This paper provides an overview of recent US Department of Health and Human Services initiatives and efforts — under the leadership of the General Counsel, the Secretary, and the President — regarding legal preparedness for public health emergencies. In addressing this topic, the paper focuses on four core elements comprising public health legal preparedness:effective legal authorities to support necessary public health activities;competencies of public health professionals to know and then to apply those laws;coordination of the (...) application of laws across jurisdictions and across multiple sectors; andinformation and best practices in public health law. (shrink)

Although Jonathan Herington, Angus Dawson, and Heather Draper offer valuable insights on how to conceptualize health hazards and understand their effects on populations, I resist the label “public health emergency” for obesity, and here is why. It is important—politically and pragmatically—to be judicious with words that have legal and real‐world consequences. Once a concept is stretched to encompass a broad swath of events, it loses its power. The broader the application of the term “public health (...) class='Hi'>emergency,” the more it loses the core idea of an emergent event. Thus, framing a long‐simmering health hazard such as obesity as an emergency would mute the voices of public health authorities seeking a surge response to a truly emergent event, such as a rapidly spreading novel disease or a natural or man‐made disaster. (shrink)

Widespread obesity poses a serious challenge to health outcomes in the developed world and is a growing problem in the developing world. There has been a raft of proposals to combat the challenge of obesity, including restrictions on the nature of food advertising, the content of prepared meals, and the size of sodas; taxes on saturated fat and on calories; and mandated “healthy-options” on restaurant menus. Many of these interventions seem to have a greater impact on rates of obesity (...) than does simply providing information about health risks and healthier lifestyles. The more interventionist policy options have, however, been implemented only slowly, in large part because of criticisms that they are unjustified infringements on the liberty of consumers. Food industry groups, free-market think tanks, and the popular press regard measures that incentivize or penalize particular food and lifestyle choices as unjustifiable state regulation of purely self-regarding behavior. To counteract the liberty-oriented position, those who favor a more interventionist role for the state have recently argued for labeling obesity as a public health emergency. By labeling obesity as a public health emergency, policy-makers could override concerns about individual liberty in order to pursue more interventionist policies designed to guide consumer choices toward healthier lifestyles. In this paper, we argue that, contrary to initial appearances, obesity possesses some of the morally relevant features of public health emergencies, though we do not argue that it actually constitutes one. (shrink)

Responses to public health emergencies can entail difficult decisions about restricting individual liberties to prevent the spread of disease. The quintessential example is quarantine. While isolating sick patients tends not to provoke much concern, quarantine of healthy people who only might be infected often is controversial. In fact, as the experience with severe acute respiratory syndrome (SARS) shows, the vast majority of those placed under quarantine typically don't become ill. Efforts to enforce involuntary quarantine through military or police powers (...) also can backfire, stoking both panic and disease spread. Yet quarantine is part of a limited arsenal of options when effective treatment or prophylaxis is not available, and some evidence suggests it can be effective, especially when it is voluntary, home-based and accompanied by extensive outreach, communication and education efforts. Even assuming that quarantine is medically effective, however, it still must be ethically justified because it creates harms for many of those affected. Moreover, ethical principles of reciprocity, transparency, non-discrimination and accountability should guide any implementation of quarantine. (shrink)

Disability Justice in Public Health Emergencies is the first book to highlight contributions from critical disability scholarship to the fields of public health ethics and disaster ethics. It takes up such contributions with the aim of charting a path forward for clinicians, bioethicists, public health experts, and anyone involved in emergency planning to better care for disabled people—and thereby for all people—in the future. Across 11 chapters, the contributors detail how existing public health emergency (...) responses have failed and still fail to address the multi-faceted needs of disabled people. They analyze complications in the context of epidemic and pandemic disease and emphasize that vulnerabilities imposed upon disabled people track and foster patterns of racial and class domination. -/- The central claim of the volume is that the ethical and political insights of disability theory and activism provide key resources for equitable disaster planning for all. The volume builds upon the existing efforts of disability communities to articulate emergency planning priorities and response measures that take into account the large body of qualitative and quantitative research on disabled people’s health, needs, and experiences. It is only by listening to disabled people’s voices that we will all fare better in future public health emergencies. (shrink)

