High degrees of uncertainty and a lack of effective therapeutic treatments have characterized the COVID-19 pandemic and the provision of drug products outside research settings has been controversial. International guidelines for providing patients with experimental interventions to treat infectious diseases outside of clinical trials exist but it is unclear if or how they should apply in settings where clinical trials and research are strongly regulated. We propose the Professional Oversight of Emergency-Use Interventions and Monitoring System as an alternative pathway based (...) on guidance developed for the ethical provision of experimental interventions to treat COVID-19 in Singapore. We support our proposal with justifications that establish moral duties for physicians to record outcomes data and for institutions to establish monitoring systems for reporting information on safety and effectiveness to the relevant authorities. Institutions also have a duty to support generation of evidence for what constitutes good clinical practice and so should ensure the unproven intervention is made the subject of research studies that can contribute to generalizable knowledge as soon as practical and that physicians remain committed to supporting learning health systems. We outline key differences between POEIMS and other pathways for the provision of experimental interventions in public health emergencies. (shrink)

Culling is used in traditional public health policies to control animal populations. These policies aim primarily to protect human interests but often fail to provide scientific evidence of effectiveness. In this article, we defend the need to move from a strictly anthropocentric approach to disease control towards a One Health ethics, using culling practices as an example. We focus on the recent badger culls in the UK, claiming that, based on data provided by the English Government, these culls may be (...) unjustified, all thing considered. We highlight the relevance of ethical reasoning rooted in One Health for this discussion, and make several suggestions including a moratorium on culling until data are provided to support the effectiveness of culling; to conduct a randomized trial to compare proactive culling with alternative methods; to apply deliberative democratic methods to assess public opinion towards the culls, and to find in Brexit an opportunity for aiming for more effective control measures. (shrink)

Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...) ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

During the WHO-GloPID COVID-19 Global Research and Innovation Forum meeting held in Geneva on the 11th and 12th of February 2020 a number of different ethical concepts were used. This paper briefly states what a number of these concepts mean and how they might be applied to discussions about research during the COVID-19 pandemic and related outbreaks. This paper does not seek to be exhaustive and other ethical concepts are, of course, relevant and important.

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep (...) this “essential industry” producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry’s implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities. (shrink)

This comment responds to Kevin Warwick’s article on predictability and responsibility with respect to brain-machine interfaces in action. It compares conventional responsibility for device use with the potential consequences of phenomenological human-machine integration which obscures the causal chain of an act. It explores two senses of “responsibility”: 1) when it is attributed to a person, suggesting the morally important way in which the person is a causal agent, and 2) when a person is accountable and, on the basis of fairness (...) about rewards and sanctions, has a duty to act responsibly and accept liability. The comment suggests that, in the absence of absolute knowledge and predictability, we continue to engage in practical forms of reasoning about the responsibility for BMI-use in ways which are inclusive of uncertainties about the liability of persons versus devices and those who create them. (shrink)

This article poses a response to one argument supporting the force feeding of political prisoners. This argument assumes that prisoners have moral autonomy and thus cannot be force fed in the early stages of their hunger strike. However, as their fasting progresses, their cognitive competence declines, and they are no longer autonomous. Since they are no longer autonomous, force feeding becomes justified. This article questions the recurrent citation of a paper in empirical support of the claim that hunger strike causes (...) mental disorders or cognitive impairments. The paper, written by Daniel Fessler, partially relies on the Minnesota Starvation Experiment conducted in 1944 to 1945 for scientific support. Using widely accepted criteria for assessing the ethical acceptability of clinical research, we argue that the Minnesota Starvation Experiment had significant scientific shortcomings and is a case of unethical research. From this, we question the appropriateness of citing the Minnesota Starvation Experiment and consequently Fessler’s paper. If Citing Fessler’s paper becomes problematic, this particular argument for the force feeding of prisoners loses much of its strength. (shrink)

It has been argued that organs should be treated as individual tradable property like other material possessions and assets, on the basis that this would promote individual freedom and increase efficiency in addressing the shortage of organs for transplantation. If organs are to be treated as property, should they be inheritable? This paper seeks to contribute to the idea of organs as inheritable property by providing a defence of a default of the family of a dead person as inheritors of (...) transplantable organs. In the course of discussion, various succession rules for organs and their justifications will be suggested. We then consider two objections to organs as inheritable property. Our intention here is to provoke further thought on whether ownership of one's body parts should be assimilated to property ownership. (shrink)

