The Brambell Report of 1965 recommended that animals should have the freedom to stand up, lie down, turn around, groom themselves and stretch their limbs. The Farm Animal Welfare Council (FAWC) developed these into the Five Freedoms, which are a framework for the analysis of animal welfare. The Five Freedoms are well known in farming, policy making and academic circles. They form the basis of much animal welfare legislation, codes of recommendations and farm animal welfare accreditation schemes, and are the (...) foundation of the Welfare Quality® assessment scheme. The Five Freedoms are also extensively employed for the education of veterinary and animal welfare science students. Hence they have proven to be of great practical utility. In this paper, the Five Freedoms framework is examined in terms of necessary and sufficient conditions for the analysis of animal welfare. Overall, the Five Freedoms are judged to be individually necessary and jointly sufficient as a framework for the analysis of animal welfare. FAWC has recently criticized the Five Freedoms for concentrating on negative aspects of welfare. However, it is shown here how the satisfaction of the Five Freedoms should lead to good welfare, from the animal’s point of view. The Five Freedoms are formulated as ideals of animal welfare. This has significant advantages that have likely contributed to their impact. However, the ideality of the Five Freedoms means that the framework is without power to determine what a satisfactory level of animal welfare is, in an ethical sense. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

The concept of vulnerability is deployed in bioethics to, amongst other things, identify and remedy harms to participants in research, yet although nonhuman animals in experimentation seem intuitively to be vulnerable, this concept and its attendant protections are rarely applied to research animals. I want to argue, however, that this concept is applicable to nonhuman animals and that a new taxonomy of vulnerability developed in the context of human bioethics can be applied to research animals. This taxonomy does useful explanatory (...) work, helping to pinpoint the limitations of the 3Rs/welfare approach currently adopted in the context of animal experimentation. On this account, the 3Rs/welfare approach fails to deliver for nonhuman animals in experimentation because it effectively addresses only one element of their vulnerability (inherent) and paradoxically through the institution of Animal Ethics Committees intended to protect experimental animals in fact generates new vulnerabilities that exacerbate their already precarious situation. (shrink)

Using an approach developed in the context of human bioethics, we argue that chimpanzees in research can be regarded as vulnerable subjects. This vulnerability is primarily due to communication barriers and situational factors—confinement and dependency—that make chimpanzees particularly susceptible to risks of harm and exploitation in experimental settings. In human research, individuals who are deemed vulnerable are accorded special protections. Using conceptual and moral resources developed in the context of research with vulnerable humans, we show how chimpanzees warrant additional safeguards (...) against harm and exploitation paralleling those for human subjects. These safeguards should include empowering third parties to act as surrogate decision makers for chimpanzees, ensuring participant “assent,” and avoiding recruitment of animal subjects based merely on convenience. (shrink)

In spite of the considerable literature nowadays existing on the issue of the moral exclusion of nonhuman animals, there is still work to be done concerning the characterization of the conceptual framework with which this question can be appraised. This paper intends to tackle this task. It starts by defining speciesism as the unjustified disadvantageous consideration or treatment of those who are not classified as belonging to a certain species. It then clarifies some common misunderstandings concerning what this means. Next, (...) it rejects the idea that there are different kinds of speciesism. Such an idea may result from confusion because there are (1) different ways in which speciesism can be defended; and (2) different speciesist positions, that is, different positions that assume speciesism among their premises. Depending on whether or not these views assume other criteria for moral consideration apart from speciesism, they can be combined or simple speciesist positions. But speciesism remains in all cases the same idea. Finally, the paper examines the concept of anthropocentrism, the disadvantageous treatment or consideration of those who are not members of the human species. This notion must be conceptually distinguished from speciesism and from misothery (aversion to nonhuman animals). Anthropocentrism is shown to be refuted because it either commits a petitio principia fallacy or it falls prey to two arguments: the argument from species overlap (widely but misleadingly known as “argument from marginal cases”) and the argument from relevance. This rebuttal identifies anthropocentrism as a speciesist view. (shrink)

In this article, we develop and defend an account of the normative significance of nonhuman animal agency. In particular, we examine how animals’ agency interests impact upon the moral permissibility of our interactions with them. First, we defend the claim that nonhuman animals sometimes have rights to self-determination. However, unlike typical adult humans, nonhuman animals cannot exercise this right through the giving or withholding of consent. This combination of claims generates a puzzle about the permissibility of our interactions with nonhuman (...) animals. If animals sometimes have rights to self-determination, but lack the capacity to consent, then when, if ever, is it permissible for us to touch them, hold them, bathe them, or confine them? In the second half of the article, we develop a solution to this puzzle. We argue that while we cannot obtain animals’ consent, they can engage in authoritative communications of will through acts of “assent” and “dissent.”. (shrink)

Next SectionIn response to public outrage stemming from exposés of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of animal (...) pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare. (shrink)