Few novel or emerging infectious diseases have posed such vital ethical challenges so quickly and dramatically as the novel coronavirus SARS‐CoV‐2. The World Health Organization declared a public health emergency of international concern and recently classified Covid‐19 as a worldwide pandemic. As of this writing, the epidemic has not yet peaked in the United States, but community transmission is widespread. President Trump declared a national emergency as fifty governors declared state emergencies. In the coming weeks, hospitals (...) will become overrun, stretched to their capacities. When the health system becomes stretched beyond capacity, how can we ethically allocate scarce health goods and services? How can we ensure that marginalized populations can access the care they need? What ethical duties do we owe to vulnerable people separated from their families and communities? And how do we ethically and legally balance public health with civil liberties? (shrink)

Spitale et al. (2024) address a public health ethics question of great importance: How should governments communicate with the public during public health emergencies? The article highlights severa...

There are three broad ethical issues related to handling public health emergencies. They are the three R's - rationing, restrictions and responsibilities. Recently, a severe shortage of annual influenza vaccine in the US, combined with the threat of pandemic flu, has provided an opportunity for policy makers to think about rationing in very concrete terms. Some lessons from annual flu vaccination likely will apply to pandemic vaccine distribution, but many preparatory decisions must be based on very rough estimates. What (...) ethical principles should guide rationing decisions, what data should inform these decisions, how to revise decisions as new data emerge, and how to implement rationing decisions on the ground are all important considerations. In addition, ethicists might be able to help policy makers think through the importance of international cooperation in surmounting global rationing dilemmas and to accept the inevitable responsibilities of government in making and implementing rationing decisions. (shrink)

This article addresses an important, overlooked regulatory challenge during global health emergencies. It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively (...) capturing these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines—which draw upon practical examples of guidelines ‘in action’—that assist in determining how to act in a particular situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples—which incorporate important lessons learned—illustrate how such guidelines can be interpreted at a practical level. (shrink)

The three primary ethical challenges in preparing for public health emergencies - addressing questions of rationing, restrictions and responsibilities - all entail confronting uncertainty. But the third, considering whether people and institutions will live up to their responsibilities in a crisis, is perhaps the hardest to predict and therefore plan for. The quintessential example of a responsibility during a public health emergency is that of health care professionals' obligation to continue caring for patients during epidemics. Historically, (...) this 'duty to treat' has sometimes gone unrecognized or ignored, but it has also famously been adhered to, including during the recent SARS epidemic. And non-crisis examples of health professionals working in the face of personal risk are very common. The duty to treat should be circumscribed by several considerations, including the levels or risk and benefit at issue, the degree of public reliance on health professional action, and the nature of the individual health professional's acceptance of greater than usual risk. Examining the professional duty to treat and the legitimate questions it raises can provide insight into other actors' responsibilities. Public health ethics as well as professional ethics can help frame answers to some key questions: How strong are ethical responsibilities during crises? To whom do they apply? Should they be more explicit - and hence more circumscribed - or less explicit and hence largely aspirational? And how can public health policies encourage responsible actions? (shrink)

The fight for public health primacy in U.S. emergency preparedness and response to COVID-19 centers on which level of government — federal or state — should “call the shots” to quell national emergencies?

