Corporate report

Animals in Science Committee and Animal Welfare and Ethical Review Body Hub Workshop: 11 October 2023

Published 20 February 2024

The AWERB Hub workshop was convened and held under the aegis of the ASC’s AWERB Subgroup. The views summarised in this report are those expressed by attendees of the workshop, and do not necessarily represent the views of the ASC. This report is not intended to be, and should not be interpreted as, a policy statement or a work plan.

Introduction

1. The tenth Animals in Science Committee (ASC) and Animal Welfare and Ethical Review Body (AWERB) Hubs Workshop was convened on 11th October 2023 via a virtual platform.

2. The aim of the day was to enable attendees to share and discuss:

• non-technical summary – review of the guidance notes for project licence applications
• an overview of the ASC independent review of the forced swim test
• the role of review and regulatory approvals processes for animal research in supporting implementation of the 3Rs: The role of AWERBs

3. More than 80 individuals attended the workshop. The attendees included the Chairs and/or their nominated representatives and AWERB members from a variety of roles and backgrounds. Also in attendance were the members of the ASC AWERB Subgroup (SG), facilitating the event, and the ASC Secretariat. The workshop was Chaired by Sally Robinson (ASC AWERB SG) with presentations from Donald Bruce, Wendy Jarrett, and Frances Rawle. The agenda for the day can be found at Annex A.

4. This report sets out the key points and findings from the day. Presentations provided at the workshop have been made available to attendees to allow circulation within their Hubs.

NTS – Review of the guidance notes for project licence applications

5. ASC AWERB Subgroup member Donald Bruce delivered the first presentation of the day which was aimed to present issues arising from the guidance notes for project licence application non-technical summaries (NTS) and gathering input from attendees.

6. The format of the session was a presentation followed by break-out groups to facilitate open discussion before feeding back to the group as a whole. Attendees were sent a set of questions to consider ahead of the meeting. Each breakout group was led by an ASC AWERB member. A copy of the presentation can be found at Annex B as a separate document.

7. The main focus points of the presentation were:

• what is the NTS for?
• problems with NTSs
• examples of poorly written NTSs
• improving the English of NTS
• incentives to writing a good NTS
• NTS quality assessment processes

8. The attendees provided feedback from their breakout groups and the key points to each question can be found below.

Does your AWERB/establishment ask the applicant to work on the NTS with the lay member or other non-technical staff member before submitting it to the AWERB? If so, what do you do?

Whilst some had specific processes, the majority of attendees fed back that there wasn’t any specific pre-meeting work done on the NTS. Lay members, animal technicians and other people outside the AWERB are consulted on the NTS before it is submitted to the Home Office. The processes ranged from formal signoffs to less formal early input.

It was found that the understanding of terminology between lay members often differed.

There was a wide range of processes used across establishments, some process examples given include:

• The applicant submitted the draft application which was then pre reviewed by the vet and NACWO for peer review, the NTS was then sent to lay reviewers who feedback comments to the applicant. The application was not sent to the AWERB until comments had been addressed. The application would not be sent to Animals in Science Regulation Unit (ASRU) unless it had been screened by a lay member. Given the number of licences produced by the establishment, a pool of lay reviewers had been developed.
• NTS might be read by a non-technical member of staff if there was no lay AWERB member, comments were then sent back and the HOLC ensures the comments are addressed by the applicant.

Other approaches included:

• Lay member feedback forms.
• One AWERB had a secondary-school teacher as a lay member.
• Library staff carrying out lay person reviews on behalf of their establishments.
• Lay members reading the whole PPL in some establishments. One AWERB has a policy to open its meetings to students on campus, to invite input from them and publishes the minutes.

Do you check the final version of the NTS with a lay member before submitting it?

Attendees at the meeting indicated that their AWERBs check the NTS with a lay member for submitting it (though wider experience shows that this is not always the case).

Attendee comments centred around a lack of feedback from the Animals in Science Regulation Unit. Where there was feedback there was a lack of consistency between Inspectors, with some establishments only ever receiving feedback when an identifier had been left in the NTS, while others did get feedback on the language used and whether it was really ‘lay’ or not.

Is the ASPel process and Guidance Note asking for the right amount of detail, particularly in the Benefits, Harms and 3Rs sections?

