This article focuses on the initial reactions to the Zika epidemic by national and international public health agencies. It presents and analyzes some responses public officials made about sexual and reproductive health at the inception of the epidemic. It also describes the different challenges and obligations faced by local and international public health agencies, as these have not been clearly outlined. The article argues that these agencies have different obligations and (...) should fulfill them despite existing obstacles. While international agencies should honor their leadership role and make recommendations at a meta-level, local agencies should provide, in the case of Zika, a framework for empowerment and grant women the freedom to achieve sexual and reproductive health so that they can avoid the consequences of this epidemic. (shrink)

Public health agencies undertake a broad range of health promotion and injury and disease prevention activities in collaboration with an array of actors, such as the community, businesses, and non-profit organizations. These activities are “multisectoral” in nature and centered on public health agencies that oversee and engage with the other actors. Public health agencies can influence the hazardous activities in the private sector in a variety of ways, “ranging from prohibition (...) and regulation to volunteerism, and from cooperation to cooption.” Hence, a public health agency that possesses the necessary administrative resources and authority is vital to the effective implementation of health policies and regulations.In the developing world, however, many state health agencies lack these basic capacities in dealing with critical health threats, including their ability to avert epidemics of communicable diseases arising from poor sanitary conditions. A serious constraint is the shortage of public health funding for health agencies in the developing world for typical agency functions. This is often aggravated by the transaction-intensive demands entailed in enforcing regulations among an array of private and public sector actors including individuals, businesses, and local bodies responsible for providing civic services. (shrink)

Laws, ordinances, regulations, and executive orders create the powers and duties of public health agencies and modify the complex community conditions that affect health. Appropriately trained legal counsel serving as legal advisors on the health officer's team facilitate clear understanding of the legal basis for public health interventions and access to legal tools for carrying them out.Legal counsel serve public health agencies via different organizational arrangements — e.g., internal staff counsel, (...) external counsel from the state attorney general's office, state health department, county or city, or private counsel under contract, or in combination. As of 2011, most state health departments employ their own counsel, and 56% use AG counsel, while 17% contract with independent attorneys; most local health departments work with attorneys and legal staff assigned by local government, by the state health agency, or contract with outside attorneys and legal staff. (shrink)

The paper identifies common barriers and challenges to Pre-Exposure Prophylaxis (PrEP) uptake and offers considerations for state and local public health departments to address barriers and retool infrastructure to increase access to PrEP to new users. Authors identify synergistic opportunities with federal agencies and funders to advance PrEP-related HIV prevention efforts, that prioritize strategies and investments to provide PrEP to people who could benefit from the intervention but are unaware of PrEP or struggle to access it. (...) Barriers discussed and examined include financing strategies to reduce financial burden of PrEP medication, expanding PrEP access and outreach beyond clinical settings, and increasing the network and reach of the provider community to serve people we oppress through policy choices and discourses of racial and socioeconomic inferiority. (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)

Today, public health regulation at all levels faces unprecedented challenges both at home and abroad. The September 11, 2001 attacks on New York and Washington, D.C., by the Al Qaeda terrorist network and the anthrax bioterrorism that followed shortly thereafter have put public health regulation at the forefront of homeland security. The anthrax scare, in particular, has greatly tested the American public health system, calling into question whether the United States and its component states (...) and localities are prepared to handle a major outbreak of infectious disease, such as smallpox, in a future bioterrorist action. While the response of public health agencies was commendable, especially in light of the magnitude of the assaults, it is manifestly clear that the American public health system will be hard pressed to meet similar challenges that may lie ahead.The events of fall 2001 follow a period of major challenges for public health. The AIDS pandemic has killed millions of people throughout the globe, especially in Africa and other parts of the developing world. (shrink)

Public health laws and policies are uniquely able to mitigate the adverse and inequitable health impacts of climate change. This article summarizes some key considerations in developing such laws and policies and a variety of approaches local public health departments are using to increase climate resilience and health equity.

