When a physician and a clinical ethicist collaborate for better patient care

Bioethics is a relatively new addition to bedside medical care in Arab world which is characterized by a special culture that often makes blind adaptation of western ethics codes and principles; a challenge that has to be faced. To date, the American University of Beirut Medical Center is the only hospital that offers bedside ethics consultations in the Arab Region aiming towards better patient‐centered care. This article tackles the role of the bedside clinical ethics consultant as an active member of the medical team and the impact of such consultations on decision‐making and patient‐centered care. Using the case of a child with multiple medical problems and a futile medical condition, we describe how the collaboration of the medical team and the clinical ethics consultant took a comprehensive approach to accompany and lead the parents and the medical team in their decision‐making process and how the consultations allowed several salient issues to be addressed. This approach proved to be effective in the Arab cultural setting and indeed did lead to better patientcentered care.     

Systemic Negligence: Why It Is Morally Important for Developing World Bioethics

In the context of clinical and non‐clinical biomedical practices, negligence is usually understood as a lapse of a specific professional duty by a healthcare worker or by a medical facility. This paper tries to delineate systemic negligence as another kind of negligence in the context of health systems, particularly in developing countries, that needs to be recognized and addressed. Systemic negligence is not just a mere collection of stray incidences of medical errors and system failures in a health system, but is proposed in this paper as a more pervasive kind of neglect. Several non‐medical factors, such as lack of social and political will, also contribute to it and hence is more difficult to address in a health system. This paper argues that recognizing systemic negligence and including it research agenda have special moral importance for researchers in developing world bioethics, public health ethics and for health activists in the developing world. For, it can be a potent health system barrier, and can seriously impair efforts to ensure patient safety, particularly in the weaker health systems. As it erodes accountability in a health system, addressing it is also important for the twin goals of ensuring patient safety and improving health system performance. Above all, it needs to be addressed because the tolerance of its persistence in a health system seems to undervalue health as a social good.     

Why Restrictions on the Immigration of Health Workers Are Unjust

Some bioethicists and political philosophers argue that rich states should restrict the immigration of health workers from poor countries in order to prevent harm to people in these countries. In this essay, I argue that restrictions on the immigration of health workers are unjust, even if this immigration results in bad health outcomes for people in poor countries. I contend that negative duties to refrain from interfering with the occupational liberties of health workers outweighs rich states' positive duties to prevent harm to people in sending countries. Furthermore, I defend this claim against the objection that health workers in poor countries acquire special duties to their compatriots that render them liable to coercive interference.     

Stem cell tourism and future stem cell tourists: policy and ethical implications

Stem cell tourism is a small but growing part of the thriving global medical tourism marketplace. Much stem cell research remains at the experimental stage, with clinical trials still uncommon. However, there are over 700 clinics estimated to be operating in mostly developing countries--from Costa Rica and Argentina to China, India and Russia--that have lured many patients, mostly from industrialized countries, driven by desperation and hope, which in turn continue to fuel the growth of such tourism. While much research has focused on such dimensions as the promotions that allow such businesses to make their services known, media coverage, some patient research, and regulatory conditions for developing country clinics, little attention has been paid to the non-affected members of the general population, the future potential users of such services. This empirical study based on five focus group discussions with a diverse group of healthy adults in a Canadian city, explored participant views of patients who use stem cell tourism services, the likelihood they would avail themselves of such services if they were to suffer similar illnesses, and the conditions under which they might do so, and the impact that admonitions and advice from international expert bodies might have on their decisions. Our findings suggest that these healthy adults are sympathetic to the drivers of hope and desperation, and, despite cautions about research limitations, may seek such treatments themselves under similar conditions. These findings are discussed in the context of the policy and ethical issues raised by this form of medical tourism.     

On Abortion: Exploring Psychological Meaning and Attitudes in a Sample of Mexican Gynecologists

Elective abortion has become an issue of ethical and political debate in many countries including Mexico. As gynecologists are directly involved in the practice of abortion, it is important to know the psychological meaning that the term ‘elective abortion’ has for them. This study explores the psychological meaning and attitudes toward elective abortion of one hundred and twenty‐three Mexican gynecologists. We used the semantic networks technique, which analyzed the words the participants associated with the term ‘elective abortion’. The defining words most frequently used by participants implied a negative sanction. There were important differences by gender and religiosity: male gynecologists, as well as those with strong religious beliefs (mainly Catholics), revealed a more negative psychological meaning and more negative attitudes than females or physicians with weak religious beliefs. A contribution of the present study is that it highlights the importance of psychology to enhancing understanding of the issue of elective abortion.     

