Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In 2000, prompted by the (...) discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice.Here, we briefly review the conceptual and practical developments in international research ethics. While much conceptual progress has been made (and the concepts are now appearing …. (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)

Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS research and recent controversies (...) about revisions to the Helsinki Declaration, which have been seen by some to be motivated by the desire to facilitate exploitative research in countries, have stimulated renewed interest in the ethics of clinical research. (shrink)

The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how the term “global health ethics” (...) has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how the term “global health ethics” (...) has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in (...) doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in (...) doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

Background Tuberculosis is a major cause of morbidity and mortality globally. Recent scholarly attention to public health ethics provides an opportunity to analyze several ethical issues raised by the global tuberculosis pandemic. Discussion Recently articulated frameworks for public health ethics emphasize the importance of effectiveness in the justification of public health action. This paper critically reviews the relationship between these frameworks and the published evidence of effectiveness of tuberculosis interventions, with a specific focus on the controversies engendered by the endorsement (...) of programs of service delivery that emphasize direct observation of therapy. The role of global economic inequities in perpetuating the tuberculosis pandemic is also discussed. Summary Tuberculosis is a complex but well understood disease that raises important ethical challenges for emerging frameworks in public health ethics. The exact role of effectiveness as a criterion for judging the ethics of interventions needs greater discussion and analysis. Emerging frameworks are silent about the economic conditions contributing to the global burden of illness associated with tuberculosis and this requires remediation. (shrink)

Economic globalization has profound implications for health. The scale of injustice at a global level, reflected in inexorably widening disparities in wealth and health, also has critical implications for health related research – in particular when the opportunities for exploiting research subjects are carefully considered. The challenge of developing universal guidelines for international clinical research is addressed against the background of a polarizing, yet interdependent, world in which all are ultimately threatened by lack of social justice. It is proposed that (...) in such a world there is a need for new ways of thinking about research and its relevance to health at a global level. Responsibility to use knowledge and power wisely requires more radical changes to guidelines for research ethics than are currently under consideration. (shrink)

The progress of history rests on the battle for supremacy of competing ideas.... The power and wealth of western countries give them a dominant role in shaping the international public discourse. This is a privileged position... [an] imbalance of voice in the international discourse [that] has built up a dangerous sense of resentment by the silent majority of the world’s people. The dominant bioethical paradigm that provides the context for research ethics discourse has evolved within western philosophy’s powerful normative framework (...) and is built on a relationship model that explains and underpins the obligations doctors have to their patients. In this one-to-one relationship, the doctor is... (shrink)

Widening disparities in health within and between nations reflect a trajectory of ‘progress’ that has ‘run its course’ and needs to be significantly modified if progress is to be sustainable. Values and a value system that have enabled progress are now being distorted to the point where they undermine the future of global health by generating multiple crises that perpetuate injustice. Reliance on philanthropy for rectification, while necessary in the short and medium terms, is insufficient to address the challenge of (...) economic and other systems spinning out of control. Innovative approaches are required and it is suggested that these could best emerge from in-depth multidisciplinary research supported by endeavours to promote a ‘global mind-set.’. (shrink)

Medical practitioners have traditionally seen themselves as part of an international community with shared and unifying scientific and ethical goals in the treatment of disease, the promotion of health, and the protection of life. This shared mission is underpinned by explicit acceptance of traditional concepts of medical morality, and by an implied link between individual human rights and the ethics of medical practice long enshrined in a range of World Medical Association (WMA) and other medical codes. These have been powerful (...) instruments exhorting individual practitioners to promote health and to defend universal principles in order to protect their patients and the physician-patient relationship even in the face of authoritarian state coercion and imposed national ideologies and policies. There has been widespread support for this approach and this should be intensified. (shrink)

The Ebola epidemic in West Africa is not merely a biomedical problem that can be seen in isolation and dealt with only through emergency medical rescue processes. The ethical dilemmas surfaced by this epidemic are also not confined to the usual micro-ethical problems associated with medical care and medical research. The pandemic, as one of many manifestations of failed human and social development that has brought the world to dangerous ‘tipping points’, requires deep introspection and action to address upstream causal (...) processes. (shrink)

