Research Ethics Committees (RECs) exist within the UK “to apply a common set of principles and standards of ethical review for research” and Animal Welfare and Ethical Review Bodies (AWERBs) exist to perform a similar function with respect to licensed research involving animal use. (For more information regarding the role and work of AWERBs refer to these Guiding principles on good practice for Animal Welfare and Ethical Review Bodies). So why on earth do REC members need to know anything about research involving animal use?
- Well, the first thing to know is that not all research involving animal use conducted here in the UK falls within the scope of the Animals in Scientific Procedures Act 1986 Amendment Legislation 2012 (commonly referred to as ASPA). This is the UK legislation that regulates the use of animals for scientific purposes. For example, a lot of research involves the use of embryonic or fetal forms of mammals, birds and reptiles. These animals are not protected until they have reached the last third of their gestation or incubation period so research that involves killing them before they reach this developmental threshold does not require a license. Similarly, researchers do not require a license to use biological materials (tissues, organs, cells, blood etc) if it is collected from animals’ post-mortem. (For more information on what ASPA does and doesn’t cover please refer to the legislative guidance). This is important for two reasons: A) because AWERBS are only required to ethically review applications for the licensed use of animals in scientific procedures so it is worth checking if your AWERB also reviews non-ASPA animal use; B) because RECs at establishments where there is no licensed animal research undertaken may not be aware that staff or students are conducting research involving the non-licensed use of animals, or animal derived biological material.
- The second thing to know is that good practice guidance issued by the BBSRC, DEFRA, EPSRC, MRC, NC3Rs, NERC, Royal Society, Wellcome Trust and other AMRC charities regarding Responsibility in the use of animals in bioscience research: Expectations of the major research council and charitable funding bodies states that “we are committed to introducing and implementing standards which reflect contemporary good practice, including when these exceed the minimum requirements of legislation and codes of practice, for all research using animals not just that regulated under ASPA” (see page 4 of the guidance). Furthermore “Implementation of the principles in this guidance is a condition of receiving funds from the funding bodies” (see page 4 of the guidance). This is important to know because the scientific, ethical and welfare concerns that have underpinned the development of good practice guidelines and standards apply to ALL research involving the use of live animals, animal derived biological material and animal-derived data.
- The third thing to know is that according to the research funders guidance “the research establishment’s ethics committee, whether the AWERB established under the ASPA or otherwise, should be central to ensuring implementation of this guidance” (see page 10 of the guidance), and “the funding bodies only support work involving the use of animals on the basis that researchers and those administering the funding comply with legal provisions, plus any related codes of conduct or guidance” (see page 6 of the guidance). This is important because good practice in the responsible use of animals in research is not routinely discussed by most RECs, (except perhaps in relation to the reproducibility and translational value of pre-clinical animal studies). Thus RECs may be unaware of their responsibilities to support the fulfilment of the expectations set out in this guidance for all relevant research grants managed by their research establishment.
So, to finish up here is a couple of points for REC members to think about and discuss because when it comes the ethical review of animal use that falls outside the scope of ASPA there is no ‘standard/one size fits all’ approach…
- Whose responsibility is it at your establishment to ethically review research involving the use of animals, animal-derived biological material, or animal derived data that falls outside the scope of ASPA?
- Is your REC, or local AWERB (if there is one) aware if there are staff or students registered with, or whose grants are administered by your research establishment who are conducting animal research that is outside the scope of ASPA?
- How can you find out if the points raised in this blog are relevant to your REC?
- For more information on the issues to consider to facilitate a robust approach to good practice in the context of research involving animals please read the UKRIO Research Integrity: A Primer on Research Involving Animals. This document has been written for research ethics committees, research staff, and research support or integrity/governance post-holders. In it you will find links to useful tools and resources, as well as example policies and forms.
- On the UKRIO website you will also find this guest blog about the ethical review of research involving animals with links to other relevant information.
- Examples of how some establishments ethically review non-ASPA animal use:
Where an establishment has an AWERB some review non-ASPA animal use or have a sub-committee specifically to fulfil this function. Examples of establishments taking this approach include: University of Bath, the University of Southampton, the Open University, Newcastle University, the University of Surrey and Queens University Belfast.
Some establishments state that non-ASPA animal use is ethically reviewed by either the AWERB or the REC. This is for example the approach taken by the University of Plymouth and the University of Exeter.
Other establishments (some with and some without an AWERB) state that non-ASPA animal use is reviewed by the REC(s). Examples of establishments taking this approach include: University of St Andrews and City University of London.
Written by Dr Nikki Osborne, Responsible Research in Practice, with thanks to Dr Jo Woodhams for her helpful comments and feedback.
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