Using animals for research raises ethical concerns that are addressed in project evaluation by weighing expected harm to animals against expected benefit to society. A harm–benefit analysis (HBA) relies on two preconditions: (a) the study protocol is scientifically suitable and (b) the use of (sentient) animals and harm imposed on them are necessary for achieving the study’s aims. The 3Rs (Replace, Reduce and Refine) provide a guiding principle for evaluating whether the use of animals, their number and the harm imposed on them are necessary. A similar guiding principle for evaluating whether a study protocol is scientifically suitable has recently been proposed: the 3Vs principle referring to the three main aspects of scientific validity in animal research (construct, internal and external validity). Here, we analyse the internal consistency and compatibility of these two principles, address conflicts within and between the 3Rs and 3Vs principles and discuss their implications for project evaluation. We show that a few conflicts and trade-offs exist, but that these can be resolved either by appropriate study designs or by ethical deliberation in the HBA. In combination, the 3Vs, 3Rs and the HBA thus offer a coherent framework for a logically structured evaluation procedure to decide about the legitimacy of animal research projects.

使用动物进行研究会引起伦理问题，在项目评估中通过权衡对动物的预期伤害与对社会的预期利益来解决这些问题。危害效益分析 (HBA) 依赖于两个先决条件：(a) 研究方案在科学上是合适的；(b) 使用（有知觉的）动物以及对它们施加的伤害对于实现研究目的是必要的。3R（替换、减少和细化）为评估是否有必要使用动物、动物数量以及对动物造成的伤害提供了指导原则。最近提出了评估研究方案是否科学适用的类似指导原则：3V 原则，指动物研究中科学有效性的三个主要方面（结构有效性、内部有效性和外部有效性）。在这里，我们分析这两个原则的内部一致性和兼容性，解决 3R 和 3V 原则内部和之间的冲突，并讨论它们对项目评估的影响。我们表明存在一些冲突和权衡，但这些可以通过适当的研究设计或 HBA 中的道德审议来解决。因此，3V、3R 和 HBA 相结合，为逻辑结构的评估程序提供了一个连贯的框架，以决定动物研究项目的合法性。