This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form (...) of outsourcing from the host country to pharmaceutical corporations. Bioethicists’ assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation. (shrink)

Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by (...) pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an increase in calls to homes by telemarketers and market researchers. Participants also stressed the importance of knowing where their names and contact details were sourced and suggested that this information be available to prospective study participants as a matter of course in the first approach or letter. We provide valuable information to epidemiologists in designing studies. (shrink)

Moral distress has been written about extensively in nursing and other fields. Often, however, it has not been used with much theoretical depth. This paper focuses on theorizing moral distress using feminist ethics, particularly the work of Margaret Urban Walker and Hilde Lindemann. Incorporating empirical findings, we argue that moral distress is the response to constraints experienced by nurses to their moral identities, responsibilities, and relationships. We recommend that health professionals get assistance in accounting for and communicating their values and (...) responsibilities in situations of moral distress. We also discuss the importance of nurses creating “counterstories” of their work as knowledgeable and trustworthy professionals to repair their damaged moral identities, and, finally, we recommend that efforts toward shifting the goal of health care away from the prolongation of life at all costs to the relief of suffering to diminish the moral distress that is a common response to aggressive care at end-of-life. (shrink)

Medical collaboration with authoritarian regimes historically has served to facilitate the use of torture as a tool of repression and to justify atrocities with the language of public health. Because scholarship on medicalized killing and biomedicalist rhetoric and ideology is heavily focused on Nazi Germany, this article seeks to expand the discourse to include other periods in which medicalized torture occurred, specifically in Argentina from 1976 to 1983, when the country was ruled by the Proceso de Reorganización Nacional military regime. (...) The extent to which medical personnel embedded themselves within the Proceso regime’s killing apparatus has escaped full recognition by both scholars and human rights activists. This article reconstructs the narrative of the Proceso’s human rights abuses to argue that health professionals knowingly and often enthusiastically facilitated, oversaw, and participated in every phase of the “disappearance,” torture, and mass murder process. (shrink)

This paper explores the bioethical issues associated with the diagnosis and treatment of vulvar cancer for Indigenous women in East Arnhem Land, Northern Territory, Australia. Based on a qualitative study of a vulvar cancer cluster of Indigenous women, the article highlights four main topics of bioethical concern drawn from the findings: informed consent, removal of body parts, pain management, and issues at the interface of Indigenous and Western health care. The article seeks to make a contribution towards Indigenous health and (...) bioethics and bring to light areas of further research. (shrink)

By emphasizing the parallels between both racial vilification and the vilification that takes place when we discuss abortion in our society, I hope to provide a new perspective on the way the United States converses about this divisive issue. This perspective, in turn, can help us see how we can move forward from the stagnate polemics that have permeated the abortion debate in the United States for the past 40 years.

Human research involving the use social media raises many of the same issues as medical research. The publication of a paper in June 2014 investigating “emotional contagion” received extensive publicity recently because of the methods used. The approach involved manipulating the “News Feeds” of Facebook users, but the participants were not informed of their involvement in the research and had no opportunity to consent or opt out. Some commentators have argued that although it would have been preferable to obtain informed (...) consent, it was not strictly required because the research was unlikely to cause significant harm and was important. This paper argues that the research was unethical because it should have been overseen by an independent ethics committee or review board and informed consent could and should have been obtained. Regardless of the importance of any research and irrespective of its likelihood to cause harm, the ethical principles that have evolved since the 1940s should be followed in all instances when experimental research is being carried out on human participants. (shrink)

The concept of moral distress can be extended from clinical settings to larger environmental concerns affecting health care. Moral distress—a common experience in complex societies—arises when individuals have clear moral judgments about societal practices, but have difficulty in finding a venue in which to express concerns. Since health care is large in scale and climate change is proving to be a major environmental problem, scaling down health care is inevitably a necessary element for mitigating climate change. Because it is extremely (...) challenging to discuss these concerns in health care settings, those concerned about climate change and health care experience distress. This article outlines some philosophical concepts and perspectives that may be useful in mitigating this distress. (shrink)

Our study of queer women patients and their primary health care providers in Halifax, Nova Scotia, reveals a gap between providers’ theoretical knowledge of “cultural competency” and patients’ experience. Drawing on Patricia Benner’s Dreyfusian model of skill acquisition in nursing, we suggest that the dissonance between the anti-heteronormative principles expressed in interviews and the relative absence of skilled anti-heteronormative clinical practice can be understood as a failure to grasp the field of practice as a whole. Moving from “knowing-that” to “knowing-how” (...) in terms of anti-heteronormative clinical skills is not only a desirable epistemological trajectory, we argue, but also a way of understanding better and worse ethical practice. (shrink)

In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex (...) and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively. (shrink)

