Healthy volunteers (HVs) who participate in clinical trials are a vulnerable group that deserves specific protection. We assessed the number and types of studies that involve HVs around the world and outline the methodological barriers to their analysis. We found that tens of thousands of HVs are involved every year in clinical trials in a large variety of countries and that the overwhelming majority of studies are not “first-in-human” but pharmacokinetic studies. The two cornerstones for both ethical and safe participation of HVs in clinical trials are properly obtained informed consent and a minimization of exposure to risk, in particular by avoiding concealed participation in multiple trials. To minimize the risk of exploitation of HVs and their exposure to risk, we propose ways to ensure genuine informed consent, and advocate setting up national healthy volunteer registries as established in France and the U.K. All vulnerable groups and individuals should receive specifically considered protection.” Healthy volunteers (HVs) who participate in clinical trials constitute a potentially vulnerable set of persons that deserve the “specifically considered protection” recommended by the Declaration. Unlike patients, who may expect some direct health benefits from their participation in a clinical trial, HVs cannot expect benefits other than financial ones. In health-related research, “resource-limited settings” are not limited to low-income countries but can exist within middle- and high-income countries, as acknowledged by the 2016 Council for International Organizations of Medical Sciences International Ethical Guidelines for Health-Related Research Involving Humans.3 In these settings, HVs are most often poor people with low literacy levels who may not be able to understand the risks they may be taking. In addition, they often are in no position to refuse financial incentives, and indeed may be actively seeking them, because for many of them, participation in clinical trials is a critical source of income. This paper aims to summarize available data on studies in HVs, outline the key ethical issues that relate to HVs’ participation in clinical trials, particularly in resource-poor settings, and propose ways to address these issues.The World Medical Association’s Declaration of Helsinki4 and in Europe5 for “repeat volunteers,” i.e., those who have participated in several clinical trials, and also by researchers in India,6 Brazil,7 Romania,8 and Portugal.9 Motivations can vary based on demographic or socioeconomic characteristics, for instance, financial gains can be the main reason for participating for younger people,10 but may be seen as of secondary importance by medical students.11A variety of reasons may motivate participation of HVs in clinical trials, such as altruism, accessing ancillary healthcare benefits , scientific interest, curiosity, meeting people, etc. However, financial gain is the primary reason why HVs participate in clinical trials. This has been well documented both in the U.S.12 Some U.S. authors have described how economically disenfranchised people are systematically used in pharmaceutical development.13 Others, describing the population of healthy people who volunteer for participation in clinical trials, have spoken of the “exploitation of a research underclass.”14 Outside of the United States, little research seems to have been carried out to document the characteristics of HV populations who participate in clinical trials. There is little doubt that in many settings, HVs can be characterized as a specifically vulnerable population that is exposed to a risk of exploitation, because they may not be able to provide genuine informed consent for participating in a clinical trial.Resource-poor settings, i.e., difficult economic conditions, low literacy levels, limited access to healthcare, etc., can be found in low- and middle-income countries, but also in high-income countries, as was well documented by U.S. teams.15 have described how 58% of a panel of HVs in Israel did not even try to form a proper understanding of potential risks and benefits on which to base a “quality decision” to participate in a trial. Similar observations were made in India,16 where a study found that most HVs had decided to participate before being offered any information during the informed consent process, or even before visiting the study centers. One of the few available papers on HVs in low- and middle-income countries shows how, in India, contract research organizations (CROs) resort to “middlemen” to recruit poor participants who have no understanding of what the studies are about and basically “chose to participate in the trials due to insufficient income and unstable jobs.”17The ability to provide informed consent rests on two pillars: the ability to properly understand the potential risks and benefits related to the proposed trial, and the ability to refuse participation. On both accounts, HVs in resource-poor settings are vulnerable: their literacy levels may not enable them to properly understand what risks they may expose themselves to, and the financial compensation provided for their participation can become an undue financial inducement if they are in no position to refuse it. Rabin et al.18 Several authors have described the tactics that some have developed to optimize their chances of being selected for the most appealing studies, most often those that offer the best financial benefits.20 For instance, Devine et al.21 showed that in a sample of 100 subjects who had participated in at least two studies in the previous year, three-quarters reported concealing some health information from researchers in their lifetime to avoid exclusion from enrollment in a study. They had designed ways to hide their participation in concomitant studies, conceal underlying medical conditions, intake of concomitant medications, or substance abuse. Participation in multiple clinical trials, simultaneously or without respecting a sufficient “wash-out” interval between studies, exposes HVs to potential safety risks related to drug-drug interactions.22 It may also compromise the validity of study results,23 thereby exposing future patients to unforeseen safety and efficacy issues.Several U.S. researchers have investigated “professional healthy volunteers,” who make a living out of their participation in multiple clinical trials. Payments of several thousand dollars for participation in a clinical trial are not unusual, which can lead in some cases to yearly incomes of over $30,000.We aimed to document the number of HVs participating in studies, anywhere in the world, that involve the administration of medicines or biologicals , with no prospect of direct medical benefit.24 a privately owned database that merges information on clinical trials from multiple sources around the world. Second, the clinicaltrials.gov25 database from the U.S. National Library of Medicine, which includes studies from multiple countries in addition to the United States . Third, a country’s national registry, the Clinical Trials Registry of India.26 And, finally, internal data from Sanofi, a global research-based pharmaceutical company.For this, we accessed four