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 presentations from this workshop are available here.

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


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


Other resources

ANIMPACT: An EU project investigating the impact of European legislation on the scientific use of animals (animal welfare and research competitiveness)
Humane endpoints (NC3Rs website)
Humane endpoints in laboratory animal experimentation

Humane endpoints and the importance of training

Humane endpoints in animal experimentation for biomedical research: ethical, legal and practical aspects
OECD Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation.

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