the conduction of multilateral and multicentre studies and by general involvement of data science as well as normative methods. This all will lead to clear recommendations, feed into future policy, and increase animal welfare.