data sources with the intent of progressively narrowing our scope and getting more detailed information, including three web-based databases. First, TrialTrove,We accessed the three web-based databases on a single occasion during the same week of September 2017, in order to get a snapshot picture of the situation. For Sanofi, we collected data on studies performed globally during the years 2014, 2015, and 2016.clinicaltrials.gov database, we selected the following filters: Phase I, early Phase I, Recruiting, Not yet recruiting, Active, Not recruiting, Enrolling by invitation, Suspended, and Unknown status. To focus on studies involving HVs, we selected the term “healthy” as a filter in “condition/disease,” in order to capture mentions of both “healthy volunteer(s)” and “healthy subject(s).” Aiming for the same objectives for the TrialTrove database, we selected the following filters: Phase I, Open, Temporarily closed, Planned, and the term Healthy in Inclusion Criteria. For the Clinical Trials Registry of India, we selected the following filters: Phase I, Not yet recruiting, Suspended, Open to recruitment, and Healthy volunteers.We used a variety of the available data filters of the web-based databases to focus only on planned or ongoing studies. For the However, trying to obtain precise and homogeneous data from web-based databases turned out to be very difficult, for a variety of reasons.can expect a benefit from their participation, that of being, potentially, protected against a disease. Lastly, HVs also participate in studies with no administration of medicines such as social science studies, sample collections, medical imagery studies, etc.; these studies are outside the scope of this paper since participants are not, usually, exposed to a medical risk.The first difficulty stems from the ambiguity of terms such as “Phase I studies” and “healthy volunteers,” resulting in wide variations in the way these studies are reported in databases or referred to in the literature. Most people equate “studies in HVs” with “Phase I studies,” that is first administrations of new chemical entities to humans. However, as will be shown later in this paper, the large majority of studies in HVs do not concern new chemical entities, but rather registered drugs which are tested for bioequivalence or bioavailability, most often versus a generic version, as part of the registration process of the generic drug. “Phase I” is also largely used for studies performed in patients. In the field of oncology in particular, early studies of new drugs potentially too toxic to be administered to HVs involve cancer patients for whom direct benefit is not usually expected but cannot be entirely ruled out. An added complication is that the term “healthy volunteer” can be used to designate people taking part in trials of preventative vaccines. These people are undoubtedly healthy, at least regarding the disease under consideration, but they clinicaltrials.gov database dedicated to Phase I trials, where a large variety of trials are recorded. This seems to indicate that some sponsors decide to voluntarily post information on “first-in-human” studies , while others use the term “Phase I” to report, for instance, any study where no direct therapeutic benefit to participants is expected, such as early studies of medicines or biologicals in cancer patients, as well as studies that are observational or focus on biological samples collections or medical imagery.The second set of difficulties comes from the fact that data on clinical trials performed with HVs are largely owned by private corporations, i.e., pharmaceutical companies (research-based and generic) that sponsor most of these studies, and by CROs that carry them out. There is no central repository where all trials in HVs can be found. U.S. regulations for “applicable clinical trials” that must be registered in the “clinicaltrials.gov” database specifically exclude Phase 1 trials of a drug and/or biological product. There is nevertheless a section of the The TrialTrove database yielded a total of 28,716 Phase I studies, performed at 13,547 sites around the world. Focusing on planned or ongoing Phase 1 trials yielded a total of 1,435 trials. clinicaltrials.gov database included a total of 250,494 studies, with no filter applied regarding study type or status . Out of these, 41,220 (16.5%) were reported as “Phase I studies,” and 11,832 were reported as planned or ongoing. Adding the term “healthy” as a “condition/disease” filter, 1,085 studies were identified. Overall, as shown in clinicaltrials.gov databases, with the notable exception of Mexico, for which the TrialTrove lists 367 trials while clinicaltrials.gov lists 2 trials.The U.S. 27 Out of a total of 9,114 studies registered, 312 (3.4%) were labeled as “Phase I” and 26 (0.3%) were reported when “Phase I” and “healthy volunteers” filters were combined. In both instances, many studies appeared to involve patients. As was observed with the U.S. database, when the term “healthy volunteer” was used as a key word, a sizeable number of studies (225) were found, with the same wide variations in the types of studies reported. The low number of “Phase I” studies is consistent with the requirement of Indian authorities that first administrations to “humans” of new chemical entities be carried out in the country of origin of the new compound. Therefore, the overwhelming majority of studies can be expected to be pharmacokinetic studies, reflecting the large number of generic companies present in India.28We repeated the same exercise with the Clinical Trials Registry of India.Given the difficulties of interpreting data extracted from databases with large amounts of data entered by a wide variety of persons, we saw the database of one large multinational research-based pharmaceutical company as a way to help shed light on the situation. At the request of the Sanofi Bioethics Committee, we obtained data on studies sponsored by Sanofi, involving HVs and administration of medicines, performed during the years 2014, 2015 and 2016. As shown in Even though assessing the actual number of studies involving HVs globally is a challenge, the data we have found from a variety of sources consistently supports some clear conclusions: tens of thousands of HVs are involved every year in clinical trials in a large variety of countries on all five continents, and the overwhelming majority of these studies appear to be pharmacokinetic rather than “first-in-human” studies. We believe that HVs would be better protected by improving the way their informed consent process is managed and by setting up national registries.To ensure that HVs properly understand the information that is provided to them during the informed consent process and are able to determine the level of risk to which they expose themselves, it can be proposed that tests be performed to check that each HV has properly understood the most critical information provided. The results of these tests should be documented, and HVs who do not demonstrate a sufficient understanding, possibly after a second round of information, should be excluded from participation. Such an approach will exclude HVs that are not able to understand