Active surveillance cultures and contact precautions is a strategy to control the transmission of methicillin-resistant Staphylococcus aureus (MRSA) within healthcare facilities. Whether to implement this strategy to routinely screen and isolate inpatients with MRSA in non-outbreak (endemic) settings, or to remove it and use standard infection control precautions only is scientifically and ethically controversial, in view of the potential adverse effects of contact precautions on patients. To support the use of standard precautions only, it has been argued that active surveillance (...) to identify patients who are asymptomatically colonised with MRSA to place them in contact precautions is unjust or unfair to these patients in various ways. This paper will unpack and examine four distinct arguments, which are advanced from a medical ethics or quality improvement ethical framework, for why this is so. Our analysis shows that while these arguments highlight the injustice of current practices, they do not provide strong ethical reasons for justifying the removal of active surveillance and contact precautions to control MRSA transmission and infection. An implication of our arguments is that the ethical frame for evaluating prevention and control strategies for MRSA, a multi-drug resistant bacteria, should shift from healthcare to primarily public health. From a public health ethics perspective, whether a strategy is unjust, or how ethically significant its lack of fairness is, depends on assessing the evidence for its public health effectiveness and necessity in a given setting, and the extent of the harms and burdens patients with MRSA bear when they are on contact precautions, which remain matters of scientific debate or uncertainty. As an ethical consideration in the debate, the chief normative implication of justice is to provide us further reasons to revise current active surveillance-contact precautions practices, and for the need for research and interventions to minimise their potential adverse effects on patients. (shrink)

During an outbreak or pandemic involving a novel disease such as COVID-19, infected persons may need to undergo strict medical isolation and be separated from their families for public health reasons. Such a practice raises various ethical questions, the characteristics of which are heightened by uncertainties such as mode of transmission and increasingly scarce healthcare resources. For example, under what circumstances should non-infected parents be allowed to stay with their infected children in an isolation facility? This paper will examine ethical (...) issues with three modes of “family presence” or “being there or with” a separated family member during the current COVID-19 pandemic: physical, virtual, and surrogate. Physical visits, stays, or care by family members in isolation facilities are usually prohibited, discouraged, or limited to exceptional circumstances. Virtual presence for isolated patients is often recommended and used to enable communication. When visits are disallowed, frontline workers sometimes act as surrogate family for patients, such as performing bedside vigils for dying patients. Drawing on lessons from past outbreaks such as the 2002-2003 SARS epidemic and the recent Ebola epidemic in West Africa, we consider the ethical management of these modes of family presence and argue for the promotion of physical presence under some conditions. (shrink)

Acts of helping others are often based on mixed motivations. Based on this claim, it has been argued that the use of a financial reward to incentivize organ donation is compatible with promoting altruism in organ donation. In its report Human Bodies: Donation for Medicine and Research, the Nuffield Council on Bioethics uses this argument to justify its suggestion to pilot a funeral payment scheme to incentivize people to register for deceased organ donation in the UK. In this article, I (...) cast a sceptical eye on the above Nuffield report's argument that its proposed funeral payment scheme would prompt deceased organ donations that remain altruistic . Specifically, I illustrate how this scheme may prompt various forms of mixed motivations which would not satisfy the report's definition of altruism. Insofar as the scheme produces an expectation of the reward, it stands diametrical to promoting an ‘altruistic perspective’. My minimal goal in this article is to argue that altruism is not motivationally compatible with reward as an incentive for donation. My broader goal is to argue that if a financial reward is used to incentivize organ donation, then we should recognize that the donation system is no longer aiming to promote altruism. Rewarded donation would not be altruistic but it may be ethical given a persistent organ shortage situation. (shrink)

Like all research, embryo research can take a variety of forms, some posing substantially more risks to persons than others. Savulescu et al argue persuasively that regulatory regimes specially designed for sensitive embryo research should differentiate between person-affecting and non-person-affecting embryo research, with substantial scrutiny only warranted for the former.1 Yet if we find Savulescu et al ’s argument persuasive, what practical implications would it have? In this commentary, we focus in particular on how such an argument might apply in (...) Singapore, one of the jurisdictions with special regulations for embryo research. We will summarise the way in which approval for oocyte and embryonic research operates in Singapore, and suggest that Savulesc et al ’s distinction requires specification to be useful in such contexts. We propose adopting a risk-stratified framework similar to that employed with Institutional Review Boards. This requires a wider view of risks than the focus by Savulescu et al on future persons. We then illustrate how such a framework would apply in five scenarios discussed in Savulescu et al. Research with embryos and oocytes is regulated in Singapore under the Human Biomedical Research Act.2 Enacted in 2015, this law sets out requirements for consent, IRB review and research oversight. By definition, all research involving gametes and embryos fall within the remit of the Act. Moreover, such research is defined as ‘restricted’; besides the Act, research involving oocytes and embryos is also subject to control under the Human Biomedical Research …. (shrink)

