Animal Testing Research Paper Example

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Abstract

Over the past 100 years, scientiﬁc research using animals has expanded greatly in scope and complexity and now occupies a central place as an investigative tool in biomedicine. Animals are used in basic research to generate fundamental knowledge about biological processes; in preclinical research to test the safety, efﬁcacy, and quality of drugs, biologics, and medical devices; in toxicologic research to test the safety of industrial and consumer products; in research training and education; and in other areas. Today, at least 100 million animals are used in research each year worldwide, though this might represent a signiﬁcant underestimate. A review of published statistics indicates that much important information about the nature of animal use in research is unavailable, and this itself is a signiﬁcant ethical problem. On the basis of available information, however, it is clear that most animal research harms animals to a signiﬁcant degree, involving suffering, conﬁnement, and death. Philosophical work in animal ethics conducted over the past 40 years has cast signiﬁcant doubt upon the ethical defensibility of much and perhaps all harmful animal research. Some “equal moral consideration” (EC) views might judge all nontrivially harmful animal research to be indefensible, except perhaps in the most extreme and urgent circumstances. “Unequal moral consideration” (UC) and utilitarian views would permit some harmful animal research, but with signiﬁcant restrictions and qualiﬁcations that go far beyond the status quo. Thus, when one considers animal research in actual practice in regulation, it is clear that significant reform is necessary in order to bring regulation and practice in line with any reasonable moral view about what animals are owed.

Introduction

While the use of animals in science has a long history, it expanded greatly in scope over the past century, with at least 100 million animals now used each year globally (Taylor et al. 2008). Animals are used to generate basic knowledge about biology; to test the safety, efﬁcacy, and quality of drugs, biologics, and medical devices; to test the safety of industrial and consumer products; in research training and education; and in other areas (Taylor et al. 2008; Knight 2011). The evolution of protections for consumers and human participants in research has resulted in a situation where animal testing is often legally required prior to testing in humans and is often thought to be an ethical mandate as well. While some progress has been made in developing alternatives to live animal use in scientiﬁc research, members of the biomedical community often assert that animal research is both responsible for most past medical progress and equally necessary for future progress (see, e.g., Knight 2011, p. 39).

Animal research raises ethical concern principally because of the harm it usually causes to animals. While strict regulations in most (if not all) countries protect human participants in research from signiﬁcant risk or harm – especially as concerns research not directly beneﬁting the participant – regulations governing animal research are much more permissive by comparison. It is customary that animals used in research are killed at the termination of the research study, and research itself often involves the inﬂiction of various diseases and physical or psychological injuries on the animals (Carbone 2004; Knight 2011). Beginning in the early 1970s, philosophers and some theologians turned an increasing amount of their attention to the ethical evaluation of animal research, focusing principally on animals’ moral standing and the question of whether harmful animal research could be justiﬁed. At present, a robust literature on animal ethics exists, with at least 1,500 books having been published and multiple journals specializing in this area (Akhtar 2012).

This essay will provide an overview of animal research ethics, with an eye toward the global context. While the fundamental ethical issues arising in animal research are the same regardless of the country in which it is performed, considering such research in the global context does highlight a few speciﬁc ethical issues concerning its practice and regulation. For clariﬁcation, “research” and “experimentation” will be used interchangeably in this entry, as will “moral” and “ethical.” Because an individual must be conscious in order to have morally relevant interests (i.e., to care about what happens to it) (Singer 2002), this analysis will focus on research using sentient (i.e., conscious) nonhuman animals, which would include almost all animal species used in research.

The Moral Importance Of Harms To Animals In Research

The moral relevance of harm to animals in research derives from the relevance of harm to morality more generally. Essentially all ethical theories, as well as common morality, embrace a principle of nonmaleﬁcence, which holds that we ought not to harm others (harm being generally deﬁned as setting back another’s interests or making them worse off). As concerns humans, while there are sometimes exceptions to this principle (e.g., harms in self-defense), nonmaleﬁcence is generally acknowledged as a strict principle, with exceptions being very limited. For present purposes, it should be emphasized that scientiﬁc research is not typically regarded as a legitimate exception, and acceptable risk or harm in humansubjects research (particularly non-beneﬁcial research) is very limited. This holds true even for utilitarian moral theories, which deﬁne the right action as that which best maximizes beneﬁts over harms among available alternatives. In theory, classical utilitarianism could allow for significant harms to be perpetrated upon some humans in research, if doing so produced a larger compensating beneﬁt to society that was otherwise unattainable. In practice, however, most utilitarian philosophers argue that the theory supports a strong principle of nonmaleﬁcence toward other humans (e.g., because following this principle as a rule tends to produce the most goodness over the long term).

