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)

Faced with the threat of pandemic influenza, several countries have made the decision to put a number of measures in place which have been incorporated into national plans. In view of the magnitude of the powers and responsibilities that States assume in the event of a pandemic, a review of the various national preparedness and response plans for pandemic influenza brought to light a series of extremely important ethical concerns. Nevertheless, in spite of the recent emergence of literature (...) focusing specifically on the ethical aspects of pandemics, too few studies explicitly examine public participation as one means of ethical contribution to public health policies. Thus this article seeks, in the first place, to present an analysis of the various national preparedness and response plans for pandemic influenza, and secondly, to outline the role that the plans envisage for ethics and more importantly for public participation. (shrink)

Faced with the threat of pandemic influenza, several countries have made the decision to put a number of measures in place which have been incorporated into national plans. In view of the magnitude of the powers and responsibilities that States assume in the event of a pandemic, a review of the various national preparedness and response plans for pandemic influenza brought to light a series of extremely important ethical concerns. Nevertheless, in spite of the recent emergence of literature (...) focusing specifically on the ethical aspects of pandemics, too few studies explicitly examine public participation as one means of ethical contribution to public health policies. Thus this article seeks, in the first place, to present an analysis of the various national preparedness and response plans for pandemic influenza, and secondly, to outline the role that the plans envisage for ethics and more importantly for public participation. (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 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)

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 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)

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)

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)

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)

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; 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.One expert's framing of the mission of public health may help improve understanding of the range of hazards for which to be legally prepared. These hazards include urgent realities — such as chronic disease, injury, disabilities, conventional communicable diseases, and an aging and obese population — and urgent threats, such as pandemic influenza, natural disasters, and terrorism. (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; 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.One expert's framing of the mission of public health may help improve understanding of the range of hazards for which to be legally prepared. These hazards include urgent realities — such as chronic disease, injury, disabilities, conventional communicable diseases, and an aging and obese population — and urgent threats, such as pandemic influenza, natural disasters, and terrorism. (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)

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)

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)

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)

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)

Law plays a critical role in all stages of a public health emergency, including planning, response, and recovery. Public health emergencies introduce health concerns at the population level through, for example, the emergence of a novel infectious disease. In the United States, at the federal, state, and local levels, laws provide an infrastructure for public health emergency preparedness and response efforts: they grant the government the ability to officially (...) declare an emergency, authorize responders to act, and facilitate interjurisdictional coordination. Law is perhaps most visible during an emergency when the president or a state's governor issues a disaster declaration establishing the temporal and geographic parameters for the response and making financial and other resources available. This legal authority has increasingly been used during the last decade. (shrink)

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

The detection and spread of pandemic 2009 H1N1 influenza in the United States led to a complex and multi-faceted response by the public health system that lasted more than a year. When the first domestic case of the virus was detected in California on April 15, 2009, and a second, unrelated case was identified more than 130 miles away in the same state on April 17, 2009, the unique combination of influenza virus genes in addition to its (...) emergence and rapid spread at the end of the typical Northern Hemisphere influenza season suggested the potential for a high morbidity, high mortality event. In response, federal, state, and local public health officials conducted epidemiologic investigations with federal and state laboratory support to help to determine the scope of the H1N1 pandemic. On April 26, the Secretary of the U.S. Department of Health and Human Services declared a public health emergency that was renewed through June 23, 2010. The pandemic that ensued tested virtually every aspect of U.S. public health preparedness and response systems, from laboratory capabilities and capacities to social distancing plans. (shrink)

The detection and spread of pandemic 2009 H1N1 influenza in the United States led to a complex and multi-faceted response by the public health system that lasted more than a year. When the first domestic case of the virus was detected in California on April 15, 2009, and a second, unrelated case was identified more than 130 miles away in the same state on April 17, 2009, the unique combination of influenza virus genes in addition to its (...) emergence and rapid spread at the end of the typical Northern Hemisphere influenza season suggested the potential for a high morbidity, high mortality event. In response, federal, state, and local public health officials conducted epidemiologic investigations with federal and state laboratory support to help to determine the scope of the H1N1 pandemic. On April 26, the Secretary of the U.S. Department of Health and Human Services declared a public health emergency that was renewed through June 23, 2010. The pandemic that ensued tested virtually every aspect of U.S. public health preparedness and response systems, from laboratory capabilities and capacities to social distancing plans. (shrink)

Preparing for and responding to public health emergencies involving medical countermeasures raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.S. Department of Health and Human Services’ Office of the General Counsel , (...) Centers for Disease Control and Prevention , and Food and Drug Administration discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Specifically, the authors describe the Public Readiness and Emergency Preparedness Act and Emergency Use Authorization authority, outlining the conditions under which these tools can be utilized and providing examples of how they have supported both pre-event and intra-event activities. (shrink)

