- Construct a lay summary.
- In dialogue with ethics committees, consider whether statements about this type of research have already been produced.
- Address the 3Rs (Replacement, Reduction, Refinement) and the 3Ss (Good Science, Good Sense, Good Sensibilities).
- Consider pre-registration and the publication of negative results.
- Perform a Harm-Benefit Assessment and justify any likely animal harm.
- Discuss the learning objectives, if the animal use is for educational or training purposes.
- Allocate a severity classification to the project.
- Define objective, easily measurable and unequivocal humane endpoints.
- Discuss the justification, if any, for death as an end-point.
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, or wildlife research whose primary aim is population management.
- Have the Three Rs (Replacement, Reduction, Refinement) been addressed, and will any advances in this area be mentioned in publications of the study (remembering that many databases only index the title and abstract of papers)? Which non-animal alternatives have been considered but rejected?
- Have the Three S's (Good Science, Good Sense and Good Sensibilities) been addressed? Sufficient time should be allocated to this point, since two of the three S's are highly subjective, but equally important. The use of commonsense and critical anthropomorphism are justifiably part of the work to assess the impact of research on animals, not least when a scientific evidence base does not exist.
- 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?
Many more links to resources on ethics are available here.
Details about pre-registration of animal studies and reporting of critical incidents are to be found in the section on Experimental Design and Statistical Analysis.
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. Extensive guidance on how to manage severe suffering 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 Swiss Federal Food Safety and Veterinary Office have a useful resources page on severity assessment and harm-benefit analysis, including advice on weighing the interests and the dignity of the animal.
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 subject of humane endpoints is covered in a separate section of Norecopa's website.
Culture of Care
The discussions mentioned here will be far easier to conduct of there is a climate of cooperation and care at the research facility, in which all parties have the confidence to express their feelings about a project, without fear of reprisals. Fostering a culture of care is recognised in the EU Directive 2010/63 as a key element of good laboratory practice (Recital 31). More information about how to achieve and maintain a culture of care is available here.
- Pre-registration and Registered Reports: A Primer from UKRN
- Data sharing: A Primer from UKRN
- Open Code/Software: A Primer from UKRN
- Preprints: A Primer from UKRN
- Open Access: A Primer from UKRN
- Advice on ethical statements when reporting animal experiments
- Codes of practice and guidance on research integrity from the UK Research Integrity Office (UKRIO)
- Severity classification of procedures
- UK Home Office advisory notes on actual severity reporting of regulated procedures
- RSPCA resource page on animal sentience (including the proceedings of a conference in 2019)
- Advice on welfare assessment from the NC3Rs
- Advice on humane endpoints from the NC3Rs
- Avoiding mortality in animal research and testing
- 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
- How to assess welfare in genetically altered animals
- Advice on severity assessment of genetically altered animals
- Guidance on the severity classification of scientific procedures involving fish
- Harm-Benefit Analysis: opportunities for enhancing ethical review in animal research
- Five selfish reasons to work reproducibly
- Ethical oversight...? Time to reflect on the meaning of ethical review on research involving animals
- 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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