There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that researchers should consider when (...) developing psychosocial interventions studies that include ethnic minorities. (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 application of human right frameworks is an increasingly important part of efforts to accelerate progress in global mental health. Much of this has been driven by several influential legal and policy instruments, most notably the United Nations’ Convention on the Rights of Persons with Disabilities, as well as the World Health Organization’s QualityRights Tool Kit and Mental Health Action Plan. Despite these significant developments, however, much more needs to be done to prevent human rights violations. This chapter focuses on (...) a critical component of this broader challenge, which is the question of how best to regulate and reduce the use of coercive measures. The recent literature on coercion in psychiatry – which addresses involuntary commitment, seclusion, restraint, and forced medication – represents a useful resource that can help guide tractable solutions in global mental health. These issues are evaluated from the perspective of global health governance, and several general recommendations are made in order to improve monitoring and enforcement, provide guidance for domestic legislative reform, and strengthen health systems. (shrink)

This paper analyses the way in which being in possession of an adequate range of options is an essential component of autonomy. I discuss the way in which the conceptualisation of options in terms of basic rights might assist this argument, and apply these ideas to HIV/AIDS clinical research in the developing world. Finally, I suggest that mechanisms should be put in place through which vulnerable research participants can express their views about the relationship between the research in which they (...) are involved, and needs of a worthwhile life. (shrink)

Ethical problems are common in clinical medicine, so medical volunteers who practice clinical medicine in developing countries should expect to encounter them just as they would in their practice in the developed world. However, as this article argues, medical volunteers in developing countries should not expect to encounter the same ethical problems as those that dominate Western biomedicine or to address ethical problems in the same way as they do in their practice in developed countries. For example, poor health and (...) advanced disease increase the risks and decrease the potential benefits of some interventions. Consequently, when medical volunteers intervene too readily, without considering the nutritional and general health status of patients, the results can be devastating. Medical volunteers cannot assume that the outcomes of interventions in developing countries will be comparable to the outcomes of the same interventions in developed countries. Rather, they must realistically consider the complex medical conditions of patients when determining whether or not to intervene. Similarly, medical volunteers may face the question of whether to provide a pharmaceutical or perform an intervention that is below the acceptable standard of care versus the alternative of doing nothing. This article critically explores the contextual features of medical volunteer work in developing countries that differentiate it from medical practice in developed countries, arguing that this context contributes to the creation of unique ethical problems and affects the way in which these problems should be analyzed and resolved. (shrink)

Psychiatric research is of critical importance in improving the care of persons with mental illness. Yet it may also raise difficult ethical issues. This article explores those issues in the context of a particular kind of research: psychosocial intervention research with control groups. We discuss 4 broad categories of ethical issues: consent, confidentiality, boundary violations, and risk-benefit issues. We believe that, despite the potential difficulties, psychosocial intervention research is vital and can be accomplished in an ethical manner. Further discussion and (...) research into these issues are warranted. (shrink)

As compared with conventional vaccine production systems, plant-made vaccines are said to enjoy a range of advantages including cost of production and ease of storage for distribution in developing countries. In this article, we introduce the science of PMV production, and address ethical issues associated with development and clinical testing of PMVs within three interrelated domains: PMVs as transgenic plants; PMVs as clinical research materials; and PMVs as agents of global health. We present three conclusions: first, while many of the (...) ethical issues raised by PMVs are familiar, PMVs add a new dimension to old issues, and raise some novel issues for ethicists and policy-makers; secondly, it is premature to promise broad applicability of PMVs across the developing world without having demonstrated their feasibility; thirdly, in particular, proponents of PMVs as a solution to global health problems must, as a condition of the ethical conduct of their research, define the commercial feasibility of PMVs for distribution in the developing world. (shrink)

Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the (...) appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

ABSTRACT Background: Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries. Methods: Recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in (...) the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Results: Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries. Conclusion: Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty. (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)

Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (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)

ABSTRACT This article attempts to show a way in which social science research can contribute in a meaningful and equitable way to philosophical bioethics. It builds on the social science critique of bioethics present in the work of authors such as Renée Fox, Barry Hoffmaster and Charles Bosk, proposing the characteristics of a critical bioethics that would take social science seriously. The social science critique claims that traditional philosophical bioethics gives a dominant role to idealised, rational thought, and tends to (...) exclude social and cultural factors, relegating them to the status of irrelevancies. Another problem is the way in which bioethics assumes social reality divides down the same lines/categories as philosophical theories. Critical bioethics requires bioethicists to root their enquires in empirical research, to challenge theories using evidence, to be reflexive and to be sceptical about the claims of other bioethicists, scientists and clinicians. The aim is to produce a rigorous normative analysis of lived moral experience. (shrink)

First, to what level of quality can medical ethics a spire, if it ignores callous discrimination in medrcal practice against large populations of the innocent poor? Second, how effective can such theories be in addressing the critical issues of medical and clinical ethics if they are unable to contribute to the closing of the gap of sociomedical disparity?Marcio Fabri dos Anjos, Medical Ethics in the Developing World: A Liberation Theology Perspective.