Each research project has its own set of ethical challenges, but the following general questions should be raised for all projects:
- Have national or local research ethics committees already produced statements relevant to the research being planned? Consideration should also be paid to the broader context of the research: for example, research directed at increasing the productivity of farming at the expense of (or without improving) individual animal welfare.
- Have the Three Rs (Replacement, Reduction, Refinement) been addressed, and will any advances in this area be mentioned in publications of the study? Which non-animal alternatives have been considered but rejected?
- Have the Three Ss (Good Science, Good Sense and Good Sensibilities) been addressed? Sufficient time should be allocated to this point, since two of the three Ss are highly subjective but equally important.
- Does the proposed study have a clear rationale and scientific relevance, and what will be the next step if the hypothesis is supported or rejected?
- Have the experiments been carried out before and is any repetition justifiable?
- What approaches to reduce distress have been considered?
- Will the project undergo pre-registration and will negative results be published, to avoid publication bias?
An evaluation of the likely sources and level of suffering of a planned procedure, followed by an assessment of the potential benefits of the research weighed against these harms, lies at the heart of legislation in the EU and elsewhere. Advice on how to conduct a harm-benefit analysis is available here. A framework for severity assessment and severity classification must be established and justified. The likely adverse effects of each procedure should be described, along with their likely incidence and methods of recognising them, with indications of how these effects can be mitigated by implementing refinement. This necessitates the involvement of personnel with the relevant expertise to recognise, assess and reduce animal suffering, especially severe suffering. Guidance on this is available on the RSPCA website. Specific justification of all unalleviated animal suffering must be provided. An estimate must be made of the maximum amount of pain, distress or lasting harm to which an individual can be exposed.
The prediction of potential benefit from animal studies is more difficult to carry out, particularly in basic research, but a belief in overall benefit is of course implicit in all decisions to perform such research. Regulatory systems often rely heavily on self-regulation and self assessment. Whereas approaches such as Value of Information analysis are used in clinical trials, there is a need to develop better operationalised strategies for assessing benefit when conducting harm-benefit analyses.
If the animal use is for educational or training purposes, the necessity and learning objectives of each procedure should be described. This should include whether the procedures are solely for demonstration or recording purposes, for the provision of animal tissue or for student participation. The groups who require this training should be specified. Provision should be made for feedback from participants to evaluate whether alternatives could have been used. Justification for rejection of alternative methods (including observation of on-going research) and for the severity level must be given. Guidelines are available from educators and from the EU Commission. Inventories such as the NORINA database contain comprehensive, curated information on alternatives and supplements to animal use in this area. Consultation with or development of institutional policies to support students wishing to express a conscientious objection to animal-based teaching methods should be encouraged.
Detailed guidance on how to conduct a harm-benefit assessment is available in a working group report from AALAS/FELASA and in a collection of documents available at the RSPCA website.
- Where can we find 3R literature? (Adrian Smith)
- Tools for better 3R-searches (Adrian Smith)
- Harm-Benefit Assessment: EU legislation and UK experience (Penny Hawkins)
- Harm-benefit Assessment: Working Group Report (Aurora Brønstad)
The determination of humane endpoints in an animal study is a core part of harm-benefit assessment. In addition, it is of vital importance in giving those responsible for the research animals adequate guidance in how to tackle critical situations which may occur outside normal working hours. Studies likely to cause pain, distress or harm to the animals may necessitate increased staffing levels to ensure adequate monitoring throughout the 24-hour period. If possible, studies should be designed so that the high-risk period occurs during normal working hours.
There is extensive advice available on how to construct humane endpoints. The criteria for measuring the animals’ status in relation to the endpoints should be as objective as possible, for example based on body weight, tumour volume or other physical parameters, to avoid ambiguity and individual differences in practice. Scientists should indicate whether pilot studies are needed to explore and define these endpoints. If death is to be an endpoint, scientists must explain why this is unavoidable and what measures can be taken to minimise suffering.
Dialogue with local animal welfare and ethics committees is likely to be an important part of this step.
Severity classification of procedures
UK Home Office advisory notes on actual severity reporting of regulated procedures
Writing non-technical summaries: a researcher's guide
UK Home Office advice on severity assessment of genetically altered animals
The use of Grimace Scales to measure pain and suffering in animals
Approaches to reducing distress in research animals (Penny Hawkins)
How the Animal Welfare Body can help with reproducibility (Penny Hawkins)
Guidelines on severity assessment and classification of genetically altered mouse and rat lines
Advice on severity assessment of genetically altered animals
Guidance on the severity classification of scientific procedures involving fish
Preclinicaltrials.eu (pre-registration of animal research)
Harm-Benefit Analysis: opportunities for enhancing ethical review in animal research
- Publication bias in animal research presented at the 2008 Society of Critical Care Medicine Conference
- Necessary but not Sufficient: the Benefit Concept in the Project Evaluation of Animal Research in the Context of EU Directive 2010/63/EU
- The bench is closer to the bedside than we think: uncovering the ethical ties between preclinical researchers in translational neuroscience and patients in clinical trials (M. Yarborough et al.)
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