Among the many components of legal preparedness for public health emergencies is the assurance that the public health workforce and its private sector partners are competent to use the law to facilitate the performance of essential public health services and functions. This is a significant challenge. Multiple categories of emergencies, stemming from natural disasters to emerging infectious diseases, confront public health practitioners. Interpreting, assessing, and applying legal principles during emergencies are complicated by the changing legal environment (...) and differences in governmental organization of emergency management functions. While law and legal competencies are essential to routine public health practices, once government declares a state of public health emergency or disaster, the legal landscape changes. Typical legal responses to protect the public's health may no longer be the norm. Public health practitioners, legal counsel, health care partners, and others need to be able to assess changing laws and policies and apply them in real-time. (shrink)

Following the tragic shootings in Newtown, Aurora, Isla Vista and others, increased national attention has focused on the relationship between mental illness and gun violence. While some have called for enhanced regulation of firearm possession by persons with mental illness, others have argued that such actions would be ineffective and enhance stigma associated with mental illness while discouraging treatment seeking.

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The frameworks aim to govern coordinated processing, sharing and transfer of health data across borders thus placing burdens on researchers who are willing or obligated to share data. In (...) this paper, we investigate ethical values and legal principles that can be applied to ensure a more streamlined approach in the governance of cross-border health data sharing during global health emergencies. A scoping review approach was used to better understand emerging evidence about issues related to the ethical and legal governance of cross-border health data sharing. We first highlight the challenges of sharing health data across borders. We then discuss how the challenges might be overcome through the application of ethical values and legal principles that have been identified in literature. This is followed by a proposal for possible ways of streamlining the governance of health data sharing from ethical and legal perspectives in a bid to better prepare for future global health emergencies and promote the responsible sharing of health data. (shrink)

There is a fine balance between civil liberties and protection of the public’s health.Legislators, especially those in the western United States, are concerned about selling the Model State Act because of the loss of civil liberties. State constitutions give governors broad powers, such as declaring martial law and giving public health leaders the authority to act. State laws should consider issues such as property rights; taking of businesses and supplies; quarantine and isolation; due process; coordination among states, counties (...) and cities; communication systems; conscription of doctors and nurses; and compensation. When two mock emergency response drills were held in New Mexico, concerns arose regarding opening records associated with dams, national laboratories, waste repositories, and three air force bases. (shrink)

This chapter contains sections titled: HIV Testing HIV Infection: Harm to Self or Harm to Others Access to Experimental Drugs and the Ethics of Research Clinical Trials Developing Preventive Vaccines Affordable Access to Life‐preserving Medication HIV Infection in Health‐care Professionals and Patients Final Remarks References Further reading.

This paper is one of the four interrelated action agenda papers resulting from the National Summit on Public Health Legal Preparedness convened in June 2007 by the Centers for Disease Control and Prevention, and multi-disciplinary partners. Each of the action agenda papers deals with one of the four core elements of legal preparedness: laws and legal authorities; competency in using those laws; and coordination of law-based public health actions; and information.This action agenda offers options for consideration by those (...) responsible for or interested in ensuring that public health professionals, their legal counsels, and relevant partners understand the legal framework in which they operate and are competent in applying legal authorities to public health emergency preparedness.Competencies are critical to an individual's ability to make effective legal response to all-hazards public emergencies. (shrink)

To optimize the data clustering effect of public health emergencies, an application research on social governance ability under public health emergencies based on artificial intelligence is proposed. First, the firefly optimization algorithm is used to collect the information data of the social governance ability of public health emergencies, establish a unified format, and save it. Then, artificial intelligence technology is used to mine the correlation of clustering data, and on this basis, a learning model integrating global structure (...) information and local structure information is established. Finally, the social governance model under public health emergencies is established. The experimental results show that the design method has high clustering accuracy, regularization cross index, and adjusted rand index (ARI) index. This shows that the design method can improve the social governance ability of data fusion clustering and improve the social governance ability. (shrink)