basic scientific concepts and would therefore help ensuring proper informed consent.National compulsory registries, where each HV must be registered before being considered for participation, can prevent individual HVs from participating in several trials at the same time and thereby ensure that they respect the required “wash-out” periods between trials. Such registries can also be used to track payments made to each individual so as to ensure that they do not go above an acceptable level that could jeopardize their ability to refuse participation. To our knowledge, France and the U.K. are the only countries where national registries have been set up.Volontaires Recherche Biomédicale,29 is based on a law (loi Huriet-Serusclat), passed in late 1988, which established a legal framework for trials involving HVs.30 It is administered by the Ministry of Health, and its operating mode was most recently revised by law in 2006.31 Registration of HVs by investigators is mandatory, and HVs must be covered by the national “Sécurité Sociale” scheme. The information entered into the database includes the identity, date and place of birth of the HV, the dates of study participation, and, if appropriate, the poststudy exclusion period during which no other study participation is allowed. The amount of financial compensation received for each study is also entered, and a maximum level of earnings is set by law, currently 4,500 Euros over a 12-month period.France’s national registry, the 32 was initially operated on a voluntary basis and administered by an independent charity. It was initiated following the findings by the Hammersmith Medical Research Phase I unit in London that from 1997 to 2001, 1 in 10 healthy volunteers they screened had completed a study of a potential new medicine within the previous 12 weeks, even though they had signed a statement to the contrary.33 The same team has documented how the use of TOPS by an increasing number of U.K. Phase I units has resulted in decreasing the incidence of subjects attempting to volunteer within 3 months of completing another trial in another unit. Since 2013, TOPS has come within the remit of the National Health Service’s Health Research Authority, and registration of individual HVs has become a standard condition of ethical approval, as well as part of the Medicines & Healthcare Products Regulatory Agency accreditation scheme. HVs are identified by their National Insurance number (for U.K. citizens) or by their passport number and country of origin (for non-U.K. citizens). TOPS does not include information on post-study exclusion periods, only the date of the last dose of study medicine received. It does not include information on payments made to HVs.The U.K. national registry, the Over-Volunteering Prevention System “TOPS”,34 Voluntary, privately managed registries have been set up in the USA and Canada: the Clinical Research Subject Verification Program35 and Verified Clinical Trials.36 U.S. researchers have advocated that a national registry could play an important role in promoting research integrity and protecting subjects from harm.40 National mandatory registries require clear operating rules and multiple safeguards to ensure, in particular, HV data privacy. They can only be set up by law, and the examples of France and the U.K. could help other countries to design similar systems.The Swiss canton of Ticino also set up a mandatory registry for HVs in the early 2000s.We have moved a long way since the early days of clinical pharmacology in the 1980s, when Phase I studies were carried out in a limited number of academic institutions in Europe and North America, and most HVs were university students, often from medical schools.A large global industry has now been set up to obtain the data required by drug developers and regulatory agencies from studies in HVs. In this paper, it was shown how difficult it is to get a proper idea of the number of clinical trials involving HVs that are carried out around the world. But however limited the data we have collected, it is clear that every year thousands of clinical trials, involving tens of thousands of HVs, are carried out, partly for “first-in-human” studies, but overwhelmingly for pharmacokinetic studies related to the registration of generic medicines. It is also clear that everywhere in the world, most HVs are vulnerable people because of their economic circumstances and/or their literacy levels.multiple clinical trials. Preventing poor people from earning a living out of participation in clinical trials may be seen as raising additional ethical concerns. As stated by Fisher,41 for some “the systematic use of economically disenfranchised people like healthy volunteers in pharmaceutical clinical development is not seen as being exploitative, but is instead presented as an opportunity for the members of these groups.” Nevertheless, the two basic tenets of ethical participation in clinical trials are proper informed consent and the avoidance of undue financial inducements that would negate the ability to freely accept or refuse participation. On both matters, no compromise should be accepted.Setting up national HV registries can be an appropriate way to ensure that HVs are prevented from concealing their participation in multiple trials and receive appropriate financial indemnification that does not represent undue financial inducement. National HV registries should help to reduce the number of people participating in Most clinical trials involving HVs are sponsored by pharmaceutical firms, both generic and research-based, and performed by CROs. The standards used by major pharmaceutical companies for the clinical trials they sponsor contribute to raising the standards of ethical and scientific quality globally. Pharmaceutical companies and CROs should take pride in supporting initiatives to ensure that this neglected, highly vulnerable group of persons benefits from the best possible safeguards. National registries, as in France and in the U.K., can only be set up by governments’ decisions. It is the responsibility of all stakeholders involved in early clinical research, both private and public, to bring these issues and proposals to the attention of political decision makers.


