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)

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)

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)

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)

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)

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.

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)

Since the early 20th century, bioethics in South Africa has moved through several stages, responding to the same forces and developments as elsewhere, for example in the United Kingdom and United States. In addition, some unique developments in South Africa, for example the death of Steve Biko, the HIV/AIDS pandemic, and a peaceful transition to democracy with increased focus on human rights have given bioethics in South Africa its own dimension. Bioethics in South Africa reflects the general concerns of the (...) field elsewhere, but it also stands at the intersection of the concerns of both developed and developing worlds. Thus, issues such as resource allocation, HIV/AIDS, and medical research take on an urgency and character that reflect South Africa's particular historical, geographical, and social conditions. (shrink)

This series of responses was commissioned to accompany the article by Singer et al, which can be found at http://www.biomedcentral.com/1472-6939/2/1. If you would like to comment on the article by Singer et al or any of the responses, please email us on [email protected].

In this paper, we propose a new model for development, one that transcends the North–South dichotomy and goes beyond a narrow conception of development as an economic process. This model requires a paradigm shift toward a new metaphor that develops sustainability, rather than sustains development. We conclude by defending a ‘report card on development’ as a means for evaluating how countries perform within this new paradigm.

A major strength of this capacity building programme is that it encourages cross-cultural considerations in the application of research ethics principles to research in developing countries.