In this paper I shed new light on contemporary developments in global health governance, policymaking, and knowledge production. Specifically, by investigating the historical roots and emergence of global health emergency governance. Drawing on the Foucauldian notion of “problematisation” and on Science and Technology Studies of disaster, I trace, examine, and elucidate three main axes through which, I argue, health emergencies became a problem of global governance. I show, first, the formation of emergency management as a (...) distinct professional field. Second, the migration of emergency management into global health governance and its proliferation within it. And third, the move from global health emergency management to the global governance of health emergencies. Overall, I suggest the rise of global health emergency governance provides crucial context for understanding social, political, and epistemic tensions and controversies in health emergencies such as COVID-19. Through the analysis, I identify a particular rationale that is rooted in emergency management and had become embedded in global health emergency governance. A rationale that involves “temporal compression” and “structural plasticity.” I discuss possible implications of this rationale for global health governance, policy, and knowledge. (shrink)

In Brazil, the epicenter of the Zika crisis, brown, black, and indigenous poor women living in municipalities with scarce resources were disproportionally affected. The gendered consequences of the epidemic exposed how intersectional lenses are central to understand the impact of public health emergencies in the lives of women and girls. The demand for Zika-affected children and women to be research participants is relevant for an ethical analysis of participant protection procedures during a crisis. We investigated how women experienced research (...) participation by analyzing their narratives. Two-year-long longitudinal qualitative study in Brazilian sites located in the epidemic's epicenter was performed using mixed methods: ethnography with women from two distinct states and individual semi-structured interviews with five women in different Zika-affected states, four of which were community leaders. All women in the study were mothers or grandmothers of Zika-affected children. Thematic analysis was used for data evaluation. Women perceived being pressured to participate in research and a lack of benefit sharing. Structural determinants of gender inequality, such as its effect on power distribution, were found to impact research participant protection. Formal procedures for research protocols approvals were insufficient in protecting participants because these instruments were unable to account for structural aspects. Communitarian mobilization, through WhatsApp groups, was found to be an important mechanism to create conditions to challenge oppressive structures. Strengthening public health, effective community-based participation in research planning and implantation of ethical strategies that promotes gender equality can have transformative effect on unequal power structures and promote participant protection. (shrink)

The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor research design, and (...) poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues. (shrink)

COVID-19 exposed flaws in the law regulating the sharing of data and human biological material. This poses obstacles to the epidemic response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter alia, the (...) promulgation of a revised version of the South African Material Transfer Agreement by the Minister of Health. This would remove uncertainty regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a health research perspective. (shrink)

On January 30, 2020, the World Health Organization declared a Public Health Emergency of International Concern (PHEIC) over what would quickly become known as SARS-CoV- 2 or COVID- 19. This emergency status was officially ended in the United States in May 2023 amidst much dissent and debate. Although emergency conditions resulting from COVID- 19 will likely wax and wane over the coming years, there is good reason to think that the incidence of severe global pandemics (...) will increase over the next century, as will declarations of emergency. The declaration of an emergency calls for urgent action, but it just as urgently demands careful reflection. Official “emergency” status licenses unparalleled executive intervention, completely reorganizing the lives of those who live under its decree. Such official recognition, however, is heavily dependent on the social context in and from which the emergency arises. Highlighting which circumstances rise to the level of an official emergency clarifies our reigning assumptions about what threshold of active harm—and in relation to which groups of people—demands immediate intervention. (shrink)

Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary (...) principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed. (shrink)

Risk and crisis communication (RCC) is a current ethical issue subject to controversy, mainly due to the tension between individual liberty (a core component of fairness) and effectiveness. In this paper we propose a consistent definition of the RCC process in public health emergencies (PHERCC), which comprises six key elements: evidence, initiator, channel, publics, message, and feedback. Based on these elements and on a detailed analysis of their role in PHERCC, we present an ethical framework to help design, govern (...) and evaluate PHERCC strategies. The framework aims to facilitate RCC, incorporating effectiveness, autonomy, and fairness. It comprises five operational ethical principles: openness, transparency, inclusivity, understandability, and privacy. The resulting matrix helps understanding the interplay between the PHERCC process and the principles of the framework. The paper includes suggestions and recommendations for the implementation of the PHERCC matrix. (shrink)