People commonly fail to recognise the behavioural signs that horses display when they experience pain and fear. Consequently, the distress remains unresolved, reducing the horse’s welfare and having potential safety implications for the handler. In order to investigate the public’s ability to recognise such signs of equine distress, members of equestrian Facebook groups were asked to view and comment on six videos; these videos were selected by the authors on account of their portrayal of horses behaving in a manner suggestive of negative affect. For comparison, responses were also obtained from six equine behaviourists, who identified behaviours suggestive of varying degrees of distress. While respondents successfully recognised behaviour consistent with negative affect in some instances, videos featuring natural horsemanship and bridle-less riding were often wrongly interpreted to be positive experiences for the horses. Despite recognising behaviours indicative of distress in some videos, a minority of respondents nevertheless said they would have been happy for their own horse to be treated similarly. Participant age and experience had little effect on the results; however, responses by people who had selected “clicker training” as their preferred equestrian activity were more closely aligned with those of the equine behaviourists, suggesting that clicker trainers might be more accurate in their recognition of equine distress than other members of the equestrian community. This study can be used to inform the outreach activity of education and welfare organisations, through improved recognition, and subsequent reduction, of equine distress.p < 0.01) but that experience of equine-ownership was not. Of the equestrian activities preferred by participants, only proponents of clicker training showed an increased likelihood of obtaining the correct answer (p = 0.05). Even when behavioural signs suggestive of negative affective states were recognised, a minority of respondents stated that they would be happy for their horse to be treated similarly. In conclusion, behavioural signs of equine distress are poorly recognised; they therefore warrant an increased prominence in education and the outreach activity of welfare organisations, in order to reduce equine suffering.A key welfare problem for horses is that people commonly fail to recognise, and consequently neglect to resolve, equine behavioural signs of distress, worsening the welfare of the horse and potentially putting the safety of the handler at risk as a result. Members of equestrian Facebook groups were asked to view six videos and assess the horse’s behaviour in each; the authors selected the videos and considered each video to demonstrate behaviour associated with negative affective states. An additional six equine behaviourists also completed the survey as an “expert comparison group” from whom we could define “correct” answers; their responses were consistent with each other and the views of the authors. Although the majority of respondents successfully recognised behaviour indicative of distress in some instances, behaviour associated with negative affective states was commonly missed; videos featuring natural horsemanship and bridle-less riding were particularly interpreted incorrectly to be positive experiences for the horses. Binary logistic regression analysis (72.1% success rate) confirmed that the different video types  were strong predictors for obtaining a correct answer ( The failure of equine caregivers to recognise, and subsequently to resolve, expressions of equine stress and pain has been highlighted as a key welfare concern . Lack ofBehavioural indicators of pain and stress are relatively well established in the literature, albeit with a high dependence on physiological information that is unavailable to typical equine owners or handlers. An equine “pain face” and “pain ethogram” have been recognised ,5,6 and The inability of owners to recognise patterns of behaviours of horses that underpin negative emotional states has been explored by  and has Identification of behavioural criteria for recognition of negative emotional states is undoubtedly challenging. However, if subtle, early indicators are missed or ignored by the handler, then there is a greater risk that these responses will escalate into more dangerous behaviours (both for human or horse), such as bucking, rearing, kicking, biting, and bolting. A greater number of dangerous behaviours lead to an increased likelihood of punitive action by the handler, mistakenly believing the horse to be recalcitrant, causing a further source of distress to the horse . TherefoThe aim of this study is to investigate the ability of members of the equestrian community to recognise signs of negative affective state. Without such recognition, the likelihood of such states being alleviated is minimal and becomes a welfare issue.The data used in this study were obtained via a survey that was distributed (in the first instance) in five equine-related Facebook groups , with members based predominantly, but not exclusively, in the U.K. Care was taken to select Facebook groups that were large (>1000 members) and representative of the equestrian community, and no particular training approach was favoured. Some participants opted to share the survey further, into other groups or personal feeds, broadening its audience more widely.The survey was conducted according to the Code of Ethics and Conduct of the British Psychological Society. Participants were informed of the purpose and contents of the survey, their right to withdraw, data confidentiality and adherence to General Data Protection Regulation; they then provided their informed consent to participate in the study and have their anonymised data published.Respondents were shown six video clips with duration of a few seconds to two minutes, in each of which a horse was being handled in a different manner—(1) ridden dressage, (2) natural horsemanship , (3) inDemographic information was obtained for each respondent—age, country of residence, preferred equestrian activity , hunting, natural horsemanship, polo, show jumping, Western and “none of the above but enjoy spending time with horses”) and level of experience (multiple answers selected from new (<5 years) horse owner, experienced owner, experienced past owner but currently not a horse-owner, not an owner and professional trainer/instructor/behaviourist/veterinarian or veterinary-nurse/farrier or trimmer/other). Finally, participants were asked to grade on a 4-point Likert scale their self-perceived ability to recognise fear, stress and anxiety in horses, and to describe the behavioural signs that they would normally use to recognise fear and stress. A 4-point scale was chosen to ensure that respondents could be more definite in their response, rather than selecting a mid-point.Each participant was given a set of 13 possible affective states—angry, anxious, conflicted (defined in the survey as “experiencing two emotions at the same moment in time”), enjoying it, excited, fearful, frustrated, playful, relaxed, stressed, stubborn, submissive, switched off or “resigned”. These affective states might or might not have been experienced by the horse, and the participant was asked to select any number of these options that they recognised in the body language of each horse. The affective states were selected on the basis of being every-day language commonly used by horse owners to describe their horses, correctly or otherwise. Participants were also asked to state on a 3-point Likert scale whether they would be happy for their own horse to be treated in such a manner and, in free text without word limit, to explain their answers. Finally, participants were asked more generally to state, in a free text answer, the behavioural responses that they considered indicative of equine distress.In order to obtain an expert consensus with which a “correct” answer could be defined, the survey was also sent directly to all clinical and accredited equine behaviourists who were listed at the time of the survey on the register held by the Animal Behaviour and Training Council (ABTC). The advantage of