Depending on how we conceptualize animals’ moral standing, the principle of nonmaleﬁcence might not apply as strongly to animals as it does to humans. However, the fact that sentient animals have interests means that they are plausible candidates to be covered by a principle of nonmaleﬁcence; what we do to animals matters to them. The general importance of nonmaleﬁcence in morality, coupled with the fact that research often harms animals, entails that such research requires justiﬁcation; it establishes animal research as a moral issue requiring discussion. Thus the moral legitimacy of harmful animal research cannot simply be taken for granted: if harms to animals are thought to be more permissible than harms to humans, some compelling reason(s) must be provided to substantiate this judgment.

DeGrazia (2002) has helpfully delineated three categories of harm to animals that apply across many types of animal use, including research. These categories are suffering, conﬁnement, and death. Suffering (deﬁned broadly here to include pain, anxiety, distress, and other aversive mental states) is a harm because it is bad in itself; it is unpleasant and aversive to the individual experiencing it. Conﬁnement is a harm for two reasons. First, it might cause suffering. Second, even if it does not cause suffering, it prevents the conﬁned animal from satisfying any number of “liberty-related” interests, such as interests in moving about, investigating new things in the environment, relaxing comfortably, playing, foraging, and so on (DeGrazia 2002). The harm of conﬁnement is especially signiﬁcant when animals are conﬁned in barren environments and/or environments preventing ample freedom of movement.

Death is usually a harm because it takes away from the animal future opportunities to satisfy interests. Thus, whatever pleasures, satisﬁed desires, or other goods the animal might have experienced in the future will be prevented when it is killed (DeGrazia 2002). This implies that in cases where animals are experiencing intractable pain or suffering, killing them does not harm them because their future lives would not be worth living (e.g., think of a veterinarian euthanizing a dog with a late-stage terminal illness). However, it is important to consider the source of intractable suffering: if animals only suffer in the ﬁrst place because they are harmed by humans, then it seems misleading to say that they are not harmed by death. Rather, they are harmed by their death as compared to how they would have fared had humans not caused the harm of intractable suffering, which is what makes the release of death seem “merciful” (some philosophers describe this as “subjunctive harm”). This point has important implications for research. While animals in research are often killed because the experiment requires it (e.g., because tissues are needed for postmortem examination) or because the animals are simply no longer needed, some animals are killed because the experiment involves the inﬂiction of harm causing intractable suffering. For this subgroup of animals, it should not be assumed that because their death releases them from suffering, it is therefore not harmful.

Animal Use Statistics And Empirical Evidence Of Harm To Animals In Research

Having laid out three main ways in which animals can be harmed by research, we are now in a position to consider global animal use statistics, with an eye toward what these statistics suggest about harms to animals in research. Many countries do not report statistics on laboratory animal use, and among those that do, such statistics are often deﬁcient in one or more respects, such as failing to include relevant species or procedures, a lack of reporting from all institutions using animals, or using vaguely deﬁned reporting categories (Taylor et al. 2008; Rowan 2012). Despite these limitations, some informative assessment of global laboratory animal use is nonetheless possible. A highly detailed statistical survey is beyond the scope of the present entry, but important points can be summarized as follows.

Number And Species Of Animals Used In Research

Based on an estimation model that they developed, Taylor and colleagues (2008) report a conservative global estimate of 58.3 million animals used in research for year 2005. Their tally covers a variety of different types of animal research, approximating the categories outlined in the introduction to this entry. Taylor and colleagues (2008) also report a more comprehensive estimate of 115.3 million animals used globally in year 2005, which includes animals killed for tissue supply, the creation of genetically modiﬁed animals, and conventional animals bred for experiments but killed as surplus (all of which were excluded under then-current EU regulations). Even this larger number might represent a significant underestimate, insofar as some prior estimates of animal use in the USA alone have ranged from 80 to 150 million animals per year (Taylor et al. 2008). According to their conservative estimate, the top ﬁve countries for animal use were the USA (17.3 million), Japan (11.1 million), China ( 3 million), and Australia (2.4 million), with France and Canada tied for ﬁfth place at approximately 2.3 million animals each. Great Britain (sixth place, 1.9 million animals) and Germany (seventh place, 1.8 million animals) were also listed as signiﬁcant users of animals in research (Taylor et al. 2008). It should be noted that no detailed statistics on laboratory animal use are available for China, apart from the estimated total number of animals used.