Harms - were referenced in isolation, with a lack of context causing an issue.

*Replacement - questions were clunky and repetitive, a refinement of the questions would be beneficial.

Severity – these questions were felt to be unhelpful, out of context, and contradictory.  At one point the advice is “do not use terms ‘moderate / severe’ and then (further down) asks for a severity assessment.

Reduction - these questions focused on power analysis, which was felt to be too technical. Attendees felt there needed to be an outline of the overall strategy and how that would be achieved.

It was felt that the quality of the NTS was heavily dependent on the applicant and their interest in investing time on those questions.

Should the questions for the NTS be separated from the main licence?

Overall, it was felt that the older system for drafting the NTS was better than the newer one which was found to result in an overly long NTS. The auto-population of the NTS was found to be unhelpful, with too many questions and repetition. The resulting, lengthy, NTSs could be overwhelming for a lay person.

It was also noted that this auto-population often resulted in an NTS being too technical or the main licence not having enough detail included as a result of less information being included to attempt to keep the NTS shorter.

It was felt that the new system made it difficult to switch between technical and lay language.

The general conclusion was a preferred approach of writing the NTS separately in lay language before filling in the main licence.

Could the questions in the ASPel form and Guidance Note be improved, and if so which one(s) and how?

It was noted that the guidance questions were ‘clumsy’ and repetitive, for instance out of three questions asked, two would be looking for the same information leading to repetition.

The guidance note examples were too technical (the example of how to explain power calculations was cited), advice should be given on how to describe complicated concepts such as power calculation in lay terminology.

Another comment suggested that the guidance could be improved by having worked examples of typical technical responses and the same things expressed in lay language.

The consensus was that the guidance note was too long and overwhelming for most to read.

In your view, are the examples given in the ‘Aims’ section of the guidance note written in non-technical language. If not, how could the question and examples be revised?

Overall, it was felt that the examples were not non-technical.  They would work better as examples of how not to write a section of an NTS, with a lay version provided alongside.

Attendees also questioned whether the guidance note had been reviewed by any lay people for feedback before it was published.

9. In all breakout groups, it was noted that there was uncertainty around who actually read NTSs and what information the ‘public’ would want to see included in them. Feedback about this, from ASRU for example, would be helpful to get the NTS right. Although it was noted that due to the format of published NTS documents, this data might be difficult to acquire.

Overview of the ASC independent review of the forced swim test

10. ASC AWERB Member Wendy Jarrett presented the second topic of the day, which was a short overview of the ASC’s independent review of licences involving the forced swim test (FST) protocol. A link to this report on the ASC’s website can be found here. A copy of the presentation can be found at Annex C as a separate document.

11. In August 2022 the Home Office commissioned the ASC stating, “the UK Government wishes to receive advice from the Committee on the evidence of alternative methods and appropriate justification for the use of the forced swim test, under the Animals (Scientific Procedures) Act (ASPA), with due consideration to the legitimate requirements of science and industry and to the protection of animals”. In addition, the ASC was asked to answer the question: “How should the 3Rs be applied regarding the forced swim test, drawing on the available evidence and licence review?”

12. The report considered evidence of alternative methods and justification for the use of the FST, its severity, its validity in the context of experiments with different research purposes, and opportunities for more fully implementing each of the 3Rs. On the basis of the findings from the review, the ASC made several recommendations to the Minister.

13. The presentation covered:

• commission & Purpose of the review
• methodology
• overview of the report
• recommendations
• Q&A

14. Attendees were invited to ask questions and submit their thoughts on the subject, and the following questions and comments were noted:

14.1. It was noted that in certain research fields finding non-animal alternatives (NAA) seemed a long way off and the attendees felt that there should be more discussion around refinement. ASC members responded to the comment, advising that refinement of the FST had been looked at in depth and they had found a considerable number of references to refinement but there were no replacement methods currently available. ASC members also commented that opinions from licence holders and stakeholders on what would be considered a more refined in vivo method were quite varied.

14.2. One attendee noted that unless the NAA agenda was pushed forward and funders acknowledged that behavioural readouts were important in fields like psychiatry, then it would be difficult to develop a robust NAA to the FST.

14.3. Attendees discussed the views of their establishments and the use of a formal ‘actively discouraged procedures’ list, several of which included the FST.

