Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests (...) of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

Critics of mass culture often identify 1950s-style status competition as one of the central forces driving consumerism. Thomas Frank has challenged this view, arguing that countercultural rebellion now provides the primary source of consumerism in our society, and that ‘cool’ has become its central ideological expression. This paper provides a rearticulation and defense of Frank's thesis, first identifying consumerism as a type of collective action problem, then showing how the ‘hip consumer’ is one who adopts a free-rider strategy in this (...) context. (shrink)

Quality improvement is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

Surveillance plays a crucial role in public health, and for obvious reasons conflicts with individual privacy. This paper argues that the predominant approach to the conflict is problematic, and then offers an alternative. It outlines a Basic Interests Approach to public health measures, and the Unreasonable Exercise Argument, which sets forth conditions under which individuals may justifiably exercise individual privacy claims that conflict with public health goals. The view articulated is compatible with a broad range conceptions of (...) the value of health. (shrink)

Ageism within the context of care has attracted increasing attention in recent years. Similarly, autonomy has developed into a prominent concept within health care law and ethics. This paper explores the way that ageism, understood as a set of negative attitudes about old age or older people, may impact on an older person’s ability to make maximally autonomous decisions within health care. In particular, by appealing to feminist constructions of autonomy as relational, I will argue that the key (...) to establishing this link is the concept of self-relations such as self-trust, self-worth and self-esteem. This paper aims to demonstrate how these may be impacted by the internalisation of negative attitudes associated with old age and care. In light of this, any legal or policy response must be sensitive to and flexible enough to deal with the way in which ageism impacts autonomy. (shrink)

ABSTRACT Most of the world's health problems afflict poor countries and their poorest inhabitants. There are many reasons why so many people die of poverty‐related causes. One reason is that the poor cannot access many of the existing drugs and technologies they need. Another, is that little of the research and development (R&D) done on new drugs and technologies benefits the poor. There are several proposals on the table that might incentivize pharmaceutical companies to extend access to essential drugs (...) and technologies to the global poor.1 Still, the problem remains – the poor are suffering and dying from lack of access to essential medicines. So, it is worth considering a new alternative. This paper suggests rating pharmaceutical and biotechnology companies based on how some of their policies impact poor people's health. It argues that it might be possible to leverage a rating system to encourage companies to extend access to essential drugs and technologies to the poor. (shrink)

Resistance to rationing health care to the elderly is enormous. This article lays out the need for rationing, based on projections of Medicare expenditure in the near future, and the judgment of policy experts that there will be no technological breakthrough that might lower costs. Various forms of rationing possibilities are discussed as well as cultural and political obstacles to needed reform. Some general principles for thinking about health care for the elderly are presented.

Rather than ‘superbugs’ signifying recalcitrant forms of life that withstand biomedical treatment, drug resistant infections emerge within and are intricate with the exercise of social and medical power. The distinction is important, as it provides a means to understand and critique current methods employed to confront the threat of widespread antimicrobial resistance. A global health regime that seeks to extend social and medical power, through technical and market integration, risks reproducing a form of triumphalism and exceptionalism that resistance itself (...) should have us pause to question. An alternative approach, based on a postcolonial as well as a ‘post-colony’ approach to health and microbes, provides impetus to challenge the assumptions and norms of global health. It highlights the potential contribution that vernacular approaches to human and animal health can play in altering the milieu of resistance. (shrink)