COERCION,AUTONOMY, AND THE PREFERENTIAL OPTION FOR THE POOR IN THE ETHICS OF ORGAN TRANSPLANTATION

The debate concerning whether to legalize and regulate the global market in human organs is hindered by a lack of adequate bioethical language. The author argues that the preferential option for the poor, a theological category, can provide the grounding for an inductive moral epistemology adequate for reforming the use of culturally Western bioethical language. He proposes that the traditional, Western concept of bioethical coercion ought to be modified and expanded because the conditions of the market system, as viewed from the perspective of organ vendors systemically deprived of access to sufficient resources, are sufficiently exploitative as to diminish the possibility of these vendors giving informed consent. Moreover, empirical studies conducted by professionals in medicine, sociology, psychiatry, economics, and medical anthropology continue to contribute support to the growing interdisciplinary consensus that functionally coercive structural factors exert the most significant influence upon a vendor's decision to sell an organ within any market, regardless of legality or degree of regulation. Therefore any proposal to legalize and regulate the organ market remains patently unethical because doing so would likely function to constrain further the agency of poor potential vendors.     

TREATMENT NEEDS IN HIV PREVENTION TRIALS: USING BENEFICENCE TO CLARIFY SPONSOR‐INVESTIGATOR RESPONSIBILITIES

Some participants will get HIV‐infected in HIV prevention trials, despite risk reduction measures. The subsequent treatment responsibilities of sponsor‐investigators have been widely debated, especially where access to antiretroviral therapy (ART) is not available. In this paper, we explore two accounts of beneficence to establish whether they can shed light on sponsor‐investigator responsibilities. We find the notion of general beneficence helpful insofar as it clarifies that some beneficent actions will be obligatory where they can be dispensed without scuppering the trial. We find the notion of specific beneficence helpful insofar as it directs investigators to attend to the needs of trial participants; however the range of interventions that could be provided remains unhelpfully broad. We then examine accounts of the investigator‐participant relationship to narrow the range of interventions that investigators should provide, concluding that health‐care, and HIV infection, are appropriate foci. We conclude that when investigators are able to meet the ART needs of their participants (e.g. referral, assisted referral or direct provision) without sacrificing trial quality, they must do so. However, there is little of this explicit direction to be found in the account of specific beneficence itself, but rather it is found in accounts of the relationship that are compatible with beneficence.     

Global Health Care Justice,Delivery Doctors and Assisted Reproduction: Taking a Note From Catholic Social Teachings

This article will examine the Catholic concept of global justice within a health care framework as it relates to women's needs for delivery doctors in the developing world and women's demands for assisted reproduction in the developed world. I will first discuss justice as a theory, situating it within Catholic social teachings. The Catholic perspective on global justice in health care demands that everyone have access to basic needs before elective treatments are offered to the wealthy. After exploring specific discrepancies in global health care justice, I will point to the need for delivery doctors in the developing world to provide basic assistance to women who hazard many pregnancies as a priority before offering assisted reproduction to women in the developed world. The wide disparities between maternal health in the developing world and elective fertility treatments in the developed world are clearly unjust within Catholic social teachings. I conclude this article by offering policy suggestions for moving closer to health care justice via doctor distribution.     

The Vulnerability of Study Participants in the Context of Transnational Biomedical Research: From Conceptual Considerations to Practical Implications

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low‐ (middle)‐income countries – summarized as transnational biomedical research (TBR) – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV‐vaccine‐trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre‐assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects.     

Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: a systematic survey of registered trials

Objective:  Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting.
Methods:  We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com . We searched for intervention trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007.
Results:  We collected data from 312 trials. Fifty-eight percent (58%, 95% CI  =  53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI  =  53 to 64) of trials report active controls. Almost no trials (1%, 95% CI  =  0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI  =  16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI  =  2.70 to 9.35, p  = < 0.001). Pharmaceutical companies are involved in 28% (CI  =  23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI  =  1.18 to 5.09, p  =  0.31).
Conclusion:  We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings.     