using the ABTC register is that those listed are highly qualified and recognised behaviourists in the U.K. and have a variety of backgrounds in terms of education and experience. Therefore, any agreement between them, regarding interpretation of the behaviours demonstrated by the horses in the videos, can be considered to be reasonably accurate. Six of the behaviourists contacted agreed to provide survey responses and consequently became an “expert comparison” group  with which the respondent data could be compared. In order to avoid any conflicts of interest, the ABTC behaviourists also authoring this paper were not included in the expert group. While use of the term “behaviourist” is unfortunate, due to behaviourism being concerned only with observable stimulus-response behaviours, it remains accepted terminology in the industry and is used here to be synonymous with “behaviour consultant”.The data were collected via the Google Forms platform, and prepared for analysis and plotted via a combination of Microsoft Excel and bespoke C-Shell scripts. The quantitative data were analysed using SPSS v. 25  for Mac. Initial relationships between variables were assessed using Pearson’s Chi square test of association. Since some pairs of variables had small sample sizes, the significance of any association was confirmed with Fisher’s exact test. Pairs of variables found to have significant associations were explored further using forced entry binary logistic regression analysis.Since the sample sizes of the experts and participants were too disparate to use for a statistically meaningful comparison, it was necessary to define whether a participant response could be considered “correct” or “incorrect”. In order to find a reasonable balance between robustness and subjectivity, a response was considered “correct” if it met two specific criteria. Criterion 1 required at least one of the responses that 4–6 of the experts , Canada (4.9%), other European countries (4.9%), Australia (3.2%), South Africa (0.5%) and Brazil (0.5%). The preferred equestrian activities of participants were numbered as 28.1% dressage, 27.6% “happy hacking”, 10.8% eventing, 10.8% clicker training, 5.4% natural horsemanship, 4.3% endurance, 2.2% Western riding, 2.2% show jumping and 0.5% polo. A further 8.1% said that that they were “none of the above but enjoyed spending time with horses”; for convenience, this group was labelled “others” in later discussion. When asked about their experience with horses, 137 participants claimed to be experienced horse owners, of whom 20 were also professionals within the equine industry; 8 were experienced former owners of whom 2 were also professionals; 19 had owned horses for fewer than 5 years, 2 of whom were professionals; and 5 were not owners at all. A further 16 selected only the ‘professionals’ category. Of the 40 stating that they were professionals within the equine industry, 29 were instructors or trainers, with some also classifying themselves as behaviourists. In response to the question about ability to recognise behavioural expressions of fear, stress and anxiety, 75 claimed “yes, definitely”, 91 “yes, somewhat”, 18 “perhaps/sometimes” and 1 “probably not”.When asked generally to state the typical signs that they would use to determine whether a horse was frightened and/or stressed, the experts listed a variety of behavioural responses, of which a subset would likely be shown by an individual horse. While some were overt behaviours, such as rearing or flight, the majority were subtle, such as eye movements, breathing rate or yawning. Some comments reflected a wider understanding of causal factors such as avoidance of tack or changes in social behaviour. While detailed analysis of these qualitative responses is beyond the scope of this paper and will be the subject of a future work, the key point is that the experts were aware of potential early behavioural indications that are likely to reflect the onset of negative affect.When asked to list the generic behavioural signs that they would use to determine whether a horse was frightened and/or stressed, many respondents were able to provide a set of subtle behaviours similar to those noted by the experts. However, a greater proportion of overt behaviours were also included, such as bolting, pushiness, vocalising, “foaming at the mouth” or trembling. While these would all have been correct responses, anecdotal experience of working in behavioural practice indicates that earlier and more subtle suggestions of distress would typically also have been present, consistent with the hierarchy of behavioural indicators of stress found in .All participants selected at least one affective state for each video clip and typically selected more than one. p < 0.001; Cramer’s V = 0.46, p < 0.001) with videos 1, 3 and 5 receiving significantly more correct answers, videos 2 and 4 receiving significantly more incorrect answers; video 6 was almost equal, receiving just one more correct answer than incorrect. p < 0.05; Cramer’s V = 0.27 and 0.24 respectively, p < 0.05). Videos 1, 2 and 6 showed a significant association and medium effect size between preferred activity and correct response . These results are illustrated in p < 0.05; Cramer’s V = 0.30, 0.26, respectively, p < 0.05), but somewhat erratically, with experienced and new owners obtaining more correct responses in video 3 and professionals scoring higher in video 6. There was no association between correct response and self-reported ability to recognise fear, stress and anxiety for any of the videos.Pearson Chi-square tests also examined the associations between obtaining a correct answer and the participants’ age, preferred equestrian activity, experience and self-perceived ability to recognise equine distress. Fisher’s exact test was included to account for small sample sizes in some pairings. Videos 3 and 5 showed a significant association between increasing age and correct response, albeit with a relatively small effect size . The model was successful in predicting 72.1% of the outcomes (p < 0.01) compared with the null, intercept-only model. p = 0.05) contribution from the activity categories was clicker training, albeit with a very large upper confidence limit.Binary logistic regression analysis was used to explore the possible association between preferred equestrian activity, participant experience and successful recognition of negative affective states. A model with three predictor variables—Video, Activity and Experience—was used to predict the likelihood of correct answers  were present, and that the more pleasurable states  were absent, would consider it an acceptable state for the horse to be in during training. The answers are represented in The panel of experts who formed the comparison group gave responses indicating that they believed the horses in all six videos to be demonstrating behavioural signs of stress. Their answers were not identical with one another, but were largely in agreement for the majority of the observations. Any inconsistency was subtle, such as interpreting affective state as “anxious” rather than “stressed”, rather than a fundamentally different qualitative understanding of the affective state. They