It is not known with certainty what percentage of animals involved in research die or are killed as part of the research, but general opinion among scholars is that it is nearly all of them (see, e.g., Carbone 2004, p. 22). Thus, the statistics reported here can be taken as a reasonable estimate of the number of animals killed in research each year worldwide.

Based on both reported and estimated statistics, rats and mice account for most of the animals used in research, comprising 77 % of laboratory animals used in the EU (Knight 2011, pp. 18–19), 96 % of animals used in Japan (Yagami et al. 2010), and 90 + % of animals used in the USA (Carbone 2004). Rats and mice account for only 27 % of research animals used in Australia (Humane Research Australia n.d.) and 41 % of research animals used in Canada (CCAC n.d.). However, for both countries, the relative percentage of rats and mice in invasive research is likely underestimated by these statistics, since both countries include in their statistics large, observational, or minimally invasive studies involving ﬁsh, other wildlife, and livestock (Taylor et al. 2008; CCAC n.d.). Other rodents (e.g., hamsters), guinea pigs, and rabbits appear to account for about 2–5 % of animals used in research (Knight 2011; Yagami et al. 2010).

The use of cold-blooded animals in research – including ﬁsh, amphibians, and reptiles – varied widely, ranging from 0.01 % (Japan, reptiles only) to 34 % (Canada) of all research animals. Similarly, birds accounted for anywhere from 0.28 % (Japan) to 10 % (Australia) of all research animals (Knight 2011, pp. 18–19; Yagami et al. 2010; Humane Research Australia n.d.; CCAC n.d.). Because the US Animal Welfare Act (AWA) does not cover rats, mice, birds, or cold-blooded animals, neither ofﬁcial nor unofﬁcial statistics are available regarding the number or percentage of birds or cold-blooded animals used in research in the USA.

Cats and dogs, as well as nonhuman primates (NHPs), generally accounted for less than 1 % each of all research animals, with the exception of the USA, where NHPs were 6 % and cats and dogs 7.6 % of all research animals (Knight 2011, pp. 18–19; Yagami et al. 2010; Humane Research Australia n.d.; CCAC n.d.; USDA 2014). However, the US numbers for these species are likely to be artiﬁcially inﬂated because rats and mice are not included in ofﬁcial statistics.

It is generally accepted that if animals are going to be used in harmful research, it is better to use animals of less advanced cognitive, affective, and social capacities, with one important aspect of the 3Rs (reﬁne, reduce, and replace animal use in research) being the replacement of more mentally sophisticated animals (e.g., NHPs, dogs, cats, or rats) with less mentally sophisticated animals (e.g., some invertebrates or ﬁsh). The underlying rationale here is that less mentally sophisticated animals are likely to be harmed less in the course of research, but also that it might be (comparatively speaking) more morally permissible to harm less mentally sophisticated animals because they have lower moral standing. However, because of problems with reporting, it is difﬁcult to accurately determine trends in the number or species of animals used in research. The use of rodents and nonhuman primates (excepting chimpanzees) appears to be on the rise, while the use of other animals (e.g., cats and dogs) appears to be declining (Carbone 2004; Conlee and Rowan 2012). The overall number of animals used in research appears to be increasing worldwide, partly because of “the increased production and use of GM [genetically modiﬁed] animals, and the initiation of large-scale chemical testing programmes, which are expected to require unprecedented numbers of animals” (Knight 2011, p. 12; see also Carbone 2004, p.26). Another possible reason for this increase includes the scaling-up of animal research in industrializing countries.

Invasiveness Of Animal Research And Use Of Pain Relief

Relatively few countries report statistics on the invasiveness of animal procedures and/or the use of pain relief. For the USA in year 2013, approximately 32 % of procedures were classiﬁed as category “D,” meaning that these procedures could cause pain or distress, but “appropriate anesthetic, analgesic, or tranquilizing drugs were used” to alleviate such distress. Approximately 9.6 % of procedures were classiﬁed as category “E,” meaning that animals were subjected to procedures potentially causing (more than minor or momentary) pain or distress and were not given anesthetic, analgesic, or tranquilizing drugs because these could interfere with the experimental objectives. Thus, such animals potentially experienced unrelieved pain and/or distress (Carbone 2004, p. 27; USDA 2014). The veracity of these statistics is undermined by the fact that they do not include mice or rats, at least 90 % of animals used in research in the USA. In addition, the percentage of laboratory animals in the USA reported as experiencing moderate to severe pain and/or distress is signiﬁcantly lower than for other countries (Rowan 2012), raising further concern about the accuracy of the ofﬁcial statistics.

