Is UK Animal Research Governance Facing a ‘New Normal’? Considering the Risks and Benefits of ‘Going Online’

Abstract

Since a return to in-office working after the extensive disruption caused by the COVID-19 pandemic and associated challenges, many conversations are still being had with regard to what the ‘new normal’ might look like in professional spaces and networks, and what lessons can be learnt from long periods of remote working. The regulation of animal research practice in the UK is no exception here and, like many other systems, it has been transformed by the increasingly recognised value of streamlining procedures through the use of virtual online spaces. In early October 2022, the author attended an AWERB-UK meeting in Birmingham (convened by the RSPCA, LAVA, LASA and IAT), which focused on the induction, training and Continuing Professional Development (CPD) opportunities for Animal Welfare and Ethical Review Body (AWERB) members. This comment article reflects on this meeting and raises some interesting questions surrounding animal research governance in an evolving online era, specifically the associated ethical and welfare dimensions.

Introduction

Those involved in scientific research experienced particular challenges in 2020, with nationwide lockdowns affecting almost all ongoing research projects, very suddenly and with no prior warning. ¹ Animal research staff specifically recount the significant uncertainty and emotional burden that they felt during these times. ² Such challenges did not wane with the gradual reopening of laboratories in which animal models played a major role in furthering our understanding of SARS-CoV-2 and COVID-19, as institutions had to navigate evolving safety/social distancing advice, an increased demand on animal model supply chains and staff/technician shortages, as well as a sudden shift in research focus. ³

In the UK, Animal Welfare and Ethical Review Bodies (AWERBs) are the institutional ethical review committees that meet regularly and undertake a number of tasks, including advising staff on the Three Rs (replacement, reduction and refinement) and other issues related to the care and use of animals, promoting a Culture of Care, and advising the establishment licence holder whether to support a project proposal before it goes to the regulator, i.e. the Animals in Science Regulatory Unit (ASRU). ASRU is the part of the Home Office responsible for the administration/enforcement of regulatory activities, including project licensing activities. AWERBs are also widely considered to be a key location through which ‘ethics’, notionally, enters the regulatory process before formal licensing review is carried out. ⁴ This short report is based on the author’s reflections after attending the AWERB-UK 2022 meeting. These meetings were established in 2016 by the Royal Society for the Prevention of Cruelty to Animals (RSPCA), along with the Institute of Animal Technology (IAT), Laboratory Animal Science Association (LASA) and Laboratory Animals Veterinary Association (LAVA). Their purpose is to bring together stakeholders from these key learned societies, as well as members of AWERBs themselves (such as scientists, animal technologists and care staff, veterinarians, lay members and AWERB Chairs) to reflect on how animal research governance emerges ‘on the ground’ in establishments that use, breed or supply research animals.

According to the RSPCA, these meetings “have provided useful insights into the problems AWERBs face” and provide “ideas and action points to overcome these”. ⁵ The impact of COVID-19 was the primary focus of the 2021 online AWERB-UK meeting, ‘Maintaining an effective AWERB in the age of COVID-19’, whereas the most recent October 2022 meeting, on the induction, training and Continuing Professional Development (CPD) opportunities for AWERB members, did not have this as an intended focus. ⁶ However, as a social scientist interested in questions of governance and the role of expectations, ⁴ the author was struck by the way in which the 2022 meeting attendees discussed the post-pandemic shift toward online training and induction methods. This raised questions about whether, when and how this online shift might change the way in which the ethical review of a project proposal is performed.

The outcomes of the 2022 meeting are not likely to be representative of the opinions of members of all AWERB types/structures, particularly on the topic of online meetings, as this recent meeting itself was held in person. This means that the opinions of those who could only attend (or who prefer to attend) online meetings may not have been represented in the same way as those who were willing and able to travel to meet in person. Equally applicable to AWERB-UK meetings more generally, it is likely that those individuals who actively engage with such events, which are organised jointly with the RSPCA, IAT, LASA and LAVA, have a specific interest in improving AWERB structures and procedures. There is, therefore, much that the outcomes of such meetings cannot reveal. This report simply hopes to stimulate further community and academic debate on the benefits and risks of such a shift in ‘normal practice’ — specifically, in line with the author’s own interests around institutional regulatory and ethical review systems.

It is first pertinent to mention that the field of animal research, and the systems that surround it, were experiencing a certain level of ‘onlineification’ long before the COVID-19 pandemic, in ways that were already revitalising the practice. For example, in the case of procedural training for animal use in research, it has been suggested that ‘virtual simulation experiments’ can represent valuable tools for increasing the confidence and capabilities of students before any laboratory practice is undertaken, thus contributing to the refinement and reduction principles of the Three Rs. ⁷ The facility of ‘online’ is also key for openness initiatives in the field, where the public can, in a sense, ‘enter’ the laboratory environment (e.g. through virtual tours or lay summaries) without physically entering these spaces — thus, circumventing the perceived safety risks associated with opening up their access. ³ However, policymaking and regulatory processes did not seem to be displaying the same pre-pandemic trend toward online formats — indeed, these processes were necessarily forced online by the 2020 pandemic. Two examples of such recent changes in practice, with regard to animal research inspection and animal research ethical review, are discussed below.