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically from (...) the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention has adopted guidelines that require Common Rule review for “research” but not “practice” activities. (shrink)

Objectives: Recent legislative changes within the United Kingdom have stimulated professional debate about access to patient data within research. However, there is currently little awareness of public views about such research. The authors sought to explore attitudes of the public, and their lay representatives, towards the use of primary care medical record data for research when patient consent was not being sought.Methods: 49 members of the public and four non-medical members of local community health councils (...) in South Wales, UK gave their views on the value and acceptability of three current research scenarios, each describing access to data without patient consent.Results: Among focus group participants, awareness of research in primary care was low, and the appropriateness of general practitioners as researchers was questioned. There was general support for research but also concerns expressed about data collection without consent. These included lack of respect and patient control over the process. Unauthorised access to data by external agencies was a common fear. Current data collection practices, including population based disease registers elicited much anxiety. The key informants were equally critical of the scenarios and generally less accepting.Conclusions: This exploratory study has highlighted a number of areas of public concern when medical records are accessed for research without patient consent. Public acceptability regarding the use of medical records in research cannot simply be assumed. Further work is required to determine how widespread such views are and to inform those advising on confidentiality issues. (shrink)

Menu labelling is a public health policy intervention that applies principles of nutrition labelling to the eating out environment. While menu labelling has received a good deal of attention with regard to its effectiveness in shaping food choices for obesity prevention, its premises have not yet been fully explored in terms of its broader applications to social equity and population health. In the following case, we focus on the example of menu labelling within the context of food (...) policy at the local level, a fruitful substantive area of consideration for public health ethics. (shrink)

What are the respective roles and responsibilities of global, national, and local communities as well as individuals themselves to address health deprivations and avert health threats? This article offers the beginnings of a theory of global health justice, arguing for universal ethical norms (general duty) with shared global and domestic responsibility (specific duties) for health. It offers a global minimalist view I call ‘ provincial globalism ’ as a mean between nationalism and cosmopolitanism, in which (...) a provincial consensus must accompany a global consensus on health morality. This minimalist account asserts global and national duties to promote human flourishing and, more specifically, individuals’ central health capabilities. In this view, justice requires prioritizing responsibilities through shared health governance to reduce shortfall inequalities in central health capabilities — a general duty to reduce premature mortality and escapable morbidity. It examines the difficulties presented by the philosophical principles of connectedness, causality, remediation, partiality, and capacity in the allocation of responsibility for global health. It offers a theory of responsibility allocation based on a functional, health agency centered and homeostatic balanced understanding of the analytical components required to solve global health problems and parcels out roles and responsibilities at the global, national, local, and individual levels accordingly. Allocations of responsibility rest on the effectiveness and special obligations of different actors, respecting self-determination by groups and individuals and seeking voluntary commitments . This view understands that the remedy for global health problems must be sustainable to take nations and the global health community to a new global health equilibrium that remedies current problems and prepares for new health threats to come. (shrink)

My life during those three months looks a lot like the public mental health system. Local Community Mental Health agencies (CMHs) are required, on a daily basis, to meet the needs of people with mental illness in a system that everyone knows is tragically under funded. The system does what it can with the resources it has and looks towards the next fiscal year, with fingers crossed, hoping for some relief. Some in the system have (...) given up hope, and consider it a "success" if their funding isn�t cut or eliminated. (shrink)

In late March of 2020, a new hashtag, #FilmYourHospital, made its first appearance on social media. The hashtag encouraged people to visit local hospitals to take pictures and videos of empty hospitals to help “prove” that the COVID-19 pandemic is an elaborate hoax. Using techniques from Social Network Analysis, this case study examines how this conspiracy theory propagated on Twitter and whether the hashtag virality was aided by the use of automation or coordination among Twitter users. We found that (...) while much of the content came from users with limited reach, the oxygen that fueled this conspiracy in its early days came from a handful of prominent conservative politicians and far right political activists on Twitter. These power users used this hashtag to build awareness about the campaign and to encourage their followers to break quarantine and film what is happening at their local hospitals. After the initial boost by a few prominent accounts, the campaign was mostly sustained by pro-Trump accounts, followed by a secondary wave of propagation outside the U.S. The rise of the #FilmYourHospital conspiracy from a single tweet demonstrates the ongoing challenge of addressing false, viral information during the COVID-19 pandemic. While the spread of misinformation can be potentially mitigated by fact-checking and directing people to credible sources of information from public health agencies, false and misleading claims that are driven by politics and supported by strong convictions and not science are much harder to root out. (shrink)