For Canada, in year 2011, research procedures causing either “moderate to severe distress or discomfort” (category D) or “severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals” (category E) accounted for 37.1 % of all procedures, with category E procedures at 3.9 % speciﬁcally (CCAC n.d.).

For Australia, in years 2005–2008 “markedly invasive procedures” (deﬁned as “procedures resulting in death [whether or not the animals were conscious], surgical procedures [excluding minor operative procedures], major physiological challenges, and the production of GM animals”) ranged from 23.3 to 39.6 % of all no observational animal use (Knight 2011, p. 23). Australian statistics do not include categorizations of animal pain and distress, nor do they include the use of anesthetic, analgesic, or anxiolytic drugs.

For the UK in year 2009, approximately 67 % of all animal research procedures used no form of anesthesia; general anesthesia was provided for terminal procedures for 9.5 % of all animals; and other forms of anesthesia were provided in approximately 24 % of procedures (as summarized by Knight 2011, pp. 26–27). However, these data on anesthetic use are not correlated to the invasiveness of procedures, nor are more speciﬁc data on analgesic or anxiolytic drug use available for the UK (though the severity of procedures in terms of pain and distress is taken into account under UK regulations when granting project licenses to perform animal research). Rowan (2012) also reports data from a 2005 feasibility study that estimates that 55–60 % of research animals in the UK experience moderate to severe pain and/or distress. This same author reports data on the Netherlands, New Zealand, and Sweden, which date from the late 1990s to early 2000s, estimating that 15–45 % of research animals experience moderate to severe pain and/or distress (Rowan 2012).

Laboratory Animal Housing

Multiple countries have promulgated regulations or guidelines regarding how animals used in research must be housed. While such regulations and guidelines often stipulate that housing should provide for animals’ physical and psychological needs, the wording of such prescriptions is at times vague, and most actual regulatory requirements for things like social housing or environmental enrichment contain exception clauses if these can be scientiﬁcally justiﬁed. Unfortunately, comprehensive data on actual laboratory animal housing conditions in practice are lacking. However, what data and opinion are available suggest that housing conditions often fail to provide for good animal welfare and at times can be outright inimical to it (Carbone 2004; Reinhardt and Reinhardt 2002).

One problem is that minimum required cage sizes are often too small, at times prohibiting even normal postural adjustments identiﬁed in the same regulations as applicable goals for animal housing (Carbone 2004). For example, the US Animal Welfare Act (AWA) stipulates a minimum cage size for a dog that “is six inches longer on each side than its body” (not counting its tail) (Carbone 2004, p. 103). Carbone notes that though the USDA’s (US Department of Agriculture) performance standards require that dogs be able to “stand, sit, turn about freely, and walk in a normal manner,” this is not possible given current regulated cage sizes, nor would it be possible for dogs to rest with hind legs or forelegs extended, as some prefer to do (Carbone 2004, p. 104). Similar issues apply to housing for other laboratory animals, including cats, rabbits, guinea pigs, rodents, and nonhuman primates (NHPs) (Carbone 2004; Reinhardt and Reinhardt 2002).

A second problem is that social animals are sometimes housed alone. Though individual housing might at times be scientiﬁcally justiﬁed, it can be highly detrimental to animals’ welfare (Reinhardt and Reinhardt 2002), and some evidence suggests that solitary housing is overused. For example, though US law “requires institutions to house primates in groups unless there is justiﬁcation, such as debilitation as a result of age or other conditions, for housing them alone… a recent analysis of documents from two large facilities… demonstrates that primates spent an average of 53 % of their lives housed alone” (Conlee and Rowan 2012). Individual housing might also be overused with other species, such as rodents (Carbone 2004).

A third problem is that cage environments are often insufﬁciently complex to robustly satisfy animals’ psychological needs. Like solitary housing, housing that is barren or otherwise unable to accommodate animals’ species-typical behaviors (e.g., exploring, burrowing, avoiding light) can be very detrimental to their welfare, and standard housing conditions have been associated with a number of indicators of poor animal welfare (Reinhardt and Reinhardt 2002; Knight 2011). In the USA, the only regulatory requirement for environmental enrichment pertains to NHPs, and this appears to be inadequately enforced. In the aforementioned study on NHP housing, for example, “it was found that that in the majority of cases, this [enrichment] requirement was ‘satisﬁed’ by a metal shape hung for a month on the bars of a metal cage” (Conlee and Rowan 2012). Available data, though limited, suggest that environmental enrichment is often (but not always) provided to other species in the USA, such as rats and mice (Hutchinson et al. 2005). While this is good, the extent of common enrichment mechanisms seems to fall well short (probably unavoidably so) of matching the complexity of the animals’ natural environments (see Knight 2011; Reinhardt and Reinhardt 2002 for further discussion). For example, the most common enrichment mechanism for rodents appears to be the provision of bedding for nest building (Hutchinson et al. 2005). This is beneﬁcial, but there can be little doubt that a small plastic cage with litter and bedding (and even a toy or hut) offers much less mental stimulation and accommodation of natural behaviors than the animals’ natural environments do.

