G. Owen Schaefer

This paper argues that one problem that besets black-box AI is that it lacks algorithmic justifiability. We argue that the norm of shared decision making in medical care presupposes that treatment decisions ought to be justifiable to the patient. Medical decisions are justifiable to the patient only if they are compatible with the patient’s values and preferences and the patient is able to see that this is so. Patient-directed justifiability is threatened by black-box AIs because the lack of rationale provided for the decision makes it difficult for patients to ascertain whether there is adequate fit between the decision and the patient’s values. This paper argues that achieving algorithmic transparency does not help patients bridge the gap between their medical decisions and values. We introduce a hypothetical model we call Justifiable AI to illustrate this argument. Justifiable AI aims at modelling normative and evaluative considerations in an explicit way so as to provide a stepping stone for patient and physician to jointly decide on a course of treatment. If our argument succeeds, we should prefer these justifiable models over alternatives if the former are available and aim to develop said models if not.

COVID-19 vaccines are likely to be scarce for years to come. Many countries, from India to the U.K., have demonstrated vaccine nationalism. What are the ethical limits to this vaccine nationalism? Neither extreme nationalism nor extreme cosmopolitanism is ethically justifiable. Instead, we propose the fair priority for residents framework, in which governments can retain COVID-19 vaccine doses for their residents only to the extent that they are needed to maintain a noncrisis level of mortality while they are implementing reasonable public health interventions. Practically, a noncrisis level of mortality is that experienced during a bad influenza season, which society considers an acceptable background risk. Governments take action to limit mortality from influenza, but there is no emergency that includes severe lockdowns. This “flu-risk standard” is a nonarbitrary and generally accepted heuristic. Mortality above the flu-risk standard justifies greater governmental interventions, including retaining vaccines for a country's own citizens over global need. The precise level of vaccination needed to meet the flu-risk standard will depend upon empirical factors related to the pandemic. This links the ethical principles to the scientific data emerging from the emergency. Thus, the FPR framework recognizes that governments should prioritize procuring vaccines for their country when doing so is necessary to reduce mortality to noncrisis flu-like levels. But after that, a government is obligated to do its part to share vaccines to reduce risks of mortality for people in other countries. We consider and reject objections to the FPR framework based on a country: having developed a vaccine, raising taxes to pay for vaccine research and purchase, wanting to eliminate economic and social burdens, and being ineffective in combating COVID-19 through public health interventions.

We live in the Information Age. Advances over the past 50 years in computing technology have enabled ever-expanding capacity to generate, store, transfer, process and analyse information about people, societies, products, services, the environment—nearly every aspect of the world. In parallel, concerns over how such data is being used have emerged, focusing especially on issues of privacy and confidentiality. Yet as technological capabilities continue to expand, the debate over ethical uses of data inevitably has evolved as well. Whereas we used to just talk about data, now there is great concern over Big Data. This chapter explores what, exactly, Big Data is; the ethical ramifications of its emergence, particularly for consent and anonymization; and what sorts of policy solutions are being proposed to address these emerging challenges. We will not defend one particular approach, but hope this chapter can be a useful reference for those who are contemplating difficult questions surrounding responsible management of Big Data.

COVID-19 has stolen millions of lives and devastated livelihoods around the world and led to the exacerbation of existing inequities within and between countries. This part of a tragic pattern in catastrophes, where the most vulnerable populations are typically the ones to bear the greatest burdens. Jecker and Au1 offer a keen observation of how one particular COVID-19 response—Zero COVID—appears particularly problematic from a health equity perspective. Under Zero COVID, countries enact stringent lockdowns and movement restrictions in order to keep cases as low as possible. Yet such restrictive policies hurt disadvantaged populations the most, by severely curtailing their ability to earn a living and forcing them to remain in cramped living spaces for potentially extended periods of time. However, the link between Zero COVID and health inequity is more complex than it might at first appear. This is because Zero COVID is itself compatible with meaningful efforts to mitigate inequities, including those caused by Zero COVID policies themselves. Conversely, certain inequities seemingly characterised by Zero COVID may persist even when Zero COVID is abandoned, indicating their ultimate root and …

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. Results Four key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective.

The success of digital COVID-19 contact tracing requires a strategy that successfully addresses the digital divide—inequitable access to technology such as smartphones. Lack of access both undermines the degree of social benefit achieved by the use of tracing apps, and exacerbates existing social and health inequities because those who lack access are likely to already be disadvantaged. Recently, Singapore has introduced portable tracing wearables (with the same functionality as a contact tracing app) to address the equity gap and promote public health. We argue that governments have an ethical obligation to ensure fair access to the protective benefits of contract tracing during the pandemic and that wearables are an effective way of addressing some important equity issues. The most contentious issues about contact tracing apps have been the potential infringements of privacy and individual liberty, especially where the use of apps or other technology (such as wearables or QR codes) is required for access to certain spaces. Here we argue that wearables, as opposed to apps alone, will make a digital contact tracing mandate more practical and explain some conditions under which such a mandate would be justified. We focus on Singapore as a case study that has recently deployed contact tracing wearables nationally, but also reference debate about wearables in Australia and New Zealand. Our analysis will be relevant to counties trialling similar portable tracing wearables.

Given the sordid history of injustices linking genetics to race and ethnicity, considerations of justice are central to ensuring the responsible development of precision medicine programmes around the world. While considerations of justice may be in tension with other areas of concern, such as scientific value or privacy, there are also tensions between different aspects of justice. This paper focuses on three particular aspects of justice relevant to this precision medicine: social justice, distributive justice and human rights. We describe the implications of each for the use of race and ethnicity in precision medicine, and also how they intersect and potentially conflict with each another. By attending to these intersections, we aim to enrich and add nuance to debates over how best to proceed with precision medicine initiatives.

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 …

In their response to ‘Public interest in health data research: laying out the conceptual groundwork’, Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees, we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current frameworks such as that found in the guidelines approved under Australia’s Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies.

The development of some COVID-19 vaccines by private companies like Moderna and Sanofi-GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the vaccine under conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations.

The development of some COVID-19 vaccines by private companies like Moderna and Sanofi-GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the vaccine under conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations.

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from precision medicine initiatives, it is important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme.

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.

Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is an ethical framework developed by the WHO for using unproven interventions in public health emergencies outside the context of medical research. It is mainly intended for use when medical research would be impracticable, but there is still a need to systematically gather data about unproven interventions. As such, it is designed as something of a middle ground between clinical and research ethical frameworks.However, I argue that MEURI does not truly lie at the intersection of clinical care and research. Due to its intent, structure and oversight requirements, it takes on most of the crucial features of research, to the point that it is best understood as a form of research. As a result, cases where MEURI could practicably be applied should instead make use of existing research frameworks. For those circumstances where research is truly impracticable, a more straightforward oversight system than MEURI is needed. While existing practices of compassionate use have some applicability, proposals to make use of clinical ethics committees to oversee unproven interventions may help achieve the right balance in acting in a patient’s best interests when the relevant evidence base is weak.

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm.