Differences in the EU regulations for biomedical research on humans and animals: an ethical analysis.

The European Union regulations for research on human and nonhuman participants differ significantly. This study aims to present a thorough analysis of these differences in the field of biomedical research. The study consists of a review of regulations issued by the European Union and Council of Europe institutions, supported by two UNESCO documents. The regulations are compared between three types of research: on humans, on nonhuman animals, and research using human embryos, within five categories: (1) Justification and scope of the regulations; (2) Inclusion criteria; (3) Consent procedures; (4) Participants' welfare; and (5) Values in research. In each category, significant differences between regulations for humans and animals are presented. These differences can be ethically analyzed in terms of values pursued in the protection of participants (intrinsic value of humans vs. value of animal welfare) and hierarchies of values in regulations (priority of participant-centered values in research on humans vs. priority of research-centered values in research on animals). Since the current protection of animals in biomedical research based on the '3Rs' principles seems not adequate, two possible ways forward are analyzed: replacement of all animals in research with other methods and a shift to research on companion animals.