One-third of all human lives end in early death from poverty-related causes. Most of these premature deaths are avoidable through global institutional reforms that would eradicate extreme poverty. Many are also avoidable through global health-system reform that would make medical knowledge freely available as a global public good. The rules should be redesigned so that the development of any new drug is rewarded in proportion to its impact on the global disease burden (not through monopoly rents). This reform (...) would bring drug prices down worldwide close to their marginal cost of production and would powerfully stimulate pharmaceutical research into currently neglected diseases concentrated among the poor. Its feasibility shows that the existing medical-patent regime (trade-related aspects of intellectual property rights—TRIPS—as supplemented by bilateral agreements) is severely unjust—and its imposition a human-rights violation on account of the avoidable mortality and morbidity it foreseeably produces. (shrink)

This article offers an integrated account of two strands of global health justice: health-related human rights and health-related common goods. After sketching a general understanding of the nature of human rights, it proceeds to explain both how individual human rights are to be individuated and the content of their associated obligations specified. With respect to both issues, the human right to health is taken as the primary illustration. It is (...) argued that the individuation of the right to health is fixed by reference to the subject matter of its corresponding obligations, and not by the interests it serves, and the specification of the content of that right must be properly responsive to thresholds of possibility and burden. The article concludes by insisting that human rights cannot constitute the whole of global health justice and that, in addition, other considerations—including the promotion of health-related global public goods—should also shape such policy. Moreover, the relationship between human rights and common goods should not be conceived as mutually exclusive. On the contrary, there sometimes exists an individual right to some aspect of a common good, including a right to benefit from health-related common goods such as programmes for securing herd immunity from diphtheria. (shrink)

Addresses the issues at the heart of international medicine and social responsibility. A number of international declarations have proclaimed that health care is a fundamental human right. But if we accept this broad commitment, how should we concretely define the state’s responsibility for the health of its citizens? Although there is growing debate over this issue, there are few books for general readers that provide engaging accounts of critical incidents, practices, and ideas in the field of (...) class='Hi'>human rights, health care, and medicine. Included in the book are case studies of such issues as AIDS among orphans in Romania, organ trafficking, prison conditions, health care rationing, medical research in the third world, and South Africa’s constitutionally guaranteed right of access to health care. It uses these topics to address themes of protection of vulnerable populations, equity and fairness in delivering competent medical care, informed consent and the free flow of information, and state responsibility for ensuring physical, mental, and social well-being. (shrink)

Regulatory approach to the right to abortion in Europe is diverse and basically related to the issue of when the right to life begins and how this question is reflected in national legislation. Such an approach and diversity is tolerated by the European Court of Human Rights, but only if some specific standards and criteria formulated in the jurisprudence of the European Court of Human Rights are reflected in national legislation. Research of the Lithuanian legal acts (...) conducted in the light of the jurisprudence of the Court shows that they are not in accordance with the jurisprudence of the European Court of Human Rights and the solutions are therefore suggested. The aim of the article is to systematically analyse the Lithuanian legal acts regulating issues of abortion and to identify the existing problems and provide suggestions as to how to solve those problems with the help of the jurisprudence of the European Court of Human Rights in abortion cases. Analysis of the Lithuanian legal acts reveals that the existing legal regulation and practice is confusing and ambiguous. Abortion questions are regulated in Lithuania by means of secondary legislation, namely by order of the Health Minister which is more than 15 years old, and the classification of diseases dangerous to woman’s health and life is based on international classification that is invalid. The order is not in reconciled with the Lithuanian criminal law. Some other ambiguities and problems are identified in the article. Abortion on a woman’s request in Lithuania is possible by the end of the 12 week of pregnancy and during the entire pregnancy, if it causes danger to woman’s health and life. The Lithuanian legislator requires that both conditions – danger to woman’s health and life – are met in order to terminate pregnancy what is unnecessary and sometimes even confusing. The author suggests providing two separate bases for abortion – danger to woman’s life or health. Foetus problems – if a foetus is irreversibly damaged or suffering from an incurable life-threatening disease, it is not a separate basis for abortion in Lithuania, however those abnormalities of the foetus are related to the health and life of a pregnant woman. In the opinion of the author, looking into the practice of the other EU countries, it is better to provide a separate ground for abortion because of abnormalities of the foetus. The basic problem in Lithuania that is similar in Poland and in Ireland is that there is no clear procedure in case a pregnant woman is not satisfied with the decision of the medical commission regarding the question of her abortion or if the opinion of members of the commission is diverse – no time guidance or appeal institution is provided. (shrink)

