Ethical Review Procedure for Use of Animals in Research

As part of our commitment to supporting the best quality scientific research in terms of ethics, conduct and impact, we fully endorse the ARRIVE guidelines produced by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) (see ‘Centre-led programmes’ at http://www.nc3rs.org.uk/ ) which focus on improving the design and reporting of animal studies.

All of our animal research is guided by the “three Rs”, namely:

• Replacement: replacing the use of animals wherever possible with alternatives such as cell/tissue/organ culture and/or computer modelling;
• Refinement: improvements to scientific procedures and husbandry which minimise actual or potential pain, suffering, distress or lasting harm and/or improvements to animal welfare in situations where the use of animals is unavoidable;
• Reduction: minimising animal use through better experimental and statistical design, obtaining comparable levels of information from fewer animals or obtaining more information from the same number of animals, thereby reducing future use of animals.

Much of our research involving animals is directed at understanding animal behaviour and welfare, the alleviation of human and veterinary disease, environmental protection, or the production of safe, nutritious food for livestock and consumers. A significant proportion involves the use of farm animals where the nature of the research does not meet the thresholds required for it to be covered by the Animals (Scientific Procedures) Act 1986.

Each research project involving animals, whether covered by the Animals (Scientific Procedures) Act 1986 or not, is conducted under the same high standards of animal care and welfare required by the Act. 

Further information can be found here: Experimental Work Involving Animals at Aberystwyth University. 

Any establishment using, breeding, or supplying animals for research is required by the Home Office to have an Animal Welfare and Ethical Review Body (AWERB) in place. 

The AWERB's roles include:

• Assessing all project licence (PPL) applications and amendments. The AWERB will consider the scientific value of all proposed work vs. any potential cost to the animals themselves. 
• Ensure the principles of the 3Rs are followed and applied to all work being done with animals. 
• Ensure facilities are appropriate for any work being done, and that competent staff are available to carry out any work. 
• Provide PPL applicants with constructive advice and recommendations.
• Ensure all work with animals provides a clear scientific rational before any work is approved. 
• Be ready to provide advice and support to members of staff who work on the establishment on a range of animal topics: care, welfare, use, facility standards, and/or acquiring animals for use on trials. 
• Oversee all work with animals including non-regulated procedures.

The membership of the Aberystwyth University AWERB is above legislative requirements and consists of:

• Chairperson
• Establishment Licence Holder (PEL-H)
• Invited Project Licence Holders (PPL-H)
• Personal Licence Holders (PIL-H)
• Named Animal Care and Welfare Officers (NACWO)
• Named Training and Competency Officers (NTCO)
• Named Veterinary Surgeons (NVS)
• Lay Members
• Health and Safety Representative
• Estates Representative
• Aberystwyth University Farms Manager
• A scientific member without responsibility under ASPA

Any member of staff who submits a proposal may be invited to attend the AWERB meeting.

Meeting dates for 2023 and associated PPL draft/amendment submission deadlines:

All undergraduate/taught postgraduate students should complete the online form, in conjunction with their supervisor. This will then be reviewed by the Home Office Compliance Team. Ensure you leave sufficient time for your ethics application ahead of your data collection schedule as you cannot collect ANY data until your project has full approval. 

Any projects which are not solely animal based (i.e. if you are distributing surveys in addition to your work with animals), you should also complete the Online Assessment form. Any queries relating to the non-animal process should be directed to ethics@aber.ac.uk

Once you begin the ethics form you will not be able to save and return to it so here are list of things you must know BEFORE you start the form:

• Will your project involve importing animal materials to the UK?

If so you must have a discussion with the Home Office Compliance Officer (HOCO - aeostaff@aber.ac.uk) before you begin the form.

• Do you plan to work with wild/exotic/stray animals?

If so, you will be required to upload proof that you have the correct permits/permissions to do so e.g. permission to access land, and any licences required to do work with wild animals. 

• Does your work fall under ASPA?

