Some animal research is arguably morally wrong, and some animal research is morally bad but could be improved. Who is most likely to be able to identify wrong or bad animal research and advocate for improvements? I argue that philosophical ethicists have the expertise that makes them the likely best candidates for these tasks. I review the skills, knowledge and perspectives that philosophical ethicists tend to have which makes them ethical experts. I argue that, insofar as IACUCs are expected to (...) ensure that research is ethical, they must have philosophical ethicists as members. (shrink)

Three Canadian institutional animal care and use committees were observed over a 1-year period to investigate animal ethical evaluation. While each protocol was evaluated, the observer collected information about the final decision, the type of protocol, and the category of invasiveness. The observer also wrote down verbatim all verbal interventions, which were coded according to the following categories: scientific, technical, politics, human analog, reduction, refinement, and replacement. The data revealed that only 16% of the comments were devoted to the 3 (...) explicit ethical categories and that most of the comments were technical. However, the analysis revealed that ethical concerns were implicit in both scientific and technical comments; either ethical norms had been translated into scientific and technical language, or some of the scientific and technical comments had an impact on the ethical treatment of animals. The results are discussed in relation to previous nonobservational research that identified potential pitfalls and bias in animal ethical evaluation. (shrink)

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles (...) in reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

Human-nonhuman chimeric research—research on nonhuman animals who contain human cells—is being used to understand human disease and development and to create potential human treatments such as transplantable organs. A proposed advantage of chimeric models is that they can approximate human biology and therefore allow scientists to learn about and improve human health without risking harms to humans. Among the emerging ethical issues being explored is the question of at what point chimeras are “human enough” to have human rights and thus (...) be owed higher standards of research protection than that currently afforded to nonhuman animals. However, this question and other related questions assume that the ethics of experimenting on nonhuman animals have been settled, which they have not. In this essay, we argue that it is imperative to give adequate attention to familiar questions about nonhuman animal research as well as new questions about chimera research and that failure to do so will result in a distorted understanding of the ethics of chimera research. (shrink)

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an (...) interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (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 Institutional Animal Care and Use Committee is entrusted with assessing the ethics of proposed projects prior to approval of animal research. The role of the IACUC is detailed in legislation and binding rules, which are in turn inspired by the Three Rs: the principles of Replacement, Reduction, and Refinement. However, these principles are poorly defined. Although this provides the IACUC leeway in assessing a proposed project, it also affords little guidance. Our goal is to provide procedural and (...) philosophical clarity to the IACUC without mandating a particular outcome. To do this, we analyze the underlying logic of the Three Rs and conclude that the Three Rs accord animals moral standing, though not necessarily “rights” in the philosophical sense. We suggest that the Rs are hierarchical, such that Replacement, which can totally eliminate harm, should be considered prior to Reduction, which decreases the number of animals harmed, with Refinement being considered last. We also identify the need for a hitherto implicit fourth R: Reject, which allows the IACUC to refuse permission for a project which does not promise sufficient benefit to offset the pain and distress likely to be caused by the proposed research. (shrink)

The use of nonhuman animals in research has long been a source of bioethical and scientific debate. We consider the oversight and use of nonhuman animals in chimeric research. We conducted interviews with twelve members of embryonic stem cell research oversight committees, nine members of institutional animal care and use committees, and fourteen scientists involved in human–nonhuman‐animal chimeric research in different areas of the United States. Interviews addressed animal welfare and conceptual issues associated with moral status and humanization of nonhuman (...) animals that contain human cells. Our findings suggest that concepts of enhanced moral status and consciousness are not very useful in human–nonhuman‐animal chimeric research in part because their meanings are not easily defined, which presents challenges to applying the concepts in research. Instead, scientists and oversight committee members we interviewed seemed to rely on standard assessments of changes in animal welfare when focusing on the ethics of human‐animal chimeric research. (shrink)

One requirement for the formation of an Institutional Animal Care and Use Committee is that they include a community member who embodies the values of the general population. This study’s aim is to investigate whether community members use moral arguments when deliberating a case of nonhuman animals used in experimentation. To this end, we tested the responses of community members in a situation similar to those confronting members of IACUC. The participants’ evaluation of the protocol was consistent with the (...) mandates of IACUC. We also found that overall no moral argument played a significant role in their evaluation of a protocol. Only arguments based on loyalty to the human species played a moderate role in the evaluation of using animals in experimental research, in a way similar to using some moral arguments regarding the importance of human welfare to justify the use of animals in experimental research. (shrink)

Animals have been and will continue to be used in educational programs, but some concerns about the responsibility for assuring their proper care and humane use need to be discussed. Research animals have been regulated and monitored quite successfully by Institutional Animal Care and Use Committees (IACUC). These Committees are extending their responsibilities to cover animals used in educational programs. Three common roles of these IACUCs are described, including oversight, investigative and training responsibilities. Guidelines developed for faculty using animals (...) at the University of Florida are presented and discussed. (shrink)

