The Animals (Scientific Procedures) Act (A(SP)A) of 1986 is the primary mechanism for regulating invasive scientific research in the UK, with any “protected” animal, i.e., vertebrates and cephalopods when either the species-specific gestation or incubation period has elapsed (in the cases of mammals, birds, and reptiles), or when they become capable of independent feeding [1
]. It is the UK’s approximate equivalent legislation to EU Directive 2010/63/EU. While the majority of research licensed under the A(SP)A is conducted in laboratories, the A(SP)A extends to research conducted outside of the laboratory, such as at practicing farms—i.e., farms used for agricultural and fish production, rather than those used exclusively for research—veterinary clinics, zoos, and wildlife and fisheries field sites, which might be built structures (e.g., field stations, enclosures designed to keep animals semicaptive) or open-air locations (e.g., in woodlands, on boats). Such venues outside of the laboratory are often classified under the A(SP)A as Places Other than Licensed Establishments (POLEs). Licensed user establishments require the presence of specific personnel and systems of control, and provision of particular environmental conditions. Although some nonlaboratory settings can meet these requirements and become licensed user establishments (e.g., farms and animal hospitals associated with universities), POLEs are locations where A(SP)A-regulated research occurs where all of these regulations cannot be met. Research at POLEs is explicitly the exception rather than the rule, since researchers must justify why they are unable to conduct the research within a licensed user establishment [1
There is increasing recognition that POLEs and comparable nonlaboratory work overseas—i.e., work that would be classified as A(SP)A-regulated research at a POLE if it occurred in the UK—present their own unique practical and ethical challenges compared with laboratory-based research. In many countries, nonlaboratory research can face less designated supervision than research undertaken within institutional laboratories, as specialized staff such as veterinarians and animal caregivers are not always present, and sites may be remote and difficult for regulators to inspect [3
]. Wildlife and fisheries researchers in the USA have highlighted how their work involves a large and confusing array of permits, in addition to those secured under the primary laws regulating animal research (the Animal Welfare Act of 1966 and the Animal Welfare Regulations, enforced by the Animal Care division of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA)) [4
]. Furthermore, wildlife and fisheries researchers have highlighted that their work may require ethical considerations beyond individual animal welfare given that research in the wild may also affect conspecifics, other species, and broader ecosystems [5
]. It has also been proposed that aspects of the 3Rs (the commitment to reduce
the number of animals used, refine
methods to minimize harm, and replace
animal research with alternatives whenever possible) may be more challenging in wildlife studies around the world. For example, it can be challenging to capture and sample sufficient wild animals to make the study viable, and postprocedure welfare monitoring is difficult when working on free-living animals that are subsequently released [3
Research at POLEs also raises questions about which activities fall under the A(SP)A and similar regulations, since the procedures undertaken are often only marginally invasive and fall near the “lower threshold”, which must be met or exceeded for a project to be regulated under the A(SP)A. This lower threshold is defined as causing “pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by inserting a hypodermic needle according to good veterinary practice” [1
]. EU Directive 2010/63/EU “on the protection of animals used for scientific purposes” took inspiration from the A(SP)A, and was transposed into UK law in 2013. For this reason, a similar threshold applies when determining the regulation of animal research across the EU, although local implementation may vary (L 276/39, Article 3 [10
]). Yet, it can be difficult to judge when procedures meet this threshold. For example, when assessing the welfare effects of biotelemetry devices on birds it is advisable to consider the behavior and ecology of the focal species, the attachment method and device location, and tag weight and shape [11
], making it potentially difficult to assess when proposed tagging of birds falls under the A(SP)A [15
]. Furthermore, in wildlife studies it may be the method of restraint or sedation rather than the attachment of a device that exceeds the lower threshold [2
]. As research projects at POLEs often sit close to this lower threshold, examining the regulation of research with nonlaboratory animals also raises questions about the regulation (or lack thereof) of animal work apparently outside of the A(SP)A, such as that often conducted by citizen scientists and ecological consultants [15
]. Animal work at POLEs can also often include, or closely resemble, nonscientific activities such as animal husbandry and veterinary treatment, which are explicitly excluded from the remit of the A(SP)A [1
]. Distinguishing research from husbandry and veterinary treatment may be challenging. Discussions within the veterinary community have therefore focused on the distinction between Recognised Veterinary Practice (RVP) and research [19
]. Similar issues may arise overseas, with researchers in Sweden, for example, pointing to the difficulty of determining when nonlaboratory research (e.g., with wildlife) is undertaken for research or management purposes, a decision which has important implications for regulation and oversight [17
Discussions around nonlaboratory research may also focus on unique ethical challenges posed by this work. For example, discussions within the veterinary community concern the prevalence [27
] and ethics of veterinary clinical trials and novel veterinary treatments with companion animals [28
]. Some ethical questions relate to relationships between veterinary researchers and the owners of animals, such as how much information owners are offered about what enrolling their pet in a clinical trial involves and their alternative options [30
], and how decisions about experimental treatments that may extend an animal’s life versus euthanasia are reached [29
