Harm-Benefit Analysis: opportunities for enhancing ethical review in animal research

To the Editor — The UK’s Animals in Science Committee (ASC) recently completed its review of the processes of harm–benefit analysis (HBA) carried out under the UK Animals (Scientific Procedures) Act 1986 (ASPA) (see Supplementary material). The ASC report focuses on the UK, where ASPA requires the HBA of a programme of work to assess whether the harm that would be caused to protected animals, in terms of suffering, pain, distress, and lasting harm, can be justified by the expected outcome, taking into account ethical considerations and the expected benefit to human beings, animals, or the environment. ASPA additionally demands consideration of “important animal welfare or ethical concerns, novel or contentious issues, or societal concerns”1. Given these complex requirements, processes of HBA need regular review to operate in a way that is responsive to scientific and societal developments. The 2017 ASC report concludes that HBA remains a legitimate ethical framework for evaluating the use of animals in research and makes 27 recommendations for improving the HBA (Supplementary material). This report thus contributes to evolving processes for the development of HBA2,3 and international advice on the implementation of HBA in Europe under the Directive 2010/63/EU4, the Office International des Epizooties (OIE) Terrestrial Animal Health Code5, and the Council for International Organizations of Medical Sciences and the International Council for Laboratory Animal Science6. Some ASC report recommendations are targeted to the regulation of animal research in the UK, but the principles underpinning this report have relevance for other processes of HBA. The long history and recent growth of HBA processes demonstrate that this ethical framework is both durable and flexible. However, as the ASC report outlines, HBA represents an ethical dilemma that cannot be fully resolved. Furthermore, the report suggests that the processes of HBA are not only important when making a prospective evaluation of the likely harms and potential benefits; they should also be applied to reduce harms and maximise benefits throughout the life of a project and to inform retrospective review. This report thus builds on the shift from understanding HBA as a one-off assessment to an openended and iterative process, which requires ongoing communication to help deliver robust and effective ethical review.