Ethics Guidance for Environmental Scientists Engaged in Surveillance of Wastewater for SARS-CoV-2.

The COVID-19 pandemic has given rise to rapid and widespread international pursuit of wastewater surveillance for genetic signals of SARS-CoV-2, the virus causing the pandemic. Environmental scientists and engineers familiar with the techniques required for this endeavor have responded. Many of the environmental scientists engaged in these investigations have not necessarily had experience with the ethical obligations associated with generating and handling human health data. The Canadian Water Network facilitated adoption of these surveillance methods by creating a national coalition, which included a public health advisory group that recognized a need for ethics guidance for the wastewater approach to public health surveillance. This Policy Analysis addresses that need and is based on a review of relevant ethics literature tightly focused on ethics applicable to public health surveillance. That review revealed that classical health bioethics governing clinical practice and general public health ethics guidance did not adequately address key issues in wastewater surveillance. The 2017 World Health Organization guidelines, directly based on a systematic literature review, specifically addressed ethical issues in public health surveillance. The application of relevant ethical guidance to wastewater surveillance is analyzed and summarized for environmental scientists.

Ethical challenges in the treatment of non-refugee migrants with tuberculosis in Canada.

While attention to the ethical issues that migrants face in accessing tuberculosis care has increased in the last few years, most of the attention has focused on challenges that refugees face when emigrating. Less attention has been given to ethical challenges that arise in the context of providing tuberculosis treatment and care to non-refugee migrants in high-income countries (HIC), particularly those that do not face immediate danger or violence. In this paper, we analyze some of the ethical challenges associated with treating migrants with tuberculosis in the Canadian context. In particular, we will discuss (i) inter- and intra-jurisdictional issues that challenge quotidian public health governance structures, and (ii) the ethical imperative for the Canadian government and its provinces to clearly differentiate access to healthcare from a person's immigration status to help overcome power imbalances that may exist between public health workers and their clients. The arguments presented herein could potentially apply to other HIC with some form of universal health coverage.

Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers.

Publication bias in animal research, its extent, its predictors, and its potential countermeasures are increasingly discussed. Recent reports and conferences highlight the potential strengths of animal study registries (ASRs) in this regard. Others have warned that prospective registration of animal studies could diminish creativity, add administrative burdens, and complicate intellectual property issues in translational research. A literature review and 21 international key-informant interviews were conducted and thematically analyzed to develop a comprehensive matrix of main- and subcategories for potential ASR-related strengths, weaknesses, facilitators, and barriers (SWFBs). We identified 130 potential SWFBs. All stakeholder groups agreed that ASRs could in various ways improve the quality and refinement of animal studies while allowing their number to be reduced, as well as supporting meta-research on animal studies. However, all stakeholder groups also highlighted the potential for theft of ideas, higher administrative burdens, and reduced creativity and serendipity in animal studies. Much more detailed reasoning was captured in the interviews than is currently found in the literature, providing a comprehensive account of the issues and arguments around ASRs. All stakeholder groups highlighted compelling potential strengths of ASRs. Although substantial weaknesses and implementation barriers were highlighted as well, different governance measures might help to minimize or even eliminate their impact. Such measures might include confidentiality time frames for accessing prospectively registered protocols, harmonized reporting requirements across ASRs, ethics reviews, lab notebooks, and journal submissions. The comprehensive information gathered in this study could help to guide a more evidence-based debate and to design pilot tests for ASRs.

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.

Trust and the ethical challenges in the use of whole genome sequencing for tuberculosis surveillance: a qualitative study of stakeholder perspectives.

BACKGROUND: Emerging genomic technologies promise more efficient infectious disease control. Whole genome sequencing (WGS) is increasingly being used in tuberculosis (TB) diagnosis, surveillance, and epidemiology. However, while the use of WGS by public health agencies may raise ethical, legal, and socio-political concerns, these challenges are poorly understood. METHOD: Between November 2017 and April 2018, we conducted semi-structured interviews with 22 key stakeholders across the fields of governance and policy, public health, and laboratory sciences representing the major jurisdictions currently using WGS in national TB programs. Thematic analysis of the interviews was conducted using NVivo 11. RESULTS: Respondents identified several ethical and practical challenges associated with WGS in TB care and surveillance, all related to issues of trust, including: 1) the power of public health; 2) data sharing and profits derived from surveillance efforts; and 3) concerns regarding who has access to, and can benefit from, the technology. Additional challenges included: the potential utility that WGS adds to a public health program, the risks associated with linking necessary epidemiological metadata to the genomic data, and challenges associated with jurisdictional capacity to implement the technology. CONCLUSIONS: Successful implementation of WGS is dependent on fostering relationships of trust between those working with genomics technology and those directly impacted by it, including clinicians. Building trust (a) between the public and the public health agencies and (b) within public health agencies themselves is critical due to the inherent complexity of WGS and its implementation for communicable disease control purposes.