ASPA covers specific types of procedures applied to 'protected animals' (vertebrates and cephalopods, excluding humans). Many UG/PGT projects will not involve regulated procedures. However, if you are unsure you should consult with your supervisor. Get in touch with the HOCO if your project does involve regulated procedures. 

• Will your work be carried out in the UK?

If not contact the HOCO before beginning your application.

• Your research objectives:

These are what you aim to find out by conducting your research. Research objectives help to demonstrate the scientific importance of your work.

• What are the potential benefits of your research?

• What are any risks your work may entail and how do you propose to mitigate them?

• Have you applied the principles of the 3Rs to your work?

Consider whether animals must be used for your work or can they be replaced? Have you taken all the steps necessary to reduce the number of animals to the very minimum required to generate valid, reproduceable results? And finally, are your methods refined to ensure the work done is efficient, effective, and generates no undue harm to the animals involved?

All questions in the ethics form are mandatory and in the case of any queries you should, in the first instance contact your supervisor or module co-ordinator. 

Prior to ANY animal research beginning a research proposal must be submitted to the Home Office Team (HOCO) to check compliance with ASPA and advise on the method of ethics approval needed. Unless you have an existing proposal to submit here is a quick form to complete so that the HOCO can advise you on the appropriate approval route. 

If your project is identified as falling under ASPA then you must ensure you are in receipt of the appropriate Home Office licences for all regulated procedures your project requires the use of. For staff this may mean obtaining a new project licence (PPL) and/or personal licence (PIL). For PGR students you may need to obtain a personal licence to do work on an existng project licence held by a member of staff (most likely your supervisor). 

If the work falls outside of the scope of ASPA i.e. utilises non-regulated procedures and/or non-protected species (invertebrates excluding cephalopods) the project is still subject to an ethical review process. 

Obtaining ethical approval will depend on whether the project falls under ASPA or not and the details for each route are set out in detail below. 

It is the legal responsibility of the University and AWERB to ensure that all regulated procedures involving protected animals only occur under the relevant Home Office licences. 

If your project will utilise an existing PPL, with the PPL holders' permission you should complete the relevant ethical approval form in sections 3 and/or 4.

If your project requires a new PPL under ASPA it must be assessed by the University AWERB prior to submission for Home Office approval.

The full process for obtaining a PPL is generally:

1. Your project has been identified by the HO team as requiring a PPL.
2. The project lead will be required to undertake a PPL training course in order to gain certification (if they do not have the certificates already).
3. Once you have a PPL certificate the HOCO will help you set up your ASPEL account and upload your certification. ASPEL is the online portal for licence management, and where you will draft your PPL application.
4. Once you have generated a full PPL draft application you will download a copy and submit it to the AWERB for review (deadline dates available above). 
5. The AWERB will review your project according to:
   1. Quality and value of the research
   2. The amount of suffering potentially experienced by any animal on trial
   3. Whether there are appropriate staff, facilities, and funding in place to run the project to the highest standard and ensure the highest level of welfare for the animals involved.
6. You will be informed of the AWERB outcome and either passed to submit your application to the team of Home Office Inspectors, or advised to make amendments before resubmitting to the AWERB, or your application may be turned down with reasoning given.
7. If your application has passed you may submit your draft PPL application to the team of HOIs for review via ASPEL who will make a final decision.

A project licence will last for up to 5 years unless the project is scheduled to end sooner. At the end of your project the AWERB will review the work done, looking at the number of animals used, how the 3Rs were implemented and whether the aims and objectives of the project were met. In addition, all publications that have been generated by the work must be submitted to the AWERB and forwarded on to the Home Office. 

The use of animals in research may not always meet the criteria above to require a HO licence. For example, a project using insects rather than protected species, do not fall under ASPA regulation. However, there is an ethics procedure which must be followed for all non-licensed animal use also. 

In this case you must complete the relevant ethical approval form in sections 3 and/or 4 in full, which will be submitted to the Home Office Team for review.

Coming soon.

Home Office Accredited Training

For those engaged in research involving regulated procedures with protected animals under a Home Office licence, researchers will be required to successfully complete the Home Office accredited modular training for each species that you will work with.

Training for a project licence is covered by two days of training followed by an exam. Once you have your PPL certificate you may apply for a project licence following the guidelines listed above. 

The training for a personal licence (PIL) is covered by a series of individual modules which are species specific. In order to gain certification, you must sit an exam and then complete a practical verification of animal handling skills overseen by the University NTCOs/NACWOs. Once you have your certification the HOCO will help you apply for a PIL through the ASPEL online system. Prior to completing any practical research work with animals all PIL holders must be signed off as competent in every procedure they plan to use. This can only be signed-off once the NTCO(s) are satisfied that the licensee has achieved the necessary competency in that procedure. 

Researchers should initially contact the HOCO who will liaise with the NTCO and advise on their individual training needs. Training may take place at the University or another venue depending on individual training needs. 

Local Training (Coming Soon)

The local training module is compulsory for all staff whether in a research capacity or not, who will be involved in working with/caring for animals. This includes farm staff, technicians, those with responsibility for the welfare of animals, and any support staff. 

All members of the university who work with animals, whether the work involves HO regulated procedures or not, are obliged to understand their own role within the local structure for the care and use of animals. This includes how they personally contribute and work with others to maintain the highest of standards of animal welfare and scientific integrity. 

Training will be provided to all members of the University (staff and students) before they begin working with animals as part of their induction process to ensure they are familiar with the legal codes of conduct and key personnel who carry out specific roles associated with the legislation. 

Provision of this training is the responsibility of the AU Named Training and Competency Officers (NTCOs), and a register of people who successfully complete the training will be maintained by the HOCO. 

PGR Inductions

Each year a compulsory induction and information session sets out the ethical approval routes that are required to begin your research. These sessions are designed to complement the specialised and discipline specific training provided by the HO and IBERS. 

Aberystwyth University uses animals, where essential, in a small portion of its work in order to conduct vital research into human health, tackling climate change, and research to improve the health and welfare of livestock. Our researchers utilise techniques which do not require animals wherever possible, and much of the research where animals are involved is non-invasive. Any work which does involve regulated procedures is strictly monitored by the Home Office. The Home Office publishes all records of scientific procedures annually here: https://www.gov.uk/government/collections/animals-in-science-statistics 

A ‘regulated procedure’ is carried out on a protected species (any vertebrate or cephalopod, excluding humans) for a specific scientific purpose. A regulated procedure may cause the animal a level of pain, suffering, distress of lasting harm. Broadly speaking – anything considered to be the equivalent to, or greater than the use of a hypodermic needle is classed as a regulated procedure.

Aberystwyth University is a signatory of the Concordat on Openness in Animal Research and also a member of Understanding Animal Research. We are committed to being open and transparent on our use of animals in research. In 2022 Aberystwyth University undertook scientific procedures involving 911 animals. Most of these involved cattle and sheep (41% and 34%). Below are the figures and some information relating to the projects conducted in 2022 involving animals under a Project Licence:

If you have any questions, please contact the Home Office Compliance Officer:

E-mail: aeostaff@aber.ac.uk

Telephone: 01970 82 3067

Useful links that you should be familiar with if you work with animals:

• Home Office - Research and Testing Using Animals
  Home Office guidance and information around the legislation relating to research involving animals. 
• Guidance on the operation of ASPA
  Important handbook for all those involved in regulated work.
• National Centre for the Replacement, Refinement and Reduction of Animals in Research
  Independent scientific organisation that works to advance the 3R principles.
• The Institute of Animal Technology
  Professional body for animal technicians.
• Laboratory Animal Science Association
  Professional body that has been set up to advance scientific knowledge and understanding of the use, care, and welfare of laboratory animals. 
• RSPCA - Research Animal Science
  Branch of the RSPCA that works with those involved in the regulation, care and use of animals in scientific experiments.