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Rationale: The ethical debate concerning the use of animals in biomedical and pharmacological research continues to be replete with misunderstandings about whether animals have moral standing. Objectives: This article briefly reviews the central ethical positions and their relationship to the basic parameters of research regulation from an international perspective. The issues associated with the validation of animal models will then be discussed. Finally, suggestions for empirical ethics research will be presented. Methods: Recent literature reviews were accessed and analyzed. Results: This review summarizes the pertinent ethical and research literature. Conclusions: In summary, regardless of the ethical perspective one favors, there is strong agreement that animals matter morally and that at a minimum their welfare must be considered. This position is reflected in the structure of national regulatory schemes that emphasize the three Rs (replacement, reduction, refinement). Researchers should more actively participate in the discussion by becoming more knowledgeable about the details of the ethical issues. Research with animal models has been problematic in that it has often focused on attempting to produce global models of psychiatric disorders, which suffer from inherent validity problems. Researchers must also become more sophisticated about issues of model validation and the nature of the animals they use.


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