Systems thinking and ethics in public health: a necessary and mutually beneficial partnership.

Systems thinking has emerged as a means of conceptualizing and addressing complex public health problems, thereby challenging more commonplace understanding of problems and corresponding solutions as straightforward explanations of cause and effect. Systems thinking tries to address the complexity of problems through qualitative and quantitative modeling based on a variety of systems theories, each with their own assumptions and, more importantly, implicit and unexamined values. To date, however, there has been little engagement between systems scientists and those working in bioethics and public health ethics. The goal of this paper is to begin to consider what it might mean to combine systems thinking with public health ethics to solve public health challenges. We argue that there is a role for ethics in systems thinking in public health as a means of elucidating implicit assumptions and facilitating ethics debate and dialogue with key stakeholders.

Ethics of health research with prisoners in Canada.

BACKGROUND: Despite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health research with prisoners in Canada. The purpose of this paper is to encourage a national conversation about what it means to conduct ethically sound health research with prisoners given the current realities of the Canadian system. Lessons from the Canadian system could presumably apply in other jurisdictions. MAIN TEXT: Any discussion regarding research ethics with Canadian prisoners must begin by first taking into account the disproportionate number of Indigenous prisoners (e.g., 22-25% of prisoners are Indigenous, while representing approximately 3% of the general Canadian population) and the high proportion of prisoners suffering from mental illnesses (e.g., 45% of males and 69% of female inmates required mental health interventions while in custody). The main ethical challenges that researchers must navigate are (a) the power imbalances between them, the correctional services staff, and the prisoners, and the effects this has on obtaining voluntary consent to research; and (b), the various challenges associated to protecting the privacy and confidentiality of study participants who are prisoners. In order to solve these challenges, a first step would be to develop clear and transparent processes for ethical health research, which ought to be informed by multiple stakeholders, including prisoners, the correctional services staff, and researchers themselves. CONCLUSION: Stakeholder and community engagement ought to occur in Canada with regards to ethical health research with prisoners that should also include consultation with various parties, including prisoners, correctional services staff, and researchers. It is important that national and provincial research ethics organizations examine the sufficiency of existing research ethics guidance and, where there are gaps, to develop guidelines and help craft policy.

Unpacking the financial costs of "bariatric tourism" gone wrong: Who holds responsibility for costs to the Canadian health care system?

SUMMARY: Canadians are motivated to travel abroad for bariatric surgery owing to wait times for care and restrictions on access at home for various reasons. While such surgery abroad is typically paid for privately, if "bariatric tourists" experience complications or have other essential medical needs upon their return to Canada, these costs are borne by the publicly funded health system. In this commentary, we discuss why assigning responsibility for the costs of complications stemming from bariatric tourism is complicated and contextual.

Ethics for pandemics beyond influenza: Ebola, drug-resistant tuberculosis, and anticipating future ethical challenges in pandemic preparedness and response.

The unprecedented outbreak of Ebola virus disease (EVD) in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this article on the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: (1) different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, (2) clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and (3) current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics.

Community Voices and Whole-Genome Sequencing for Tuberculosis: Storytelling and the Importance of Listening.

One of the primary public health functions of a tuberculosis (TB) program is to arrest the spread of infection. Traditionally, TB programs have relied on epidemiological information, gathered through contact tracing, to infer that transmission has occurred between people. The ability of drawing such inferences is extensively context dependent. Where epidemiological information has been strong, such as 2 cases of TB occurring sequentially within a single household, confidence in such inferences is high; conversely, public health authorities have been less certain about the significance of TB cases merely occurring in the same wider social group or geographic area. Many current laboratory tests for TB used globally may be sufficient to confirm a diagnosis and guide appropriate therapy but still be insufficiently precise for distinguishing two strains reliably. In short, drawing inferences regarding a chain of transmissions has always been as much art as science.

Reciprocity, Fairness and the Financial Burden of Undertaking COVID-19 Hotel Quarantine in Australia.