The risks of harm to nonhuman primates, and the absence of benefits for them, are critically important to decisions about nonhuman primate research. Current guidelines for review and practice tend to be permissive for nonhuman primate research as long as minimal welfare requirements are fulfilled and human medical advances are anticipated. This situation is substantially different from human research, in which risks of harms to the individual subject are typically reduced to the extent feasible. A risk threshold is needed for (...) the justification of research on nonhuman primates, comparable to the way risk thresholds are set for vulnerable human subjects who cannot provide informed consent. Much of the laboratory research conducted today has inadequate standards, leading to common physical, psychological, and social harms. (shrink)

Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and (...) populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability. (shrink)

Among the "hard cases" of captive animal research is the continued use of chimpanzees in harmful experimental science. In a recent article I contend that contemporary animal welfare science and chimpanzee behavioral studies permit, if not require, a reappraisal of the moral significance of chimpanzee dissent from participation in certain experiments. In what follows, I outline my earlier argument, provide a brief survey of some central concepts in pediatric research ethics, and use these to enrich an understanding of chimpanzee dissent (...) useful for research ethics. (shrink)

In this paper, we present three necessary conditions for morally responsible animal research that we believe people on both sides of this debate can accept. Specifically, we argue that, even if human beings have higher moral status than nonhuman animals, animal research is morally permissible only if it satisfies (a) an expectation of sufficient net benefit, (b) a worthwhile-life condition, and (c) a no unnecessary-harm/qualified-basic-needs condition. We then claim that, whether or not these necessary conditions are jointly sufficient conditions of (...) justified animal research, they are relatively demanding with the consequence that many animal experiments may fail to satisfy them. (shrink)

To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that “minimal (...) risk” should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children’s welfare. (shrink)

The ethics of using nonhuman animals in biomedical research is usually seen as a subfield of animal ethics. In recent years, however, the ethics of animal research has increasingly become a subfield within research ethics under the term “animal research ethics”. Consequently, ethical issues have become prominent that are familiar in the context of human research ethics, such as autonomy or self-determination, harms and benefits, justice, and vulnerability. After a brief overview of the development of the field and a discussion (...) of relevant theoretical ethical frameworks, I consider two of these issues, namely autonomy and self-determination on the one hand, and harms and benefits on the other hand. My concern is with philosophical and ethical issues, rather than animal research oversight. I focus my discussion on nonhuman primates, as the most plausible nonhuman candidates for this approach. I conclude that the approach, although promising, depends strongly on the moral status of nonhuman research subjects. (shrink)

One of the most controversial areas of animal research is the use of nonhuman primates for fundamental research. At the centre of the controversy is the question of whether the benefits of research outweigh the harms. We argue that the evaluation of harms and benefits is highly problematic. We describe some common procedures in neurological research using nonhuman primates and the difficulties in evaluating the harm involved. Even if the harm could be quantified, it is unlikely that it could be (...) meaningfully aggregated over different procedures, let alone different animals. A similar problem arises for evaluating benefits. It is not clear how benefits could be quantified, and even if they could be, values for different aspects of expected benefits cannot be simply added up. Sorting harms and benefits in three or four categories cannot avoid the charge of arbitrariness and runs the risk of imposing its structure on the moral decision. The metaphor of weighing or balancing harms and benefits is inappropriate for the moral decision about whether to use nonhuman primates for research. Arguing that the harms and benefits in this context are incommensurable, we suggest describing the moral consideration of harms and benefits as a coherent trade-off. Such a decision does not require commensurability. It must be well-informed about the suffering involved and the potential benefits, it must be consistent with the legal, regulatory and institutional framework within which it is made, and it must cohere with other judgments in relevant areas. (shrink)

More than twenty years after its original publication, The Case for Animal Rights is an acknowledged classic of moral philosophy, and its author is recognized as the intellectual leader of the animal rights movement. In a new and fully considered preface, Regan responds to his critics and defends the book's revolutionary position.

Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is true. Without explicit (...) justification, it is not clear why or whether this should be the case. Ethics regulations guiding human subject research include principles such as respect for persons—and related duties—that are required as a matter of justice while regulations guiding animal subject research attend only to highly circumscribed considerations of welfare. Further, the regulations guiding research on animals discount any consideration of animal welfare relative to comparable human welfare. This paper explores two of the most promising justifications for these differences␣between the two sets of regulations. The first potential justification points to lesser moral status for animals on the basis of their lesser capacities. The second potential justification relies on a claim about the permissibility of moral partiality as␣found in common morality. While neither potential justification is sufficient to justify the regulatory difference as it stands, there is possible common ground between supporters of some regulatory difference and those rejecting the current difference. (shrink)

A common assumption in the selection of nonhuman animal subjects for research and the approval of research is that, if the risks of a procedure are too great for humans, and if there is a so-called scientific necessity, then it is permissible to use nonhuman animal subjects. I reject the common assumption as neglecting the central ethical issue of the permissibility of using nonhuman animal subjects and as being inconsistent with the principle of justice used in human subjects research ethics. (...) This principle requires that certain classes of individuals not be subjected to a disproportionate share of the burdens or risks of research. I argue for an extension of this principle to nonhuman animal research and show that a prima facie violation of the principle occurs because nonhuman animals bear an overwhelmingly disproportionate share of the risks of research without sufficient justification or reciprocal benefit. (shrink)

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a (...) result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)