A post-pandemic shift to more remote working methods: Animal research inspection and ethical review

Online animal research inspection

One of the issues mentioned at the AWERB-UK workshop was the potential impact of the UK Home Office Animals in Science Regulation Unit (ASRU) ‘Change Programme’. This programme was announced in 2021, with the aim of improving efficiency in the implementation of the Animals (Scientific Procedures) Act 1986 (ASPA), including revisiting their ‘inspection’ system.

Part of the role of a Home Office Inspector (HOI) is to visit institutions and determine “whether the holder is complying with the provisions of this Act and the conditions of the licence”. ⁸ The change, put simply, means that ASRU inspectors will be expected to perform fewer official in-person visits, with a move toward a new remote “audit-based” system, developed “through the ways of working adopted during COVID-19”. ⁹ ASRU themselves have given reassurance that the move is only intended to increase efficiency. However, some stakeholders, including the RSPCA, have voiced concerns that the new approach may result in less effective oversight of laboratories that use animals, with an increase in paperwork and a potential decrease in animal welfare standards. ¹⁰ Furthermore, as a result of the Change Programme, institutions no longer have an assigned HOI visiting regularly and acting as the first port of call to discuss proposed applications, ask for advice, and invite to attend AWERB meetings. ¹¹ Significantly reducing this contact, and increasing the amount of paperwork correspondence in place of in-person conversations, perhaps risks jeopardising the opportunity for valued situational advice provided by key personnel sitting between the Home Office and the institutions themselves. Equally, through the desire to streamline systems, the RSPCA also has concerns over the assertion by the ASRU that they plan to be clearer about ASPA’s official remit in order to increase the clarity of any regulatory guidance produced and disseminated. Thus, the RSPCA seem to be predicting that a by-product of ‘going online’ in this way, with the concomitant reduced frequency of ASRU inspections, could lead to a prioritisation of the meeting of ‘minimum standards’ rather than the promotion of other valuable best practice guidance produced by stakeholders. ¹⁰

Online animal research ethical review

Another topic discussed at the workshop was the logistics of holding AWERB meetings. These meetings have undergone changes in many institutions since the pre-pandemic era, with many continuing to meet virtually, some holding hybrid meetings and others operating entirely via email correspondence. The benefits of retaining a remote-working system could be that it helps address one of the major challenges AWERBs across the country face — namely, the lack of members’ time and resources to achieve all of the many AWERB deliverables in a timely manner. ¹² NHS Human Research Ethics Committee (REC) meetings have also made this transition to an online format for the same reasons. ¹³

As noted earlier, the AWERB-UK meeting held in 2021 more explicitly dealt with these issues, although these discussions took place mid-pandemic, when lockdown restrictions meant that meeting in an online setting was the only available option. At the 2021 meeting, attendees reflected that some AWERB induction and training programme content could be delivered effectively online, but not all of it. Detrimental issues that were identified as being associated with ‘going online’ included:

— the difficulty in building of relationships with key individuals;

— an individual’s potential lack of confidence in contributing to discussions in an online environment; and

— problems in “getting an overall feel for the establishments’ policies, attitudes and culture”. ¹⁴

This latter point is of particular concern, in that an institution’s AWERB is expected to operate in accordance with their institution’s individual core values. This means that the establishment and development of the AWERB is essential to the way in which an ethical review is performed at a particular institution. Equally, another report from the same 2021 meeting noted a significant “focus on project review at the expense of the other AWERB tasks, particularly those involving open discussions such as ethical issues and the local Culture of Care”. ¹⁵ Many of these same concerns were still emerging at the recent 2022 meeting, and are of course a concern among those interested in the dynamics of the ethical review at this key regulatory stage.

Discussion

The recent move of animal research inspections and animal research ethical reviews toward more online-based processes, as described above, marks an incredibly important transitional phase in the governance of animal research. Regulatory processes ensure that researchers and research institutions are made accountable for their proposed research, requiring them to justify that their research is necessary and that it is done in the most efficient manner, prioritising the welfare of the animal(s) involved. Regulatory processes have been significantly and gradually refined over the past 50 years, in order to improve the implementation of the Three Rs principles and harm–benefit analyses. ¹⁶ Thus, of such ‘socioethical opportunities’, ¹⁷ there are a number of considerations pertinent to their changing nature that should not be overlooked. These are particularly important to note now, at a point where decisions are being made across the industry as to whether to return to in-person meetings. This consideration process was evident in a key Animals in Science Committee (ASC) and AWERB Hub Chairs Meeting, where the future platform of their meetings was discussed. ¹⁸