In this article we consider some of the implications of the UK Human Rights Act 1998 for nurses in practice. The Act has implications for all aspects of social life in Britain, particularly for health care. We provide an introduction to the discourse of rights in health care and discuss some aspects of four articles from the Act. The reciprocal relationship between rights and obligations prompted us to consider also the relationship between guidelines in (...) the United Kingdom Central Council’s Code of professional conduct and the requirements of the Human Rights Act 1998. We conclude with the recommendation that the new legislation should be welcomed for its potential to support good practice and to urge critical and reflective practice rather than as yet another burdensome bureaucratic imposition. (shrink)

"Human dignity" has been enshrined in international agreements and national constitutions as a fundamental human right. The World Medical Association calls on physicians to respect human dignity and to discharge their duties with dignity. And yet human dignity is a term--like love, hope, and justice--that is intuitively grasped but never clearly defined. Some ethicists and bioethicists dismiss it; other thinkers point to its use in the service of particular ideologies. In this book, Michael Barilan offers an (...) urgently needed, nonideological, and thorough conceptual clarification of human dignity and human rights, relating these ideas to current issues in ethics, law, and bioethics. Combining social history, history of ideas, moral theology, applied ethics, and political theory, Barilan tells the story of human dignity as a background moral ethos to human rights. After setting the problem in its scholarly context, he offers a hermeneutics of the formative texts on Imago Dei; provides a philosophical explication of the value of human dignity and of vulnerability; presents a comprehensive theory of human rights from a natural, humanist perspective; explores issues of moral status; and examines the value of responsibility as a link between virtue ethics and human dignity and rights. Barilan accompanies his theoretical claim with numerous practical illustrations, linking his theory to such issues in bioethics as end-of-life care, cloning, abortion, torture, treatment of the mentally incapacitated, the right to health care, the human organ market, disability and notions of difference, and privacy, highlighting many relevant legal aspects in constitutional and humanitarian law. (shrink)

Human rights are high priority norms that empower right holders to demand the benefits protected by their rights. This is no less true of socioeconomic human rights than civil and political human rights. I argue that realizing human socioeconomic rights requires that they be enacted into state law in such a way that individual right holders have the power to bring legal action in defense of their rights. Contrary to Thomas (...) Pogge, it is not enough for states simply to provide the benefits required by human rights. Unfortunately, limited resources mean that successful litigation by right holders threatens to disempower other right holders by distorting a fair distribution of limited resources, since those with the resources to litigate can command a disproportionate and unjust share of limited resources. Using the human right to health as an example, I argue that an important part of the solution requires specifying different aspects of the content of the right to health and adopting appropriately strong standards of judicial review. (shrink)

One important aspect of globalization is the increasingly dense and influential regime of global rules that govern and shape interactions everywhere. Covering trade, investment, loans, patents, copyrights, trademarks, labor standards, environmental protection, use of seabed resources, production and marketing of weapons, maintenance of public security, and much else, these rules—structuring and enabling, permitting and constraining—have a profound impact on the lives of human beings and on the ecology of our planet. It is therefore important to think carefully, in moral (...) terms, about their design. (shrink)

In July 2018, the Nuffield Council on Bioethics released the report Genome editing and human reproduction: Social and ethical issues, concluding that human germline modification of human embryos for implantation is not ‘morally unacceptable in itself’ and could be ethically permissible in certain circumstances once the risks of adverse outcomes have been assessed and the procedure appears ‘reasonably safe’. The Nuffield Council set forth two main principles governing anticipated uses and envisions applications that may include health (...) enhancements as a public health measure. This essay provides a critique of three aspects in the Nuffield Council’s Report: its presumption of therapeutic efficacy, its inflation of parental rights to create a certain type of child, and its reliance on a specially commissioned report that appears to distort key definitions in international law. (shrink)

Child Labour in Kashmiri Society: A Socio-human Rights Study The Constitution of India guarantees fundamental rights and the full freedom to enjoy childhood. In spite of that millions of children are being put to arduous work for short and narrow gains. By 1989, the standards concerning children were brought together in a single legal instrument agreed to by the international community. It unambiguously spelt out the rights to which every child is entitled, regardless of place of (...) birth, descent, sex, religion, or social origin. A number of aspects, such as gender, family background, cultural acceptance, issues of health and recreation, the legal aspect and so on, have been covered. The life worlds of working children, legal protection to children from exploitation and the human rights perspective of child labour is the main focus of this article. (shrink)

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that (...) affect what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)