Conventional and well-established guidelines for the ethical conduct of clinical research are necessary but not sufficient for addressing research dilemmas related to public health research. There is a particular need for a public health ethics framework when, in the face of an epidemic, research is urgently needed to promote the common good. While there is limited experience in the use of a public health ethics framework, the value and potential of such an approach is increasingly being appreciated. Here we use (...) two examples of adolescent women as potential candidates for participation in microbicide trials to illustrate how ethical decisions for public health research can be enhanced by drawing on both traditional research ethics guidance, and the emerging framework for public health ethics. (shrink)

Intense scientific work on HIV/AIDS has led to the development of effective combination drug therapies and there is hope that effective vaccines will soon be produced. However, the majority of people with HIV/AIDS in the world are not benefiting from such advances because of extreme poverty. This article focuses on the pandemic as a reflection of a complex trajectory of social and economic forces that create widening global disparities in wealth and health and concomitant ecological niches for the emergence of (...) new infectious diseases. While the biomedical approach to HIV/AIDS is necessary, has prolonged the lives of many individuals and could offer much at the level of population health, it cannot, in isolation, improve the health of populations. To achieve the latter will require understanding and addressing the deeper social causes of pandemics. Broadening the discourse on ethics to include public health ethics and the ethics of international relations could contribute to reducing the impact of the pandemic and to preventing the emergence of new infectious diseases in the future. (shrink)

It is widely acknowledged that the HIV and AIDS pandemic is a global emergency and that cheap, effective treatment should be provided for as many people as possible worldwide. But there are many challenges to rolling out antiretroviral treatment in resource-poor settings. These include the cost of drugs, sustaining their supply and distribution, the complexity of treatment regimens, selection of patients for treatment, shortage of medical and nursing personnel, inadequacy of healthcare facilities, the need for uninterrupted, lifelong treatment, and monitoring (...) for drug resistance. Great efforts, nationally and internationally, are required to meet these challenges. (shrink)

Disturbing international inequalities in health abound. Life expectancy in Swaziland is half that in Japan. A child unfortunate enough to be born in Angola has 73 times as great a chance of dying before age 5 as a child born in Norway. A mother giving birth in southern sub-Saharan Africa has 100 times as great a chance of dying from her labor as one birthing in an industrialized country. For every mile one travels outward toward the Maryland suburbs from downtown (...) Washington, DC on its underground rail system, life expectancy rises by a year – reflecting the race and class inequities in American health. Are the glaring, even larger, international health inequalities also unjust? -/- All of us no doubt think they are grossly unfortunate. Many of us think they are unfair or unjust. Why should some people be at such a health disadvantage through no fault of their own, losers in a natural and social lottery assigning them birth in an unhealthy place? Others of us are troubled by the absence of the kinds of human relationships that ordinarily give rise to the claims of egalitarian justice that we make on each other – for example, being fellow citizens or even interacting in a cooperative scheme. Who has obligations of justice to reduce these international inequalities? And do those obligations hold regardless of how the inequalities came about? What institutions are accountable for addressing them? (shrink)

ABSTRACT A major focus within the modern bioethics debate has been on reshaping power relationships within the doctor–patient relationship. Empowerment of the vulnerable has been achieved through an emphasis on human rights and respect for individual dignity. However, power imbalances remain pervasive within healthcare. To a considerable extent this relates to insufficient attention to social injustice. Such power imbalances together with the development of new forms of power, for example through new genetic biotechnology, raise the spectre of increasing social injustice. (...) Attention will be drawn to the need to extend the bioethics debate to include ethical considerations regarding public health. Changes in political philosophy will also be required to reshape international power relations and improve population health. (shrink)

The blinkered debate on organ donation neglects the widening gap between the developed and developing worldsThe current debate about organ donation and the associated advocacy for selling kidneys, while laudable for its concern about increasing the ability to save the lives of some people with chronic renal failure, is characterised by four features that locate the reasoning process within a narrow and inadequate framework. Firstly, the focus on saving lives is myopic, with the lives of the most privileged in the (...) world receiving most attention. Secondly, the debate is firmly set within a value system in which market values dominate. Thirdly, health is considered from a highly individualistic perspective with little understanding of the importance of social solidarity in health. Finally, a constricted moral vocabulary is used to discuss the ethics of organ sales.MYOPIC CONCERN FOR SAVING LIVESMany articles making pleas for more organs begin by describing the number of people waiting for donated organs, the number of donors who could give organs but are not doing so, and how many lives could be saved if more organs could be made available. Great concern is expressed about a few thousand …. (shrink)

In meeting the challenges of fashioning a new health care system, South Africa stands poised to contribute to a better future for its own citizens and the subcontinent.