The 2016 CIOMS International ethical guidelines for health‐related research involving humans states that ‘health‐related research should form an integral part of disaster response’ and that, ‘widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided’ (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that (...) it is therefore unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high‐mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage. (shrink)

This paper investigates the state of the law in Canada in regards to a public health emergency, and in particular the jurisdictional logic that might come into effect were a public health emergency to occur. Although there has yet to be a national public health emergency in Canada, threats of such crises are likely to arise in the future. It is therefore recognised as necessary to address Canada’s legal preparedness for a public health (...) emergency and evaluate proposed reforms to the legal structure that could facilitate response. This paper contributes to this goal by identifying multiple jurisdictional factors that could inform legal interpretations in a public health emergency. It considers how the legal system and the courts are dealing with public health as a national security issue while taking into account s. 7 of the Canadian Charter. It also looks at the power of the government defined in the Emergencies Act [1985, c. 22] and a proposed legal reform that would make it easier for the government to act unilaterally in a public health emergency. The paper draws on the legal theory of Robert Cover to analyse the hermeneutics of jurisdiction that characterise legal interpretations of public health in Canada, as well as the relationship between jurisdiction and legal violence that these hermeneutics imply. It then develops a case study of the use of medical triage in a public health emergency to explore the possibility of holding the state liable under private law for harm caused to individuals by public health decisions. The paper concludes by suggesting that the state’s public health power can be conceptualised as a form of legal violence and that the courts in Canada should adopt a jurisgenerative approach to legal interpretation in the area of public health. (shrink)

Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks (...) in LMICs where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies. (shrink)

Over 200 health journals call on the United Nations, political leaders, and health professionals to recognize that climate change and biodiversity loss are one indivisible crisis and must be tackle...

Responses to the COVID-19 pandemic have been widely criticized for being too delayed and indecisive. As a result, the precautionary principle has been endorsed, applauded, and proposed to guide future responses to global public health emergencies. Drawing from controversial issues in response to COVID-19, especially in Vietnam, this paper critically discusses some key ethical and legal issues of employing the precautionary principle in public health emergencies. Engaging with discussions concerning this principle, especially in environmental law where the precautionary (...) principle first appeared as a guiding principle with objective content(s), this paper formulates the precautionary principle as ‘in dubio pro salus’, which is about advising, justifying and demanding states to proactively prepare for scenarios arising out of any public health emergency. It distinguishes the precautionary principle into moderate and hard versions. A moderate version largely takes a holistic approach and fulfils a series of criteria specified in this paper, while a hard version either permits restrictive measures to be deployed primarily on a hypothetic basis or expresses an instrumental mentality. The hard version should be rejected because of the ethical and legal problems it raises, including risk-risk tradeoffs, internal paradoxes, unjustified causing of fear and unreasonable presupposition. Ultimately, this paper defends the moderate version. (shrink)

It has now been 10 years since the framework for public health legal preparedness was put forth as a model to meet new public health challenges in the 21st century. Public health legal preparedness is defined as the “attainment by a public health system of specified legal of standards essential to the preparedness of the public health system.” The framework has continued to develop over time and four core elements have emerged to make up the (...) basis for public health legal preparedness. The four core elements are: laws and legal authorities; competency in using laws effectively and wisely; coordination of legally based interventions across jurisdictions and sectors; and information on public health laws and best practices. (shrink)

May 11, 2023, marked the end of the federal COVID-19 Public Health Emergency (PHE). During the PHE, regulatory flexibilities allowed telehealth to more effectively connect physicians providing care and patients seeking it. This paper discusses the implications of the end of the PHE on telehealth coverage, payment, reimbursement, and licensure, and exposes inconsistencies and inequities in extant state regulations.