Poor pregnancy outcomes and inequalities in these outcomes remain a major challenge, even in prosperous societies that have high-quality health care and public health policy in place. In this article, we propose that justice demands the improvement of what we call the ‘health agency’ of parents-to-be as part of a response to these poor outcomes. We take health agency to have three aspects: the capacity to form health-goals one has reason to value, the control (...) one perceives to have over achieving those health-goals and the freedom one has to achieve those health-goals. We will moreover argue that this demand of justice can be best based on a perfectionist rather than neutralist method of justification. Subsequently, we will argue that perfectionist policy may be paternalistic but not wrongfully paternalistic. This leads us to conclude that perfectionism should be adopted to inform and justify public health policy that is aimed at improving health agency in general and counteracting poor pregnancy outcomes and inequalities in perinatal health outcomes in particular. (shrink)

One of the defining features of the capability approach to health, as developed in Venkatapuram's book Health Justice, is its aim to enable individual health agency. Furthermore, the CA to health hopes to provide a strong guideline for assessing the health-enabling content of social and political conditions. In this article, I employ the recent literature on the liberal concept of vulnerability to assess the CA. I distinguish two kinds of vulnerability. Considering circumstantial vulnerability, I argue (...) that liberal accounts of vulnerability concerned with individual autonomy, align with the CA to health. Individuals should, as far as possible, be able to make health-enabling decisions about their lives, and their capability to do so should certainly not be hindered by public policy. The CA to health and a vulnerability-based analysis then work alongside to define moral responsibilities and designate those who hold them. Both approaches demand social policy to address circumstances that hinder individuals from taking health-enabling decisions. A background condition of vulnerability, on the other hand, even though it hampers the capability for health, does not warrant the strong moral claim proposed by the CA to health to define health as a meta-capability that should guide social policy. Nothing in our designing social policy could change the challenge to health agency when we deal with background conditions of vulnerability. (shrink)

In the case discussion, ‘Equity in Public Health Ethics: The Case of Menu Labelling Policy at the Local Level’ , Mah and Timming state that menu labelling would ‘place requirements for information disclosure on private sector food businesses, which, as a policy instrument, is arguably less intrusive than related activities such as requiring changes to the food content’. In this commentary on Mah and Timming’s case study, I focus on discussing how menu-labelling policy permits governments to avoid (...) addressing the heart of the problem, which is high-calorie, high-sodium restaurant food. Menu labelling policy does not address food content in a way that is meaningful for change, instead relying on individuals to change their behaviour given new information. Besides having questionable efficacy, this raises concerns about moralizing food choices. (shrink)

This book presents the first critical examination of the overlapping ethical, sociocultural, and policy-related issues surrounding disasters, global bioethics, and public health ethics. These issues are elucidated under the conceptual rubric: Public health disasters. The book defines PHDs as public health issues with devastating social consequences, the attendant public health impacts of natural or man-made disasters, and latent or low prevalence public health issues with the potential to rapidly acquire pandemic (...) capacities. This notion is illustrated using Ebola and pandemic influenza outbreaks, atypical drug-resistant tuberculosis, and the health emergencies of earthquakes as focal points. Drawing on an approach that reckons with microbial, existential, and anthropological realities; the book develops a relational-based global ethical framework that can help address the local, anthropological, ecological, and transnational dynamics of the ethical issues engendered by public health disasters. The book also charts some of the critical roles that relevant local and transnational stakeholders may play in translating the proposed global ethical framework from the sphere of concept to the arena of action. This title is of immense benefit to bioethics scholars, public and global health policy experts, as well as graduate students working in the area of global health, public health ethics, and disaster bioethics. (shrink)

The obligations of organisations associated with policy formation and implementation of international mass public health programmes are explored. Lines of responsibility are considered to become unclear because of the large number of agencies associated with such programmes. A separation of the relevant obligations among the bodies responsible for the formulation and those responsible for the implementation of the policies is suggested. The continuing oral polio vaccine campaign against poliomyelitis in India is used to illustrate the general argument. (...) Although the aim of the programme is legitimate and laudable, unnecessary harm is currently being caused to some children as a result of elements of the policy and this should be rectified immediately. Such mass programmes should take care to ensure that people are not unnecessarily sacrificed in the drive to attain the desirable ends of the policy. (shrink)

