Ethics and Controversies in Animal Subjects Research and Impact on Clinical Decision-Making.

The harm inflicted on animals in biomedical research is justified, by those who accept it, by weighing it against proposed benefits for humans, but these are underappreciated and overstated, respectively. Clinical translation is poor due to interspecies and intraspecies differences, hindering the understanding of diseases and the development of safe and effective new human drugs. An urgent shift away from animal use toward human-focused new approach methodologies would enable human diversity to be factored more effectively into clinical practice. From an ethical perspective, more needs to be done to facilitate and encourage biomedical research to have a human focus throughout.