The U.S. 2010 Patient Protection and Affordable Care Act exempts members of health care sharing ministries from the individual mandate to have minimum essential insurance coverage. Little is generally known about these religious organizations and even less critical attention has been brought to bear on them and their ACA exemption. Both deserve close scrutiny due to the exemption’s less than clear legislative justification, their potential influence on the ACA’s policy and ethical success, and their salience to current religious liberty debates (...) surrounding the expansion of religious exemptions from ACA responsibilities for both individuals and corporations. Analyzing documents of the United States’ three largest health care sharing ministries and related material, I examine these organizations and their ACA exemption with particular consideration of their ethical dimensions. Here a thick description of the nature and workings of health care sharing ministries precedes a similar account of the ACA exemption. From these empirical analyses, five ethical and policy concerns emerge: the charity versus insurance status of these ministries; the conflation of two ACA religious exemptions; the tension between the values of religious liberty and of justice; the potential undermining of ACA policy goals; and the questionable compliance of health care sharing ministries with ACA exemption requirements. An accurate and informed understanding of HCSMs is required for policymakers and others to justify the ACA exemption of health care sharing ministry members. A sufficient justification would address at least the five ethical and policy concerns raised here. (shrink)

The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner Regulations 1996 and the common law, which require that off-label drug use is of (...) an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions. (shrink)

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site (...) visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)

Premenstrual dysphoric disorder was recently moved to a full category in the DSM-5 . It also appears set for inclusion as a separate disorder in the ICD-11 . This paper argues that PMDD should not be listed in the DSM or the ICD at all, adding to the call to recognise PMDD as a socially constructed disorder. I first present the argument that PMDD pathologises understandable anger/distress and that to do so is potentially dangerous. I then present evidence that PMDD (...) is a culture-bound phenomenon, not a universal one. I also argue that even if medication produces a desired effect, there are biological correlates with premenstrual anger/distress, such anger/distress seems to occur monthly, and women are more likely than men to be diagnosed with affective disorders, none of these factors substantiates that premenstrual anger/distress is caused by a mental disorder. I argue that to assume they do is to ignore the now accepted role that one’s environment and psychology play in illness development, as well as arguments concerning the social construction of mental illness. In doing so, I do not claim that there are no women who experience premenstrual distress or that their distress is not a lived experience. My point is that such distress can be recognised and considered significant without being pathologised and that it is unethical to describe premenstrual anger/distress as a mental disorder. Further, if the credibility of women’s suffering is subject to doubt without a clinical diagnosis, then the way to address this problem is to change societal attitudes towards women’s suffering, not to label women as mentally ill. The paper concludes with some broader implications for women and society of the change in status of PMDD in the DSM-5 as well as a sketch of critical policy suggestions to address these implications. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

The 1987 Cartwright Report into events at New Zealand’s National Women’s Hospital catalysed sweeping changes to promote and protect patients’ rights. A generation on, it is comfortable to believe that such sustained and deliberate violations of patient rights “couldn’t happen here” and “couldn’t happen now.” And yet, contemporary examples beg a different truth. Three of Cartwright’s messages hold an enduring relevance for health practitioners and patients: the need for patients to be respected as people; to be supported to make informed (...) choices; and to have their voices heard, even when they whisper. These challenges cannot be met in isolation from broader determinants of patients’ rights and will require social, technological, and cultural change in order to prevent another “unfortunate experiment.”. (shrink)

The conception of the doctor–patient relationship under Australian law has followed British common law tradition whereby the relationship is founded in a contractual exchange. By contrast, this article presents a rationale and framework for an alternative model—a “Trust Model”—for implementation into law to more accurately reflect the contemporary therapeutic dynamic. The framework has four elements: an assumption that professional conflicts with patient safety, motivated by financial or personal interests, should be avoided; an onus on doctors to disclose these conflicts; a (...) proposed mechanism to contend with instances where doctors choose not to disclose; and sanctions for non-compliance with the regime. (shrink)

Maternal mortality is still very high in Africa, despite progress in control efforts at the global level. One elemental link is the question of autonomy in maternal health, especially at the household level where intrinsic human rights are undermined. A rights-based consideration in bioethics is an approach that holds the centrality of the human person, with a compelling reference to the fundamental human rights of every person. A philosophical and sociological engagement of gender and the notion of autonomy within the (...) household reveals some fundamental rights-based perplexities for bioethical considerations in maternal health. The right to self-determination is undermined, and therefore women’s dignity, freedom and autonomy, capacities, and choices are easily defiled. This study applies a rights-based approach to maternal health and demonstrates how rights concerns are associated with negative outcomes in maternal health in Africa. The discussion is situated at the household level, which is the starting point in health care. The paper submits that beyond legal and political rights within the context of the state, rights-based issues manifest at the household level. Many of those rights issues, especially relating to women’s autonomy, are detrimental to maternal health in Africa. Therefore, a rights-based approach in the social construction of maternal health realities will contribute to alleviating the burden of maternal mortality in Africa. (shrink)