The use of animals to model humans in biomedical research relies on the notion that basic processes are sufficiently similar across species to allow extrapolation. Animal model validity is discussed in terms of the similarity between the model and the human condition it is intended to model, but no formal validation of models is applied. There is a stark contrast here with the use of non-animal alternatives in toxicology and safety studies, for which an extensive validation is required. We discuss both the potential and the limitations of validating preclinical animal models for proof-of-concept studies, by using an approach similar to that applied to alternative non-animal methods in toxicology and safety testing. A major challenge in devising a validation system for animal models is the lack of a clear gold standard with which to compare results. While a complete adoption of the validation approach for alternative methods is probably inappropriate for research animal models, key features, such as making data available for external validation and defining a strategy to run experiments in a way that permits meaningful retrospective analysis, remain highly relevant.

In many countries the approval of animal research projects depends on the decisions of Animal Ethics Committees (AEC’s), which review the projects. An animal ethics review is performed as part of the authorization process and therefore performed routinely, but comprehensive information about how well the review system works is not available. This paper reviews studies that assess the performance of animal ethics committees by using Donabedian’s structure-process-outcome model. The paper points out that it is well recognised that AECs differ in structure, in their decision-making methods, in the time they take to review proposals and that they also make inconsistent decisions. On the other hand, we know little about the quality of outcomes, and to what extent decisions have been incorporated into daily scientific activity, and we know almost nothing about how well AECs work from the animal protection point of view. In order to emphasise this viewpoint in the assessment of AECs, the paper provides an example of measures for outcome assessment. The animal suffering is considered as a potential measure for outcome assessment of the ethics review. Although this approach has limitations, outcome assessment would significantly increase our understanding of the performance of AECs.

The use of animals for research remains a highly controversial issue that receives much public attention and comment. This was illustrated, for example, by the participation in the European Commission's internet consultation on the revision of Directive 86/609/EEC, which regulates their use in this way. Moreover, scientists using animals in their work still face fierce, sometimes violent opposition that includes death threats or the vandalism of research facilities by anti‐vivisectionist and animal rights groups who want to see all use of animals in research completely banned. Given the polarizing nature of the issue, it is not always easy for the public and lawmakers to effectively weigh the benefits of biomedical research against the deaths of the animals used. > …it is not always easy for the public and lawmakers to effectively weigh the benefits of biomedical research against the deaths of the animals used To address public resistance to animal experiments, governments and scientific entities have called for increased transparency and an informed dialogue between regulators, scientists and the concerned public. As a part of this endeavour, several European countries, notably Denmark and the UK, have begun to post summaries of approved animal experiments on the websites of responsible authorities. The rationale is that more transparency will increase public confidence in the appropriate conduct and regulation of animal research and therefore help to maintain public acceptance. However, this approach towards greater transparency leaves out one crucial piece of information, which is of both ethical and scientific relevance: the link between approved experiments and the results thus generated. The scientific community also misses an important opportunity to bring together information from prospective ethics reviews—which contain detailed information about animal procedures and ‘3R’ considerations (replacement, refinement and reduction), but little scientific information—with retrospective peer‐reviewed results that provide extensive scientific information but say very …

Although animal experiments play an important role in biomedical research, their use is ethically challenging. Primarily in Europe, North America and Australasia ethics committees are set up to...