were unanimous, however, in stating that all horses were experiencing a negative affective state and selected one or more of angry, anxious, conflicted, fearful, frustrated, relaxed, stressed, submissive and switched-off for each horse. They did not consider any of the horses to be experiencing any positive affect, with the exception of just one stating that the horse in video 6  appeared relaxed. None thought any horse showed stubbornness at any point. None of the experts would have been happy for their own horse to be interacted with in the manner shown in videos 1–5; 5 of the 6 experts selected “partially” for video 6 , the 6th selected “No”.The experts’ responses contrast with the participants’ responses and the results of this study support previous findings , that eqGiven both the differences in individual horse responses to stressors and the subjectivity of observers, it is perhaps not sufficient to list ethograms of behaviours that might be signs of distress. Good welfare depends on understanding and meeting the physical and emotional needs of the individual horse, as detailed in e.g. ,25. The Under the rules of the Fédération Equestre Internationale, dressage judges are expected to recognise and reward “the happy athlete” as a key objective . Of courThere were limitations to the design of this study. The survey was more likely to be completed by people interested in behaviour and promotion of the survey on social media groups that were not particularly behaviourally-focused was attempted in order to obtain a sample representative of the equestrian community. However, the survey was shared by friends and supporters of EBTA, increasing the chances of it becoming biased. Future studies could be improved through restricting the survey to (for example) riding clubs or college students rather than relying on the power of social media. In addition, in defining Criteria 1 and 2 it was possible that some responses could be rejected as “incorrect” when they were still possibly correct at a subjective level. For example, anyone labelling the horses in videos 1–5 as “anxious” alone would have been marked as incorrect, arguably erroneously; similarly the distinction between frustrated and angry—the experts selected frustrated but not angry. This effect was mitigated since most respondents selected multiple options for affective states; future studies might be improved if respondents were required to select a set number of affective states instead of allowing this variable to float freely. However, since only one of the experts’ selections was required for a “correct” answer, it was felt that it was already relatively easy for participants to succeed. A final limitation was that “conflicted” and “submissive” were insufficiently defined to be sure that participants were consistent in their use of the terms. “Conflicted” was defined as “experiencing two emotions at the same moment in time” but in some responses the two emotions in question did not seem to be conflicting. Similarly, “submissive” has different connotations to different people; behaviourists commonly regard it negatively, that the horse is overly compliant, however, some respondents clearly regarded it to mean a desirable obedience, again implying a distinction in mindset with potential welfare implications.While this study clearly showed the need for improved recognition of early behavioural indications of negative affective states, the means by which this could be implemented is not straightforward. Clarity in definition of terminology is necessary, as well as caution regarding labels such as “stubborn” or “submissive”, which perhaps reflect a need for a more empathic approach, and investigation into the cause of the behaviour is needed. Furthermore, having clear definitions is of no help to horses unless that information is disseminated more effectively into the horse-owning community; research into the best channels of communication is also key. The expert group responses were almost unanimous and it would be interesting to explore whether agreement could be increased still further, particularly in distinguishing between closely-linked affective states such as fear, stress and anxiety. The study could be improved further if a larger group of experts were consulted, adding weight to the definition of a “correct” answer.These results also offer the possibility of further associations to explore. What is it about natural horsemanship and bridle-less riding that renders people more likely to misinterpret the horses’ behaviour, when those same people would be more successful if assessing a dressage horse? The Chi square analysis suggested that clicker trainers might have a greater understanding of behaviour than the wider equestrian public and this result remained inconclusive following the binary logistic regression analysis. Further study would be interesting, both to confirm the effect and also with a view to distinguishing whether behaviourally-minded people are attracted to clicker training, or whether the need for detailed understanding of operant conditioning results in a more generalized ability and desire to recognise more subtle behaviours.


Medicine is a high-status, high-skill occupation which has traditionally provided access to good quality jobs and relatively high salaries. In Ireland, historic underfunding combined with austerity-related cutbacks has negatively impacted job quality to the extent that hospital medical jobs have begun to resemble extreme jobs. Extreme jobs combine components of a good quality job—high pay, high job control, challenging demands, with those of a low-quality job—long working hours, heavy workloads. Deteriorating job quality and the normalisation of extreme working is driving doctor emigration from Ireland and deterring return.Semi-structured qualitative interviews were conducted with 40 Irish emigrant doctors in Australia who had emigrated from Ireland since 2008. Interviews were held in July–August 2018.Respondents reflected on their experiences of working in the Irish health system, describing hospital workplaces that were understaffed, overstretched and within which extreme working had become normalised, particularly in relation to long working hours, fast working pace, doing more with less and fighting a climate of negativity. Drawing on Hirschman’s work on exit, voice and loyalty (1970), the authors consider doctor emigration as exit and present respondent experiences of voice prior to emigration. Only 14/40 respondent emigrant doctors intend to return to work in Ireland.The deterioration in medical job quality and the normalisation of extreme working is a key driver of doctor emigration from Ireland, and deterring return. Irish trained hospital doctors emigrate to access good quality jobs in Australia and are increasingly likely to remain abroad once they have secured them. To improve doctor retention, health systems and employers must mitigate a gainst the emergence of extreme work in healthcare. Employee voice  should be encouraged and used to inform health system improvement and to mitigate exit. Research into doctor migration indicates that it is driven by a combination of push factors which encourage doctors to