Responses to outbreaks, epidemics and pandemics involves a heterogeneous set of activities that aim to address threats to public health. In addition to research, non-research activities, such as prevention and control interventions, and surveillance, are conducted. The boundaries between research and non-research responses can rapidly blur during a public health emergency such as the COVID-19 pandemic. There may be common elements between these types of activities, and they may draw on the same resources and infrastructure. Non-research activities, such as surveillance (...) and emergency non-research use of unproven interventions, and research activities must all be undertaken in an ethical manner as components of emergency response. However, care is needed to distinguish between non-research public health activities and research, because research often has considerations and requirements for its ethical conduct which are distinct from non-research public health activities. Research aims to produce generalizable knowledge, and mechanisms such as participant consent and independent ethics review aim to ensure that the rights and interests of research participants are respected. Ensuring that research and non-research activities are appropriately distinguished can additionally promote proper coordination of such activities, and increase trust and social accountability in pandemic responses. Consequently, it is important to distinguish between these different activities on the basis of their primary aim, and to consider whether their implementation is justifiable, based on their aims and the relevant ethical framework for each type of activity, and how they are coordinated as part of the larger collective activity of emergency response and management. Complex questions arise about how the different stakeholders involved in decision-making should make valid and justifiable decisions about whether the response activity is research or non-research. The cases in this chapter invite consideration about how such decisions should be made, and their implications, in the context of applications to conduct retrospective research into the outcomes of emergency uses of unproven interventions outside clinical trials, and of characterising antibody-testing initiatives and systematic data collection activities as surveillance or research. (shrink)

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications (...) for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (shrink)

This article argues that outbreak preparedness and response should implement a ‘family presence’ policy for infected patients in isolation that includes the option of physical visits and care within the isolation facility under some conditions. While such a ‘physical family presence’ policy could increase infections during an outbreak and may raise moral dilemmas, we argue that it is ethically justified based on the least infringement principle and the need to minimize the harms and burdens of isolation as a restrictive measure. (...) Categorical prohibition of PFP during the course of an outbreak or epidemic is likely to result in unnecessary harms to patients and families, and violate values such as the moral commitments of families to care for each other. Supporting the option of PFP under particular circumstances, on the other hand, will least infringe these moral considerations. An additional reason for a family presence policy is that it may facilitate voluntary cooperation with isolation and other restrictive measures. We provide an analysis of these considerations for supporting modes of family presence during an outbreak emergency, before defending the riskier option of PFP in the isolation facility from plausible objections and concerns. (shrink)

BackgroundHealth screening is undertaken to identify individuals who are deemed at higher risk of disease for further diagnostic testing so that they may possibly benefit from interventions to modify the natural course of disease. In Singapore, screening tests are widely available in the form of a package, which bundles multiple tests in one session and commonly includes non-recommended tests. There are various ethical issues associated with such testing as they may not be clinically appropriate and can result in more harm (...) than benefit. This article describes the practice of health screening packages, identifies the ethical issues arising from such packages and discusses the implications of these ethical issues on policy and practice of screening in Singapore.MethodsA content analysis of the websites of providers offering general health screening packages to individuals was conducted. A total of 14 health screening package providers were analysed for how packages were conducted and promoted, how clinically appropriate screening tests were, and the price range and composition of screening packages. A normative ethical analysis based on the four principles approach of beneficence, non-maleficence, autonomy and justice in biomedical ethics was used.ResultsTwelve of the 14 providers included non-recommended tests such as tumour markers, treadmill stress tests and MRI scans in their general health screening packages. Package prices ranged from S$26 to S$10,561, with providers charging higher when more tests were included. Health screening packages were broadly conducted in three stages: the offer and selection of a health screening package; medical assessment and performance of screening tests; a post-screening review. While material provided by all providers was factual, there was no information on the potential risks or harms of screening.ConclusionSeveral ethical issues were identified that should be addressed with regard to health screening packages in Singapore. A key issue was the information gap between providers and patients, which may result in patients undergoing inappropriate testing that may be more harmful than beneficial. Health screening packages can stimulate unnecessary demand for healthcare and contribute to an inequitable distribution of healthcare resources. (shrink)