Morton David B
School Bioscience, University of Birmingham, Birmingham B15 2TT, UK.
Animals (Basel). 2023 Feb 22;13(5):800. doi: 10.3390/ani13050800.
This paper presents and illustrates, with a working example, a hypothesis for the assessment of ongoing severity before and during an experiment that will enable humane endpoints and intervention points to be applied accurately and reproducibly, as well as helping to implement any national legal severity limits in subacute and chronic animal experiments, e.g., as specified by the competent authority. The underlying assumption of the model framework is that the degree of deviation from normality of specified measurable biological criteria will reflect the level of pain, suffering, distress and lasting harm incurred by or during an experiment. The choice of criteria will normally reflect the impact on an animal and have to be chosen by scientists and those caring for the animals. They will usually include measurements of good health such as temperature, body weight, body condition and behaviour, which vary according to the species, husbandry and experimental protocols and, in some species, unusual parameters such as time of the year (e.g., migrating birds). In animal research legislation, endpoints or severity limits may be specified so that individual animals do not suffer unnecessarily or endure severe pain and distress that is long-lasting (Directive 2010/63/EU, Art.15.2). In addition, the overall severity is estimated and classified as part of the harm: benefit licence assessment. I present a mathematical model to analyse the measurement data to determine the degree of harm (or severity) incurred. The results can be used to initiate alleviative treatment if required or if permitted during the course of an experiment. In addition, any animal determined to have breached the severity classification of a procedure can be humanely killed, treated or withdrawn from the experiment. The system incorporates the flexibility to be used in most animal research work by being tailored to the research, the procedures carried out and the species under investigation. The criteria used to score severity can also be used as additional scientific outcome criteria and for an analysis of the scientific integrity of the project.
本文通过一个实际示例展示并阐释了一个关于在实验前和实验过程中评估持续严重程度的假设。该假设能够准确且可重复地应用人道终点和干预点，同时有助于在亚急性和慢性动物实验中落实任何国家法定的严重程度限制，例如由主管当局规定的限制。模型框架的基本假设是，特定可测量生物学标准偏离正常状态的程度将反映实验期间或实验所导致的疼痛、痛苦、苦恼和持久伤害的程度。标准的选择通常会反映对动物的影响，并且必须由科学家和照顾动物的人员来选择。这些标准通常会包括对健康状况的测量，如体温、体重、身体状况和行为，这些会因物种、饲养管理和实验方案的不同而有所差异，并且在某些物种中，还会包括一些不寻常的参数，如一年中的时间（例如候鸟）。在动物研究立法中，可能会规定终点或严重程度限制，以确保个体动物不会遭受不必要的痛苦，或忍受长期的剧痛和苦恼（指令2010/63/EU，第15.2条）。此外，在危害：益处许可评估中，会对总体严重程度进行估计和分类。我提出了一个数学模型来分析测量数据，以确定所造成的伤害（或严重程度）程度。如果在实验过程中需要或允许，结果可用于启动缓解治疗。此外，任何被判定违反程序严重程度分类的动物都可以被人道处死、治疗或从实验中撤出。该系统具有灵活性，通过根据研究、所执行的程序和所研究的物种进行调整，可用于大多数动物研究工作。用于评估严重程度的标准也可用作额外的科学结果标准，并用于分析项目的科学完整性。