From its inception, the COVID-19 pandemic has been a disruptive force on U.S. health care and public health systems. President Biden’s announced termination of the national public health emergency on May 11, 2023 portends a return to normalcy and relief for Americans from the greatest infectious disease scourge the nation has ever faced. In reality, closing out this pandemic presents a tempest of legal and practical complications.

In the first wave of the COVID-19 pandemic, healthcare workers in some countries were forced to make distressing triaging decisions about which individual patients should receive potentially life-saving treatment. Much of the ethical discussion prompted by the pandemic has concerned which moral principles should ground our response to these individual triage questions. In this paper we aim to broaden the scope of this discussion by considering the ethics of broader structural allocation decisions raised by the COVID-19 pandemic. More specifically, we (...) consider how nations ought to distribute a scarce life-saving resource across healthcare regions in a public health emergency, particularly in view of regional differences in projected need and existing capacity. We call this the regional triage question. Using the case study of ventilators in the COVID-19 pandemic, we show how the moral frameworks that we might adopt in response to individual triage decisions do not translate straightforwardly to this regional-level triage question. Having outlined what we take to be a plausible egalitarian approach to the regional triage question, we go on to propose a novel way of operationalising the ‘save the most lives’ principle in this context. We claim that the latter principle ought to take some precedence in the regional triage question, but also note important limitations to the extent of the influence that it should have in regional allocation decisions. (shrink)

COVID-19 continues to dominate 2020 and is likely to be a feature of our lives for some time to come. Given this, how should health systems respond ethically to the persistent challenges of responding to the ongoing impact of the pandemic? Relatedly, what ethical values should underpin the resetting of health services after the initial wave, knowing that local spikes and further waves now seem inevitable? In this editorial, we outline some of the ethical challenges confronting those running (...) health services as they try to resume non-COVID-related services, and the downstream ethical implications these have for healthcare professionals’ day-to-day decision making. This is a phase of recovery, resumption and renewal; a form of reset for health services.1 This reset phase will define the ‘new normal' for healthcare delivery, and it offers an opportunity to reimagine and change services for the better. There are difficulties, however, healthcare systems are already weakened by austerity and the first wave of COVID-19 and remain under stress as the pandemic continues. The reset period is operating alongside, rather than at the end, of the pandemic and this creates difficult ethical choices. ### Balancing the greater good with individual care Pandemics—and public health emergencies more generally—reinforce approaches to ethics that emphasise or derive from the interests of communities, rather than those grounded in the claims of the autonomous individual. The response has been to draw on more public health focused ethics, ‘if demand outstrips the ability to deliver to existing standards, more strictly utilitarian considerations will have to be applied, and decisions about how to meet the individual's need will give way to decisions about how to maximise overall benefit’.2 Alongside this, effective …. (shrink)

This is one of four interrelated action agenda papers resulting from the National Summit on Public Health Legal Preparedness convened in June 2007 by the Centers for Disease Control and Prevention and nineteen multi-disciplinary partner organizations. Each of the action agenda papers deals with one of the four core elements of public health legal preparedness: laws and legal authorities; competency in using those laws; coordination of law-based public health actions; and information. Options presented in this paper are (...) for consideration by policymakers and practitioners — in all jurisdictions and all relevant sectors and disciplines — with responsibilities for all-hazards emergency preparedness.This paper focuses on the fourth core element: information that can be used in shaping and applying law as a public health tool, specifically in the context of public health emergencies. (shrink)

Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes (...) during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics. (shrink)

