The harm-benefit analysis involves considering the potential benefits of a research project against the likely harms to animals. This is the basis of ethical frameworks underpinning regulations on animal experiments in the UK, European Union and elsewhere, whether done by the competent authority or by an ethics or animal care and use committee. It is also part of the decision making process by the individual researcher and other bodies listed on our ethical review page.
Assessments of harms and benefits are matters of judgement, which are contestable and change over time according to societal attitudes. Attitudes, in turn, can be affected by concerns about particular research directions. For example, there may be concerns about artificial intelligence; the 'diseasification' of what to many people are natural processes (such as the visual effects of ageing) and the associated search for 'cures'; or developments in technology such as using CRISPR-Cas9 to edit animal's genomes in rapid and unprecedented ways. Increased understanding of the nature of animals and their ability to suffer also influence societal attitudes.
Opinion can also differ on what is a harm or a legitimate benefit, and on the relative weighting that should be accorded to different kinds of harms and benefits. Harms to animals are often underplayed, and benefits exaggerated, so it is important to obtain accurate information on both and to challenge rhetoric.
All potential sources of harms throughout the lifetime experience of the animals should be considered, not just the effects of procedures. This includes any discomfort, pain or distress associated with housing, husbandry, transport, restraint and humane killing. Considering what will happen to the animals, and identifying all sources of potential harm, helps to adequately inform the harm-benefit analysis and ethical decision-making, as well as implementing the 'R' of refinement.
Predicting benefit is more difficult, particularly if there is no immediate application of the results and the research is just one step in a long-term approach to a disease problem. For those outside the immediate scientific field, it may not be easy to understand the scientific detail and judge the necessity - and quality - of research projects. For a broader discussion of 'benefits', see the RSPCA Lay Members' Resource Book (PDF 6,742KB).
Several schemes and systems to aid decision making have been developed. Ultimately, how harms and benefits are considered against one another depends on the perspectives, priorities, interests and approaches of the individuals involved in the process. Involving participants from a variety of perspectives, including those who have no vested interest in the outcome of the review, helps to ensure the integrity of the harm-benefit analysis.
Useful references on the harm-benefit analysis include:
- Animals in Science Committee review of harm-benefit analysis
- UK Home Office Guidance on harm/benefit analysis
- UK Animal Procedures Committee review of 'cost'-benefit assessment in the use of animals in research
- Guiding principles on good practice for Animal Welfare and Ethical Review Bodies - RSPCA/LASA (2015) (PDF 1.76MB)
- A resource book for lay members of ethical review and similar bodies worldwide - third edition (2015) (PDF 6,742KB)
- Current concepts of Harm-Benefit Analysis of Animal Experiments - Report from the AALAS-FELASA Working Group on Harm-Benefit Analysis - Part 1
- Recommendations for Addressing Harm-Benefit Analysis and Implementation in Ethical Evaluation - Report from the AALAS-FELASA Working Group on Harm-Benefit Analysis - Part 2