Society is broken. We can design our way to a better one. In our increasingly interconnected world, self-interest and social-interest are rapidly becoming indistinguishable. If the oceans die, if society fractures, or if global warming spirals out of control, personal success becomes meaningless. But our broken system incentivizes behavior that only makes these problems worse. If true human rights progress is to be achieved today, it is time we dig deeper-rethinking the very foundation of our social system. In (...) this engaging, important work, Peter Joseph, founder of the world's largest grassroots social movement in the world-The Zeitgeist Movement-draws from economics, history, philosophy, and modern public-health research to present a bold case for rethinking activism in the 21st century. The conventional wisdom views poverty, social oppression, and the growing loss of public health as unfortunate and immutable side effects of our way of life. The New Human Rights Movement argues that these outcomes are, in fact, contrived-only natural to our outdated economic system. Social activists can never succeed in dramatically improving human life on this planet until they understand the structural reasons these problems exist. Arguing against the long-standing narrative of universal scarcity and other pervasive, legitimizing myths that defend the current state of affairs, The New Human Rights Movement ultimately presents the case for an updated economic approach. Joseph explores the potential of this grand social shift and how we can design our way to a post-scarcity world-a world where poverty doesn't exist and the human family has become truly sustainable. The New Human Rights Movement reveals the critical importance of a unified activism in this direction, through understanding and working to alter the inherent injustice of our current social system. This book not only warns against what is in store if we continue to ignore our broken society but also reveals the positive future possible if we succeed. Will you join the movement? (shrink)

Background Respect for human rights and bioethical principles in prisons is a crucial aspect of society and is proportional to the well-being of the general population. To date, these ethical principles have been lacking in prisons and prisoners are victims of abuse with strong repercussions on their physical and mental health. Methods A systematic review was performed, through a MESH of the following words (bioethics) AND (prison), (ethics) AND (prison), (bioethics) AND (jail), (ethics) AND (jail), (bioethics) AND (...) (penitentiary), (ethics) AND (penitentiary), (prison) AND (human rights). Inclusion and exclusion criteria were defined and after PRISMA, 17 articles were included in the systematic review. Results Of the 17 articles, most were prevalence studies (n.5) or surveys (n.4), followed by cross-sectional studies (n.3), qualitative studies (n.1), retrospective (n.1) and an explanatory sequential mixed-methods study design (n.1). In most cases, the studies associated bioethics with prisoners’ access to treatment for various pathologies such as vaccinations, tuberculosis, hepatitis, HIV, it was also found that bioethics in prisons was related to the mental health of prisoners, disability, ageing, the condition of women, the risk of suicide or with the request for end-of-life by prisoners. The results showed shortcomings in the system of maintaining bioethical principles and respect for human rights. Conclusions Prisoners, in fact, find it difficult to access care, and have an increased risk of suicide and disability. Furthermore, they are often used as improper organ donors and have constrained autonomy that also compromises their willingness to have end-of-life treatments. In conclusion, prison staff (doctors, nurses, warders, managers) must undergo continuous refresher courses to ensure compliance with ethical principles and human rights in prisons. (shrink)

Public goods, as well as commercial commodities, are affected by exclusive arrangements secured by intellectual property (IP) rights. These rights serve as an incentive to invest human and material capital in research and development. Particularly in the life sciences, IP rights regulate objects such as food and medicines that are key to securing human rights, especially the right to adequate food and the right to health. Consequently, IP serves private (economic) and public interests. (...) Part of this charge claims that the current IP regime is privatizing the very building blocks of research and development – that used to be part of the commons. The public domain, in contrast to the private domain, may be the locus of much more diverse forms of creativity that at the same time ensures a wider plurality of productive traditions. An IP regime must support a sense of public morality because it is dependent upon civil support. This inevitably prompts questions of what are “good” exclusive rights and what are “bad” exclusive rights, and how shall such IP rights be developed. We argue that the democratization of the current IP regimes is an important first step to respond to these issues. (shrink)

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I provide (...) support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests. (shrink)

Against a backdrop of non-ideal political and legal conditions, this article examines the health capability paradigm and how its principles can help determine what aspects of health care might legitimately constitute positive health care rights—and if indeed human rights are even the best approach to equitable health care provision. This article addresses the long American preoccupation with negative rights rather than positive rights in health care. Positive health care (...) class='Hi'>rights are an exception to the overall moral range and general thrust of U.S. legal doctrine. Some positive rights to health care have arisen from U.S. Constitutional Eighth Amendment cases and federal and state laws like Medicare, Medicaid, the State Children’s Health Insurance Program, the Emergency Medical Treatment and Active Labor Act, and the Patient Protection and Affordable Care Act. Finally, this article discusses some of the difficulties inherent in implementing a positive right to health care in the U.S. (shrink)

Those considering careers in medicine and other health and humanitarian disciplines as well as those concerned about the growing presence of militarized ...

