COVID-19 vaccination certificates and lifting public health and social measures: ethical considerations.

Background: To reopen society, various countries are planning or have implemented differential public health and social measures (PHSMs) for COVID-19-vaccinated individuals, by exempting these individuals from some of the measures. Aims: To examine the ethical considerations raised by differential PHSMs by differrnt countries based on individual vaccination status verified by vaccination certificates. Discussion: Decisions on whether and when measures should be lifted specifically for vaccinated individuals should be guided by scientific and ethical considerations. These considerations include the public health risks of differential lifting, particularly in a context where a substantial portion of society is not vaccinated; mitigation of inequities and unfair disadvantages for unvaccinated individuals; and whether to permit other health certificates or credentials besides proof of vaccination as alternative options to access specific activities or services, as a way to balance public health and freedom of movement. Conclusion: Vaccination certificates may undermine a population-based approach to COVID-19 vaccination to achieve and accelerate universal lifting of PHSMs, result in unfair and inequitable health and social outcomes, and generate social divisions at a time when solidarity within (and between) countries is necessary to navigate the pandemic and its burdens. Further research on the ethical acceptability and impact of COVID-19 vaccine certificates in countries that have implemented them should be carried out to inform future ethical considerations on this issue.

Experiences of risk in Australian hotel quarantine: a qualitative study.

BACKGROUND: In response to the threat of COVID-19 infection, Australia mandated a 14 day quarantine period in a designated facility for all travellers returning from overseas from late March 2020. These facilities were usually hotels, or hotel-like serviced apartments, and also included a repurposed former mining village in the Northern Territory. This paper aimed to investigate the experiences of risk of people quarantined in designated supervised facilities in Australia, which has not been systematically explored before. METHODS: In this qualitative study semi-structured interviews were conducted with 58 participants quarantined between March 2020 and January 2021. Participants were returned Australian citizens and residents who were required to undergo mandatory supervised quarantine for COVID-19. Interviews were conducted using video teleconferencing (via Zoom), transcribed and coded, then analysed thematically. RESULTS: While participants generally supported the concept of quarantine to protect the Australian public, they were critical of elements of it where they felt exposed to risk (COVID-related or not). They also described instances where infection control within the system seemed inadequate. For some, particularly those quarantined with small children, they reported that the facilities were inadequate or inappropriate for health and wellbeing. Using thematic analysis, three major themes were identified that related to problems in the existing system: perception of being subjected to high risk through lax standards of COVID protection in the quarantine process; risks to the community identified in quarantine; and risk in non-hotel managed quarantine facilities. CONCLUSIONS: There are systemic issues with infection control in hotel quarantine, which can be further undermined by individual non-compliance. Risks to safety for those in quarantine can be reduced, both in terms of infection control within hotel quarantine and, in the case of the Northern Territory facility, timely in-person medical care as needed for non-COVID conditions. Systems of infection control need ongoing review to ensure that people entering quarantine are protected from known risks of infection at every stage. Medical services in quarantine facilities should be examined to ensure timely and appropriate non-COVID medical services are available.

Uncertainty and agency in COVID-19 hotel quarantine in Australia.

Mandatory 14-day hotel COVID-19 quarantine was introduced for international arrivals into Australia in late March 2020, with no precedent and little time to prepare. This public health initiative was a key factor in Australia's relatively low COVID-19 burden in the first 18 months of the pandemic. We conducted an empirical bioethics study exploring the experience of people who had quarantined in hotels in Australia. We used in depth interviews to develop an understanding of context and normative analysis to consider whether the way the program is conducted is ethically justifiable. 58 people participated; they had been in hotel quarantine in different parts of Australia in the period March 2020-January 2021. Participants faced considerable uncertainty while in quarantine and many experienced this as burdensome. Some uncertainty resulted from not being given information about key aspects of quarantine, some from rules that changed frequently or were otherwise inconsistent, some from being physically isolated. Lack of information and uncertainty contributed to diminished agency. Communication efforts made by individual hotels was well received. Earlier ethics literature about quarantine does not take into account the context our participants described, where the hotel and supervision arrangements were central to the experience. We argue that more suitable arrangements must be made if quarantine is to be an ongoing proposition.

Top five ethical lessons of COVID-19 that the world must learn.

As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned.

How should we conduct pandemic vaccination?

Vaccination plays an important role in pandemic planning and response. The possibility of developing an effective vaccine for a novel pandemic virus is not assured. However, as we have seen with SARS-CoV-2 vaccine development, with sufficient resources and global focus, successful outcomes can be achieved in a relatively short period. However even when vaccine is available it will initially be scarce. When one becomes available, how should it be distributed? In this paper we explicate how ethical thinking that is carefully attuned to context is essential to decisions about how we should conduct vaccination in a pandemic where demand exceeds supply. We focus on two key issues. First, setting the aims for a pandemic vaccination programme. Second, thinking about the means of delivering a chosen aim. We outline how pandemic vaccine distribution strategies can be implemented with distinct aims, e.g. protecting groups at greater risk of harm, saving the most lives, or ensuring societal benefit. Each aim will result in a focus on a different priority population and each strategy will have a different benefit-harm profile. Once we have decided our aim, we still have choices to make about delivery. We may achieve at least some ends via direct or indirect strategies. Such policy decisions are not merely technical, but necessarily involve ethics. One important general issue is that such planning decisions about distribution will always be made under conditions of uncertainty about vaccine safety and effectiveness. However, planning how to distribute vaccine for SARS-CoV-2 is even harder because we understand relatively little about the virus, transmission, and its immunological impact in the short and long term.

An Ethics Framework for Making Resource Allocation Decisions Within Clinical Care: Responding to COVID-19.

On March, 24, 2020, 818 cases of COVID-19 had been reported in New South Wales, Australia, and new cases were increasing at an exponential rate. In anticipation of resource constraints arising in clinical settings as a result of the COVID-19 pandemic, a working party of ten ethicists (seven clinicians and three full-time academics) was convened at the University of Sydney to draft an ethics framework to support resource allocation decisions. The framework guides decision-makers using a question-and-answer format, in language that avoids philosophical and medical technicality. The working party met five times over the following week and then submitted a draft Framework for consideration by two groups of intensivists and one group of academic ethicists. It was also presented to a panel on a national current affairs programme. The Framework was then revised on the basis of feedback from these sources and made publicly available online on April 3, ten days after the initial meeting. The framework is published here in full to stimulate ongoing discussion about rapid development of user-friendly clinical ethics resources in ongoing and future pandemics.

Building an Ethics Framework for COVID-19 Resource Allocation: The How and the Why.

This paper expands on "An Ethics Framework for Making Resource Allocation Decisions within Clinical Care: Responding to COVID-19," which is also published in this special issue of the Journal of Bioethical Inquiry. I first describe and explain the steps we took to develop this framework, drawing on previous experience and literature to explain what frameworks can and cannot do. I distinguish frameworks from other kinds of guidance and justify why our framework takes the form it does. Our key aim was to help answer practical questions faced by frontline clinicians. I then explain some of the normative issues that shape the content of the framework itself. Here, I engage critically with the resource allocation literature and justify the particular positions that we take in the framework. Although we undertook this work to address resource allocation decisions anticipated during the unfolding COVID-19 pandemic, it will also serve as an example for others who wish to design practical ethics frameworks for other bioethical issues that will emerge in the future.

Prioritising access to pandemic influenza vaccine: a review of the ethics literature.

BACKGROUND: The world is threatened by future pandemics. Vaccines can play a key role in preventing harm, but there will inevitably be shortages because there is no possibility of advance stockpiling. We therefore need some method of prioritising access. MAIN TEXT: This paper reports a critical interpretative review of the published literature that discusses ethical arguments used to justify how we could prioritise vaccine during an influenza pandemic. We found that the focus of the literature was often on proposing different groups as priorities (e.g. those with pre-existing health conditions, the young, the old, health care workers etc.). Different reasons were often suggested as a means of justifying such priority groupings (e.g. appeal to best overall outcomes, fairness, belonging to a vulnerable or 'at risk' group etc.). We suggest that much of the literature, wrongly, assumes that we are able to plan priority groups prior to the time of a particular pandemic and development of a particular vaccine. We also point out the surprising absence of various issues from the literature (e.g. how vaccines fit within overall pandemic planning, a lack of specificity about place, issues of global justice etc.). CONCLUSIONS: The literature proposes a wide range of ways to prioritise vaccines, focusing on different groups and 'principles'. Any plan to use pandemic vaccine must provide justifications for its prioritisation. The focus of this review was influenza pandemic vaccines, but lessons can be learnt for future allocations of coronavirus vaccine, if one becomes available.

"Stop talking around projects and talk about solutions": Positioning health within infrastructure policy to achieve the sustainable development goals.

PURPOSE AND SETTING: Infrastructure is a global multi-trillion dollar market presenting many opportunities and risks for sustainable development. This article aims to foster better conceptualisation of the connections and tensions between infrastructure policy and public health in the light of the Sustainable Development Goals, especially 'good health and wellbeing' (number 3) and 'industry, innovation and infrastructure' (number 9), based on findings from interviews with a purposive sample of senior practicing Australian infrastructure policy makers. PRINCIPAL FINDINGS: We use an institutional framework to explore the ideas, actors, rules and mandates, and procedures underpinning the inclusion of health in infrastructure policy. Informants defined infrastructure as the construction and provision of services that facilitate economic, environmental and social outcomes. The tendency to default to infrastructure as essential for economic success has fundamental challenges for the SDGs, particularly the politically driven pursuit of 'mega-project' legacies, sector-specific siloed governance arrangements, and inadequate conceptualisations of costs and benefits. CONCLUSIONS: Public health and infrastructure policy are mutually re-enforcing given they both concern the public interest with implications for all 17 SDGs. Positioning health and wellbeing as fundamental societal outcomes from infrastructure decisions would go a long way to helping achieve the SDGs.

Including health impacts in environmental impact assessments for three Australian coal-mining projects: a documentary analysis.

Notwithstanding the historical benefits of coal in aiding human and economic development, the negative health and environmental impacts of coal extraction and processing are of increasing concern. Environmental impact assessments (EIAs) are a regulated policy mechanism that can be used to predict and consider the health impacts of mining projects to determine if consent is given. The ways in which health is considered within EIA is unclear. This research investigated 'How and to what extent are health, well-being and equity issues considered in Environmental Impact Assessments (EIAs) of major coal mining projects in New South Wales, Australia'. To this end we developed and applied a comprehensive coding framework designed to interrogate the publicly available environmental impact statements (EISs) of three mines in New South Wales (NSW), Australia, for their inclusion of health, well-being and equity issues. Analysis of the three EISs demonstrates that: the possible impacts of each mine on health and well-being were narrowly and inadequately considered; when health and well-being were considered there was a failure to assess the possible impacts specific to the particular mine and the communities potentially affected; the cumulative impacts on human health of multiple mines in the same geographical area were almost completely ignored; the discussions of intragenerational and intergenerational equity did not demonstrate a sound understanding of equity and, it is essential that governments' requirements for the EIA include detailed analysis of the health, well-being, equity and cumulative impacts specific to the proposed mine and relevant communities.

Ending TB in Australia: Organizational challenges for regional tuberculosis programs.

The World Health Organization's End TB Strategy aims to eliminate tuberculosis (TB) by 2050. Low-burden countries such as Australia are targeted for early elimination (2035), which will require an increase in the intensity and scope of case finding and treatment of people with latent TB infection (LTBI). Because 80 % of TB disease in Australia occurs in metropolitan Sydney (New South Wales) and Melbourne (Victoria), the commitment to move towards elimination has major implications for TB programs in these jurisdictions. We report on a case study analysis that compares and contrasts key attributes of each of these healthcare organizations. Such analysis has important implications for all countries seeking to implement international agreements within local health structures. Differences in the organizational structure, culture and systems of care in NSW and Victoria may facilitate or create barriers to changes in organizational system functions, especially the way in which TB prevention and LTBI treatment is delivered. Ratification of global health treaties and the development of national strategies, alone, is insufficient for realizing the promised outcomes. Even in high income countries, global health agendas such as TB elimination can be complicated by differences in local system structure and funding. As the timelines tighten towards 2035, more work must be done to identify the organizational conditions and service models that will facilitate progress towards TB elimination.

Developing and Implementing new TB Technologies: Key Informants' Perspectives on the Ethical Challenges.

OBJECTIVE: To identify the ethical challenges associated with the development and implementation of new tuberculosis (TB) drugs and diagnostics. METHODS: Twenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis. RESULTS: Divergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation. CONCLUSIONS: This project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities. POLICY IMPLICATIONS: Efforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies.

Why research ethics should add retrospective review.

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a 'tick box' exercise to get over the 'hurdle' of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people's capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project's ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others' perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

A failure in solidarity: Ethical challenges in the development and implementation of new tuberculosis technologies.

Prominent tuberculosis (TB) actors are invoking solidarity to motivate and justify collective action to address TB, including through intensified development and implementation (D&I) of technologies such as drugs and diagnostics. We characterize the ethical challenges associated with D&I of new TB technologies by drawing on stakeholder perspectives from 23 key informant interviews and we articulate the ethical implications of solidarity for TB technology D&I. The fundamental ethical issue facing TB technological D&I is a failure within and beyond the TB community to stand in solidarity with persons with TB in addressing the complex sociopolitical contexts of technological D&I. The failure in solidarity relates to two further ethical challenges raised by respondents: skewed power dynamics that hinder D&I and uncertainties around weighing risks and benefits associated with new technologies. Respondents identified advocacy and participatory research practices as necessary to address such challenges and to motivate sustained collective action to accelerate toward TB elimination. We present the first empirical examination of bioethical accounts of solidarity in public and global health. Our study suggests that solidarity allows us better to understand and address the ethical challenges that arrest the D&I of new TB technologies. Solidarity lends credence to policies and practices that address the relational nature of illness and health through collective action.