This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...) social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

: Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they (...) are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles. (shrink)

The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

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)

This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...) rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored. (shrink)

: The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

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)

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)

Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates. In keeping with the dynamics of the relationship between researcher and subject, they have limited but substantive fiduciary obligations.