emigrate from their country of origin (or country of training), and pull factors, which attract them to specific destination countries. Early research into doctor migration found that it tended to be driven by poor medical career advancement opportunities at home, a desire for specialist training opportunities abroad  and the Doctor emigration poses a challenge to all health systems in that it has an immediate impact on the supply of doctors into the workforce , but it While the drivers of migration have remained remarkably consistent over time , the direction of migration flows change in response to local and global economic conditions. For instance, the 2008 global economic recession and resultant austerity measures—including widespread pay cuts, recruitment embargoes, staff reductions and increased workloads —led to hAlthough medicine is a high-status, high-skill occupation which has traditionally provided access to good quality jobs and relatively high salaries, continuing to provide such benefits in the context of an economic recession and period of austerity is a challenge. Health systems and health employers must adapt to today’s expectations of what constitutes a good quality medical job , and do Drawing on interviews with Irish hospital doctors in Australia, this paper considers how deteriorating job quality and the normalisation of extreme working is driving Irish trained hospital doctors to exit  the IrisJob quality is ‘the extent to which a job has work and employment-related factors that foster beneficial outcomes for the employee, particularly psychological wellbeing, physical wellbeing and positive attitudes’ . Good-qu‘Extreme jobs’ combine components of a good quality job—high pay, high job control, challenging demands, with those of a low-quality job—long working hours and very high workloads . In induThe content of jobs and expectations of what constitutes a good-quality job can change over time and in response to wider social and economic conditions. For instance, austerity measures have shaped work by decreasing health budgets, reducing staffing levels and causing workloads to increase. This has contributed to the ‘growing sense in which “normal” workplaces are becoming “extreme” ’, particuWorkers face choices when dissatisfied with their job quality. Here we turn to Hirschman and his theory of exit, voice and loyalty . HirschmMedicine offers doctors a ‘boundaryless global career’ , an attrIrish doctors have a long tradition of emigration. The established pattern was to emigrate for 1–2 years to complete a fellowship in the USA or the UK, before returning to work in Ireland. As doctors returned in sufficient numbers to ensure strong competition for consultant posts, emigration was widely considered beneficial , rather The dynamics of doctor emigration changed, post-2008, as the Irish health system endured ‘radical resource cuts’ , includiDrawing on 40 interviews with emigrant Irish doctors who moved to Australia since 2008, this paper considers how deteriorating job quality and the normalisation of extreme working drive emigration—conceptualised as exit. Possibilities for voice , 26, 27 N = 51). This paper focusses on a subset of doctors (N = 40), i.e. those who migrated to Australia since 2008. Semi-structured qualitative interviews were conducted in Australia in July–August 2018. In an era of increased emigration, Australia has become a key destination for Irish trained doctors  my problem anyway’ (Respondent 1).For these two respondents, feeling unsupported by their employer during major life events strongly influenced their decision to exit the Irish health system.3.Always fighting a climate of negativityRespondents described how the combination of long working hours and busy work environments resulted in work-related stress and anxiety:‘I was . . . quite unhappy and probably a hard person to live with because I was under immense stress’ (Respondent 11).‘It’s probably just part and parcel of being an intern, but I met friends of mine crying in side rooms off of wards just in bits about what just happened’ (Respondent 8).Disrespectful behaviour from colleagues, both medical and non-medical, had an impact on the work environment and created a negative atmosphere at work. Respondents who had experienced or had witnessed such behaviour, had accepted it as the norm at the time.‘the bigger the hospital, the angrier people were. A lot of aggression, a lot of fighting, just because everyone is exhausted and burnt out’ (Respondent 49).‘I don't think we need sympathy, we just need a fair deal, that's all. . . the way it's lined up everyone's overworked, that's the hospitals in general: the nurses are overworked, the doctors are overworked. It means that there's a lot of antagonism all the time’ (Respondent 43).A related issue was that respondents felt that they did not have adequate time to care for colleagues who were struggling; ‘everyone's just busy trying to just keep their own mental health up, so they're not great at looking after others’ (Respondent 13). This meant that those in need of support, of collegiality, were not always able to access it: ‘nothing terrible . . . ever happened, but I just felt secluded and alone’ (Respondent 18).A further source of negativity was the challenge of negotiating overtime payments. This was an area of conflict between hospital administrators and junior hospital doctors. As hospitals were eager to ensure compliance with the European Working Time Directive‘When I was an intern, I worked hundred-hour weeks as a standard . . . the administrator . . . would pay maybe 83 of the hours that week’ (Respondent 13).‘The hospital I worked in, I did 24-hour shifts. In fact, it was even worse than that. You'd only get paid for a 24-hour shift, but you'd have to do 26 hours. And you'd just be not paid for two hours because they couldn't be seen to break the 24-hour rule’ (Respondent 23).4.Emigration as exitDeteriorating job quality and the normalisation of extreme working influenced the decision to emigrate. This coincided with (and was reinforced by) austerity-related staffing and funding cutbacks within their hospital work environments. These impacted on senior, or consultant hospital doctors, as well as on junior colleagues or trainees, as this respondent explains:‘the deteriorating quality of the job . . . we were having to take responsibility for . . . juniors that weren’t up to scratch and for doing extra work for colleagues’ (Respondent 31).‘I was going to leave medicine before I came out [to Australia]. . . I was burnt out. I was definitely suffering burnout when I moved out here. Yeah, no question, after my year as a Reg, I was definitely suffering burnout after that year. And it was a job I loved doing. . . it was with a team that I loved working with, but just gets too much’ (Respondent 49).