Harm-benefit analysis of animal studies - AALAS-FELASA WG

The ethical evaluation of research projects that involve the use of animals is imperative in the United Stated and in Europe. As part of the ethical evaluation, both the 8th edition of the Guide for the Care and Use of Laboratory Animals and the European Directive 2010/63/EU require that the objectives and benefits of the studies against potential harm inflicted to animals be weighed, i.e. a “harm-benefit analysis”. The harm-benefit analysis is the cornerstone of ethical evaluation, as it will determine if the use of animals is justified. This analysis may already be occurring at some level through a variety of approaches used by IACUCs and local or government ethics committees. However, the concept and practical implementation of the harm-benefit analysis is still nebulous for many of the project applicants and committee members – and to the public who want accountability for this component of protocol/project review. Therefore, refinement of the harm-benefit analysis is indicated. The additional benefit of refining the harm-benefit analysis would be to provide a buttress to the justification of animal use for investigators. A guideline on the practical implementation of the harm-benefit analysis would help researchers and committee members, and provide information that would help to improve the public’s understanding of the reasons for the use of animals in biomedical research. The overarching ethical principles that need to be considered when engaging in animal research are driven by the same doctrines of replacement, reduction, and refinement in both the United Stated and Europe. A jointly produced document would therefore be applicable in both geographical areas, as well as serve as an important guideline which members of the scientific community could access when working towards harmonization of ethical review processes.