Perhaps the animal research topic could benefit from research and commentary from social science on issues regarding online working. For example, Braun et al. write of such concerns in the context of Responsible Research and Innovation (RRI) — a key focus of the Horizon 2020 programme for science — and comment on the lack of discipline-wide dialogue around responsible decision-making in online settings, urging people to ask: What from the sphere of human encounters is lost in digital space? and What does it mean in terms of access and power? ¹⁷ They also note several specific concerns relevant to this case. For example, they note that increased online meetings bring additional pressure on individuals to fit more into their days, reducing the time for meeting preparation and reflection, and for more informal (yet valuable) conversations. The time carved out for such reflection is even further reduced in the event of AWERB meetings taking place via email correspondence, and the same could be said with reduced contact with HOIs (as per the UK’s Change Programme). For animal research governance specifically, previous AWERB-UK meetings have indicated that AWERB members feel that their hard work is not always recognised by senior management, ¹² making appointment to the committee less attractive to prospective members. If these meetings remain online, then there is a risk that this feeling is further perpetuated as a result of management being less likely to notice their attendance, as the AWERB meeting becomes one of the many online meetings they attend each day.

A second concern noted by Braun et al. ¹⁷ relates to the shift in social dynamics in online settings, particularly the inflexibility associated with using a ‘raise hand’ function (on an online conferencing platform such as MS Teams or Zoom), which undermines the capacity for creative exploration of certain issues and going off agenda. This limits any extra exploratory conversations, and this is particularly significant for the AWERB, where one of its tasks is to “act as a forum for discussion”. ⁸ There is also a risk of potentially marginalising the lay members (particularly new ones), who may be less inclined to ‘disrupt’ progress in such a forum, particularly if they have not had the opportunity to build relationships with other members. This itself was a concern raised by a lay member at the most recent AWERB-UK meeting. One way of potentially mitigating this is to utilise AWERB ‘sub-groups’, as some institutions already do, by assigning each smaller group with a different central focus (for example, a group which only reviews project licence applications). This would reduce the size of the meetings, and may improve interactivity. However, attendees of the meeting gave little indication that the use of this approach was being actively employed in the face of such online transition. Furthermore, if the use of sub-groups was employed as a solution to the above-mentioned disadvantages of an online shift in working practice, AWERB committees would also need to consider its potential impact on the general proficiencies of the committee in other respects. For example, the use of sub-groups may fragment tasks, discussions, expertise and thinking around certain issues, as well as possibly spreading lay membership too thinly or resulting in no lay input at all on some of the committees’ activities (as lay members are reportedly difficult to recruit). ¹⁹

The third and final concern expressed by Braun et al. on the topic of virtual RRI decision-making is what can be lost online with regard to how people “feel” each other through unconsciously signalling and interpreting body language when “understanding, inspiring and sharing together”. ¹⁷ Of course, the very nature of animal research governance gives rise to challenging conversations and decisions. Moving these conversations online (or to be undertaken via email or paperwork), without serious thought being given to the possible repercussions of doing so, could disrupt much of the progress that has been made over the past 50 years in optimising the process. The concern from the perspective of the author’s research is that such changes risk reducing the capacity of the AWERB to broaden the scope of ‘ethics’ in the context of animal research.

Conclusions

This short comment article has highlighted two examples of apparent shifts, or further shifts, toward more remote ways of working in the governance of animal research. There is no doubt that other international examples could be cited, as well as examples from other areas of science governance. This comment aims to stimulate further debate about what may be gained and what may be lost if online working becomes further embedded as the new norm. Insights from social science may be helpful here — for example, thinking about science in general, some have argued that there is a key role for face-to-face interaction, as it is in-person that we get to energise ideas, build trust among colleagues, transfer tacit skills, as well as use body language to convey meaning or “settle disagreements quickly and efficiently”.^17,20 Such factors are arguably particularly important for the governance of animal research, in relation to both inspection and ethical review. Those who share this opinion note the need to actively foster that which may be lost online. ²¹

It is not the intention of this comment article to offer any concrete recommendations, tools or solutions to monitor the impact of such changes internally. To do so, more engagement with a variety of AWERBs and AWERB members and Chairs would be required for such recommendations to be meaningful and practicable. It is hoped, however, that it may ignite some reflection on what may be gained and lost in such shifts. To improve their capacity to engage in such reflection, AWERB members could consider attending AWERB-UK meetings, which provide a forum through which to raise some of these questions and recommend ways to address them. For example, after the 2021 AWERB-UK meeting (on remote meetings amid the pandemic), a list was published of recommended discussion points that AWERBs could reflect on internally. ¹⁵ These questions centred on topics such as: meeting duration/structure; the capacity to fully address all AWERB functions and tasks at online meetings; the potential impact on project review; and AWERB member induction and training.

In the past, AWERB-UK meetings have also produced documents that advise on using the AWERB as a forum for more general discussion, which could also assist in navigating such shifts meaningfully. ¹² From the social sciences, we can draw from a breadth of existing and emerging literature on Responsible Research and Innovation (RRI). For example, Braun et al. ¹⁷ draw from several RRI tools^22,23 to guide their analysis and discussion. Fundamentally, at this time of an observable shift in how research regulation is being carried out, this review encourages AWERBs to explore the question: How should we balance the maintenance of ‘sound science’, high standards of ethical review and animal welfare, with the pressures of time and resources that have made the online space so attractive?