For other major users of animals in research, such as Australia, China, and Japan, detailed data on laboratory animal housing conditions are not readily available, though the aforementioned issues are likely not unique to the USA or UK situations. Special mention should be made of the UK regulations, which require cage sizes larger than those in the USA (Carbone 2004). New EU regulations containing stronger enrichment provisions just went into effect, though exceptions are again provided for scientiﬁc reasons (EU 2010, Article 33 & Annex III). It is too soon to assess how these regulations will be implemented in practice.

Can Harmful Animal Research Be Justified?

Even with the incomplete data in hand, it is clear that most animal research signiﬁcantly harms animals. Animals are routinely subjected to diseases, debilities, and injuries in the course of scientiﬁc research; frequently suffer some degree of pain and/or distress in the process; and are usually killed at the termination of the study. Further, they are typically conﬁned in environments not conducive to their well-being. These harms are generally not the result of regulatory noncompliance, but rather are allowable under the laws of respective countries. Can this sort of harmful animal research be justiﬁed?

Historically, moral views about animals have been heavily conditioned by various religious traditions, which in many cases have denied or minimized the moral standing of animals (Waldau 2001). At present, this inﬂuence has waned among intellectuals in Western countries, with secular philosophy dominating discussions of animal ethics. However, religious outlooks might be more inﬂuential among intellectuals in other parts of the world and also among laypersons in the West. This entry will not review religious arguments on the moral standing of animals in any detail, partly because there are many religions with many denominations and tenets. It should be emphasized, though, that religious moral outlooks often depend on assumptions that are accepted on faith, raising serious questions about the intellectual authority of such outlooks. Apart from general issues pertaining to the rationality of theism, speciﬁc attempts to link religion with morality, such as divine command or natural law theories, are vulnerable to well-known and serious criticisms. For the present author, secular moral systems represent a more fruitful approach to thinking about animals’ moral standing.

Turning to such secular systems, the ﬁrst point to emphasize is that the moral justiﬁcation of harmful animal research cannot be accomplished simply by enumerating a list of beneﬁts that it has produced, even if we accept these beneﬁts at face value. Since we would not accept such a justiﬁcation in the case of human beings, the question is whether there are morally relevant differences between humans and animals that would license harmful animal research. Whether harmful animal research can be justiﬁed depends on both animals’ moral standing and more general moral norms. Common morality and contemporary research ethics are heavily deontological (framing morality in terms of rights and duties), each recognizing a strong duty of nonmaleﬁcence where humans are concerned. Therefore, animals’ moral standing within this kind of normative framework will be considered ﬁrst.

Contemporary philosophers writing about animal ethics are in near-unanimous agreement that sentient animals have direct moral standing; in fact, it is possible to ﬁnd only a handful of critiques disputing this view. Animals’ moral standing is usually argued for by a combination of considerations: ﬁrst, that animals have interests and are thus plausible candidates for moral consideration; second, that most persons have intuitions about the wrongness of animal cruelty; third, that such intuitions are best explained by the view that animals have direct moral standing; and, fourth, that moral theories denying the moral standing of animals suffer from fatal ﬂaws, such as the inability to accommodate certain classes of humans whom we agree should have moral standing (see, e.g., DeGrazia 2002 for discussion).