In late March 2020 in response to the COVID-19 pandemic, Australia introduced mandatory 14-day supervised quarantine at hotels and other designated facilities for all international arrivals. From July 2020, most states and territories introduced a fixed charge for quarantine of up to $3220 per adult. The introduction of the fee was rationalised on the basis that Australians had been allowed sufficient time to return and there was a need to recover some of the cost associated with administering the program. Drawing on an empirical study of 58 returned Australian citizens and residents quarantined between March 2020 and January 2021, this paper aims to explore how people experienced paying for hotel quarantine, particularly with respect to fairness and relatedly, the principle of reciprocity. Reciprocity requires that the state has an obligation to assist individuals in discharging their duty to comply with public health measures and avoid disproportionate burdens accruing to populations or individuals. Though participants had varying opinions on whether they thought it fair to be charged for their quarantine, for many, the fee constituted a significant burden and source of stress. Given the undertaking of quarantine is primarily for the benefit of the public good, we argue the financial cost imposed on individuals does not meet the demands of reciprocity. It is imperative that future quarantine and isolation arrangements consider seriously the need to minimise burdens of individuals subject to such measures, and that fees do not become a new norm in public health and infectious disease control.

Research ethics review during the COVID-19 pandemic: An international study.

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

Is the Cure Worse than the Disease? The Ethics of Imposing Risk in Public Health.

Efforts to improve public health, both in the context of infectious diseases and non-communicable diseases, will often consist of measures that confer risk on some persons to bring about benefits to those same people or others. Still, it is unclear what exactly justifies implementing such measures that impose risk on some people and not others in the context of public health. Herein, we build on existing autonomy-based accounts of ethical risk imposition by arguing that considerations of imposing risk in public health should be centered on a relational autonomy and relational justice approach. Doing so better captures what makes some risk permissible and others not by exploring the importance of power and context in such deliberations. We conclude the paper by applying a relational account of risk imposition in the cases of (a) COVID-19 measures and (b) the regulation of sugar-sweetened beverages to illustrate its explanatory power.

Data Sharing During Pandemics: Reciprocity, Solidarity, and Limits to Obligations.

South Africa shared with the world the warning of a new strain of SARS-CoV2, Omicron, in November 2021. As a result, many high-income countries (HICs) instituted complete travel bans on persons leaving South Africa and other neighbouring countries. These bans were unnecessary from a scientific standpoint, and they ran counter to the International Health Regulations. In short, South Africa was penalized for sharing data. Data sharing during pandemics is commonly justified by appeals to solidarity. In this paper, we argue that solidarity is, at best, an aspirational ideal to work toward but that it cannot ground an obligation to share data. Instead, low-and-middle income countries (LIMCs) should be guided by the principle of reciprocity, which states that we ought to return good for good received. Reciprocity is necessarily a conditional principle. LMICs, we argue, should only share data during future pandemics on the condition that HICs provide enforceable assurances that the benefits of data sharing will be equitably distributed and that LMICs won't be penalized for sharing information.

Ethics and Health Security in the Australian COVID-19 Context: A Critical Interpretive Literature Review.

Background The concept of "health security" is often used to motivate public health responses, yet the ethical values that underpin this concept remain largely unexamined. The recent Australian responses to COVID-19 serve as an important case study by which we can analyse the pre-existing literature to see what ethical values shaped, and continue to shape, Australia's response. Methods We conducted a critical interpretive literature review of academic and grey literatures within key databases, resulting in 2,220 sources. After screening for duplicates and relevance, we analysed ninety-six sources. Results First, risk and uncertainty are a leading focus, with a heavy concentration on risks to life and health. Second, free movement, safety, and security were recurringly emphasized, albeit narrowly focused upon the safety of the population. Third, legitimacy was a recurring theme, and it is here that discussions of "health security" figured highly. Conclusion Discussions of harm from government and associated official bodies fail to adequately distinguish between various senses of harm. Moreover, while the literature often discusses the balancing of rights, the steps involved in the weighing of these rights is rarely adequately explained and defended. We suggest that decision-makers should endeavour to clearly identify and defend the values undergirding their decisions in the public sphere.

Priority setting of ICU resources in an influenza pandemic: a qualitative study of the Canadian public's perspectives.

BACKGROUND: Pandemic influenza may exacerbate existing scarcity of life-saving medical resources. As a result, decision-makers may be faced with making tough choices about who will receive care and who will have to wait or go without. Although previous studies have explored ethical issues in priority setting from the perspective of clinicians and policymakers, there has been little investigation into how the public views priority setting during a pandemic influenza, in particular related to intensive care resources. METHODS: To bridge this gap, we conducted three public town hall meetings across Canada to explore Canadian's perspectives on this ethical challenge. Town hall discussions group discussions were digitally recorded, transcribed, and analyzed using thematic analysis. RESULTS: Six interrelated themes emerged from the town hall discussions related to: ethical and empirical starting points for deliberation; criteria for setting priorities; pre-crisis planning; in-crisis decision-making; the need for public deliberation and input; and participants' deliberative struggle with the ethical issues. CONCLUSIONS: Our findings underscore the importance of public consultation in pandemic planning for sustaining public trust in a public health emergency. Participants appreciated the empirical and ethical uncertainty of decision-making in an influenza pandemic and demonstrated nuanced ethical reasoning about priority setting of intensive care resources in an influenza pandemic. Policymakers may benefit from a better understanding the public's empirical and ethical 'starting points' in developing effective pandemic plans.