In this book by the award-winning author of Just Healthcare, Norman Daniels develops a comprehensive theory of justice for health that answers three key questions: what is the special moral importance of health? When are health inequalities unjust? How can we meet health needs fairly when we cannot meet them all? Daniels' theory has implications for national and global health policy: can we meet health needs fairly in ageing societies? Or protect health in (...) the workplace while respecting individual liberty? Or meet professional obligations and obligations of justice without conflict? When is an effort to reduce health disparities, or to set priorities in realising a human right to health, fair? What do richer, healthier societies owe poorer, sicker societies? Just Health: Meeting Health Needs Fairly explores the many ways that social justice is good for the health of populations in developed and developing countries. (shrink)

Machine generated contents note: Preface; Introduction; Part I. Global Health, Definitions and Descriptions: 1. What is global health? Solly Benatar and Ross Upshur; 2. The state of global health in a radically unequal world: patterns and prospects Ron Labonte and Ted Schrecker; 3. Addressing the societal determinants of health: the key global health ethics imperative of our times Anne-Emmanuelle Birn; 4. Gender and global health: inequality and differences Lesley Doyal and Sarah Payne; 5. Heath (...) systems and health Martin McKee; Part II. Global Health Ethics, Responsibilities and Justice: Some Central Issues: 6. Is there a need for global health ethics? For and against David Hunter and Angus Dawson; 7. Justice, infectious disease and globalisation Michael Selgelid; 8. International health inequalities and global justice: toward a middle ground Norman Daniels; 9. The human right to health Jonathan Wolff; 10. Responsibility for global health? Allen Buchanan and Matt DeCamp; 11. Global health ethics: the rationale for mutual caring Solly Benatar, Abdallah Daar and Peter Singer; Part III. Analyzing Some Reasons for Poor Health: 12. Trade and health: the ethics of global rights, regulation and redistribution Meri Koivusalo; 13. Debt, structural adjustment and health Jeff Rudin and David Sanders; 14. The international arms trade and global health Salahaddin Mahmudi-Azer; 15. Allocating resources in humanitarian medicine Samia Hurst, Nathalie Mezger and Alex Mauron; 16. International aid and global health Anthony Zwi; 17. Climate change and health: risks and inequities Sharon Friel, Colin Butler and Anthony McMichael; 18. Animals, the environment and global health David Benatar; 19. The global crisis and global health Stephen Gill and Isabella Bakker; Part IV. Shaping the Future: 20. Health impact fund: how to make new medicines accessible to all Thomas Pogge; 21. Biotechnology and global health Hassan Masun, Justin Chakma and Abdallah Daar; 22. Food security and global health Lynn McIntyre and Krista Rondeau; 23. International taxation Gillian Brock; 24. Global health research: changing the agenda Tikki Pang; 25. Justice and research in developing countries Alex John London; 26. Values in global health governance Kearsley Stewart, Gerald T. Keusch and Arthur Kleinman; 27. Poverty, distance and two dimensions of ethics Jonathan Glover; 28. Teaching global health ethics James Dwyer; 29. Towards a new common sense: the need for new paradigms of global health Isabella Bakker and Stephen Gill; Index. (shrink)

Significant improvements in human rights and democracy have been made since the adoption of the Universal Declaration of Human Rights by the United Nations in 1948. Yet, human rights, especially women's rights, are still being violated in many parts of the developing world. The adverse effects of such violations on women's and children's health are well known, but they are rarely measured. This study uses cross-national data from over 145 countries to estimate (...) the impact of democracy and respect for human rights on various measures of women's health while controlling for confounding socio-economic factors such as income, education, fertility and healthcare. It finds that democracy and regards for human rights contribute positively to women's health outcomes, as do socio-economic variables. (shrink)

The obligations set by the individual right to health are likely to conflict, at least if states are its addressee, with the obligations set by the collective rights to self‐determination that certain sub‐state communities have (or should be recognized). In this paper, I argue that conceiving of the right to health and of collective rights to self‐determination as both aiming at the promotion of individual agency might help us alleviate this particular problem. To do so, I (...) first explain how we can conceive of the right to health and of collective rights to self‐determination as protecting crucial aspects of individuals' agency. It is because both health and the capacity to participate in particular collectives are important ways in which our agency is enabled. I then argue that this conception of the purpose of those rights offers a principle to guide our practical deliberation when the protection of health and the protection of collective self‐determination seem to conflict. Finally, I specify how I think this principle might guide us when it comes to understanding the obligations that the right to health sets for the state towards members of selfdetermining sub‐state communities, both in terms of the provision of healthcare goods and services and the provision of the underlying determinants of health. (shrink)