]. This last example highlights how the unique challenges of research at POLEs may arise from the presence of animal owners and other members of the public, whose permission may be required for research to proceed. This reflects the point regularly made in social studies of science, that while laboratories tend to be contained and controlled spaces, usually only accessible to those involved in research and research support, nonlaboratory spaces of research, or “fields”, are often multiuse spaces where various members of the public and other stakeholders are colocated [34
Despite these ongoing discussions about the unique challenges and questions arising in nonlaboratory research, POLEs remain largely ignored in wider discussions about UK animal research. For example, there is no published information on the types and distribution of research venues that might be defined as a POLE, the number of research projects carried out at POLEs, and the number of animals studied specifically at POLEs in the UK. Figures on the number of non-A(SP)A projects and animals studied in research outside of the laboratory, such as subthreshold studies involving trapping and marking of wildlife, are also largely unknown. Furthermore, while the laboratory animal arena features numerous specialized networks intended to share information and provide support for those involved (e.g., in the UK, the Laboratory Animal Science Association (LASA), Laboratory Animals Veterinary Association (LAVA), and Institute of Animal Technology (IAT)), fewer such networks exist for nonlaboratory research at POLEs. Some commentators have also observed that most guidelines apply more appropriately to the laboratory rather than to companion animals [28
] and wildlife [9
], although this may be changing, as heralded, for example, by introduction in 2016 of guidelines under the A(SP)A targeted at researchers working with animals taken from the wild [2
]. Similar issues may arise overseas, with researchers in the USA, for example, describing a perceived lack of attention from Institutional Animal Care and Use Committees to the unique ethics and practical challenges encountered in nonlaboratory research [4
Research for the Animal Research Nexus project (AnNex; https://animalresearchnexus.org/
) uses methods from social sciences, humanities, and public and stakeholder engagement to understand emerging issues in animal research and helps to encourage communication across the sector [39
]. One substrand of AnNex focuses on animal research at POLEs; this research has suggested that many who work at POLEs would appreciate further discussion about the unique challenges that POLEs present to the researcher compared with laboratory settings. For this reason, a workshop was convened to explore the practical, ethical, and regulatory challenges encountered by researchers working at POLEs. The goal of the workshop was to bring together a diverse array of people with expertise from a variety of different POLEs to identify key challenges faced in their work, and discuss areas that may require attention from policy-makers and researchers. The aim of this paper is to describe key themes that emerged from the workshop discussions and offer recommendations for addressing outstanding questions and issues relating to animal research conducted at POLEs.
2. Materials and Methods
The workshop organizers (AP, BG, PHW, RM)—all social scientists involved in research for the AnNex project—recruited contributors via email on the basis of their expertise in a specific area relating to research at POLEs, as determined by a review of literature and the organizers’ professional networks (see Table S1
, for further detail on organizers’ and contributors’ expertise and roles in the workshop). Not all experts contacted were able to attend the workshop in person. The aim was to recruit contributors who could collectively identify and analyze key issues in several types of POLEs—namely farms, fisheries, zoos, veterinary clinics, and wildlife field sites—and possessed a diverse range of backgrounds and areas of expertise, including regulators, veterinarians, researchers, ethicists, social scientists, and citizen scientists. However, it should be noted that because no information is available on the kinds of sites that are classified as POLEs, it is possible that the workshop neglected some areas.
The workshop was invite-only, and purposively designed to be small in order to maximize the sharing of experiences. Attendees spoke from their own disciplinary backgrounds and experiences, but did not necessarily speak on behalf of their organizations. The workshop took place at Keble College at the University of Oxford on the 30th of September and 1st of October, 2019. All invited speakers gave verbal presentations in person, except CN who spoke remotely via a prerecorded presentation. J. Lane gave a public plenary on wildlife research ethics and regulation at the start of the meeting. The workshop the following day was organized as four panel discussions featuring 2–3 presentations followed by questions and discussion (see Table S1
): (1) introduction and wildlife (ND, SJR/RD, JA); (2) marine research, zoos, and farms (MW, KP, KM); (3) veterinary clinics (DW, ZB); and (4) reflections (SW, J. Lorimer). While presentations in panel 4 (reflections) were 10 min each, others were each 20 min and were requested to respond to the following questions, which were prepared based on emerging themes from the AnNex research on POLEs, and on the broader aims of the AnNex program. These questions (as outlined in [40
How does the category of animal (e.g., pets, wild animals, those housed in zoos or farms) shape ethical obligations, veterinary treatment, and humane end-points? How does the A(SP)A manage these ethical obligations and influence decisions?
How are boundaries drawn between work under and outside of the A(SP)A, and how do these boundaries shape research and animal welfare practice and regulation?
How do the general public and other stakeholders engage with research at POLEs?
How does taking scientific research with animals out of the laboratory shape the knowledge produced?
How is research with animals outside of the laboratory best regulated?
Throughout the workshop and as preagreed, all attending members of AnNex responsible for organizing the workshop (AP, BG, PHW, RM) took notes. All attendees at the workshop agreed to coproduce this synthesized work as coauthors. The workshop organizers, with input from all attending, identified key themes based on consolidated notes and presentation slides shared by speakers. Descriptions of key themes were compiled in the form of summary notes, which were approved and modified by speakers prior to sharing online via the AnNex website [40
]. In the following sections we expand on these key themes, drawing on discussions during the workshop and wider reading, and offer recommendations for addressing outstanding questions and issues relating to research carried out at POLEs.