Animal research governance and ethics
Governance
Animal research legislation
UK animal research is governed by the Animals (Scientific Procedures) Act 1986 Amended Regulations 2012 (A(SP)A) and regulated by the Home Office (a branch of the UK government).
Under A(SP)A animal research must:
- be carried out at a licensed establishment
- be part of a licensed project
- be conducted by an investigator with their own personal licence, and who is competent in the procedures on live animals.
- be governed by an ethics committee, under A(SP)A called the Animal Welfare and Ethical Review Body (AWERB).
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be done under scrutiny and with help from Named Persons which are lawfully responsible under A(SP)A to fulfil specific duties.
Home Office inspectors audit facilities regularly to ensure full compliance with A(SP)A and good practice.
The Crick is a signatory of the Concordat on Openness on Animal Research, which sets out how organisations report the use of animals in scientific, medical and veterinary research in the UK.
Ethical review
A(SP)A requires that each establishment has an Animal Welfare and Ethical Review Body (AWERB) in place to fulfil several tasks laid out in the legislation. For example, AWERBs are required to advise on the application of 3Rs (replacement, reduction and refinement principles), to follow the progress and outcomes of projects carried out in the establishment and to promote a culture of care.
Our Animal Welfare and Ethical Review Body (AWERB)'s function is divided between several committees to ensure it fulfils its responsibilities. The AWERB is led by the Biological Research Facility’s Strategic Oversight Committee (BRF-SOC), supported by three key subcommittees:
- Production, Use, Care and 3Rs, which promotes the 3Rs, ensuring a culture of care and good practice, which promotes the 3Rs, ensuring a culture of care and good practice in animal husbandry and procedural use.
- Project Licence Review, which considers applications for new project licences and amendments to existing projects to ensure that the work proposed is necessary and ethically justified.
- Animal Accommodation, Compliance and Environment, which monitors the housing conditions of animals.
Members for the committees are drawn from across the institute, and there is some crossover between committees, leading to effective decision making and communication flow. There are also procedures in place to make sure no one is involved in making decisions about their own projects.
Membership of all the committees includes scientists at various seniority levels and areas of expertise. Named Persons fulfilling specific functions under the A(SP)A and other specialists for the committees are drawn from across the institute e.g. biostatisticians, facilities engineers. This is to enhance the committees’ expertise as well as lay people from outside the Crick who provide an external view and source of challenge. There is some crossover between committees, leading to effective decision making and communication flow. There are also procedures in place to make sure no one is involved in making decisions about their own projects.
Several supporting groups also provide feedback to these AWERB committees: the Named Persons Forum, the Technician Discussion Group, and unit and function specific user groups.
Organisational chart showing the structure of AWERB
Types of Named Persons
- Named Veterinary Surgeon (NVS) – person with main responsibility in monitoring, treating animals and advising on animal health and welfare
- Named Training and Competency Officer (NTCO) – person who ensures that those who work with animals are adequately educated, trained, supervised until competent.
- Named Animal Care and Welfare Officer (NACWO) – pereson responsible for overseeing day to day husbandry, care and welfare of animals
- Named Information Officer (NIO) – person responsible for ensuring that those who deal with animals have access to up-to-date information on species and best practice in procedures performed at the establishment.
- Named Person Responsible for Compliance (NPRC) – person responsible for ensuring that all those working under A(SP)A adhere to condition on establishment, project and personal licences and that AWERB and Named Persons fulfil their functions.
Writing a new project licence application and the ethical review process
Project licence drafting and ethical review is a lengthy and detailed process. It is essential to produce a good quality, well thought through application that stands up to the scrutiny of first the ethical review body and then the Home Office inspector.
At the Crick, the licencing and compliance team gets involved in the project licence drafting as soon as they are notified of the need for a new PPL.
The drafting process includes conversations with the applicant covering the purpose of the proposed work and planned methods which will enable progress towards the objectives. Literature searches, and consultations with a group of science and technology experts are carried out to review any possibilities for parts of the work to be achieved through non-animal methods, e.g. on organoids or via computer modelling. The choice of procedures are discussed to ensure best practice is proposed. All the research and drafting of the proposal takes typically 3–4 months.
