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)

Emerging infectious diseases remain a significant and dynamic threat to the health of individuals and the well-being of communities across the globe. Over the last decade, in response to these threats, increasing scientific consensus has mobilised in support of a One Health approach so that OH is now widely regarded as the most effective way of addressing EID outbreaks and risks. Given the scientific focus on OH, there is growing interest in the philosophical and ethical dimensions of this approach, and (...) a nascent OH literature is developing in the humanities. One of the key issues raised in this literature concerns ethical frameworks and whether OH merits the development of its very own ethical framework. In this paper, we argue that although the OH approach does not demand a new ethical framework, an OH approach does furnish the theoretical resources to support a novel ethical framework, and there are benefits to developing one that may be lost in its absence. We begin by briefly explaining what an OH approach to the threats posed by EIDs entails before outlining two different ways of construing ethical frameworks. We then show that although on one account of ethical frameworks there is no need for OH to generate its own, there may be advantages for its advocates in doing so. (shrink)

Surveillance is essential for communicable disease prevention and control. Traditional notification of demographic and clinical information, about individuals with selected infectious diseases, allows appropriate public health action and is protected by public health and privacy legislation, but is slow and insensitive. Big data–based electronic surveillance, by commercial bodies and government agencies, which draws on a plethora of internet- and mobile device–based sources, has been widely accepted, if not universally welcomed. Similar anonymous digital sources also contain syndromic information, which can be (...) analysed, using customised algorithms, to rapidly predict infectious disease outbreaks, but the data are nonspecific and predictions sometimes misleading. However, public health authorities could use these online sources, in combination with de-identified personal health data, to provide more accurate and earlier warning of infectious disease events—including exotic or emerging infections—even before the cause is confirmed, and allow more timely public health intervention. Achieving optimal benefits would require access to selected data from personal electronic health and laboratory records and the potential to re-identify individuals found to be involved in outbreaks, to ensure appropriate care and infection control. Despite existing widespread digital surveillance and major potential community benefits of extending its use to communicable disease control, there is considerable public disquiet about allowing public health authorities access to personal health data. Informed public discussion, greater transparency and an ethical framework will be essential to build public trust in the use of new technology for communicable disease control. (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 the past decade, numerous ethical frameworks have been developed to support public health decision‐making in challenging areas. Before the COVID‐19 pandemic began, members of the authorship team were involved in research programmes, in which the development of ethical frameworks was planned, to guide (a) the use of new technologies for emerging infectious disease surveillance; and (b) the allocation of scarce supplies of pandemic influenza vaccine. However, as the pandemic evolved, significant practical challenges emerged that led to our questioning the (...) value of these frameworks. We now believe that a normative instrument, such as a framework, cannot adequately or reliably provide the ethical guidance that needs to be incorporated into public health decision‐making during natural disasters or infectious disease emergencies. Recently it has been suggested that there are potentially more dynamic, flexible, and effective ways to navigate decisions involving complex considerations entailed in policies and practices during a public health emergency. In this paper, we first outline the key functions of a public health ethics framework, before describing why we believe it would not be fit for purpose during a crisis. We end by considering whether proposed alternative methods to promote ethical public health decision‐making goals have the potential to meet these objectives. (shrink)

