HARMS AND BENEFITS IN LAW
“Where severe suffering is unavoidable, there should be an exceptionally high level of benefit and likelihood of achievement.” UK Animals in Science Committee
Possible reasons for translational failure include poor pre-clinical experimental design, inappropriate animal ‘models’, inherent species differences and heterogeneity of patients in clinical trials. Whatever the reason, the justification for severe suffering is compromised if translation is poor. Similarly, if any model generates a long series of published papers, but these do not lead to new therapies in the clinic, at some point it will no longer be ethical to continue that line of research.
Some questions that AWERBs or equivalent committees may like to ask:
- Why is severe suffering needed?
- What is being done to reduce/avoid this?
- Are the benefits sufficiently high to justify the suffering?
- Can you demonstrate that the model is translatable?
- Could the protocol be run with a moderate severity limit?
- What if we said ‘no’’?
Many other questions relate directly to benefit and have a bearing on the justification for severe procedures. For instance, could a particular clinical issue be resolved more rapidly and effectively via human behaviour change protocols, ‘social prescribing’, or policy changes, than with a new medicine? Is there a good level of dialogue with relevant clinicians, to ensure that the proposed benefits are realistic and actually wanted and needed in the field? For ‘basic’ research in which suffering may be severe, how much weighting should be given to human knowledge and interest, without an immediate applied medical benefit?
ADDRESSING DIFFERENT PERSPECTIVES
There is wide agreement on the need to reduce severe suffering using the 3Rs. However, there may be differing perspectives on the more challenging questions around benefit and ‘need’ as set out above, and about the ethics of going ahead with the research, and it is important to accept and address these. (See ‘Doing ethics’, appendix 2 of the RSPCA Lay Members’ Resource Book).
In the UK, an ideal forum for discussing such issues is the local, institutional Animal Welfare and Ethical Review Body (AWERB). One of its functions is the provision of a forum for discussion and development of ethical advice, which is an ideal place to discuss how severe models and procedures will be reviewed and refined within an establishment and decisions made. Outside the UK, the AWB, IACUC, AEC and other ethics committees can convene these kinds of discussions.
Opening the issue up to wider consultation enables additional in-house expertise and viewpoints to be included. When all perspectives are taken into account, it might be decided to define the types of benefit and purpose for which severe protocols may, or may not, be permitted within the institution, or to mandate that all potentially severe procedures are managed to not exceed ‘moderate’ via the use of humane endpoints.
Other issues that could be considered as part of an ongoing ethical discussion are: whether it is more, or less, ethically acceptable to use animals of certain species in severe protocols, and why; and how people within the institution actually interpret the concept of ‘severe’; for example, views about ‘harms that ought not to be done’ and ‘naturalness’ may be important to staff. Holding these discussions outside of project application review can allow views to be more freely expressed and ensure that the establishment’s individual culture is defined and understood.
More information about ethical review can be found on the RSPCA website.
AVOIDING AND REDUCING SEVERE SUFFERING
Avoiding and reducing severe suffering helps to fulfil legal requirements, reduce ethical concerns and improve scientific quality - this website will help you to achieve this.
Practical ways to reduce or avoid severe suffering include: