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.

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.

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.

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.

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.

Assessing the public acceptability of proposed policy interventions to reduce the misuse of antibiotics in Australia: A report on two community juries.

OBJECTIVE: To elicit the views of well-informed community members on the acceptability of proposed policy interventions designed to improve community use of antibiotics in Australia. DESIGN: Two community juries held in 2016. SETTING AND PARTICIPANTS: Western Sydney and Dubbo communities in NSW, Australia. Twenty-nine participants of diverse social and cultural backgrounds, mixed genders and ages recruited via public advertising: one jury was drawn from a large metropolitan setting; the other from a regional/rural setting. MAIN OUTCOME MEASURE: Jury verdict and rationale in response to a prioritization task and structured questions. RESULTS: Both juries concluded that potential policy interventions to curb antibiotic misuse in the community should be directed towards: (i) ensuring that the public and prescribers were better educated about the dangers of antibiotic resistance; (ii) making community-based human and animal health-care practitioners accountable for their prescribing decisions. Patient-centred approaches such as delayed prescribing were seen as less acceptable than prescriber-centred approaches; both juries completely rejected any proposal to decrease consumer demand by increasing antibiotic prices. CONCLUSION: These informed citizens acknowledged the importance of raising public awareness of the risks, impacts and costs of antibiotic resistance and placed a high priority on increasing social and professional accountability through restrictive measures. Their overarching aim was that policy interventions should be directed towards creating collective actions and broad social support for changing antibiotic use through establishing and explaining the need for mechanisms to control and support better prescribing by practitioners, while not transferring the burdens, costs and risks of interventions to consumers.

Eliminating latent tuberculosis in low-burden settings: are the principal beneficiaries to be disadvantaged groups or the broader population?

Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide, and the burdens of this disease continue to track prior disadvantage. In order to galvanise a coordinated global response, WHO has recently launched the End TB Campaign that aims to eliminate TB by 2050. Key to this is the introduction of population screening programmes in low-burden settings to identify and treat people who have latent TB infection (LTBI). The defining features of LTBI are: that it is not an active disease but confers an increased risk of disease; the socially disadvantaged are those most in danger and uncertainty persists as to who will be harmed or benefitted from screening-led prophylactic interventions. Systematic screening programmes that include surveillance, case-finding and treatment of asymptomatic individuals inevitably redistribute the risk of harms and the potential for benefits within a population. The extent to which those targeted within such programmes should be exposed to higher levels of risk in the pursuit of individual or community benefits requires careful consideration prior to implementation. As currently construed, it remains unclear who stands to benefit most from how LTBI screening in high-income countries is being organised, and whose health is being prioritised: members of disadvantaged groups or the broader community. Unless the aims of LTBI screening programmes in these settings are made transparent and their prioritisation ethically justified, there is a significant danger that such a targeted intervention will further disadvantage those who have the least capacity to bear the burdens of TB elimination.

Ethical Frameworks in Public Health Decision-Making: Defending a Value-Based and Pluralist Approach.

A number of ethical frameworks have been proposed to support decision-making in public health and the evaluation of public health policy and practice. This is encouraging, since ethical considerations are of paramount importance in health policy. However, these frameworks have various deficiencies, in part because they incorporate substantial ethical positions. In this article, we discuss and criticise a framework developed by James Childress and Ruth Bernheim, which we consider to be the state of the art in the field. Their framework distinguishes aims, such as the promotion of public health, from constraints on the pursuit of those aims, such as the requirement to avoid limitations to liberty, or the requirement to be impartial. We show how this structure creates both theoretical and practical problems. We then go on to present and defend a more practical framework, one that is neutral in avoiding precommitment to particular values and how they ought to be weighted. We believe ethics is at the very heart of such weightings and our framework is developed to reflect this belief. It is therefore both pluralist and value-based. We compare our new framework to Childress and Bernheim's and outline its advantages. It is justified by its impetus to consider a wide range of alternatives and its tendency to direct decisions towards the best alternatives, as well as by the information provided by the ranking of alternatives and transparent explication of the judgements that motivate this ranking. The new framework presented should be useful to decision-makers in public health, as well as being a means to stimulate further reflection on the role of ethics in public health.

Snakes and ladders: state interventions and the place of liberty in public health policy.

In this paper I outline and explore some problems in the way that the Nuffield Council of Bioethics' report Public Health: Ethical Issues (2007) presents its 'Intervention Ladder'. They see the metaphor of a ladder both as capturing key normative priorities and as making a real and important contribution to ethical policymaking in public health. In this paper I argue that the intervention ladder is not a useful model for thinking about policy decisions, that it is likely to produce poor decisions and that it is incompatible with the report's stated approach to relevant public health policy values.

Ebola: what it tells us about medical ethics.

Good medical ethics needs to look more to the resources of public health ethics and use more societal, population or community values and perspectives, rather than defaulting to the individualistic values that currently dominate discussion. In this paper I argue that we can use the recent response to Ebola as an example of a major failure of the global community in three ways. First, the focus has been on the treatment of individuals rather than seeing that the priority ought to be public health measures. Second, the advisory committee on experimental interventions set up by the WHO has focused on ethical issues related to individuals and their guidance has been unclear. Third, the Ebola issue can be seen as a symptom of a massive failure of the global community to take sufficient notice of global injustice.

The nature and ethics of natural experiments.

Natural experiments are an important methodology often used to answer research questions that would, otherwise, be impossible to address, or employed because of ethical concerns about the use of randomisation to interventions that carry known risks. The UK Medical Research Council (MRC) recently produced an extremely useful document discussing the nature and significance of natural experiments within medical and public health research. In this paper, however, we suggest that the MRC document's definition of the term 'natural experiment' is insufficiently precise. In response, we offer a taxonomy of different types of natural experiments and related methods, and explore the ethical implications of these different types. We argue that while the ethical issues that may arise within natural experiments in relation to risks of harm or informed consent may differ from those within the randomised controlled trial, they are not thereby less pressing. The implications of the argument are explored and recommendations made for those involved in research governance.

Innovations in research ethics governance in humanitarian settings.

BACKGROUND: Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. DISCUSSION: We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. SUMMARY: We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.

Academic freedom and the professional responsibilities of applied ethicists: a comment on Minerva.

Academic freedom is an important good, but it comes with several responsibilities. In this commentary we seek to do two things. First, we argue against Francesca Minerva's view of academic freedom as presented in her article 'New threats to academic freedom' on a number of grounds. We reject the nature of the absolutist moral claim to free speech for academics implicit in the article; we reject the elitist role for academics as truth-seekers explicit in her view; and we reject a possible more moderate re-construction of her view based on the harm/offence distinction. Second, we identify some of the responsibilities of applied ethicists, and illustrate how they recommend against allowing for anonymous publication of research. Such a proposal points to the wider perils of a public discourse which eschews the calm and careful discussion of ideas.

What makes public health studies ethical? Dissolving the boundary between research and practice.

BACKGROUND: The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. DISCUSSION: The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. SUMMARY: Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond.

Information, choice and the ends of health promotion.

In this paper I provide a critique of a set of assumptions relating to agency, choice and the legitimacy of actions impacting health that can be seen in some approaches to health promotion. After a brief discussion about the definition of health promotion, I outline two contrasting approaches to this area of health care practice. The first is focused on the provision of information and the second is concerned with seeking to change people's preferences in a particular way. It has been argued by a number of critics of health promotion that only the first approach is ethical, as it is for individuals to make their own lifestyle choices and adopt their own conception of the good life. I argue against this 'information' approach to health promotion on two grounds. First, I suggest that given the aims of health promotion, the provision of information is, as a matter of fact, of limited effectiveness in achieving these aims (and it may worsen health inequalities). Second, I argue that we have good reasons to question the appropriateness of respecting many of the preferences that individuals happen to have, given the origins and quality of such preferences. I then go on to argue, that by contrast we have good reasons to focus on changing at least some of the preferences that people have related to their lifestyle choices. This involves a commitment to both paternalism and a defence of a certain conception of the good life, but both can be defended. I use the example of potential responses to the growing problem of obesity to illustrate my argument, arguing that only policy that, at least sometimes, aims at preference change will be both effective and ethical.

Research Ethics of Involving Adolescents in Health Research Studies: Perspectives From Australia.

PURPOSE: Adolescent participation in health research studies is critical yet complex given the lack of clarity around issues such as consent. This study aimed to understand how those conducting research in Australia navigate research ethics in health research involving adolescents, through qualitative interviews. METHODS: Purposive sampling was used to recruit 23 researchers involved in adolescent health research using semi-structured in-depth interviews. Interviews were conducted via Zoom and audio-recorded after obtaining informed consent. Thematic analysis was used to construct themes and data were organised using NVivo. RESULTS: Two contrasting positions emerged from the data: (1) framing of adolescents as inherently vulnerable, their participation in research understood in terms of risk and protection and (2) adolescent engagement in research is understood in terms of empowerment, emphasising their capacity to make decisions about research participation. We traced these positions through three key themes, particularly in relation to the role of ethics committees: (1) competing positions as a result of inferior or superior knowledge about adolescent lives, (2) competing positions resulting in a risk averse or an empowerment approach, and (3) reflections on processes of obtaining consent which involves gatekeeping and tokenism. DISCUSSION: Our study highlights the contentious topic of navigating ethics committee requirements for the needs of adolescents. Majority of participants felt the current research ethics establishment is not favourable for researchers or adolescents themselves. While it is imperative that perceptions of ethics committees also be studied in the future, our study provides preliminary understanding of how experiences and perceptions shape how researchers interact with the research ethics establishment.

Informed consent and cluster-randomized trials.

We argue that cluster-randomized trials are an important methodology, essential to the evaluation of many public health interventions. However, in the case of at least some cluster-randomized trials, it is not possible, or is incompatible with the aims of the study, to obtain individual informed consent. This should not necessarily be seen as an impediment to ethical approval, providing that sufficient justification is given for this omission. We further argue that it should be the institutional review board's task to evaluate whether the protocol is sufficiently justified to proceed without consent and that this is preferable to any reliance on community consent or other means of proxy consent.