General Principles Regarding Ethical Evaluation of Projects Involving Laboratory Animals in Scientific Research


  • Serban Morosan University of Sorbonne, Paris
  • Cristin Coman ,,Cantacuzino” National Medico-Military Institute for Research and Development, Precilinical Testing Unit, Bucharest, Romania



laboratory animals, project authorization, ethical evaluation, harm/benefit analysis


A large part of global biomedical research is still relying on animal models. In Europe, the use of animals is strictly regulated. The 86/609/EU Directive was updated in 2010 (2010/63/EU Directive) in order to harmonize the regulatory frameworks across European Union and to protect the animal welfare better. This Directive started to be transposed into Romanian legislation in 2014 and all the welfare standards have been fully implemented in 2015. Authorization of the projects using animals in scientific purposes is now mandatory for all institutions working on animal models. The centerpiece of the authorization file is the ethical evaluation, which is performed by a commission established by the user institution. Assessment should be done according to some of ethical principles to ensure the awareness use of animals if otherwise not possible. These principles include the justification of project goals for the use of animals, harm/benefit analysis, staff competence, and details of animal welfare. Only evaluating projects using animals and respecting the principles of ethics we can provide a good science and respect for life.