This paper investigates the ethical implications of research at the interface between biodiversity and both human and animal health. Health and sanitary crises often lead to ethical debates, especially when it comes to disruptive interventions such as forced vaccinations, quarantine, or mass culling of domestic or wild animals. In such debates, the emergence of a “Planetary health ethics” can be highlighted. Ethics and accountability principles apply to all aspects of scientific research including its technological and engineering applications, (...) regardless of whether they are considered “hard sciences”, such as state-of-the-art technology in the fields of medicine, veterinary medicine, agronomy, or environment, or “soft”, such as local or global governance, health, socio-ecosystems, and the environment. Ethical reflection in the interdisciplinary field of biodiversity and health requires the examination of relevant scientific domains, such as biology, ecology, evolution, human medicine, animal medicine, anthropology, and law, and their epistemology and representation as well as scientific pluralism, which is crucial to establish genuine interdisciplinarity. Navigating the ethics-scape necessitates going beyond the hierarchy of science by recognising that scientific knowledge has implications for both scientific and non-scientific perspectives on the study of nature. The example of a Nipah virus outbreak is used to illustrate how the so-called “modern epidemiological” approach often focuses on risk factors associated with individual behavioural characteristics or collective practices, whereas the so-called “eco-social” approach focuses on global, socio-economic, and environmental factors that are the contextual causes of the health problem affecting the community. “Modern epidemiologists” aim to “correct” individual or practice factors using a “minimal set” of ethics, whereas “eco-social” scientists have to act systemically, which requires integrated research that acknowledges scientific pluralism, avoids the hierarchy of sciences, but accepts the pluralism of ethics and values. (shrink)

Ethical guidelines for conducting clinical trials have historically been based on a perceived therapeutic obligation to treat and benefit the patient-participants. The origins of this ethical framework can be traced to the Hippocratic oath originally written to guide doctors in caring for their patients, where the overriding moral obligation of doctors is strictly to do what is best for the individual patient, irrespective of other social considerations. In contrast, although medicine focuses on the health of the person, public (...) class='Hi'>health is concerned with the health of the entire population, and thus, public health ethics is founded on the societal responsibility to protect and promote the health of the population as a whole. From a public health perspective, research ethics should be guided by giving due consideration to the risks and benefits to society in addition to the individual research participants. On the basis of a duty to protect the population as a whole, a fiduciary obligation to realise the social value of the research and the moral responsibility to distribute the benefits and burdens of research fairly across society, how a public health perspective on research ethics results in fundamental re-assessments of the proper course of action for two salient topical issues in research ethics is shown: stopping trials early for reasons of efficacy and the conduct of research on less expensive yet less effective interventions. (shrink)

This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research.This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory (...) actors seek to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application.This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action. (shrink)

Competing contemporary theories of health, the reductionist and the relativist of an objective goal, can be classified as objectivist theories. The ultimate goal of all living things is life, the standard by which states or functions can be measured, and thereby defined as healthy or disease states. While disease can be classified in a taxonomy of biological dysfunctions without remainder, health is a richer concept that includes not only biological values, but also moral values, both leading to the (...) ultimate goal of human flourishing. (shrink)

Public health raises critical ethics issues and concerns, making public heath ethics an essential topic for students and public health professionals. The 73 chapters in this volume examine public health ethics across a broad range of public health topics both in the U.S. and globally. It is the first ever comprehensive collection devoted to public health ethics.

A mark of our modern age is the translation of the non-digital to the digital, an evolution likely only to accelerate and to demand the proactive development of robust ethical guidance to navigate...

A growing volume of research from global data demonstrates that institutional care under conditions of deprivation is profoundly damaging to children, particularly during the critical early years of development. However, how these individuals develop over a life course remains unclear. This study uses data from a survey on the health and development of 420 children mostly under the age of three, placed in 12 infant care institutions between 1958 and 1961 in Zurich, Switzerland. The children exhibited significant delays in (...) cognitive, social, and motor development in the first years of life. Moreover, a follow-up of a subsample of 143 children about 10 years later revealed persistent difficulties, including depression, school related-problems, and stereotypies. Between 2019 and 2021, these formerly institutionalized study participants were located through the Swiss population registry and invited to participate once again in the research project. Now in their early sixties, they are studied for their health, further development, and life-course trajectories. A mixed-methods approach using questionnaires, neuropsychological assessments, and narrative biographical interviews was implemented by a multidisciplinary team. Combining prospective and retrospective data with standardized quantitative and biographical qualitative data allows a rich reconstruction of life histories. The availability of a community sample from the same geographic location, the 1954–1961 cohort of the Zurich Longitudinal Studies, described in detail in a paper in this issue, enables comparison with an unaffected cohort. This article describes the study design and study participants in detail and discusses the potential and limitations of a comparison with a community sample. It outlines a set of challenges and solutions encountered in the process of a lifespan longitudinal study from early childhood into the cusp of old age with a potentially vulnerable sample and summarizes the lessons learned along the way. (shrink)