In the early days of HIV awareness, prior to universal precautions, as a local health officer, I was supervising an openly gay employee. The county executive asked me the HIV status of the employee and threatened my employment if I did not reveal it. I was reluctant to do so, believing it would be an invasion of the employee’s privacy. I contacted the county attorney who advised me that I could reveal the employee’s HIV status to the county (...) executive but he was not willing to put his guidance in writing. Ultimately, I spoke with the employee’s attorney and was given permission to reveal the employee’s HIV status. The experience, however, left a bad taste in my mouth. I felt the county attorney was acting politically in support of the county executive rather than doing what was legally appropriate. He certainly did not act as an advocate for the local health department! (shrink)

Public-health measures are very effective and efficient means of improving health, yet public health is either neglected by the literature or fraught with unease, mainly due to the combination of the aggregate-distributive tension with the element of compulsion.The author argues that this unease can be decreased by 1) a pluralist-holistic view of health, situating the normative value of health in its effect on well-being, incorporating both the objective and subjective source of the value (...) of health; and 2) by a rich concept of reciprocity.This article supports Martha Nussbaum’s critique of social-contract thinking for placing too much weight on the scale of normal functioning and productive reciprocity, as well as Sen’s distinction between well-being and agency freedom.To reach an adequate understanding of the value and goal of public health within the general setting of health care, a pluralist conception of health, well-being and reciprocity is necessary. (shrink)

After WWII, global concerns about the uses of nuclear energy and radiation sources in agriculture, medicine, and industry brought about calls for radiation protection. At the beginning of the 1960s radiation protection involved the identification and measurement of all sources of radiation to which a population was exposed, and the evaluation and assessment of populations in terms of the biological hazard their exposure posed. Mexico was not an exception to this international trend. This paper goes back to the origins of (...) the first studies on the effects of radiation and on radioprotective compounds in the Genetics and Radiobiology Program of the National Commission of Nuclear Energy founded in 1960, at a time when the effects of radiation on living beings and radiation protection demanded the attention of highly localized groups of scientists and the creation of international as well as national institutions, and its connection to dosimetry and radiation protection until the 1990s. This historical reconstruction examines the circulation of knowledge, scientists, and their material and cognitive resources, to show that radiobiology, with dosimetry and radiation protection as cases in point, not only were carried out with high international standards in parallel with international agencies, but also reflected local material needs, including the standardization of new experimental techniques. (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 makes a conceptual inquiry into the notion of ‘publics’, and forwards an understanding of this notion that allows more responsible forms of decision-making with regards to technologies that have localized impacts, such as wind parks, hydrogen stations or flood barriers. The outcome of this inquiry is that the acceptability of a decision is to be assessed by a plurality of ‘publics’, including that of a local community. Even though a plurality of ‘publics’ might create competing normative demands, (...) its acknowledgment is necessary to withstand the monopolization of the process of technology appraisal. The paper presents four ways in which such an appropriation of publicness takes place. The creation of dedicated ‘local publics’, in contrast, helps to overcome these problems and allows for more responsible forms of decision-making. We describe ‘local publics’ as those in which stakeholders from the different publics that are related to the process of technology implementation are brought together, and in which concerns and issues from these publics are deliberated upon. The paper will present eight conditions for increasing the effectiveness of such ‘local publics’. (shrink)

Public-health measures are very effective and efficient means of improving health, yet public health is either neglected by the literature or fraught with unease, mainly due to the combination of the aggregate-distributive tension with the element of compulsion.The author argues that this unease can be decreased by 1) a pluralist-holistic view of health, situating the normative value of health in its effect on well-being, incorporating both the objective and subjective source of the value (...) of health; and 2) by a rich concept of reciprocity.This article supports Martha Nussbaum’s critique of social-contract thinking for placing too much weight on the scale of normal functioning and productive reciprocity, as well as Sen’s distinction between well-being and agency freedom.To reach an adequate understanding of the value and goal of public health within the general setting of health care, a pluralist conception of health, well-being and reciprocity is necessary. (shrink)