Background Outbreaks of infectious disease cause serious and costly health and social problems. Two new technologies – pathogen whole genome sequencing and Big Data analytics – promise to improve our capacity to detect and control outbreaks earlier, saving lives and resources. However, routinely using these technologies to capture more detailed and specific personal information could be perceived as intrusive and a threat to privacy. Method Four community juries were convened in two demographically different Sydney municipalities and two regional cities in (...) New South Wales, Australia to elicit the views of well-informed community members on the acceptability and legitimacy of: making pathogen WGS and linked administrative data available for public health researchusing this information in concert with data linkage and machine learning to enhance communicable disease surveillance systems Fifty participants of diverse backgrounds, mixed genders and ages were recruited by random-digit-dialling and topic-blinded social-media advertising. Each jury was presented with balanced factual evidence supporting different expert perspectives on the potential benefits and costs of technologically enhanced public health research and communicable disease surveillance and given the opportunity to question experts. Results Almost all jurors supported data linkage and WGS on routinely collected patient isolates for the purposes of public health research, provided standard de-identification practices were applied. However, allowing this information to be operationalised as a syndromic surveillance system was highly contentious with three juries voting in favour, and one against by narrow margins. For those in favour, support depended on several conditions related to system oversight and security being met. Those against were concerned about loss of privacy and did not trust Australian governments to run secure and effective systems. Conclusions Participants across all four events strongly supported the introduction of data linkage and pathogenomics to public health research under current research governance structures. Combining pathogen WGS with event-based data surveillance systems, however, is likely to be controversial because of a lack of public trust, even when the potential public health benefits are clear. Any suggestion of private sector involvement or commercialisation of WGS or surveillance data was unanimously rejected. (shrink)

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide (...) advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries. (shrink)

Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing to special (...) features of both surgery and innovation. (shrink)

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

Surgical innovation promises improvements in healthcare, but it also raises ethical issues including risks of harm to patients, conflicts of interest and increased injustice in access to health care. In this article, we focus on risks of injustice, and use a case study of robotic prostatectomy to identify features of surgical innovation that risk introducing or exacerbating injustices. Interpreting justice as encompassing matters of both efficiency and equity, we first examine questions relating to government decisions about whether to publicly fund (...) access to innovative treatments. Here the case of robotic prostatectomy exemplifies the difficulty of accommodating healthcare priorities such as improving the health of marginalized groups. It also illustrates challenges with estimating the likely long-term costs and benefits of a new intervention, the difficulty of comparing outcomes of an innovative treatment to those of established treatments, and the further complexity associated with patient and surgeon preferences. Once the decision has been made to fund a new procedure, separate issues of justice arise at the level of providing care to individual patients. Here, the case of robotic prostatectomy exemplifies how features of surgical innovation, such as surgeon learning curves and the need for an adequate volume of cases at a treatment centre, can exacerbate injustices associated with treatment cost and the logistics of travelling for treatment. Drawing on our analysis, we conclude by making a number of recommendations for the just introduction of surgical innovations. (shrink)

In this paper we argue that surgeons face a particular kind of within-role conflict of interests, related to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed consent. The standard remedies for conflicts of interest are transparency and recusal, (...) which are unlikely to address this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation. (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)

We thank Zohar Lederman and Benjamin Capps for engaging with our paper on One Health and ethical frameworks, however we want to take issue with them on three points. First, they appear to misunderstand the distinction we appeal to between ethical theory and ethical frameworks, and so misinterpret what we are trying to achieve in our paper. Second, in spite of what they seem to imply, we agree that an OH approach can obscure differences in values, and that to progress (...) the field there needs to be recognition of competing values and their implications for OH. Finally, we are puzzled by their interest in pursuing a deliberative process, as this seems at odds with other positions they take in their paper, and also opens up many questions that need to be addressed. (shrink)

Studies with captive fowl have revealed that they possess greater cognitive capacities than previously thought. We now know that fowl have sophisticated cognitive and communicative skills, which had hitherto been associated only with certain primates. Several theories have been advanced to explain the evolution of such complex behavior. Central to these theories is the enlargement of the brain in species with greater mental capacities. Fowl present us with a conundrum, however, because they show the behaviors anticipated by the theories but (...) do not have the expected changes in the brain. Consequently fowl present two challenges of interest to us here. One is a scientific challenge to explain their remarkable capabilities. The other is an ethical challenge regarding our treatment of animals with higher cognitive skills. (shrink)