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization declared a public health emergency of international concern pursuant to the revised International (...) class='Hi'>Health Regulations [IHR ], and many governments declared national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services made public health emergency and Public Readiness and Emergency Preparedness Act declarations. In addition, the Food and Drug Administration issued Emergency Use Authorizations, and President Obama declared a National Emergency. Select state and local governments also declared emergencies. (shrink)

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization declared a public health emergency of international concern pursuant to the revised International (...) class='Hi'>Health Regulations [IHR ], and many governments declared national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services made public health emergency and Public Readiness and Emergency Preparedness Act declarations. In addition, the Food and Drug Administration issued Emergency Use Authorizations, and President Obama declared a National Emergency. Select state and local governments also declared emergencies. (shrink)

Law can greatly facilitate responses to public health emergencies, including naturally-occurring infectious disease outbreaks and intentional or accidental exposures to chemical, biological, radiological, or nuclear agents. At the federal level, the Secretary of the Department of Health and Human Services, as the lead for federal public health and medical responses to public health emergencies and incidents, has a range of authorities to support federal, state, tribal, local, and territorial responses. For example, under the (...) Public Health Service Act, the Secretary may provide temporary assistance to States to meet health emergency needs or deploy medicine and supplies from the Strategic National Stockpile. The Secretary also may determine that a disease or disorder presents a public health emergency, which may be the first step in triggering other critical legal authorities for response.Since the 2001 anthrax attacks, one focus of public health preparedness has been on developing, distributing, and rapidly dispensing medical countermeasures for CBRN emergencies and pandemics. (shrink)

Law plays a critical role in all stages of a public health emergency, providing an infrastructure for planning, response, and recovery efforts. A growing body of research has underscored the potential for certain types of state laws, such as those granting liability protections to responders, to influence the public health workforce's participation in emergency responses. It is therefore especially important to focus on particular state-level laws that may be associated with individuals' increased or (...) decreased willingness to respond. We conducted a systematic identification and analysis of specific state emergency preparedness laws that may affect individuals' willingness to respond and offer recommendations for policymakers seeking to promote more effective responses to public health emergencies. (shrink)

Even as public health ethics was developing as a field, major incidents such as 9/11 and the SARS epidemic propelled discourse around public health emergency preparedness and response. Policy and practice shifted to a multidisciplinary approach, recognizing the broad range of potential threats to public health, including biological, physical, radiological, and chemical threats. This propelled the development of surveillance systems to detect incidents, laboratory capacities to rapidly test for potential threats, and (...) therapeutic and social countermeasures to prepare for and respond to a range of hazards. In bringing public health ethics and emergency preparedness together, Emergency Ethics: Public Health Preparedness and Response adds depth and complexity to both fields. As global threats continue to emerge, the book, edited by Bruce Jennings, John D. Arras, Drue H. Barrett, and Barbara A. Ellis, will offer a vital compass. (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)

In an emergency, challenges faced by disabled individuals may be exacerbated by ineffective communication, power outages, transportation shortcomings, and inhospitable shelters. During Hurricanes Katrina and Rita, Gulf Coast shelters did not routinely provide closed captioning or sign language interpreters; for individuals with auditory disabilities, understanding instructions issued in these shelters was extremely difficult. Individuals with mobility-related disabilities experienced challenges evacuating from their homes due to public transportation that could not accommodate wheelchairs. After the hurricanes, difficulties arose in identifying (...) wheelchair-accessible trailers and in communicating with disabled trailer residents. Failing to anticipate these challenges intensifies the disadvantaged situation of those with disabilities during an emergency. (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)

South African research ethics committees (RECs) faced significant challenges during the COVID-19 pandemic. Research ethics committees needed to find a balance between careful consideration of scientific validity and ethical merit of protocols, and review with the urgency normally associated with public health emergency research. We aimed to explore the views of South African RECs on their pandemic preparedness and response during COVID-19. We conducted in-depth interviews with 21 participants from RECs that were actively involved in (...) the review of COVID-19 related research, at seven academic institutions across South Africa. Interviews were conducted remotely using an in-depth interview guide that included questions regarding REC preparedness and response to COVID-19. Interviews were conducted until data saturation, and audio-recordings were transcribed verbatim and coded. An inductive approach to thematic analysis was used to organise data into themes and sub-themes. This study focused on three main themes: coping during COVID-19, building REC capacity during pandemic times and a consistently cautious approach to mutual recognition of REC reviews. Despite an initial sense of unpreparedness, RECs were able to adapt and maintain careful ethical oversight of both COVID and non-COVID research, and the rigour of REC reviews. Several important lessons for preparedness and response to future pandemics were identified, including heightened awareness of publication, funding and political pressures, the importance of regular training for RECs and researchers, and strategies to enhance moral resilience of REC members. Incremental steps are needed to build trust and authentic partnerships among RECs in inter-pandemic times, to facilitate collaboration during future public health emergencies. (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.