The draft is then checked by Home Office Liaison Contact – the person responsible for communication between the establishment (i.e. Crick) and the inspectorate at the Home Office and if no major changes are required, the application is then reviewed by the Named Persons: veterinarian, Named Care and Welfare Officer, Named Training and Competency officer, Named Information Officer. When this review is complete the applicant will need to address any comments made. The whole process of the preliminary review and revision takes around 2–3 months.
Finally, the application is sent to the full AWERB committee (PPL Review Subcommittee at the Crick). The committee makes written comments but also meets an applicant who presents the basis of their research proposal, justifies the animal use and numbers, and discusses their application of each of the 3Rs. During the meeting committee members have a chance to discuss the proposal and make further recommendations.
After the meeting, the applicant needs to address all comments and recommendations, before the application is formally submitted to the Home Office. This part of review process takes another 1–2 months.
The application is typically reviewed by the Home Office within 5 months.
If you would like to learn about the projects that are currently being carried out at the Crick, you can find the non-technical summaries of all of our active project licences published on our webpage
Severity levels
We consider all animal work at the Crick carefully, weighing the potential benefits of the research against the potential harm to the animals, as per our Animals in Research Policy.
Before any work involving animals begins, our Animal Welfare and Ethical Review Body (AWERB) scrutinises it to ensure that the researchers can only answer their scientific question by using animals, that the experiments cause as little harm to the animals as possible, and all measures are taken to minimise animal suffering like the appropriate use of anaesthesia and analgesia (pain relief) and the use of sterile conditions in surgical procedures.
A(SP)A recognises four categories of suffering: 'sub-threshold', 'mild', 'moderate' and 'severe' and a fifth category, 'non-recovery'.
Sub-threshold: The procedure has a negligible impact on the animal's wellbeing
For example, a mouse is given a compound present in broccoli alongside their normal mouse diet to see if the compound helps the animal's gut. The compound doesn't affect the food intake, and after three months the mouse was humanely killed and its gut was analysed.
Non-recovery: The whole experimental procedure that animal experiences in their life is done under general anaesthetic and the animal is humanely killed before it wakes up
For example, a healthy genetically altered mouse was put under anaesthetic. Electrodes were inserted into its brain to record brain cell signals while the mouse was kept unconscious. Once the recordings were complete, the animal was humanely killed while still under anaesthetic.
Mild: The procedure only causes minor, short-term pain or distress with no lasting impact
For example, a mouse was given a modified low-protein diet for four weeks after weaning. At the start of the experiment, a drop of blood was collected by pricking a tail vein. This was repeated after two weeks and four weeks. The mouse was humanely killed, and tissue was collected to study the effect of a low-protein diet on organ development during the first four weeks after weaning.
Moderate: The procedure may cause pain, distress or discomfort and a noticeable difference to the animal's natural state, but they are able to move, eat and drink relatively normally
For example, a genetically altered zebrafish was used for egg collection. Over time, it developed a curved spine, which compromised its normal movements. The animal was humanely killed when the curvature became apparent.
For example, a mouse was given a flu virus by inhalation. The mouse became unwell, was less active and ate less for two days. This resulted in a 10% loss in body weight. Before and during the infection, blood samples were collected for analysis. The mouse recovered completely after five days, and was kept for further blood testing for another three months and was then humanely killed before tissue was collected for further analysis.
Severe: The procedure has a major impact on the animal's health and wellbeing, and they don't live or behave normally. They might experience a significant level of pain, distress or discomfort.
For example, a mouse had surgery to remove its thymus before further studies. The mouse recovered completely from the anaesthetic, but the following morning it was reluctant to move and was not eating or drinking. The animal was then humanely killed.
For example, a genetically altered mouse was injected with tumour cells. As the tumour grew, it was monitored using regular MRI scans with the mouse under anaesthetic. Six weeks into the study, the mouse was unexpectedly found dead after showing no signs of suffering. Post mortem analysis found that the tumour had also grown into the heart, which wasn't visible on the MRI scans.
