Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern (...) by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (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)

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)

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)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable (...) to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children’s sustained dissent should be respected in all cases. (shrink)

On December 15, 2011, a final report was issued by the Committee on the Use of Chimpanzees in Biomedical and Behavioral Research, which had been convened by the U. S. Institute of Medicine (IOM) in collaboration with National Research Council (NRC) of the National Academies. Within a month of its release, this report was designated by Wired Science one of the “top scientific discoveries of 2011” (Wired Science Staff 2011). The ad hoc Committee responsible for this report was formed at (...) the request of the National Institutes of Health (NIH) in response to congressional inquiry that had been prompted by expressions of public concern.1 The issues addressed in the report are profoundly ethical, despite NIH’s .. (shrink)

Literature on the mental capacities and cognitive mechanisms of the great apes has been silent about whether they can act autonomously. This paper provides a philosophical theory of autonomy supported by psychological studies of the cognitive mechanisms that underlie chimpanzee behavior to argue that chimpanzees can act autonomously even though their psychological mechanisms differ from those of humans. Chimpanzees satisfy the two basic conditions of autonomy: (1) liberty (the absence of controlling influences) and (2) agency (self-initiated intentional action), each of (...) which is specified here in terms of conditions of understanding, intention, and self-control. In this account, chimpanzees make knowledge-based choices reflecting a richly information-based and socially sophisticated understanding of the world. Finally, two major theories of autonomy (Kantian theory and two-level theory) are rejected as too narrow to adequately address these issues, necessitating the modifications made in the present approach. (shrink)

In this paper we propose a new way of conceptualizing animals in experimentation – the animal-as-patient. Construing and treating animals as patients offers a way of successfully addressing some of the entrenched epistemological and ethical problems within a practice of animal experimentation directed to human clinical benefit. This approach is grounded in an epistemological insight and builds on work with so-called ‘pet models’. It relies upon the occurrence and characterization of analogous human and nonhuman animal diseases, where, if certain criteria (...) of homology and mechanism are met, the animal simultaneously becomes a patient and a spontaneous model of the human disease. (shrink)