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)

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 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)

Community resilience, a system’s ability to maintain its essential functions despite disturbance, is a cornerstone of public health preparedness. However, as currently practiced, community resilience generally focuses on defined neighborhood characteristics to describe factors such as vulnerability or social capital. This ignores the way that residents of some neighborhoods (as ‘essential workers’’) were required during the COVID-19 pandemic to sacrifice their wellbeing for the sake of others staying at home in more affluent neighborhoods. Using the global care (...) chain theory, we analyze the way that the resilience of affluent neighborhoods depends on siphoning off the labor of other, less affluent neighborhoods, creating what we call the parasitic nature of resilience. We argue that understanding this neighborhood interdependence—and accounting for its parasitic nature— should be prioritized by public health authorities to prevent unintentional harm in future pandemics. Otherwise, any public health emergency response that relies on this labor (as did the COVID-19 pandemic response) depends on exploitative practices that produce the very disparities the response is trying to address. We explore the theoretical grounding and practical effects of this idea to provide the preparedness enterprise with an initial set of theoretical tools to move from a model of community resilience to one of community renewal. The community renewal model is based on an underlying ethics of care, in which systems are redesigned to become more prosocial during a public health response. We believe this model can more successfully address the tragic inequities in labor and health outcomes that we see during public health emergencies. (shrink)

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)

In September 2010 at the Johns Hopkins Hospital, one of the nation's elite academic hospitals located in East Baltimore, Maryland, Paul Warren Pardus entered the facility to visit his mother, a patient. During a discussion with her doctor in a hospital hallway, Pardus became “overwhelmed” about the care and condition of his mother, pulled a handgun from his waistband, and shot the doctor in the chest. Pardus then locked himself and his mother in her room, shot and killed her, and (...) committed suicide.Dr. Gabe Kelen, a national expert on emergency preparedness and director of the Johns Hopkins emergency department, admitted several years later that this tragic event “really got us thinking in a very serious way.” Together with colleagues at the Johns Hopkins Office of Critical Event Preparedness and Response, Kelen conducted research on the threat and impact of “active shooters” in health care settings. (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)

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)

Public health emergencies have occurred throughout history, encompassing such events as plagues and famines arising from natural causes, disease pandemics interrelated with wars, and industrial accidents such as the 1986 Chernobyl disaster, among others. Law and legal tools have played an important role in addressing such emergencies. Three prime U.S. examples are Congressional authorization of quarantine as early as 1796, legally mandated smallpox vaccination upheld in a landmark 1905 U.S. Supreme Court ruling, and the President's 2003 executive order (...) adding SARS to the federal government's list of “quarantinable communicable diseases.”The public health emergencies of the present — both actual and potential — pose equally serious threats but do so in the context of greatly magnified expectations that stem directly from the attacks of September 11, 2001, and the immediately following anthrax attacks. (shrink)

Public health emergencies have occurred throughout history, encompassing such events as plagues and famines arising from natural causes, disease pandemics interrelated with wars, and industrial accidents such as the 1986 Chernobyl disaster, among others. Law and legal tools have played an important role in addressing such emergencies. Three prime U.S. examples are Congressional authorization of quarantine as early as 1796, legally mandated smallpox vaccination upheld in a landmark 1905 U.S. Supreme Court ruling, and the President's 2003 executive order (...) adding SARS to the federal government's list of “quarantinable communicable diseases.”The public health emergencies of the present — both actual and potential — pose equally serious threats but do so in the context of greatly magnified expectations that stem directly from the attacks of September 11, 2001, and the immediately following anthrax attacks. (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)

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)

Public health legal preparedness begins with effective legal authorities, and law provides a key foundation for public health practice in the United States. Laws not only create public health agencies and fund them, but also authorize and impose duties upon government to protect the public's health while preserving individual liberties. As a result, law is an essential tool in public health practice and is one element of public (...) class='Hi'>health infrastructure, as it defines the systems and relationships within which public health practitioners operate.For purposes of this paper, law can be defined as a rule of conduct derived from federal or state constitutions, statutes, local laws, judicial opinions, administrative rules and regulations, international codes, or other pronouncements by entities authorized to prescribe conduct in a legally binding manner. Public health legal preparedness, a subset of public health preparedness, is defined as attainment of legal benchmarks within a public health system. (shrink)

Public health legal preparedness begins with effective legal authorities, and law provides a key foundation for public health practice in the United States. Laws not only create public health agencies and fund them, but also authorize and impose duties upon government to protect the public's health while preserving individual liberties. As a result, law is an essential tool in public health practice and is one element of public (...) class='Hi'>health infrastructure, as it defines the systems and relationships within which public health practitioners operate.For purposes of this paper, law can be defined as a rule of conduct derived from federal or state constitutions, statutes, local laws, judicial opinions, administrative rules and regulations, international codes, or other pronouncements by entities authorized to prescribe conduct in a legally binding manner. Public health legal preparedness, a subset of public health preparedness, is defined as attainment of legal benchmarks within a public health system. (shrink)