HIV testing of pregnant women: an ethical analysis

Recent global advances in available technology to prevent mother-to-child HIV transmission necessitate a rethinking of contemporary and previous ethical debates on HIV testing as a means to preventing vertical transmission. In this paper, we will provide an ethical analysis of HIV-testing strategies of pregnant women. First, we argue that provider-initiated opt-out HIV testing seems to be the most effective HIV test strategy. The flip-side of an opt-out strategy is that it may end up as involuntary testing in a clinical setting. We analyse this ethical puzzle from a novel perspective, taking into account the moral importance of certain hypothetical preferences of the child, as well as the moral importance of certain actual preferences of the mother. Finally, we balance the conflicting concerns and try to arrive at an ethically sound solution to this dilemma. Our aim is to introduce a novel perspective from which to analyse testing strategies, and to explore the implications and possible benefits of our proposal. The conclusion from our analysis is that policies that recommend provider-initiated opt-out HIV testing of pregnant mothers, with a risk of becoming involuntary testing in a clinical setting, are acceptable. The rationale behind this is that the increased availability of very effective and inexpensive life-saving drugs makes the ethical problems raised by the possible intrusiveness of HIV testing less important than the child's hypothetical preferences to be born healthy. Health care providers, therefore, have a duty to offer both opt-out HIV testing and available PMTCT (preventing mother-to-child transmission) interventions.     

Social Responsibility and the State's Duty to provide Healthcare: An Islamic Ethico‐Legal Perspective

The United Nations Educational, Scientific and Cultural Organization's (UNESCO) Declaration on Bioethics and Human Rights asserts that governments are morally obliged to promote health and to provide access to quality healthcare, essential medicines and adequate nutrition and water to all members of society. According to UNESCO, this obligation is grounded in a moral commitment to promoting fundamental human rights and emerges from the principle of social responsibility. Yet in an era of ethical pluralism and contentions over the universality of human rights conventions, the extent to which the UNESCO Declaration can motivate behaviors and policies rests, at least in part, upon accepting the moral arguments it makes. In this essay I reflect on a state's moral obligation to provide healthcare from the perspective of Islamic moral theology and law. I examine how Islamic ethico‐legal conceptual analogues for human rights and communal responsibility, ?uqūq al‐’ibād and far? al‐kifāyah and other related constructs might be used to advance a moral argument for healthcare provision by the state. Moving from theory to application, I next illustrate how notions of human rights and social responsibility were used by Muslim stakeholders to buttress moral arguments to support American healthcare reform. In this way, the paper advance discourses on a universal bioethics and common morality by bringing into view the concordances and discordances between Islamic ethico‐legal constructs and moral arguments advanced by transnational health policy advocates. It also provides insight into applied Islamic bioethics by demonstrating how Islamic ethico‐legal values might inform the discursive outputs of Muslim organizations.     

RACE,SCIENCE AND A NOVEL: AN INTERDISCIPLINARY DIALOGUE

In the novel Racists by Kunal Basu (2006), two competing scientists initiate an experiment that they believe will prove which race is superior. The research subjects, one white and one black infant, are sequestered on an isolated island in the care of a mute nurse. The contest must be waged in a ‘natural laboratory’ with no artificial interventions and with the prospect that one will die at the hands of the other. The politics of empire, the slave trade and the advent of a new scientific way of viewing life, Darwinism, set the stage for the fictional experiment, but the ramifications of such thinking extend into the present. Coming from the disciplines of nursing, philosophy and science, we discuss how a novel can illuminate the moral dimensions of science and healthcare. The critical distance afforded by the novel provides a rich terrain for the examination of issues such as race, care and the purity of science. Despite the recent dominance of social explanations of race, science requires the examination of the differences between human beings at the biological level. The view that biology is destiny is a powerful one with dangerous consequences, especially since the belief that certain human beings' destinies are far worthier than others is a corollary of such a view. In this paper, we present the cross‐disciplinary conversation, which has been facilitated by this novel. We hope this will inform ethics educators of the rich potential of using fiction as a pedagogical tool.     

IMPROVING GLOBAL HEALTH: COUNTING REASONS WHY

This paper examines cumulative ethical and self-interested reasons why wealthy developed nations should be motivated to do more to improve health care in developing countries. Egalitarian and human rights reasons why wealthy nations should do more to improve global health are that doing so would (1) promote equality of opportunity, (2) improve the situation of the worst-off, (3) promote respect of the human right to have one's most basic needs met, and (4) reduce undeserved inequalities in well-being. Utilitarian reasons for improving global health are that this would (5) promote the greater good of humankind, and (6) achieve enormous benefits while requiring only small sacrifices. Libertarian reasons are that this would (7) amend historical injustices and (8) meet the obligation to amend injustices that developed world countries have contributed to. Self-interested reasons why wealthy nations should do more to improve global health are that doing so would (9) reduce the threat of infectious diseases to developed countries, (10) promote developed countries' economic interests, and (11) promote global security. All of these reasons count, and together they add up to make an overwhelmingly powerful case for change. Those opposed to wealthy government funding of developing world health improvement would most likely appeal, implicitly or explicitly, to the idea that coercive taxation for redistributive purposes would violate the right of an individual to keep his hard-earned income. The idea that this reason not to improve global health should outweigh the combination of rights and values embodied in the eleven reasons enumerated above, however, is implausibly extreme, morally repugnant and perhaps imprudent.     