Occupational health and safety (OHS), as a fundamental human right, forms the basis of the obligation of employers to employees, requiring employers to do what is right. Responsible management practices encompass cognisance of sustainability, responsibility as well as legal, financial and moral aspects related to OHS compliance. As point of departure, an overview of core OHS criteria for small businesses is provided, with reference to awareness of these criteria in the G20 countries. This article utilises quantitative and qualitative (...) data analysis to examine the reasons why small business owners/managers comply with occupational health and safety directives, such as the Occupational Health and Safety Act (OHS Act) and the Compensation for Occupational Injuries and Diseases Act (COIDA) in South Africa, determine if such reasons for compliance culminate in actual compliance, and determine the perceived effect of direct and indirect costs of OHS incidents. A total of 350 small business owners/managers took part in this study. The findings indicate that whilst small business owners/managers realise the rationale behind OHS compliance in terms of moral, legal and financial components, moral aspects related to OHS compliance are deemed most important. Small business owners/managers thus seem to realise the importance of OHS compliance. However, when it comes to adhering to their responsibility in terms of general safety regulations of the OHS Act and registration with the Compensation Fund as specified in the COIDA (as examples of actual compliance), small business owners/managers’ compliance does not reflect such realisation. A model to enhance OHS standards in small businesses, encompassing legal, moral and financial rationales, is proposed. (shrink)

Background Mental health nurses advocate for patients through a person-centered approach because they care for people experiencing mental distress who tend to be limited to exercising their human rights and autonomy through interpersonal relationships. Therefore, it is necessary to provide high-quality person-centered care for these patients by identifying the influencing factors. Aim This study aims to identify the factors affecting mental health nurses in performing person-centered care for patients. Research design This study had a cross-sectional, descriptive-correlational (...) survey design. Participants and method Nurses ( N = 166) working at psychiatric wards in Korea completed an online questionnaire on moral sensitivity, attitudes toward people with mental illness, and person-centered care. The t-test and stepwise multiple regression analysis were used. Ethical considerations Ethical approval for the study was obtained from the relevant ethics committee. Findings Moral sensitivity was a significant factor correlating with the provision and perception of person-centered care. Attitudes toward patients had no effect on person-centered care. The predictor variables for the provision of person-centered care (R2 = 0.247) were moral sensitivity (β = 0.33), having a professional qualification (β = 0.19), marital status (β = 0.18), and closed ward (β = −0.15). The predictor variables for the perception of person-centered (R2 = 0.150) care were closed ward (β = −0.25), moral sensitivity (β = 0.23), and marital status (β = 0.18). Discussion and conclusion Mental health nurses can strengthen person-centered care by improving moral sensitivity related to the ethical aspect of nursing and professional competence to address the complex needs of patients. Person-centered care needs to be applied more carefully in closed wards where human rights issues may arise. Through these efforts, the dignity of patients can be protected. (shrink)

Public health and human rights are complementaryapproaches to protecting and promoting human well-being and dignity. Public health addresses the needs of populations and seeks, through intervention and education, to prevent the spread of disease. Enshrined in international law, human rights describe the obligations of governments to safeguard their citizenry from harm and to create conditions where each individual can achieve his or her full potential. Human rights norms lie at the core (...) of public health theory and practice, and their enforcement can help to ensure an equitable distribution of health resources. (shrink)

This pioneering new book suggests how different traditions of sociological thought can contribute to an understanding of the theory and practice of rights. Rights: Sociological Perspectives provides a sociological treatment of a wide range of substantive issues but without losing sight of key theoretical questions. It considers some varied cases of public intervention, including welfare, caring, mental health provisions, pensions, justice and free speech, alongside the rights issues they raise. Similarly, it examines the question of (...) class='Hi'>rights from the point of view of distinctive population groups, such as prisoners and victims, women, ethnic minorities, indigenous peoples, and lesbians and gays. It also contains two specifically theoretical chapters, which provide a critical overview of the existing approaches to the construction and implementation of rights. Rights: Sociological Perspectives offers a diverse and detailed exploration of the contribution sociological thought can make to this increasingly important aspect of social life and will be an invaluable aid to students. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically (...) on health research conducted in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

This paper offers four arguments against a moral human right to health, two denying that the right exists and two denying that it would be very useful (even if it did exist). One of my sceptical arguments is familiar, while the other is not.The unfamiliar argument is an argument from the nature of health. Given a realistic view of health production, a dilemma arises for the human right to health. Either a state's moral duty (...) to preserve the health of its citizens is not justifiably aligned in relation to the causes of health or it does not correlate with the human right to health. It follows that no one holds a justified moral human right to health against the state.Education and herd immunity against infectious disease both illustrate this dilemma. In the former case, the state's moral duty correlates with the human right to health only if it demands too much from a cause of health; and in the latter, only if it demands nothing from a cause of health (that is, too little). (shrink)

Is there a human right to health? If so, what are its grounds? Can a legal or moral human right to health provide any practical guidance when it comes to making decisions about, for instance, the allocation of scarce health resources? There are many possible answers to these questions in the literature. This article surveys some of these replies. First, however, it examines the distinctions between legal and moral human rights and rights (...) to health vs. health care. It then surveys the literature on potential grounds for a moral human right to health. It concludes by considering replies to several common objections to the existence of a human right to health. (shrink)

