Coordination Funds

协调基金

• 批准号: 441490213
• 负责人: Professor Dr. René H. Tolba
• 金额: --
• 依托单位: Institut für Versuchstierkunde sowie Zentrallaboratorium für Versuchstiere
• 依托单位国家: 德国
• 项目类别: Research Units
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/441490213?language=en
• 关键词: Coordination; Funds

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.

随着欧盟指令2010/63/EU的实施，3R原则和严格的严重性评估原则（优化的先决条件）已成为动物实验的法定指导原则。所有的科学程序都必须根据它们是否会对动物造成轻度、中度或重度的疼痛、痛苦、痛苦或持久伤害来分类。因此，需要循证的有效方法和实际指导。为了识别和开发这些方法，2017年4月启动了FOR 2591“动物研究中的严重程度评估”，涵盖了德国7个机构和瑞士1个机构的15个小组。第一个供资期的目的是评估参数和开发新的创新技术，以便在一套全面而简洁的动物模型中进行客观的严重程度评估。参数的评估集中在评估的客观性，可扩展性，适用性，程度的侵入性和灵敏度。超过65种方法的应用55个模型系统揭示了一套核心的适用参数。此外，多模态评估策略被证明是必不可少的，因为动物在实验过程中经历了不止一个维度的严重程度，包括疼痛，焦虑，痛苦，伤害和情感内部状态。利用测量变量进行严重性评估需要数据科学方法。这些便利了参数的挖掘、选择和非冗余组合，以及对严重程度的客观分级。在第二个资助期内，我们计划开发经验证的参数化综合评分系统，并利用这些系统比较模型、动物和方法，以及评估循证改进方法。理想情况下，这些系统应该独立于人类对数据采集、分析和评估的判断。因此，参数以及评分系统和它们的基本算法需要进行验证和评估有关的泛化和鲁棒性。将开发家庭笼监测系统，以实现对动物的常规、自动化和非接触式实时评估。最后，将在法定框架内明确实施循证严重性评估的规范性要求，因此，FOR 2591将继续遵循作为一个具有强大协同作用的多学科团队的理念。生物医学研究将与工程、药代动力学和伦理/法律的专业知识相结合。通过开展多边和多中心研究以及数据科学的普遍参与和规范方法，将提高研究质量和有效性。这一切都将导致明确的建议，为未来的政策提供支持，并增加动物福利。