Citizen participation, by now one of the main topics on the institutional agenda in many European countries, involves different fields of public action, mostly on a local level – social inclusion, urban renewal, development, the environment, health/social services, etc. It still remains, however, vague as a concept with a great variety of actors, procedures and powers involved in its practices. In this scenario, the present article asks two questions: what powers and what freedoms are involved in participation? (...) How are they constructed and increased? The article then goes on to argue how voice is relevant for understanding the many stories of participation, referring to the classic concept of voice formulated by Albert Hirschman and the elaborations offered by Amartya Sen and Arjun Appadurai in their dialogue over capabilities and capacities. (shrink)

The purpose of this article is to explore the concept and scope of public health and to argue that particularly in low-income contexts, where social injustice and poverty often impact significantly on the overall health of the population, the link between public health and social justice should be a very firm one. Furthermore, social justice in these contexts must be understood as not simply a matter for local communities and nation-states, but in so far (...) as public health is concerned, as a matter of global concern and responsibility. The interpretation of the scope of public health by any particular nation is I believe contingent on the current socio-political context and the conception of social or distributive justice that underpins this context. Furthermore I will argue here that the link between public health and social justice ought to be founded on a conception of social justice that adequately addresses issues of social injustice, and patterns of systematic disadvantage, that contribute to ill health and that so commonly prevail in many low- and middle-income social contexts. (shrink)

Uncertainty is inherent in new and unexpected viral outbreaks such as the current COVID-19 pandemic. It imposes challenges for health officials in soliciting cooperative behavioural changes based on incomplete information. In this paper, we use evolving mask recommendations in the United States as an example to analyse the ethical importance and practical demonstration of trustworthiness in pandemic messaging and decision-making. We argue that responsible public health interventions in the time of uncertainties requires explicit intersecting ethical considerations both (...) in action and in communication to promote trustworthiness. First, as public health decisions have to be made in the face of incomplete and evolving data, health officials need to exhibit competence while committing to epistemic humility. They can explain the methods used in making and updating mask recommendations as well as explicitly acknowledge the need to incorporate sociocultural and other contextual considerations in translating scientific data into mask recommendations. Second, officials and agencies must uphold and communicate decisional transparency as part of their effort to demonstrate accountability and promote the public’s understanding of the evolving pandemic. Third, especially since both the pandemic and mask recommendations may have disparate impact on different populations, officials should start with the fair implementation of the least restrictive measures that can help reduce harm. (shrink)

The Covid‐19 pandemic has revealed myriad social, economic, and health inequities that disproportionately burden populations that have been made medically or socially vulnerable. Inspired by state and local governments that declared racism a public health crisis or emergency, the Anti‐Racism in Public Health Act of 2020 reflects a shifting paradigm in which racism is considered a social determinant of health. Indeed, health inequities fundamentally rooted in structural racism have been exacerbated by the (...) Covid‐19 pandemic, which calls for the integration of antiracist praxis to promote ethical public health research processes. This commentary describes ways in which antiracist praxis—which emphasizes empowerment of traditionally marginalized populations—offers strategies to explicitly address power imbalance, stigmatization, and other consequences of structural racism in public health research. (shrink)

This Article considers the conditions under which administrative agencies - particularly those with public health-related missions - may obtain partial autonomy from external interests or politicians. In the process, it critiques the proposition that administrative agencies in advanced industrialized countries such as the United States are routinely “captured” by external economic interests. Through case studies and the application of relevant theory from law and the study of political organization, the Article describes how agencies can produce (...) a measure of autonomy by forging coalitions of stakeholders both internal and external to the agency, and considers how partial autonomy may be modeled as a strategic process involving decisions under uncertainty. The Article then investigates how American publichealth agencies such as the Food and Drug Administration, the Food Safety Inspection Service, and the Centers for Disease Control have been able to use their partial autonomy to develop significant health policy innovations. Although agencies are by no means guaranteed even a partial degree of autonomy, they are nonetheless capable of affecting their political and legal environment, with consequences not only for public-health policy but also for the legitimacy of the nation-state. (shrink)

In an effort to respond to the large surge in COVID-19 cases in Arizona that began between May and July 2020, the Arizona State University (ASU) Student Outbreak Response Team (SORT) formed a remote, volunteer-based case investigation team that worked in partnership with a local public health department through delegated public health authority.

