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)

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)

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?

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...

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)

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 (...) class='Hi'>health 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)

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)

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)

The question of clinical science in public health emergencies (e.g., natural disasters, environmental releases, infectious diseases, and especially pandemics) raised by Edwards (2013) is a typical...

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)

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)

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)

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)

This paper argues that Zika virus infection has its ethical implications beyond the reproductive health of women. It claims that Zika virus infection like public health emergency exposes the underlying health determinants and health status of women. Therefore, ethical mitigation of Zika like public health emergencies should consider these underlying health determinants and health status of women. For, undermining and overlooking these underlying determinants and health status of women, during (...) the public health emergencies, enhance the health inequities. The recent Zika virus infection in Brazil has triggered different ethics consultation and has prompted to outline ethical recommendations. However, the recommendations have either focused on the reproductive health of women or on the core strategies of public health emergency. Considering this as a gap in perspective to prepare for Zika like public health emergencies, this paper argues that it is the underlying holistic health of women, precisely, health capability, which should be given due ethical consideration. Finally, the paper concludes highlighting the fact that focusing on the holistic health of the women during Zika like public health emergencies and beyond can bring in long-term benefits for global health equity. (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)

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)

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)

The purpose is to minimize the substantial losses caused by public health emergencies to people’s health and daily life and the national economy. The tuberculosis data from June 2017 to 2019 in a city are collected. The Structural Equation Model is constructed to determine the relationship between hidden and explicit variables by determining the relevant indicators and parameter estimation. The prediction model based on Artificial Neural Network and Convolutional Neural Network is constructed. The method’s effectiveness is verified (...) by comparing the prediction model’s loss value and accuracy in training and testing. Meanwhile, 50 pieces of actual cases are tested, and the warning level is determined according to the T-value. The results show that comparing and analyzing ANN, CNN, and the hybrid network of ANN and CNN, the hybrid network’s accuracy is higher than the other two algorithms, 89.1 and 90.1%. Also, the hybrid network has sound prediction effects and accuracy when predicting actual cases. Therefore, the early warning method based on ANN in deep learning has better performance in public health emergencies’ early warning, which is significant for improving early warning capabilities. (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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than (...) harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (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)

Much of the sustained attention on pandemic preparedness has focused on the ethical justification for plans for the “crisis” phase of a surge when, despite augmentation efforts, the demand for life...

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 manuscript summarizes the most common barriers to effective administrative preparedness and how to surmount them through the use of promising practices, strategies, and NACCHO developed resources focused on addressing unique jurisdictional requirements and needs.

Background 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 reviews 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. Conclusions 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)

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 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 policy makers and practitioners — in all jurisdictions and all relevant sectors and disciplines — with responsibilities for all-hazards emergency preparedness.Advancing and protecting the public's health depends upon the coordination of actions by many, diverse partners. For effective public health preparedness, there must be effective coordination of legal tools and law-based strategies across local, state, tribal, and federal jurisdictions, and also across sectors such as public health, health care, emergency management, education, law enforcement, community design, and academia. (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)

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)

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)

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)

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 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 policy makers and practitioners — in all jurisdictions and all relevant sectors and disciplines — with responsibilities for all-hazards emergency preparedness.Advancing and protecting the public's health depends upon the coordination of actions by many, diverse partners. For effective public health preparedness, there must be effective coordination of legal tools and law-based strategies across local, state, tribal, and federal jurisdictions, and also across sectors such as public health, health care, emergency management, education, law enforcement, community design, and academia. (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)