A growing body of research highlights that adults with autism spectrum disorder have poor health outcomes, yet effective health interventions are lacking for this population. While mobile health applications demonstrate potential for promoting physical activity in adults with ASD, scientific evidence for supporting this tool’s long-term effectiveness on PA behavior change remains inconclusive. This study aimed to provide the latest information on PA research and the prospective role of mobile health applications for promoting PA in adults (...) with ASD. A literature review demonstrated that a few available studies show contradictory results regarding PA levels in adults with ASD, and behavior change techniques and gamification-guided mobile health applications can be promising tactics to leverage autism’s strengths and increase PA in these individuals. Optimizing design decisions based on needs analysis and user feedback is crucial to identifying and developing a sustainable mobile health intervention for PA promotion in adults with ASD. (shrink)

Health disparities education is an integral and required part of medical professional training, and yet existing curricula often fail to effectively denaturalize injustice or empower learners to advocate for change. We discuss a novel collaborative intervention that weds the health humanities to the field of health equity. We draw from the health humanities an intentional focus retraining provider imaginations by centering patient narratives; from the field of health equity, we draw the linkage between stigmatized social (...) identities and health disparities. We describe a longitudinal health equity curriculum for the Hospice and Palliative Medicine fellowship in Memphis, Tennessee, to give trainees exposure to the concept of structural violence and how it affects clinical care. The curriculum was developed in partnership with humanities and social sciences faculty who staff a Health Equity academic program at a small liberal arts college in Memphis. This curriculum has been implemented for the past four years in support of 22 hospice and palliative medicine fellows. Group debriefs and a mixed methods survey have revealed widespread and lasting impact towards understanding health equity concepts, enhanced communication and treatment of patients, and empowerment to address the broader needs and policies affecting patients and the communities in which they live. Ultimately, we model an educational initiative that integrates equity across the full scope of healthcare practice and equips learners with skills for sustaining compassionate practices, focusing on equity-oriented, person-centered care across the full scope of healthcare practice. (shrink)

Last summer, I was thinking about a public service project for my disability discrimination law course. I teach the course in fall, and try to incorporate a project each year. Integrating a public service project into a traditional doctrinal course fits within the trend toward expanding teaching techniques beyond the case method in order to better prepare students for the practice of law. It was also inspired in part by the Carnegie Foundation's 2007 report, “Educating Lawyers: Preparation for the Profession (...) of Law,” as a way to foster “civic professionalism,” and to “[link] the interests of legal educators with the needs of legal practitioners and with the public the profession is pledged to serve.” That link is especially important to disability discrimination law, as issues critical to the lives of people with disabilities often go unnoticed and unaddressed by people without disabilities. (shrink)

The United Nations (UN) General Assembly High-Level Meeting (HLM) on pandemic prevention, preparedness and response (PPPR) was a missed opportunity to bring high-level commitment and momentum to the global governance of health emergencies. Intended to bring much-needed attention to a policy issue that is rapidly slipping down the international agenda, the fraught diplomacy among member states, lack of consensus on key issues, and weak UN Political Declaration in New York foreshadow a difficult road ahead for upcoming negotiations under the (...) World Health Organization (WHO) in Geneva. This column chronicles the evolving engagement of the UN in global health governance, examines the diplomatic process leading to the UN HLM on PPPR, and assesses the contributions and missed opportunities of its resulting Political Declaration. (shrink)

Much has been said about the potential of digital health technologies for democratizing health care. But how exactly is democratization with digital health technologies conceptualized and what does it involve? We investigate debates on the democratization of health care with digital health and identify that democratization is being envisioned as a matter of access to health information, health care, and patient empowerment. However, taking a closer look at the growing pool of empirical data (...) on digital health, we argue that these technologies come short of materializing these goals, given the unequal health outcomes they facilitate. Building on this evidence, we argue that not only debates on democratization need to be connected to concerns of social determinants of health but also debates on the impact of digital health need to go far beyond democratization and engage with concerns of health justice. (shrink)