This study examines public health nurses’ perceptions and concerns about the implications of Japan’s new long-term care insurance law concerning care provision for elderly people and their families. Respondents voiced their primary concern about this law as access to services for all elderly people needing care, and defined their major responsibility as strengthening health promotion and illness prevention programmes. Although wanting to expand their roles to meet the health care, social and public policy advocacy needs (...) of elderly persons and their families, respondents also stated their concern for the possible lack of enough resources for this expansion to support family caregivers adequately. They viewed their first function as developing collaborative relationships with local government officials to help to assure sufficient resources to provide the necessary foundation for long-term care programmes to deliver services to all those in need. These concerns fall within the larger ethical issue of distributive justice in a society based on the obligations of the state to citizens and the family to its members, especially elderly relatives, who, according to traditional Japanese values, retain respect. (shrink)

Background Since 2015, Michigan has required parents who request nonmedical exemptions (NMEs) from school or daycare immunization mandates to receive education from local public health staff (usually nurses). This is unlike most other US states that have implemented mandatory immunization counseling, which require physicians to document immunization education, or which provide online instruction. -/- Purpose To attend to the activity and dispositions of the public health staff who provide “waiver education”. -/- Method This study reports (...) results of focus group interviews with 39 of Michigan's vaccine waiver educators (37 nurses), conducted during 2016 and 2017, and analyzed in 2018. -/- Findings Four themes emerged from analysis of the transcripts of these interviews: Participants had (1) complex and nuanced observations and evaluations of parents' judgments and feelings about vaccines and vaccine education; (2) sympathetic attitudes about alternative vaccine schedules; (3) critical and supportive evaluations of institutional policies and the background political context of immunization education; and (4) consistent commitments to respect parents, affirm their values, and protect their rights. Discussion These results show that public health nurses are sensitive to the burdens mandatory immunization education places on families, the motivations for parents' requests for nonmedical exemptions, and the values implicated by personal immunization decisions and government immunization policies. In light of the unique training, experiences, and public reputation of nurses, there is good reason for additional investigation into the roles that nurses can play in immunization education and in vaccine mandate policies, more generally. (shrink)

This article is about the cholera epidemic that occurred in the Benghazi Sanjak, a region under the rule of the Ottoman Empire, in the year 1858. The purpose of this study is to highlight the measures taken by both the central and local governments against the cholera epidemic that occurred in 1858 and to shed light on the management of the outbreak. In this context, the social health practices and the public's sensitivity towards health in the (...) Benghazi Sanjak during the Karamanli administration in Tripolitania in the early 1800s, as well as the period after it became directly connected to the Ottoman central government from 1835, will be examined, and the historical process leading up to the epidemic will be presented. The implementation of the quarantine measures introduced by the Ottoman Empire from the 1840s onwards, particularly in Benghazi, also holds a significant position in understanding the outbreak. The study is crucial in revealing the advancements in the health sector of the Benghazi Sanjak. The article emphasizes that the region of Berka, where the Benghazi Sanjak is located, was frequently afflicted by epidemics, but by the 1860s, there was noticeable improvement in the health sector. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for revision. Instead, it is (...) also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (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)

In another tumultuous term of the United States Supreme Court in 2022-2023 a series of critical cases implicate instant and forthcoming changes in multiple fronts that collectively shift the national public health law and policy environment.

Federal, state, and local laws shape the use of health information for public health purposes, such as the mandated collection of data through electronic disease reporting systems. Health professionals can leverage these data to better anticipate and plan for the needs of communities, which is seen in the use of electronic case reporting.