The abandonment of Australians in India: an analysis of the right of entry as a security right in the age of COVID-19.

In May 2021, when the Delta variant of SARS-CoV2 was wreaking havoc in India, the Australian Federal Government banned its citizens and residents who were there from coming back to Australia for 14 days on penalty of fines or imprisonment. These measures were justified on the grounds of protecting the broader Australian public from potentially importing the Delta strain, which officials feared would then seed a local outbreak. Those Australians stranded in India, and their families and communities back home, claimed that they were abandoned by Prime Minister Scott Morrison's government. This case-along with other barriers used as part of border control measures in the name of public health-raises the following question: is it ever morally permissible for a state to ban its citizens and residents from entering their own country during a pandemic? I conclude that it's impermissible. I argue that persons have a right of entry that should be understood as a security right. This security right should be non-derogable because it's a foundational good that is necessary for life-planning purposes. Moreover, it is a right that people should be able to rely upon absolutely, even during pandemics. At the very least, should someone believe that there are rare exceptions to the right of entry on public health grounds, governments have a duty-grounded in the principle of reciprocity-to support those who are temporarily denied entry. In the case of Australians stranded in India, I will argue that the Australian Federal Government failed on all accounts.

Ethical health security in the age of antimicrobial resistance.

OBJECTIVE: Owing to its potential human, social and economic costs, antimicrobial resistance (AMR) is frequently referred to as a threat to health security. Simultaneously, health security and the preservation of antimicrobials are often described as a global public good. However, how the term 'public good' is used in the context of health security, and the values that underpin it, remains ambiguous. Policymaking is never value-free, and a better examination of such values is critical to understanding how issues such as AMR are problematised and how policy decisions are informed. DESIGN: We used McDougall's version of critical interpretive synthesis to capture the recurring concepts and arguments within public policy, political science and applied ethics literature on AMR. Articles were analysed by identifying recurring ideas and developing themes across the literature. RESULTS: A total of 77 papers were included in our review. In the context of health security and AMR, the concept of 'public good' appears to be used interchangeably with 'common good', reflecting confusion, but sometimes meaningful differences, regarding how antimicrobials, as a good, are conceived. Main approaches to addressing AMR are statism, globalism and regionalism, which appeal to different values in guiding policymakers. Common justificatory values underpinning preservation of antimicrobials as a public good were prevention of harm, solidarity, justice and rights. CONCLUSION: The findings suggest that within the literature there is a lack of conceptual clarity as to whether antimicrobials constitute a public good or a common good. Moreover, the way in which antimicrobials are conceived and the approaches through which AMR as a threat to health security is addressed appear to be grounded in values that are often implicit. Being explicit about the values that underpin AMR and health security is not simply an intellectual exercise but has very real policy and programmatic implications.

Between rules and resistance: moving public health emergency responses beyond fear, racism and greed.

In times of a public health emergency, lawyers and ethicists play a key role in ensuring that government responses, such as travel restrictions, are both legally and ethically justified. However, when travel bans were imposed in a broadly discriminatory manner against southern African countries in response to the Omicron SARS-CoV-2 variant in late 2021, considerations of law, ethics or science did not appear to guide politicians' decisions. Rather, these bans appeared to be driven by fear of contagion and electoral blowback, economic motivations and inherently racist assumptions about low-income and middle-income countries (LMICs). With a new pandemic treaty and amendments to the WHO's International Health Regulations (IHR) on the near-term horizon, ethics and international law are at a key inflection point in global health governance. Drawing on examples of bordering practices to contain contagion in the current pandemic and in the distant past, we argue that the current IHR is not adequately constructed for a just and equitable international response to pandemics. Countries impose travel restrictions irrespective of their need or of the health and economic impact of such measures on LMICs. While the strengthening and reform of international laws and norms are worthy pursuits, we remain apprehensive about the transformative potential of such initiatives in the absence of collective political will, and suggest that in the interim, LMICs are justified in seeking strategic opportunities to play the same stark self-interested hardball as powerful states.