Until now, it has mostly been assumed that the kind of health the human right to health is concerned with is clearly understood and universal. Here, I question this assumption and offer an explicitly political and pluralistic account of health that is designed to help guide international and cross-cultural interventions on behalf of health. In order to be a useful mechanism of accountability, the human right to health needs an enforceable minimum standard of (...) health by which to judge situations and to determine if a violation of rights has occurred, but due to its international nature, it also needs to admit a large degree of cultural flexibility. With the account of health that I provide, I hope to clarify what makes up that minimum standard in a way that avoids unjustified parochial bias, while not being so permissive as to undermine the political force of a universal human right. (shrink)

Purpose. The purpose of this paper is to investigate the anthropological and socio-philosophical dimensions of human existence of the older age group given the challenges of pandemic threats caused by COVID-19. To this end, it is planned to solve a number of tasks, among which one should distinguish the following: 1) to investigate the manifestations of age discrimination in the context of the social and labor areas of human existence; 2) to focus on the asymmetry of the behavior (...) of society and the state relative to persons of the older age group in the field of healthcare in the context of a pandemic crisis; 3) to represent the anthropological features of changes in the socialization and activity of older people under the current conditions of globalization-pandemic challenges. Theoretical basis. Despite such a broad representation of the age-related issue in public relations, there are still no practical guarantees that would apply to discriminatory aspects of older age groups in various areas of their manifestation. The synergistic evolution of social reality requires substantive analysis of the issue under the current conditions for the transformation of social life, which is affected by globalization crises caused by the pandemic threats of COVID-19. Originality. The stereotypical assumptions underlying legal policy and established social relations are based solely on the application of chronological age. The novelty is in justifying an individual approach to the elderly through the personification of the personal characteristics of a person. The study of anthropological and socio-philosophical dimensions of the existence of a person of the older age group in the face of the challenges of pandemic threats caused by COVID-19 has made it possible to analyze the destructive nature of age discrimination in the context of the social and labor areas of human existence. As well as focus on the asymmetry of the behavior of society and the state in relation to these persons in the field of health care, and emphasize the anthropological features of changes in the socialization and human activity under the current conditions of globalization-pandemic challenges. Conclusions. External threats to human existence call for special attention to the implementation and protection of human rights, freedoms, individual freedoms, and identity. Pandemic threats have transformed all dimensions of human existence, especially for those groups of society that are less socially protected. The pandemic crisis has created additional grounds for discrimination against older people in various areas of human existence. Equalization of persons by age without personifying the personal characteristics of an individual is discrimination on an age basis, which violates the principles of democracy and humanism in the society, leads to stigmatization of the person, is the cause of the anthropological crisis of a person. (shrink)

While human rights law has evolved to provide guidance to governments in realizing human rights in public health emergencies, the COVID-19 pandemic has challenged the foundations of human rights in global health governance. Public health responses to the pandemic have undermined international human rights obligations to realize the rights to health and life, human rights that underlie public health, and international assistance and cooperation. As (...) governments prepare for revisions of global health law, new opportunities are presented to harmonize global health law and human rights law, strengthening rights-based governance to respond to future threats. (shrink)

This book addresses the moral, social and political problems emerging from the practice of healing and caring, biomedical research and the provision of health care services. The primary aim of many professional bioethicists is, of late, to solve as efficiently as possible, the problems encountered by health care providers and scientists in clinical, laboratory and administrative settings. Seen from the viewpoint of applied philosophy, however, this is a dangerous tendency if the grounds for the suggested solutions are not (...) properly examined. Even choices which are harmless and seem to involve no immoralities can be indirectly hazardous if those making choices appeal to dubious ethical principles or inaccurate data. This is why this book is dedicated to the examination of the reasons that people can and should have for their health care related decisions as well as to the formulation of good solutions to difficult problems. It covers criterial in life and death decisions, voluntary euthanasia and medical paternalism, wrongful medical authoritarianism, health education, preventive medicine and the welfare of the population, AIDS, discrimination and legal restrictions, and health care policy-making. (shrink)