Moving beyond the question of whether animals have moral standing, there is the question of how much moral standing they have. DeGrazia (2002) has distinguished between equal moral consideration (EC) and unequal moral consideration (UC) views. EC views hold that animals’ interests should be given equal moral weight or consideration to relevantly similar human interests. This view (or its substantive equivalent) has been endorsed by numerous leading scholars in animal ethics (e.g., DeGrazia 2002; Singer 2002 and others); it is also the most persuasive view in the author’s opinion. EC views are typically defended by way of negative argument: having established that animals have moral standing, we ask whether there are any good reasons to think that their interests deserve less moral consideration than human interests, and it turns out to be the case that all candidate reasons are not good reasons. To take a much-discussed example, if it is held that animals deserve less moral consideration than humans on the basis that animals are not self-aware beings capable of sophisticated rational agency, then this also has the consequence that infants, senile persons, and mentally disabled persons deserve less moral consideration than “fully rational” humans. Most persons will not want to accept this conclusion. However, it is dubious that this “rational agency” argument for morally discounting animals’ interests can be upheld while also ﬁnding a defensible way to include nonrational humans in the sphere of individuals deserving of full moral standing. Numerous attempts to do this have been made on the basis of slippery slope arguments, granting moral standing on the basis of what is “typical” for the species, and other considerations, but each such attempt has been substantially criticized (see DeGrazia 2002; Nobis 2004). Similar difﬁculties attend to arguments for morally discounting animals’ interests on the basis of their inability to use language, form contracts, or acknowledge reciprocal duties or the absence of particular social bonds between humans and other animals.

If animals deserve equal moral consideration to humans, then it is doubtful that most (and perhaps any) nontrivially harmful animal research will be morally defensible, at least as concerns research not directly beneﬁting the animals used and at least if we assume a general principle of nonmaleﬁcence. (To deny this general principle would be to turn human-subjects research ethics on its head.) Because the “badness” of suffering lies primarily in how it is experienced, humans and animals have a relevantly similar interest in avoiding equal amounts of suffering (DeGrazia 2002) – in fact, it has been argued that animals’ lack of self-awareness makes their suffering worse because they cannot comprehend it. Since we do not tolerate the imposition of nontrivial pain and suffering in non-beneﬁcial research on humans unable to provide consent, a principle of EC would seem to rule out similar research in animals. Further, since lesser harms are not necessarily permissible harms, it does not follow that since some actions (e.g., killing) might usually harm humans more than animals, that such actions are therefore more morally defensible when perpetrated upon animals. Rather, since nonmaleﬁcence is generally a strict moral principle, applying to small as well as large harms, and applying in a wide variety of contexts (including research), it should follow that on an EC view, most nontrivially harmful, non-beneﬁcial animal research (i.e., most animal research!) will be impermissible (Rossi 2010).

UC views hold that animals’ interests deserve less moral weight or consideration than humans’ interests, regardless of whether animals’ and humans’ interests are prudentially comparable (DeGrazia 2002). Because many arguments for morally discounting animals’ interests are problematic (see above), the main motivation for UC views seems to lie less with explicit arguments and more with the intuition that since human lives are generally thought to be more prudentially valuable than animal lives (i.e., that human lives are richer in experience than animal lives), they should therefore be thought more morally valuable as well. The most plausible version of a UC view, the sliding-scale view, holds that moral considerability is a function of the prudential value of a life. At the top of the hierarchy stand humans, who deserve full moral consideration.

As one moves “down” the phylogenetic scale, animals of progressively lesser cognitive, affective, and social complexity are granted progressively lesser moral consideration (DeGrazia 2002).

One way to think about the operationalization of the sliding-scale UC view is that as one moves down the scale of moral considerability, progressively weaker reasons will be sufﬁcient to override animals’ interests in the name of research. Conversely, as one moves up the scale of moral consider ability, progressively stronger reasons will be required to override animals’ interests. For animals of high cognitive, affective, and social complexity, who most closely approach humans in these areas (e.g., great apes and dolphins, but also perhaps some birds), very strong reasons will be required to override their interests in research – not quite as strong as for humans, but given the low threshold of allowable risk and harm in human-subjects research, the threshold for such animals will not be much higher. Slightly lower on the scale of moral consider ability will sit other animals of lesser, but still substantial, cognitive, affective, and social complexity (e.g., perhaps dogs) – And so on, with animals of still lesser capacities sitting slightly lower on the scale. As should be obvious, any serious attempt to implement a sliding-scale UC view will require the integration of substantial information on the mental capacities of nonhuman animals used in research. Further, it will be important to avoid bias in such assessments, since we might underestimate the mental lives of some animals because we are less sympathetic to them (this seems reasonably likely, e.g., with rodents).