The standard view of Kant’s retributivism, as well as its more recent reworking in the ‘limited’ or ‘partial’ retributivist reading are, it is argued here, inadequate accounts of Kant on punishment. In the case of the former, the view is too limited and superficial, and in the latter it is simply inaccurate as an interpretation of Kant. Instead, this paper argues that a more sophisticated and accurate rendering of Kant on punishment can be obtained by looking to his construction of (...) the concept of justice. In so doing, not only is a superior account of Kant furnished, but also one up to the task of resolving the vexed issue of justifying legal punishment. (shrink)

The public can influence animal welfare law and regulation. However what constitutes ‘the public’ is not a straightforward matter. A variety of different publics have an interest in animal use and this has implications for the governance of animal welfare. This article presents an ethnographic content analysis of how the concept of a public is mobilized in animal welfare journals from 2003 to 2012. The study was undertaken to explore how experts in the discipline define and regard the role of (...) the public in determining animal welfare standards. Analysis indicates that experts in animal welfare constitute different types of citizen and consumer publics around specific types of animal use, framed by different theories of value. These results suggest a need for greater clarity about the roles and responsibilities of experts and publics in animal welfare reform processes. Clearly citizens and consumers can both contribute to promoting higher welfare standards, but an over-reliance on market mechanisms and consumer behaviour to assign value is beset by moral hazards, foremost being the risk of disarticulating the concept of animal welfare from the public good. (shrink)

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given (...) the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling. (shrink)

Mobile phone-based applications (apps) can promote faster targeted actions to control COVID-19. However, digital contact tracing systems raise concerns about data security, system effectiveness, and their potential to normalise privacy-invasive surveillance technologies. In the absence of mandates, public uptake depends on the acceptability and perceived legitimacy of using technologies that log interactions between individuals to build public health capacity. We report on six online deliberative workshops convened in New South Wales to consider the appropriateness of using the COVIDSafe app to (...) enhance Australian contact tracing systems. All groups took the position (by majority) that the protections enacted in the app design and supporting legislation were appropriate. This support is contingent on several system attributes including: the voluntariness of the COVIDSafe app; that the system relies on proximity rather than location tracking; and, that data access is restricted to local public health practitioners undertaking contact tracing. Despite sustained scepticism in media coverage, there was an underlying willingness to trust Australian governing institutions such that in principle acceptance of the new contact tracing technology was easy to obtain. However, tensions between the need to prove system effectiveness through operational transparency and requirements for privacy protections could be limiting public uptake. Our study shows that informed citizens are willing to trade their privacy for common goods such as COVID-19 suppression. But low case numbers and cautionary public discourses can make trustworthiness difficult to establish because some will only do so when it can be demonstrated that the benefits justify the costs to individuals. (shrink)

Though it involves significant harms and is a widespread and entrenched practice, legal punishment lacks a sure philosophical footing. In spite of frequent attempts by utilitarians, retributivists and so called "mixed solution" advocates the problem of justifying punishment remains. This book aims to redress this shortcoming by turning to the German thinkers Kant and Hegel and their idealism to fashion punishment's justification. In the case of Kant this is achieved by developing his construction of justice, while for Hegel it involves (...) taking seriously his theory of recognition and aspects of his logic. In applying ideas from this tradition to a contemporary problem, this book will appeal to both those interested in Kant and Hegel scholarship and its recent resurgence, as well as to students of jurisprudence. (shrink)

Volume 19, Issue 6, June 2019, Page 28-29.

This article examines strategies used by human rights advocates to lobby for policy at intergovernmental organizations. We suggest that the literatures’ central questions are about how best to organize, connect, and communicate, which are usually seen through theory on transnational advocacy networks and framing. We add that these questions should be seen as gendered, given the continued male dominance within diplomatic corps. With unusual access to their strategy, we conduct a case study of one advocate’s successful campaign to get the (...) United Nations to adopt a country-specific resolution. Like others, we found this campaigning relies upon the use of networks to overcome formal obstacles to access, human rights language to frame the problem, analysis of tally sheets of member states’ voting, and in-person lobbying. We also point out strategies key to their success that are not usually noticed by scholars, such as the gendered dynamics that get advocates in the door. (shrink)