The obligations of organisations associated with policy formation and implementation of international mass public health programmes are explored. Lines of responsibility are considered to become unclear because of the large number of agencies associated with such programmes. A separation of the relevant obligations among the bodies responsible for the formulation and those responsible for the implementation of the policies is suggested. The continuing oral polio vaccine campaign against poliomyelitis in India is used to illustrate the general argument. Although the aim (...) of the programme is legitimate and laudable, unnecessary harm is currently being caused to some children as a result of elements of the policy and this should be rectified immediately. Such mass programmes should take care to ensure that people are not unnecessarily sacrificed in the drive to attain the desirable ends of the policy. (shrink)

Professor Thomas Pogge, Professorial Fellow, Centre for Applied Philosophy, LPO Box 8260, Canberra. Tel.: +61 261255485; Email: tp6{at}columbia.edu ' + u + '@' + d + ' '//--> Abstract I would pay three million to go into space, says the banker to his attorney. — I wouldn't go if you paid me, the latter laughs, for me the French Riviera is quite exciting enough. Ah, I would pay a million for an extra year of life , the elderly tourist effusively (...) tells his lover. — We have never had even a hundred dollars , the Cambodian teenager replies, we are a large family. CiteULike Connotea Del.icio.us What's this? (shrink)

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct (...) of human behavior research and research capacity building in the host country. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...) A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (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.

Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks (...) that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take. (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).

: This essay distinguishes between two kinds of group harms: harms to individuals in virtue of their membership in groups and harms to "structured" groups that have a continuing existence, an organization, and interests of their own. Genetic research creates risks of causing both kinds of group harms, and engagement with the groups at risk can help to mitigate those harms. The two kinds of group harms call for different kinds of group engagement.

In October 2005, UNESCO (the United Nations Educational, Scientific and Cultural Organization) adopted the Universal Declaration on Bioethics and Human Rights. This was the culmination of nearly 2 years of deliberations and negotiations. As a non-binding instrument, the declaration must be incorporated by UNESCO’s member states into their national laws, regulations or policies in order to take effect. Based on documentary evidence and data from interviews, this paper compares the declaration’s universal principles with national bioethics guidelines and practice in Kenya (...) and South Africa. It concentrates on areas of particular relevance to developing countries, such as protection of vulnerable persons and social responsibility. The comparison demonstrates the need for universal principles to be contextualised before they can be applied in a meaningful sense at national level. The paper also assesses the ‘added value’ of the declaration in terms of biomedical research ethics, given that there are already well-established international instruments on bioethics, namely the World Medical Association Declaration of Helsinki and the CIOMS (Council for International Organizations of Medical Sciences) guidelines on biomedical research. It may be that the added value lies as much in the follow-up capacity building activities being initiated by UNESCO as in the document itself. (shrink)

Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks (...) that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take. (shrink)

In “The Real Problem With Equipoise,” Chiong (2006) raises two distinct, but interrelated issues concerning the concept of equipoise. The first deals with the role of equipoise in evaluating intern...

The term community in ethics and bioethics traditionally has been used to designate either a specific kind of moral relationship available to rational agents or, in contrast, the context in which any sense of rational agency can even be understood. I argue that bioethics is better served when both selves and community are expressed through a more processive language that highlights the functional character of such concepts. In particular, I see the turn to processive community in bioethics as a turn (...) towards method, contextualization, and narrative. In clinical practice, such a processive account demands that bioethics concentrate on methods of developing healthy dialogue and deeper understanding from within the problematic situation rather than trying to fix problems using ethical tools developed from outside the present situation. Community, I argue, is in and of the interactive processes of inquiry itself. Such inquiry, such communitying, requires that we engage individual patients in context; it demands more than simply gaining their permission or mere consent; it demands developing a supportive environment for participation. (shrink)

In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...) participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)