‘The system. Yeah, I left Ireland to recharge, get out of there. I was really dissatisfied with how my career was going. I didn't see myself being three years into my career after working so hard in medical school to do so well and publish to many papers, and then to kind of turn around and be like, what's gone wrong? . . . Yeah, it was just to try and . . . Self-preservation basically’ (Respondent 22).5.Exit and voiceRespondents felt that working as a hospital doctor in Ireland put them at risk of burnout and that they needed to exit the Irish health system, or the medical profession, to find more sustainable ways of working.All respondents were emigrant doctors who, by definition, had already exited the Irish health system at the time of interview. Most respondents (38/40) held junior hospital doctor posts within the Irish health system immediately prior to their emigration. Some explained that they had opted for exit rather than voice because of their precarious employment circumstances.‘in every hospital we're temporary staff. . . So, all that needs to happen is the contract doesn't need to be renewed’ (Respondent 49).As junior hospital doctors, known in the Irish context as NCHDs , respondents were relatively junior members of the medical profession who held short-term employment contracts within the hospital. Perhaps as a result of this, voice was considered an isolating activity which would carry significant career risks:‘In order for us to stay and rectify some of these issues would require someone taking the hospitals to task on it, but that requires someone standing up . . . you put your head above that stand, it’s chopped off and that’s it. Your career is done . . . you can’t complain too loudly, or it will definitely negatively impact your career’ (Respondent 49).‘This . . . clash with one of the professors . . . No one really standing up for what they privately thought was really disgraceful, but obviously, I guess, the culture is there . . . you don’t say anything’ (Respondent 13).‘I left Ireland as noisily as I could. I did two radio interviews on the day I was leaving . . . I was in the newspaper, blah, blah’ (Respondent 17).Another deterrent to voice is that it can fail to influence change. Several respondents had voiced dissatisfaction with the Irish health system prior to exit, citing their involvement in grassroots or union campaigns for change, or simply by highlighting the reasons for their exit.There was a sense of inevitability from respondents when the anticipated change failed to materialise and the decision to emigrate was taken. One respondent felt that their exit from the Irish health system might, paradoxically, influence health system change:‘one of my reasons for leaving was I might do a better service by leaving, help drag it down, and the quicker we drag it down, the quicker we can build it back up again’ (Respondent 38).In this way, they felt that exit could contribute to the health system collapse they felt was a prerequisite for change.Respondents described hospital workplaces in Ireland that were understaffed and overstretched and within which stressful and adversarial work relationships had become normalised. Based on Buchanan et al.’s criteria , our fin‘Extreme becomes normal in mundane, prestigious or “mainstream” workplaces as more organizations become overstretched. “Extreme” is common and socially acceptable, and professionals are . . . expected to find a way to cope with or even embrace this new normal’ [ normal’ .The deterioration in job quality and working conditions occurred against a backdrop of historic underfunding , combineN = 40) intending to return to work in the Irish health system, echoing the findings of a 2014 survey which found that only 1 in 4 emigrant Irish trained doctors (N = 307) intended to return [The challenge posed by doctor emigration for the Irish health system is twofold—firstly that the traditional pattern of short-term doctor migration for postgraduate training associated with a high likelihood of return, appears to have been altered in the decade since 2008. The reasons for emigration have changed, with dissatisfaction with the Irish health system [o return . Secondlo return , 53, thio return  of emigro return  which hao return , which ho return  are alsoDoctor emigration is an individual solution to the unsolved health system problem of deteriorating job quality and the normalisation of extreme work. Migrating to Australia enabled Irish doctors to escape extreme working and improve their job quality, while continuing to work in hospital medicine. This illustrates that ‘exit’ is a viable option to Irish trained doctors, as highly skilled, English-speaking migrants whose skills are in demand globally.Emigration as the preferred solution to deteriorating job quality could be considered as a failure of voice, defined as ‘any attempt at all to change, rather than to escape from, an objectionable state of affairs’ . The higIn relation to voice, a distinction could be drawn between junior and senior hospital doctors (consultants), as they have different status within the health system which likely impacts on their propensity to use voice and perhaps their likelihood of success. Although both junior and senior hospital doctors experience the strain of extreme working and deteriorating job quality in the Irish health system since 2008, the authors anticipate that their differing status within the hospital and wider health system may influence their capacity to inform health system change. In 2013, junior hospital doctors in Ireland used their collective voice to launch a high-profile campaign to cap their working hours. The campaigns, ‘enough is enough’ and ’24 no more’ —successfrely on employee voice to provide ‘organisational intelligence about patient safety hazards and . . . quality of patient care’ [Hirschman warns that people tend to ‘underestimate the effectiveness of voice when exit is dominant’ . This hant care’ . If hospnt care’  was highIn this regard, it will be interesting to see the extent to which two 2019 campaigns for change in the Irish health system, will succeed. The campaigns focussed on pay equality and patient safety (#carecantwait and #fightforfairness) and are led by senior hospital doctors, with the backing of the Irish Hospital Consultants Association (IHCA) and the Irish Medical Organisation (IMO). Although the campaigns give voice to similar issues, i.e. patient safety and improved pay and conditions for hospital doctors, the involvement of senior hospital doctors and the backing of their representative bodies may enhance the likelihood that voice successfully informs change.Respondent doctors are exiting the Irish health system because of a deterioration in medical job quality to the point of extremity. Health systems and employers must mitigate the emergence of extreme work in healthcare to retain doctors and ensure that health systems can continue to provide healthcare. But what can be done in response? In relation to medical job quality, Shapiro et al. recommend that it can be strengthened (and wellbeing promoted) by attending to job quality at five levels, beginning with the most basic—ensuring access to rest breaks, providing doctors with a safe work environment and access to job security, showing appreciation and adequately compensating doctors and enabling them to contribute to medicine to the best of their ability . The theIn relation to doctor emigration, Hirschman described the point in Irish history at which Irish mass emigration came to be seen as a threat to the State rather than a ‘safety valve’  and how,