What kinds of reasons count? Many philosophers (e.g., Rollin 2012) would say that if harmful animal research is ever justiﬁed, it is justiﬁed only in light of the beneﬁts that ﬂow from it. (Even in the case of basic research, the eventual goal is usually to apply knowledge gained for the purpose of improving human or animal welfare.) Thus a cost-beneﬁt calculus will be required to justify harms to animals, regardless of their place on the scale of moral consider ability. What will change as one moves down the scale will be the strength and probability of beneﬁt sufﬁcient to override animals’ interests. Value judgments will of necessity be involved in this cost-beneﬁt assessment. It seems clear, though, that the mere possibility of beneﬁt will not be sufﬁcient to justify harms to animals – more substantial evidence will be required. Some beneﬁts, even if realized, will not be of sufﬁcient importance to justify harms to animals. Particularly in cases where severe harms are inﬂicted upon mentally sophisticated animals, it might be true that even a high probability of an important beneﬁt might not be sufﬁcient justiﬁcation. (Recall that even very great beneﬁts are usually not thought sufﬁcient to justify the inﬂiction of severe harms on other persons.) Finally, since it is the prudential value of a life (i.e., the richness of a life to the individual living it) that is justifying UC on this view (as opposed to, say, God’s will or species per se), it seems appropriate that the “discounting rate” for animals’ interests should not be overly steep and should be proportional to the anticipated beneﬁt of an experiment. Thus the sliding-scale UC view is far from laissez-faire in what it would permit.

Finally, one might ethically analyze animal research from a utilitarian point of view. Classical utilitarianism holds that the morally right action is the one that best promotes overall welfare among available alternatives, counting up all beneﬁts and harms produced by the action. Though it is logically possible to grant animals UC within a utilitarian framework, most commentators see EC for all humans and animals as a deﬁning feature of utilitarianism. According to utilitarianism, harms to animals might be justiﬁed if the research in question produces more beneﬁt than harm and if there are no alternatives available in which a similar net beneﬁt can be accomplished with less harm to animals. However, while utilitarianism can in theory justify harmful animal research, it has been questioned whether, in practice, much harmful animal research will be justiﬁed. This is because harms to animals are certain while beneﬁts to humans are merely hoped for, because much animal research does not even seem to be intended to produce an important beneﬁt, and because the net beneﬁts of animal research have recently come under ﬁre because of its poor predictive value (DeGrazia 2002; Knight 2011; Rollin 2012; Bass 2012).

How Well Do Existing Animal Research Practices Meet Criteria For Moral Justification?

A minimum ethical requirement for animal research should be the reporting of accurate and complete statistics on animal use. Such data are necessary for informed monitoring and debate about the issues, including the appraisal of harms to animals in research, the monitoring of trends in animal use and the implementation of the “3Rs,” and the assessment of how regulations are being interpreted and complied with (Taylor et al. 2008). Because animal research is increasingly global in nature, with private companies that conduct animal research more often holding ofﬁces in more than one country, accurate statistics are also necessary to determine whether “strong regulation in one country results in researchers shifting experimentation to countries with weaker regulation” (Taylor et al. 2008, p. 328). Thus the lack of ofﬁcial, complete, and accurate statistics on global laboratory animal use is a signiﬁcant ethical problem. Further, if it is assumed “that only those countries with speciﬁc legislation to control animal experiments produce statistics, it seems there may be minimal legislation in most countries in which animals are used in research and testing” (Taylor et al. 2008, p. 339).

Turning to known regulations, a number of additional problems are apparent upon close inspection. For a combination of reasons, in numerous countries, not all animals used in research will be covered by regulations. This can arise because regulated laboratory animal care and use programs are voluntary (Canada), because the government only promulgates guidelines but not enforceable regulations (Japan), or because regulations do not cover certain species of animals and/or funding sources. Concerning the latter issue, it is noteworthy that US institutions using rats or mice (90 + % of research animals) are not subject to regulation if they do not receive federal funds to support the research (Carbone 2004; Guillén 2013). The USA has also been criticized for lax enforcement of existing regulations (Conlee and Rowan 2012; Pippin 2013), and for other countries like China, the absence of meaningful statistics on animal research makes it impossible to know whether relevant regulations are being enforced.

While the UK and now EU more broadly (as of 2013) require cost-beneﬁt assessment of animal research protocols (i.e., harms to animals in research must explicitly be justiﬁed by the anticipated beneﬁt of the research), for most other countries – including most of the top animal users – such cost-beneﬁt assessment is not required. As a result, animal research regulations, even where they exist, are often permissive in allowable harm to animals. Regulatory requirements for the alleviation of animal pain and distress usually contain exception clauses if such alleviation is inconsistent with the scientiﬁc objectives of a research project. Animal death per se (outside of any pain or distress caused in killing) is not typically conceptualized in regulation as a harm to animals, including in the UK and EU regulations. And while the UK and broader EU regulations prohibit the inﬂiction of severe, prolonged, and unrelieved pain or distress, other countries’ regulations do not appear to place a cap on maximum allowable animal pain or distress (see Carbone 2004; Guillén 2013; UK Home Ofﬁce 2014 for descriptions and citations of regulations). On a related note, while most regulations require the humane killing of laboratory animals, some commonly used and accepted techniques, such as decapitation or carbon dioxide gassing, have been criticized because they may cause pain and/or distress (Rollin 2012; Carbone 2004).