The coronavirus disease-2019 (COVID-19) has caused shortages of life-sustaining medical resources, and future waves of the virus may cause further scarcity. The Yale New Haven Health System developed a triage protocol to allocate scarce medical resources during the COVID-19 pandemic, with the primary goal of saving the most lives possible, and a secondary goal of making triage assessments and decisions consistent, transparent, and fair. We outline the process of developing the protocol, summarize the protocol, and discuss the major ethical (...) challenges encountered, along with our answers to the challenges. These challenges include (1) the role of age and chronic comorbidities; (2) evaluating children and pregnant patients; (3) racial, ethnic, and socioeconomic disparities in health; (4) prioritization of healthcare workers; and (5) balancing clinical judgment versus protocolized assessments.We conclude with a review of the limitations of our protocol and the lessons learned. We hope that a robust public discussion of such protocols and the ethical challenges they raise will result in the fairest possible processes, less need for triage, and more lives saved during future waves of the pandemic and similar public health emergencies. (shrink)

Information is the fourth core element of public health legal preparedness and of legal preparedness for public health emergencies specifically. Clearly, the creation, transmittal, and application of information are vital to all public health endeavors. The critical significance of information grows exponentially as the complexity and scale of public threats increase.Only a small body of organized information on public health law existed before the 21st century: a series of landmark books published beginning in 1926 by Tobey, (...) Grad, and Wing ; model public health laws published as early as 1907; systematic reviews of original research studies published in the 1990s; and a small but growing number of articles published in public health journals and law reviews.With the new century came new public health law programs and activities at the Centers for Disease Control and Prevention, in public health professional associations, and in numerous non-profit and academic organizations. (shrink)

Making research data readily accessible during a public health emergency can have profound effects on our response capabilities. The moral milieu of this data sharing has not yet been adequately explored. This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies. There are three notable reasons that stand in opposition to a duty to share one’s data, relating to: (i) data property (...) and ownership, (ii) just distribution of benefits and burdens and (iii) the contemporary ethos of science. We argue each reason can be successfully met with corresponding rationale in favour of data sharing. Further support for data sharing has been echoed in policies of health agencies, funding bodies and academic institutions; in documents on the ethical conduct of biomedical research; and in discussions on the nature of public health. From this, we ascertain that sharing data is the morally sound default position. This article then highlights the key roles reciprocity and solidarity play in supporting the practice of data sharing. We conclude with recommendations to regard public health research data as a common-pool resource in order to build a framework for stable data sharing management. (shrink)

Research represents an essential component of the response to infectious disease outbreaks and to other public health emergencies, whether they are localised, of international concern, or global. Research conducted in such contexts also comes with particular ethics challenges, the awareness of which has significantly grown following the Ebola outbreak in West Africa, the Zika outbreak in Latin America and the COVID-19 pandemic. These challenges include the need for implementing meaningful community engagement with the researched communities, not just to build (...) unidirectional trust towards the research team, but to achieve a genuine and mutually respectful partnership before, during and after the research. Here, we describe the real-life experience of 10 well-established research clinics in Nairobi, where a successful experience of community engagement linking prevention and care to research was interrupted during the COVID19 pandemic. We contrast this experience with the concept and processes of community engagement as described in selected scientific manuscripts and guidelines, to formulate some conclusions and recommendations. We contend that more action is needed, from research ethics committees and other key-research stakeholders, to align policies and practices with ethics guidance and with evidence-based recommendations from the academic literature, to achieve meaningful community engagement during emergency research, irrespective of the scale and location of an outbreak or public health crisis. Failure to do so, will aggravate the (postcolonial) asymmetries of power in global health and local systems. (shrink)

Public health emergencies, including infectious disease outbreaks and natural disasters, are issues faced by every community. To address these threats, it is critical for all jurisdictions to understand how law can be used to enhance public health preparedness, as well as improve coordination and collaboration across jurisdictions. As sovereign entities, Tribal governments have the authority to create their own laws and take the necessary steps to prepare for, respond to, and recover from disasters and emergencies. Legal preparedness is (...) a key component of public health preparedness. This article first explains legal preparedness and Tribal sovereignty and then describes the relationship between Tribal Nations, the US government, and states. Specific Tribal concerns with respect to emergency preparedness and the importance of coordination and collaboration across jurisdictions for emergency preparedness are discussed. Examples of collaborative efforts between Tribal and other governments to enhance legal preparedness are described. (shrink)