Because we can: clashes of perspective over researcher obligation in the failed PrEP trials

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities.     

Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug

Drug‐resistant tuberculosis (TB) has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug‐resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration (FDA) in the United States (US) and the Medicines Control Council (MCC) in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing of the drug is completed. These campaigns raise ethical concerns about whether patients should be offered experimental, unapproved, medicines for the treatment of life‐threatening illnesses, and if authorities should approve drugs for life‐threatening illnesses when vital questions about safety and efficacy remain outstanding.     

Considerations for a Human Rights Impact Assessment of a Population Wide Treatment for HIV Prevention Intervention

Increasing attention is being paid to the potential of anti‐retroviral treatment (ART) for HIV prevention. The possibility of eliminating HIV from a population through a universal test and treat intervention, where all people within a population are tested for HIV and all positive people immediately initiated on ART, as part of a wider prevention intervention, was first proposed in 2009. Several clinical trials testing this idea are now in inception phase. An intervention which relies on universally testing the entire population for HIV will pose challenges to human rights, including obtaining genuine consent to testing and treatment. It also requires a context in which people can live free from fear of stigma, discrimination and violence, and can access services they require. These challenges are distinct from the field of medical ethics which has traditionally governed clinical trials and focuses primarily on patient researcher relationship. This paper sets out the potential impact of a population wide treatment as prevention intervention on human rights. It identifies five human right principles of particular relevance: participation, accountability, the right to health, non‐discrimination and equality, and consent and confidentiality. The paper proposes that explicit attention to human rights can strengthen a treatment as prevention intervention, contribute to mediating likely health systems challenges and offer insights on how to reach all sections of the population.     

The dilemma posed by minority medical traditions in pluralistic societies: The case of China and Canada

Pluralistic societies such as China and Canada frequently find themselves pursuing potentially contradictory goals. China's contradiction results from a desire to preserve cultural diversity while eliminating ‘backward tendencies’ which work against the economic and social development of the country as a whole. Canada's contradiction results from a desire to preserve cultural diversity while maintaining an emphasis upon equality of rights and responsibilities for all Canadians. Behind these differences in ideology, however, is a more basic structural contradiction ‐ namely, that cultural pluralism, while considered an asset as long as it is restricted to preserving unique cultural traditions, is nevertheless a threat to a strong central government if interpreted to imply the power to set policy at the local level. To explore this issue, this article compares China and Canada in terms of three related topics. First, it briefly examines the multicultural policy of China and Canada. This is followed by a discussion of medical pluralism in China and Canada, with an emphasis upon the health of minority groups and the status of minority healing traditions. Finally, common perceptions of shamanic healing traditions in both China and Canada are considered. It is in relation to shamanism that the dilemma posed by cultural pluralism is most clearly delimited.     

The need for systematic reviews of reasons

There are many ethical decisions in the practice of health research and care, and in the creation of policy and guidelines. We argue that those charged with making such decisions need a new genre of review. The new genre is an application of the systematic review, which was developed over decades to inform medical decision-makers about what the totality of studies that investigate links between smoking and cancer, for example, implies about whether smoking causes cancer. We argue that there is a need for similarly inclusive and rigorous reviews of reason-based bioethics, which uses reasoning to address ethical questions. After presenting a brief history of the systematic review, we reject the only existing model for writing a systematic review of reason-based bioethics, which holds that such a review should address an ethical question. We argue that such a systematic review may mislead decision-makers when a literature is incomplete, or when there are mutually incompatible but individually reasonable answers to the ethical question. Furthermore, such a review can be written without identifying all the reasons given when the ethical questions are discussed, their alleged implications for the ethical question, and the attitudes taken to the reasons. The reviews we propose address instead the empirical question of which reasons have been given when addressing a specified ethical question, and present such detailed information on the reasons. We argue that this information is likely to improve decision-making, both directly and indirectly, and also the academic literature. We explain the limitations of our alternative model for systematic reviews.