Although Australia has comparatively few individuals seeking asylum, it has had a mandatory detention policy in place since 1992. This policy has been maintained by successive governments despite the overwhelmingly negative impact mandatory detention has on mental health. For mental health professionals working in this environment, a number of moral, ethical, and human rights issues are raised. These issues are discussed here, with a focus on dual loyalty conflicts and drawing on personal experience, the bioethics and (...) human rights literature, and recent parliamentary inquiries. For those who continue to work in this environment, future directions are also discussed. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Globalization, a process characterized by the growing interdependence of the world's people, impacts health systems and the social determinants of health in ways that are detrimental to health equity. In a world in which there are few countervailing normative and policy approaches to the dominant neoliberal regime underpinning globalization, the human rights paradigm constitutes a widely shared foundation for challenging globalization's effects. The substantive rights enumerated in human rights instruments include the right (...) to the highest attainable level of physical and mental health and others that are relevant to the determinants of health. The rights stipulated in these documents impose extensive legal obligations on states that have ratified these documents and confer health entitlements on their residents. Human rights norms have also inspired civil society efforts to improve access to essential medicines and medical services, particularly for HIV/AIDS. Nevertheless, many factors reduce the potential counterweight human rights might exert, including and specifically the nature of the human rights approach, weak political commitments to promoting and protecting health rights on the part of some states and their lack of institutional and economic resources to do so. Global economic markets and the relative power of global economic institutions are also shrinking national policy space. This article reviews the potential contributions and limitations of human rights to achieving greater equity in shaping the social determinants of health. (shrink)

Professional management in health care is very much dependent on the model of health that is assumed by healthcare providers. The current model derives from a chemical/mechanical view of the patient body. Simply put: we are healthy if all of our mechanical parts are working properly and if all of the chemicals in our body are in the right proportions and have the appropriate reactions. This view is based on philosophical accounts of the body that go back to (...) Paracelsus, Bacon, Descartes and others. It became the central basis of medical practice only in the late 19th Century after several hundred years of research and professional politics. The success of the chemical/mechanical model has been so great that the social and relational aspects of health have been largely ignored. Yet we know that people require the resources not only of (mechanical) exercise and proper nutrition (chemical) in order to develop into healthy adults; they also need loving relationships, good friends and a viable social context. A growing movement has emerged that includes philosophers who recognize the Cartesian error, physicians and nurses who are searching for a more humane healthcare management, and patients and families who feel the need for a better understanding of the social and relational aspects of their health. The Chemical/Mechanical Patient traces the intellectual development of the chemical/mechanical model of the patient and its implementation and the provides a sound and readily understandable philosophical and historical basis for this new and growing movement towards a social/relational model of health. This book names the problem and prepares us to respond to the exaggerated place of the chemical mechanical model in our society. It provides a historical and conceptual background and explains how the chemical/mechanical model of health gained such a strong hold over our thinking and took the place of the earlier Galenic humoral model. It sketches a promising outline of a more humanized model for understanding health and calls for help to fully articulate it. In that way, it joins a growing movement to go beyond our current chemical/mechanical orientation. (shrink)

Human rights protect the conditions of a minimally decent life of which mental health is an indispensable element. Adequate care for mental health is thus recognized as part of the human right to health. However, for populations living far from urban centers, adequate in-person (mental) health care is often extremely costly and thus not provided. Digital mental health care options have become an effective alternative to in-person treatment. Benefitting from these new digital (...) opportunities, though, requires sufficient access to the internet. Because everyone has a human right to adequate health care, and digital mental health care is now an effective option for progressively realizing this human right for people who live in remote regions, these people also have to be understood to have a right to access to the internet. This right to internet access creates duties for public authorities and the international community to create the required digital infrastructure and (where needed) to cover the costs of internet access where this is the only feasible way of delivering, or progressively realizing, the mental health care that is indispensable for having the opportunity to lead minimally decent lives. (shrink)

Artificial Intelligence (AI) is taking centre stage in economic growth and business operations alike. Public discourse about the practical and ethical implications of AI has mainly focussed on the societal level. There is an emerging knowledge base on AI risks to human rights around data security and privacy concerns. A separate strand of work has highlighted the stresses of working in the gig economy. This prevailing focus on human rights and gig impacts has been at the (...) expense of a closer look at how AI may be reshaping traditional workplace relations and, more specifically, workplace health and safety. To address this gap, we outline a conceptual model for developing an AI Work Health and Safety (WHS) Scorecard as a tool to assess and manage the potential risks and hazards to workers resulting from AI use in a workplace. A qualitative, practice-led research study of AI adopters was used to generate and test a novel list of potential AI risks to worker health and safety. Risks were identified after cross-referencing Australian AI Ethics Principles and Principles of Good Work Design with AI ideation, design and implementation stages captured by the AI Canvas, a framework otherwise used for assessing the commercial potential of AI to a business. The unique contribution of this research is the development of a novel matrix itemising currently known or anticipated risks to the WHS and ethical aspects at each AI adoption stage. (shrink)

