Harm-Benefit Assessment

Article 36 of the EU Directive 2010/63 requires Member States to ensure that no project is carried out unless a favourable project evaluation has been received by the competent authority. The details of how to conduct a project evaluation are given in Article 38.
Part of this is a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and may ultimately benefit human beings, animals or the environment.

Guidance for performing a project evaluation, including harm-benefit assessment and retrospective assessment of projects is available on the EU Commission website.

Norecopa, in collaboration with the University of Bergen, arranged a workshop on harm-benefit assessment at Voss in May 2015.

The report of a joint AALAS-FELASA Working Group on Harm-Benefit Analysis, led by Aurora Brønstad, was published in Laboratory Animals in June 2016 (vol. 50, no. 1 suppl) in two parts:

• Current concepts of Harm–Benefit Analysis of Animal Experiments – Report from the AALAS–FELASA Working Group on Harm–Benefit Analysis – Part 1 by Aurora Brønstad, Christian E Newcomer, Thierry Decelle, Jeffrey I Everitt, Javier Guillen, and Kathy Laber.

• Recommendations for Addressing Harm–Benefit Analysis and Implementation in Ethical Evaluation – Report from the AALAS–FELASA Working Group on Harm–Benefit Analysis – Part 2 by Kathy Laber, Christian E Newcomer, Thierry Decelle, Jeffrey I Everitt, Javier Guillen, and Aurora Brønstad.

A presentation summarising the proposals of the Working Group can be downloaded here.

A FELASA/ECLAM/ESLAV report entitled Classification and reporting of severity experienced by animals used in scientific procedures delivers guidance on the assignment of severity, both prospectively and at the end of a procedure. More links to severity assessment, including classification in fish, are available here on Norecopa's website.

See also the PREPARE guidelines for planning animal experiments, and in particular the section on ethical issues and Harm-Benefit Assessment. See also the sections on humane endpoints and humane killing.

Other resources

• Home Office UK advice (2015): The Harm-Benefit Analysis Process - New Project Licence Applications
• ANIMPACT: An EU project investigating the impact of European legislation on the scientific use of animals (animal welfare and research competitiveness)
• Eggel & Grimm (2018): Necessary but not sufficient. The benefit concept in the project evaluation of animal research in the context of Directive 2010/63/EU