Disasters and public health emergencies raise a variety of ethical dilemmas, often including those that require balancing the best interests of individuals against those of groups or communities. The on-going COVID-19 pandemic provides examples of these ethical conflicts, as do other recent outbreaks. Decisions and actions in this context must address different ethical issues, ranging from those directly related to autonomy, consent, privacy and confidentiality to those related to interventions and technologies, such as efficacy, effectiveness, safety and fair access. (...) This paper aims to identify ethical conflicts with complex resolutions involving aspects related to values, rights and needs of individuals and the collective, and to suggest how such challenges could lead to more positive experiences and outcomes when confronted in future emergencies. (shrink)

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies (...) including interventional and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)

Public health emergencies, such as the Covid-19 pandemic, put great pressure on healthcare workers (HCW) across the world, possibly increasing the risk of experiencing ethically challenging situations (ECS). Whereas experiencing ECS as a HCW in such situations is likely unavoidable, mitigation of their adverse effects (e.g., moral distress) is necessary to reduce the risk of long-term negative consequences. One possible route of mitigation of these effects is via work environmental factors. The current study aimed to examine: [1] risk factors (...) associated with ECS among HCW [2], intensity of moral distress associated with ECS across various occupational factors (i.e., profession, degree of exposure to patients with Covid-19), and [3] the impact of work environmental factors on this association, in a sample of HCW during the pandemic. We employed multiple logistic and linear regression to self-report data from 977 HCWs at four Norwegian hospitals responding to a survey at the fourth wave of the pandemic. About half of HCW in this study had experienced ECS during the pandemic, and levels of moral distress associated with such were higher than in previous studies using similar assessment methods. Younger age, female sex, geographical work area (mid-north of Norway), and profession (nurse) were all associated with higher odds (range of OR: 1.30–2.59) of experiencing ECS, as were direct contact with patients with Covid-19. Among those participants who reported that they had experienced ECS during the pandemic, moral distress levels when recalling those situations were moderate (Mean 5.7 on a 0–10 scale). Men reported somewhat lower intensity of moral distress (partial eta squared; ηp2 = 0.02). Reporting a manageable workload (ηp2 = 0.02), and greater opportunity to work according to best practice (ηp2 = 0.02), were associated with lower levels of moral distress. Our findings suggest that moral distress could potentially be mitigated on an organizational level, particularly by focusing on ensuring a manageable workload, and an ability to work according to best practice. To build sustainable healthcare systems robust enough to withstand future public health emergencies, healthcare organizations should implement measures to facilitate these aspects of HCWs’ work environment. (shrink)

In response to commentators, we argue that whether waiving patent rights will meaningfully improve access to COVID-19 vaccines for low income and middle-income countries (LMICs), particularly in the short term, is an empirical matter. We also reject preferentially allocating vaccines to countries that hosted trials because doing so unethically favours those with research infrastructure, rather than those facing the worst burdens from COVID-19.

A community's abilities to promote health and maximize its response to public health threats require fulfillment of one of the four elements of public health legal preparedness, the capacity to effectively coordinate law-based efforts across different governmental jurisdictions, as well as across multiple sectors and disciplines. Government jurisdictions can be viewed “vertically” in that response efforts may entail coordination in the application of laws across multiple levels, including local, state, tribal, and federal governments, and even with international (...) organizations. Coordination of legal responses to public health emergencies also may involve a horizontal dimension comprising numerous and diverse sectors, such as public health, public and private health care, emergency management, education, law enforcement, the judiciary, and the military.Although responses to many acute health threats can implicate multiple jurisdictions and sectors, the jurisdictional and sectoral dimensions of legal preparedness are complex and may vary substantially by the nature of a threat, its geographic and geopolitical extent, and the operational response demanded. (shrink)