The role of review and regulatory approvals processes for animal research in supporting implementation of the 3Rs: The role of AWERBs

15. The Chair welcomed Dr Frances Rawle to present the final topic of the day. The session consisted of a presentation with time allotted questions at the end. A copy of the presentation can be found at Annex D as a separate document.

16. Dr Rawle was commissioned and funded by the NC3Rs to look at approvals processes for animal research in supporting implementation of the 3Rs. This was due to concerns about how slowly 3Rs developments are adopted into routine practice. A link to the full report can be found here.

17. The presentation covered the following:

• background and context
• project approach
• replacement
• reduction
• refinement
• barriers to the adoption of 3Rs advances
• recommendations
• good practice

17. Dr Rawle invited open discussion around three questions:

What should initial training and CPD requirements for AWERB members be?

• Attendees discussed the training provided at their establishment, with several noting that resourcing and time were some of the biggest challenges.
• One establishment holds day long refresher courses in the legal and ethical areas every other year.
• The majority of ‘training’ involved background and guidance reading of documentation created by external stakeholders such as the RSPCA.
• It was noted that there were probably many actions taken to train a new AWERB member that, if put into a structure could form a more formal training package. Some of these actions could include attending an AWERB meeting as an observer, reading material, and visiting the animal facilities etc.
• It was noted that having some sort of ‘expected standard’ from the regulator might help bring together the training processes across different establishments.
• Any training needed to be of reasonable length to ensure understanding whilst making sure volunteers, such as lay members, were not overwhelmed and recruitment made more difficult due to the time commitment needed.

Can you access experimental design and statistical expertise? Is support available for researchers?

• It was agreed that there was a shortage of access to statistical expertise, experimental design, and data analysis. It could be beneficial to have a named statistical expert on an AWERB who could provide advice when needed. However, the statistics aren’t always applicable to experimental design.
• Government funding for statisticians with experience in experimental design would provide a substantial benefit to the research community and enable training of new generations of researchers.
• The UK Reproducibility network’s approach of targeting early career researchers, sending them on workshops with a remit to go back and train their colleagues is one approach that is being considered.

How could information from retrospective reviews and retrospective assessments be shared?

• One establishment holds retrospective reviews in front of all licensees and the project licence holders are expected to present what they’ve done around the 3Rs as well as what they have achieved in the last year. This provides an annual record of all improvements made during the course of their licence and works well for sharing their best practice around the 3Rs.
• Outside of the establishment, best practice is generally shared by NACWOs amongst their networks.
• It was noted that the retrospective assessment process was not set up in the right way to be able to extract anything meaningful while still protecting the anonymity of the researchers involved.

19. It was noted by one attendee that there was a lot of replacement work going on in establishments such as mathematical modelling, which doesn’t get mentioned on licences as it is not animal orientated. This can give the appearance that less 3Rs work is being carried out than in reality. It was suggested that sharing this information would highlight the work around the 3Rs being carried out.

20. This could be further supported by facilitating cross-department working within establishments to enhance communication between those with different expertise.

Final thoughts and feedback

21. The Chair thanked all the presenters and the attendees for their contributions and invited them to provide overall feedback and thoughts on the workshop along with any suggestions for future topics.

22. Attendee feedback was very positive, with all finding it a very useful workshop with ideas and information to take back to their individual AWERBs.

23. Potential future topic suggestions were:

• formal training structure for new AWERB members
• follow up information from 2022 AWERB/RSPCA discussion on ‘The key to effective AWERBs lying with the ELH’

Annex A

Animals and Science Committee AWERB Hubs Workshop 11 October 2023, 10:00-13:00

Time	Session	Lead
10.00 - 10.05	Welcome, Introductions and Workshop Protocol	Sally Robinson
10.05 - 11.15	NTS – Review of the guidance notes for project licence applications	Donald Bruce
11.15 - 11.35	An overview of the ASC independent review of the Forced Swim Test	Wendy Jarrett
11.35- 11.50	Break
11.50 - 12.50	The role of review and regulatory approvals processes for animal research in supporting implementation of the 3Rs: The role of AWERBs	Frances Rawle
12.50 - 13.00	Open table discussion and Feedback	Sally Robinson