Human rights may be the most globalized political value of our times. The rights paradigm has been criticized, however, for being theoretically unsound, legalistic, individualistic and based on the assumption that there is a given and universal humanness. Its use in the area of health is relatively new. Proponents point to its power to frame health as an entitlement rather than a commodity. The problems and the possibilities of a rights approach in addressing (...) class='Hi'>health ethics issues are explored in this article. (shrink)

Working at the bedside and within communities as patient advocates, nurses frequently intervene to advance individuals’ health and well-being. However, the International Council of Nurses’ Code of Ethics asserts that nurses should expand beyond the individual model and also promote a rights-enabling environment where respect for human dignity is paramount. This article applies the results of an ethnographic human rights study with displaced populations in Rwanda to argue for a rights-based social advocacy role for (...) nurses. Human rights advocacy strategies include sensitization, participation, protection, good governance, and accountability. By adopting a rights-based approach to advocacy, nurses contribute to health agendas that include more just social relationships, equitable access to opportunities, and health-positive living situations for all persons. (shrink)

The connection between health and human rights continues to play a prominent role within global health law. In particular, a number of theorists rely on the claim that there is a relation of interdependence between health and human rights. The nature and extent of this relation, however, is rarely defined, developed or defended in a conceptually robust way. This paper seeks to explore the source, scope and strength of this putative relation and what (...) role it might play in developing a global health law framework. (shrink)

ABSTRACT Public health authorities sometimes have to make decisions about the use of preventive medical measures—e.g. vaccination programmes—which could, if realised, save millions of lives, but could also kill a certain (small) number of those subjected to the measures. According to a rough‐and‐ready utilitarian calculation, such measures should be taken, but there are also possible objections to this view. A liberal objection to the use of mandatory preventive measures which might harm human beings is that people have a (...) right to decide for themselves whether or not they want to participate in the programme. A further objection is based on the claims that first, the authorities are directly killing those who die because of, say, vaccination programmes, and second, directly killing human beings is forbidden (since every human being has a right to live). The latter objection is discussed at length in the present paper. The validity of three doctrines, the doctrines of the double effect, of acts and omissions, and of killing and letting die, are considered with reference to the use of preventive measures, and found inapplicable. The objection is, however, refuted by comparing some hypothetical examples, and the initial utilitarian calculation is reinforced. (shrink)

Should people have a legal human right to health? And, if so, what exactly does protecting this right require? This essay defends some answers to these questions recently articulated in Global Health Impact. It explains how these answers depend on a particular way of thinking about health and the minimally good life, how quality of life matters at and over time, what various agents should do to help people who are unable to live well enough, and (...) many other things. Moreover, it suggests some ways of improving common metrics for measuring and advancing our collective global health impact. (shrink)

Genetics is a biomedical science that investigates heredity, variability, occurrence of genetic diseases and their prevention. Genetic science has many fields of science, which deal with different genetic processes, methods, aspects and fields of application. The genetic research in Europe related to the individual as the main subject of the research is exposed to a wide range of ethical and legal issues. From the developments in genetic science other sciences have evolved, thanks to which the modern world is able to (...) protect the genetic information of data, and to receive the sanction while ignoring the laws of such data. However, many problems still persist in the field of protection of personal genetic information, such as regulatory standards, the inviolability of an individual, the assurance of freedom and privacy of information. This manuscript attempts to reveal the main aspects of genetic human data protection, to research conduct regulations, ethics and issues related to the protection of individuals, such as protection of privacy, discrimination, confidentiality, etc. The article mainly focuses on the Conventions and Protocols elaborated by the Council of Europe because of its role in bioethics and focus on human rights. The author examined the documents such as the Convention on Human Rights and Biomedicine, the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and others. Genetic discrimination is strictly forbidden by international conventions and declarations, which means that discrimination on the grounds of personal genetic information (diseases, abnormalities) is not possible in all areas, including employment and insurance. However, individuals face some problems in getting a job due to the publicity and information disclosure to their employers, or in increasing the amount of insurance premiums. However, the disclosure of genetic information may have relevant, statutory consequences and the victims may apply to court for defending these rights. It is essential to protect genetic rights, as any form of discrimination against a person on the grounds of their genetic heritage is prohibited and intervention in the health field or disclosure of such information is only possible after the person concerned has given their free and informed consent. (shrink)

Health care insurance schemes, whether private or public, are notoriously unaccommodating to individuals with disabilities. While most nonelderly nondisabled persons in the U.S. are insured through private sources, coverage sources for nonelderly persons with disabilities have traditionally been a mix of private and public coverage. For all age groups, the employment-to-population ratio is much lower for persons with a disability than for those with no disability. Moreover, employed persons with a disability were more likely to be self-employed than those (...) with no disability. As a group, therefore, nonelderly people with disabilities have not been as well positioned as others to obtain private health care insurance because in the U.S., acquiring such coverage usually is employer based. (shrink)