Law is indispensable to the public's health. The twentieth century proved this true as law contributed to each of the century's ten great public health achievements: vaccination, healthier mothers and babies, family planning, safer and healthier foods, fluoridation of drinking water, the control of infectious diseases, the decline in death from heart disease and stroke, recognition of tobacco use as a health hazard, motor vehicle safety, and safer workplaces.The readers of this journal can give examples (...) of the relevant types of laws with ease: Jacobson v. Massachusetts, the 1905 U.S. Supreme Court case that upheld the constitutionality of compulsory vaccination; mandatory immunization for school admission; authorization of state prenatal care programs; mandatory fortification of foods; Title X of the Public Health Service Act; the Pure Food and Drugs Act of 1906; the Safe Drinking Water Act of 1974, and hundreds of state and local enactments regulating food; fluoridation ordinanceswater, and sanitation; the Surgeon General's warning notices on cigarette packs and restrictions on marketing tobacco; seat belt laws and mandated vehicle and highway design features; and laws like the federal Occupational Safety and Health Act of 1970 that regulate working conditions. (shrink)

The governance of pharmaceutical medicines entails complex ethical decisions that should, in theory, be the responsibility of democratically accountable government agencies. However, in many Low- and Middle-Income Countries (LMICs), regulatory and health systems constraints mean that many people still lack access to safe, appropriate and affordable medication, posing significant ethical challenges for those working on the “front line”. Drawing on 18 months of fieldwork in Ghana, we present three detailed case studies of individuals in this position: an urban (...) retail pharmacist, a rural over-the-counter medicine retailer, and a local inspector. Through these case studies, we consider the significant burden of “ethical labour” borne by those operating “on the ground”, who navigate complex moral, legal and business imperatives in real time and with very real consequences for those they serve. The paper ends with a reflection on the tensions between abstract, generalised ethical frameworks based on high-level principles, and a pragmatic, contingent ethics-in-practice that foregrounds immediate individual needs – a tension rooted in the gap between the theory and the reality of pharmaceutical governance that shifts the burden of ethical labour downwards and perpetuates long-term public health risks. (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)

Over the last century, droughts have caused more deaths internationally than any other weather- or climate-related disaster. Like other natural disasters, droughts cause significant changes in the environment that can lead to negative health outcomes. As droughts are becoming more frequent and intense with climate change, public health systems need to address impacts associated with these events. Partnering with federal and local entities, we evaluated the state of knowledge of drought and health in the United (...) States through a National Drought and Public Health Summit and a series of subsequent regional workshops. The intended outcome was to develop public health strategies for implementing activities to better support and prepare public health systems for future droughts. The information gathered from this work identified multiple policy and law options to address the public health issues associated with drought. These policy recommendations include the use of public health emergency declarations for drought events, increased usage of preparedness evaluations for drought emergencies, and engagement of drought and climate experts in state and local risk assessments. As drought events are projected to increase in frequency and magnitude with climate change, taking policy action now will help decrease the health impacts of drought and save lives. (shrink)

Among the morass of critical issues impacting the results of the midterm elections in 2022 were core public health issues related to health care access, justice, and reforms. Collectively, voters’ communal health and safety concerns dominated outcomes in key races which may shape national, state, and local legal approaches to protecting the public’s health in the modern era.

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance, epidemiological investigations, and evaluation (...) and monitoring. Few debate that these essential public health activities, often specifically authorized by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects. (shrink)

The COVID-19 pandemic has brought the long-standing public health practice of contact tracing into the public spotlight. While contact tracing and case investigation have been carefully designed to protect privacy, the huge volume of tracing which is being carried out as part of the pandemic response in the United States is highlighting potential concerns around privacy, legality, and equity. Contact tracing during the pandemic has gained particular attention for the new use of digital technologies—both on the consumer (...) side in the form of Exposure Notification applications, and for public health agencies as digital case management software systems enable massive scaling of operations. While the consumer application side of digital innovation has dominated the news and academic discourse around privacy, people are likely to interact more intensively with public health agencies and their use of digital case management systems. Effective use of digital case management for contact tracing requires revisiting the existing legal frameworks, privacy protections, and security practices for management of sensitive health data. The scale of these tools and demands of an unprecedented pandemic response are introducing new risks through the collection of huge volumes of data, and expanding requirements for more adept data sharing among jurisdictions. Public health agencies must strengthen their best practices for data collection and protection even in the absence of comprehensive or clear guidance. This requires navigating a difficult balance between rigorous data protection and remaining highly adaptive and agile. (shrink)