The anti-doping policies of the World Anti-Doping Agency (WADA) aim to promote a level playing field and protect the health of the athlete. Anti-doping policy discourages research using performance enhancing drugs (PEDs) or methods and prohibits athlete support personnel, including healthcare providers, from providing advice, assistance, or aid to an athlete or others seeking to use, or using PEDs until harm has occurred. Athletes are individually responsible for the presence of a prohibited substance in their bodies and face sanction (...) regardless of knowledge or intent. I will argue (i) that WADA policies fail to meet the epistemic and control conditions needed to adequately assign individual responsibility and (ii) that transferring responsibility for use of PEDs solely to the athlete results in harm. WADA is drifting perilously close to the morally impermissible ‘doing of harm’ to athletes by initiating or sustaining a causal sequence of events that can result in harm. (shrink)

Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government (...) programs. Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006–2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights. (shrink)

This study examines the association between mystical experience, as captured by the Francis-Louden Mystical Orientation Scale, and psychological health, as captured by the Eysenckian three dimensional model of personality, among 329 students attending a state university in Turkey. The data reported no significant association between mystical orientation and psychoticism scores, and a small but significant positive association between mystical orientation and neuroticism scores, after controlling for sex differences. This finding suggests that there may be a small inverse association between (...) mystical experience and psychological health among students in Turkey. (shrink)

I Several years ago, when the Carter administration announced that it would support congressional action to end the public fund ing of abortions, the President was asked at a press conference whether he thought that such a policy was unfair; he responded, "Life is unfair." His remarks provoked a storm of controversy. For other than those who, for principled reasons, opposed abor tion on any grounds, it seemed that the President's comments were cruel, violating what was thought to be an (...) American com mitment to providing equal access to health services to all citi zens, regardless of their capacity to pay. Those sentiments had, in fact, been reflected in public opinion polls that had, for at least three decades, indicated that Americans supported the propo sition that the government should guarantee health care to all. Ultimately, those beliefs had been translated into the oft-ex 1 pressed political demand for a one-class system of health care. This commitment to equality is rather remarkable. American society evidences a striking willingness to tolerate vast inequal ities with regard to income and wealth. While it guarantees ed ucation to all children, there is not even a pretense that the children of the wealthy and the children of the poor ought to get precisely the same kind of schooling. While some commitment 'Hazel Erskine. "The Polls: Health Insurance," Public Opinion Quarterly, XXXIX (Spring, 1975), 128-143. (shrink)

The reform of the health care system will include a mandate: Individuals are required to purchase health insurance provided that affordable options are available. But what is affordable health insurance? Three accounts of affordability of health coverage have been advanced. The first two accounts are empirical. The third account is needs-based. All three accounts are inadequate. I propose a fourth, the reasonable tradeoff account, according to which individuals should only be required to make reasonable tradeoffs in (...) order to pay for their health coverage. That is, health insurance is affordable if in order to pay for it one does not to have to sacrifice other benefit(s) that are comparable in importance to the benefits of health coverage. (shrink)

Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present (...) a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner. (shrink)

Is solidarity in bioethics or public health ethics necessary? If so, why? Is there room for a principle of obligatory solidarity in bioethics or in public health ethics? In the first part of this paper, I assess the meaning of the value of solidarity in ethics. In the second part, I propose insights into the republican interpretation of solidarity, or, more correctly, “civic” solidarity. This is crucial to be able to distinguish between different sources of, and justifications for, (...) solidarity, some legitimate and some not legitimate. In the third part of the paper, I apply the republican concept of civic solidarity to the field of bioethics and public health ethics. This is intended to show how civic republicanism can correct both liberal deficiencies and communitarian excesses in bioethics. Civic solidarity is essential to finding this middle way. It is a key concept, considering the challenges that we face as citizens, health professionals and patients. Finally, the paper concludes with a summary and a plan for further research in this area. (shrink)