The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is (...) fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings. (shrink)

Studies in several developing countries for treatmen to prevent HIV-transmission from mother to child generated considerable controversy in 1997. Critics of the studies argued that basic principles of research ethics were violated. According to the critics, researchers subjected women in developing countries to studies that would have been unethical in the United States and that the researchers were therefore engaged in unethical exploitation ofcitizens of the developing countries in which the studies were conducted.While the critics agreed that unethical exploitation had (...) occurred, they differed on the exact nature of the exploitation. Some observers condemned the researchers for employing a double standard — because the researchers were applying a standard of care that would have been unacceptable in their own country. In the view of these critics, researchers should have been comparing the experimental treatment to established therapy rather than to placebo, as would have been required in the United States or other developed countries. (shrink)

Studies in several developing countries for treatmen to prevent HIV-transmission from mother to child generated considerable controversy in 1997. Critics of the studies argued that basic principles of research ethics were violated. According to the critics, researchers subjected women in developing countries to studies that would have been unethical in the United States and that the researchers were therefore engaged in unethical exploitation ofcitizens of the developing countries in which the studies were conducted.While the critics agreed that unethical exploitation had (...) occurred, they differed on the exact nature of the exploitation. Some observers condemned the researchers for employing a double standard — because the researchers were applying a standard of care that would have been unacceptable in their own country. In the view of these critics, researchers should have been comparing the experimental treatment to established therapy rather than to placebo, as would have been required in the United States or other developed countries. (shrink)

Autonomy has been hailed as the foremost principle of bioethics, and yet patients’ decisions and research subjects’ voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased (...) and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others.Clinical research settings are even more prone to erode subjects’ autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings.Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy. (shrink)

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland (...) version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results. (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.

In 1997 a debate broke out about the ethical acceptability of using placebo as a comparative alternative to establishe effective treatment in trials conducted in developing countries for the purpose of preventing perinatal HIV-transmission. The debate has now been going on for more than five years. In spite of extensive and numerous attempts at resolving the controversy, the case seems far from being settled. The aim of this paper is to provide an updated account of the debate, by identifying empirical (...) arguments employed in the controversy and by critically assessing their use in the debate. A notion of resolution of moral conflicts will be introduced that makes it possible to give a more positive verdict on the moral results of this controversy. Finally, the procedural problem of safe-guarding the selection of empirical arguments against undue forms of normative bias will be addressed. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when (...) there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. (shrink)