In D.A.B.E., Inc., v. Toledo-Lucas County Board of Health, the Supreme Court of Ohio held that the Ohio Revised Code does not grant a local board of health the power to proscribe smoking in all public places as defined by the Lucas County Regional Health District Clean Indoor Air Regulation.On May 24, 2001, the Board of Health of the Lucas County Regional Health District adopted the regulation in question, prohibiting smoking in all (...) class='Hi'>public areas in Lucas County, which were defined as “every enclosed, indoor area to which members of the general public are invited or in which members of the general public are normally permitted.” In addition, the regulation prohibited smoking within twenty feet of any entrance or open window of these public areas and in all vehicles of public transportation. (shrink)

This paper proposes a theoretical framework for understanding fat stigma and its impact on people’s well-being. It argues that stigma should never be used as a tool to achieve public health ends. Drawing on Bruce Link and Jo Phelan’s 2001 conceptualization of stigma as well as the works of Hilde Lindemann, Paul Benson, and Margaret Urban Walker on identity, positionality, and agency, this paper clarifies the mechanisms by which stigmatizing, oppressive conceptions of overweight and obesity damage identities and (...) diminish moral agency, arguing that the use of obesity-related stigma for public health ends violates the bioethics principles of nonmaleficence, autonomy, and justice. (shrink)

Preemption is a powerful strategy used by special interest groups to undermine strong, local public health standards. Currently, 20 states in the U.S. have preemption ordinances in place related to clean indoor air initiatives. These preemption laws are the direct result of an ongoing and aggressive campaign of tobacco companies to thwart clean indoor air initiatives, which ultimately, according to tobacco industry internal documents, cause significant reductions in their annual revenues. Clean indoor air policies have arisen from (...) a greater understanding of the documented health risks associated with exposure to secondhand smoke and action by local government to protect the public from these hazards. The efforts of the tobacco industry undermine local authority and seek to shift policy action to the state and federal levels, where the industry has greater political influence. (shrink)

In the fall of 2001, the need for a vigorous and effective public health system became more apparent than it had been for many decades. With the advent of the first widescale bioterrorist attack on the United States, the government's obligation to respond and take steps to protect the public health became self-evident.Also obvious was the need for of an effective partnership between federal, state, and local officials. Local officials are almost always on the (...) front lines of the struggle against bioterrorism. They are the first to recognize a suspicious case and to provide testing and treatment for the affected population. At the same time, state officials are needed to support and coordinate local efforts, providing an expertise that may be lacking in many communities, especially smaller ones.But few would doubt that the federal government has a key role to play. The Centers for Disease Control and Prevention is expected to lead the epidemiological investigation and provide expertise on how to cope with diseases that remain unfamiliar to most physicians. (shrink)

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (...) class='Hi'>Public health activities that might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection, and laboratory testing.There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons. (shrink)

The paper ‘Biodefence and the production of knowledge’ by Buchanan and Kelley1 is an extremely valuable addition to the scientific and bioterrorism defence literature. It points out the myriad of ways that the structure of current debates about the dual use problem neglects important values, and discussions of how these values should be considered in policy making. In this commentary, I will focus on only one of these areas: what the authors characterise as ‘dual use opportunity’. My goal is not (...) to challenge the authors’ main points , but to draw out the complicated set of value conflicts that this single area of bioterror defence policy has neglected.Buchanan and Kelley characterise the concept of ‘dual use opportunity’ as the idea that ‘research undertaken for biodefence may contribute, or might be made to contribute, to the alleviation of the burden of disease among the world's worst-off people.’ I have argued for a similar idea of dual use opportunity in a different context by suggesting that we should prioritise global public health infrastructure over narrowly defined research on specific agents and/or projects that seek to prevent altogether biological attacks—a goal that, I have argued, is futile given the almost limitless number of forms of, and mutations to, disease bacteria and viruses that might be employed by biological terrorists.2–5 Effective control of an epidemic requires a fundamental infrastructure of surveillance and reporting. Because the …. (shrink)