Furthermore, the requirement of cost-beneﬁt assessment in the EU is of questionable stringency. For the UK speciﬁcally, this requirement has been active since 1986, but the UK does not release statistics on animal pain and distress, nor does it make actual cost-beneﬁt assessments available. Further, relevant costs to animals do not include death per se, and cost-beneﬁt analysis does not apply to situations where animal use is required by law (e.g., in product safety testing) (Nufﬁeld 2005; UK Home Ofﬁce 2014). Therefore, the degree of weight given to animals’ interests in the UK cost-beneﬁt assessment is unclear at best and might be reasonably questioned for these and other reasons (including the increasing number of animals used in research in the UK). Under the broader EU regulations, costs to animals can be justiﬁed if the research “may ultimately beneﬁt humans, animals or the environment” (EU, 2010, emphasis here), which appears to be a rather weak standard.

The implementation of alternatives to animal experiments is also arguably insufﬁcient under current regulation and practice. In some countries (e.g., Canada, the USA, Japan, China, and Australia), the use of alternatives is not mandated, but rather only their consideration by the investigator is mandated. In the EU (including the UK), the use of alternatives to animals in research is now (as of 2013) required if alternatives are determined to be scientiﬁcally satisfactory for accomplishing experimental objectives. However, “scientiﬁcally satisfactory” is left undeﬁned in both regulation and guidance, and so it is unclear how stringent this requirement will be in practice. More broadly, numerous commentators have criticized the slow uptake of replacements to animal models, arguing that alternatives are often undervalued and underutilized by working scientists and regulatory agencies. Inadequate funding of alternatives has also been highlighted as a problem (see, e.g., Knight 2011; Nufﬁeld 2005).

With respect to species, the use of chimpanzees in research has been banned in many countries. This is an important mark of moral progress, insofar their use in harmful research is especially difﬁcult to justify ethically. The USA is signiﬁcantly scaling back its use of chimpanzees in research, but some animals will be retained for future studies (Conlee and Rowan 2012). However, the use of other nonhuman primates in research is increasing, which is problematic on account of both their moral status and the difﬁculty in meeting their needs while in conﬁnement.

Finally, the fundamental reason for conducting most animal research in the ﬁrst place – its purported beneﬁt to human health and welfare – has recently come in for renewed criticism. In recent years, a number of systematic reviews have indicated that much animal research is poorly designed from a methodological standpoint (e.g., with inadequate sample sizes, randomization, or blinding) and furthermore that the predictive value of both toxicological and preclinical animal research is rather poor, often falling near or even below 50 % (see Knight 2011; Akhtar 2012; Bass 2012). Whether this predictive value will improve as methodological quality improves is unknown, but to the extent that animal research does not lead to the kinds of beneﬁts often claimed for it, the overall ethical justiﬁcation for much actual research becomes seriously weakened.

Conclusion

This entry has reviewed a number of key features of contemporary animal research, including its overall global scope, the nature and extent of harms suffered by animals in research, the possible ethical justiﬁcation of harmful animal research, and the current state of its regulation. In contrast to research on human beings, it is clear that the overwhelming majority of animals used in research experience some harm, and often significant harm, in the course of the research. It is also clear that the type and amount of data collected on global animal research practices are markedly deﬁcient. While harmful animal research might sometimes be ethically justiﬁed, advances in philosophical scholarship over the past four decades have cast doubt on the extent to which this will generally be true. Cogent arguments have been advanced against most or even all harmful animal research. Philosophical theories permitting some harmful animal research typically place signiﬁcant restrictions on what is permissible. When the reality of actual research practice is measured against such theories, it becomes clear that much current animal research is not sufﬁciently justiﬁed ethically. As one review put it over 15 years ago: “The leading book-length works in this ﬁeld exhibit a near consensus that the status quo of animal usage is ethically indefensible and that at least signiﬁcant reductions in animal research are justiﬁed” (DeGrazia 1999). In the intervening years, this philosophical consensus has only solidiﬁed. Meanwhile, though some progress has been made with respect to the ethical regulation of animal research, in large measure, the preceding quote still seems applicable. For practicing scientists, regulators, ethicists, and animal advocates, then, there is still much work to do.

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