In meeting the challenges of fashioning a new health care system, South Africa stands poised to contribute to a better future for its own citizens and the subcontinent.

At this crucial time, on the centenary of major reforms, we invite all concerned stakeholders to join us in much needed rethinking for reforms of professional education in the 21st century. . . . All health professionals in all countries should be educated to mobilise knowledge and to engage in critical reasoning and ethical conduct so that they are competent to participate in patient and population-centred health systems as members of locally responsive and globally connected teams. What this Commission argues (...) for is nothing less than a remoralisation of health professionals’ education. For decades, health professionals have colluded with centres of power (governmental, commercial, institutional, even .. (shrink)

I am very pleased to see the response by J S Taylor to my critique of the “organs debate”. He makes some notable and important points, but also some errors to which attention should be drawn.Taylor erroneously attributes to me concern that the organ debate excessively focuses on saving the lives of a few people. My concern was about the narrow framework within which the debate is embedded and that it focuses on the lives of a few privileged people—those who (...) can pay—while largely neglecting the lives of those who cannot. The fact that some attention has been paid to such issues in some journals does not negate the importance of my claim. Moreover, it is not that the question of millions of premature deaths has …. (shrink)

A new context for ethics and ethics education is evident in a rapidly changing world and our threatened planet. The current focus on considerations of inter-personal ethics within an anthropocentric perspective on life should be extended to embrace considerations of global and ecological ethics within an eco-centric perspective on global and planetary health. The pathway to understanding and adapting to this new context includes promoting shifts in life styles from selfish hyper-individualism and wasteful consumerism towards cautious use of limited resources (...) within an increasingly interdependent world in which the equal moral worth of all and sustainability are valued. Critical scholarly approaches to global politics and to the global political economy could facilitate such change and encourage iterative interactive processes instead of seeking conclusive definitive ‘scientific’ solutions to all problems. Hopefully this shift in perspective could be achieved firstly through sensitization to new and increasingly challenging ethical dilemmas, and then by encouraging rational thinking and action based on global and ecological considerations rather than on false economic dogma and the distorted workings of a market civilization. Moving ahead with these activities must begin with promotion of education, learning and self-reflection to foster the widespread development of a global state of mind. Such a shift would require an expanded ethical discourse, with consideration of ethical dilemmas beyond human inter-personal relationships. These should include intra-institutional and inter-institutional relationships, as well as relational ethics between nations in a post-Westphalian world, and between humans and nature in an era now called the Anthropocene, to ensure survival on a planet undergoing entropy.The adverse effects of intense competition could be reduced by encouraging greater cooperation, linking security issues to global health and social justice issues, and using inspirational narratives and examples of moral imagination/moral leadership. These educational programs should be initiated in schools and become mandatory for all first-year College and University students. Such an agenda is feasible given human ingenuity, determination, resilience and adequate resources, but will also require political and social will as its drivers. (shrink)

Offers theoretical and practical guidance for addressing global health, and a deeper understanding of the challenges humanity faces.

Given the fragility of individual and population wellbeing in an interdependent world threatened by many overlapping crises, the suggestion is made that new legal mechanisms have the robust potential to reduce human vulnerability locally and globally.

The most common response to the challenge of protecting health through law is to focus on protecting the rights of vulnerable individuals and to enhance their access to health care. Each one of us is vulnerable or potentially vulnerable because of the fragile, existential nature of the human condition. Catastrophic and unexpected events could instantaneously transform us from a state of total independence and potential vulnerability to one of extreme vulnerability and complete dependence. Some legal provisions have the potential to (...) provide a modicum of protection when we find ourselves in those situations. There are also legal provisions that contribute to beneficial social circumstances; for example, legislation enabling universal access to medical care, and operationalizing respect for the individual’s right to health care, as advocated for by other authors in this issue. (shrink)