During the 1980s, federal regulations transferred significant portions of the responsibility for monitoring the care and use of research animals from animal care programs to Institutional Animal Care and Use Committees (IACUCs). After a brief review of the history of the regulation of the use of animals in research preceding and during the 4 decades following World War 11, this article raises 4 problems associated with the role IACUCs currently play in monitoring the use of animals in research: (a) lack (...) of expertise, (b) diverted resources, (c) conflict of interest, and (d) restrictions of academic freedom. It is concluded that the care and treatment of animals used in research would be served better and organized more rationally if the day-to-day responsibilities for approving projects and caring for animals were separated more clearly from broader, oversight functions, with the former being assigned to animal care programs and the latter to IACUCs. (shrink)

BackgroundAlthough animal research ethics committees are well established in Western countries, this field is weakly developed and its concept is poorly understood in the Middle East and North Africa region.ObjectiveOur main objective was to introduce the concept and requirements of ethical approaches in dealing with experimental animal in research and teaching in Egypt.MethodsDue to its very recent inception, Cairo University, Faculty of Science IACUC decided to operate in accordance with Guide for the Care and Use of Laboratory Animals 8th (...) Edition 2011 since Egypt has not yet compiled its own guide.ResultsFifty protocols were reviewed in 2013–2014. Only ten protocols were reviewed in 2013, but in 2014, forty protocols were reviewed. In 2013 all protocols were approved and in 2014, number of approvals were 35, the number of deferrals were 4, and one refused protocol. Master’s theses research protocols constituted the majority of the total reviewed protocols. This is attributed to the decision of the Board of the Faculty of Science, Cairo University in September, 2013 that the approval of the IACUC is mandatory before conducting any research involving animals or theses registration.ConclusionThe first IACUC was established in the Cairo University, Faculty of Science, since 2012. The challenges encountered by the committee were diverse, such as the absence of laws that control the use of animal models in scientific research, lack of guidelines and, mandatory ethical approval for any experimental animal research. (shrink)

This chapter provides a brief introductory history of biomedical practitioners’ efforts at self-regulation though oaths, codes, and statements of ethical principle, tracing them from ancient oaths through the nineteenth-century transition to codes of medical ethics. The more recent foundation for modern biomedical ethics was laid in post-World-War II oaths and codes written in the aftermath of the Holocaust, and later modified in response to animal rights and patients’ rights movements that promoted principles and practices enforced by semi-self-regulatory acronym-laden ethics committees— (...) HECs, IACUCs, IRBs/REBs/RECs. The last section of this chapter discusses the modern origins of self-regulatory ethical principles for benchside biomedicine and biomedical publications. (shrink)

Committee composition is a recurrent theme within the literature on Institutional Animal Care and Use Committees (IACUCs). The ability of IACUCs to ensure the ethical treatment of nonhuman research subjects depends upon who makes up these committees. Non-scientists and those not affiliated with the research institution have been deemed indispensable for the democratic, objective review of protocols and, thus, for ethical treatment. IACUCs’ critics and partners alike have persistently offered suggestions for how to further optimize committee composition towards these ends. (...) This paper contributes to the ongoing conversation by advocating for the addition of holistic species experts to IACUCs, arguing that holistic species experts are as indispensable for the political and epistemic viability of protocol reviews as non-scientists and non-affiliates. Holistic species experts are defined here as members of the larger community who have extensive firsthand experience with animals living and dying under relatively ideal conditions. If we accept that non-scientists and non-affiliates are crucial for IACUCs' ethical treatment of animals, then we have every reason to embrace holistic species experts. The values, welfare expertise, and productive epistemic dissonance that these experts bring to the table would prove invaluable. (shrink)

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership (...) lacks the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and (c) the committee's operational base of authority is alien to academic culture and violates essential aspects of academic freedom. In addition, he found that the system is burdensome, requiring enormous expenditures of time and money that inappropriately diverts resources away from the business of scientific discovery. We dispute several aspects of Steneck's historical account and the coherence of his proposals. We believe his proposals, if followed, would be a step back into a failed past. (shrink)

Is the use of animals in undergraduate education ethically justifiable? One way to answer this question is to focus on the factors relevant to those who serve on Institutional Animal Care and Use Committees . An analysis of the debate surrounding the practice of dissection at the undergraduate level helps shed light on these issues. Settling that debate hinges on claims about the kind of knowledge gained from dissection and other “hands-on” kinds of experiences, and whether such knowledge is needed (...) to meet educational goals. Most undergraduate courses will probably lack a sufficient justification for the use of animals for dissection, since the educational goals can be met with non-animal alternatives. In addition, there are some general guidelines that can be extrapolated from this debate, which should be of assistance in deciding whether a sufficient justification has been given for animal use. One guideline is that justifications for animal use should require demonstrating that the use adds value to the educational experience in a way that is directly tied to the course objectives. Furthermore, the use of animals should not be simply built into the objectives of a course in such a way that the use is merely assumed, with no actual justification provided. One must beware of putative standards for justification that would fail to rule out any possible animal use. (shrink)