Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.

Women are routinely subjected to penetrating surveillance during pregnancy. On the surface, this may appear to flow from a cultural commitment to protect babies – a cultural practice of “better safe than sorry” that is particularly vigilant given the vulnerability of fetuses and babies. In reality, pregnancy occasions incursions against human rights and well-being that would be anathema in other contexts. Our cultural practices concerning risk in pregnancy are infused with oppressive norms about women’s responsibility for pregnancy outcomes and the (...) demands of extreme self-sacrifice from women to protect their fetuses. Of particular concern is our culture’s willingness to enforce norms concerning risk during pregnancy using coercive measures including forced cesarean sections and criminal penalties for exposing fetuses to risk. This chapter will consider assaults on self-determination, bodily integrity and privacy inherent in such interventions, as well as the structural violence and “mangled pieties” that buttress such practices in our unjust society. (shrink)

Clinical trials are a central mechanism in the production of medical knowledge. They are the gold standard by which such knowledge is evaluated. They are widespread both in the United States and internationally; a National Institute of Health database reports over 106,000 active industry and government-sponsored trials (National Institutes of Health n.d.). They are an engine of the economy. The work of trials is complex; multiple people with diverse interests working across multiple settings simultaneously participate in them, and they are (...) underwritten by multiple organizational structures and diverse funding mechanisms. In the past several years, concern about the ethics of clinical trials has spiked dramatically .. (shrink)

Howard Minkoff, Raaga Unmesha Vullikanti and Mary Faith Marshall argue that the U.S. Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization not only undermines the right to abortion b...

A note ofurgencycan sometimes be heard, even in otherwise unhurried writers, when they ask for a justification of morality. Unless the ethical life, or morality, can be justified by philosophy, we shall be open to relativism, amoralism, and disorder. As they often put it: when an amoralist calls ethical considerations in doubt, and suggests that there is no reason to follow the requirements of morality,what can we say to him?Why should one be moral? This question is nearly as old as (...) the discipline of moral philosophy itself; it has been troubling ethicists ever since Glaucon challenged Socrates to disprove that “the life of the unjust man is much better than that of the just.” To find an answer to the question of why one should be moral has been taken to be one of the most fundamental tasks of moral philosophy. And even a casual survey of the history of ethics will reveal that there are many ways of trying to answer the question. (shrink)

Our society's practice of inadequately representing women as subjects of clinical research is unjust, not only because it results in inequalities in the quality and availability of care that have a detrimental impact on women's health, but also because it is linked to women's oppression. Although recent policy changes help to resolve the problems, more must be done. Additional remedies for the injustices of our society's research practices are proposed.

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examines 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES - and in particular, behavioral health (...) - research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work. (shrink)

Why should one be moral? There is a very strong tradition in moral philosophy of attempting to answer this question by trying to provide a rational justification of morality. Rationalist moral theorists interpret this question as a challenge posed by amoralists, agents who lack any moral sentiments, and so who take themselves to have no reason to be moral. Thus, rationalist moral theorists set out to show that, whatever our sentiments, rationality--which is supposed to be essential to all agents--demands that (...) we be moral. Much of moral philosophy has been devoted to the tasks of giving rationalist justifications of morality, and of assessing the success of various attempts to do so. Yet few philosophers explicitly note that the rationalist project presupposes a substantive conception of morality--a conception which abstracts from agents' particular desires and sentiments altogether. And little attention has been paid to the question of whether we ought to accept the rationalist understanding of the 'Why be moral?' question and the conception of morality which goes with it. It is to that question which I turn in my thesis. ;I begin by characterizing rationalist moral theory and the impersonal conception of morality it presupposes. Admittedly, it appears that a rationalist justification would provide a powerful answer to the amoralist's query of why she should be moral. However, I argue that such a justification cannot carry enough force to provide the promised answer to the amoralist. I maintain that the difficulties rationalism encounters in justifying morality point to an alternative paradigm of justification in ethics and a notion of morality which differs from the impersonal one presupposed by rationalism. (shrink)

We agree with Alfandre and colleagues that ethics guidance for contingency conditions in public health emergencies is urgently needed. The Minnesota COVID Ethics Collabora...

Pandemic plans are increasingly attending to groups experiencing health disparities and other social vulnerabilities. Although some pandemic guidance is silent on the issue, guidance that attends to socially vulnerable groups ranges widely, some procedural (often calling for public engagement), and some substantive. Public engagement objectives vary from merely educational to seeking reflective input into the ethical commitments that should guide pandemic planning and response. Some plans that concern rationing during a severe pandemic recommend ways to protect socially vulnerable groups without (...) prioritizing access to scarce resources based on social vulnerability per se. The Minnesota Pandemic Ethics Project (MPEP), a public engagement project on rationing scarce health resources during a severe influenza pandemic, agrees and recommends an integrated set of ways to attend to the needs of socially vulnerable people and avoid exacerbation of health disparities during a severe influenza pandemic. Among other things, MPEP recommends: 1. Engaging socially vulnerable populations to clarify unique needs and effective strategies; 2. Engaging socially vulnerable populations to elicit ethical values and perspectives on rationing; 3. Rejecting rationing based on race, socioeconomic class, citizenship, quality of life, length of life-extension and first-come, first-served; 4. Prioritizing those in the general population for access to resources based on combinations of risk (of death or severe complications from influenza, exposure to influenza, transmitting influenza to vulnerable groups) and the likelihood of responding well to the resource in question. 5. Protecting critical infrastructures on which vulnerable populations and the general public rely; 6. Identifying and removing access barriers during pandemic planning and response; and 7. Collecting and promptly analyzing data during the pandemic to identify groups at disproportionate risk of influenza-related mortality and serious morbidity and to optimize the distribution of resources. (shrink)

Contrary to the popular belief that feminism has gained a foothold in the many disciplines of the academy, the essays collected in Theorizing Backlash argue that feminism is still actively resisted in mainstream academia. Contributors to this volume consider the professional, philosophical, and personal backlashes against feminist thought, and reflect upon their ramifications. The conclusion is that the disdain and irrational resentment of feminism, even in higher education, amounts to a backlash against progress.

Many commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza.

Healthcare rationing during pandemics has been widely discussed in global bioethics literature. However, existing scenarios and analyses have focused on high income countries, except for very few disease areas such as HIV treatment where some analyses related to African countries exist. We argue that the lack of scholastic discourse, and by extension, professional and democratic engagement on the subject constitute an unacceptable ethical omission. Not only have African governments failed to develop robust ethical plans for pandemics, ethicists in this region (...) have been unable to ignite public discourse on rationing. Therefore, we aim to initiate a debate on how rationing health and social goods could be done ethically in Ghana during the current and future pandemics. The paper discusses and critiques some moral considerations for rationing and their relevance in the Ghanaian context. This contribution may facilitate ethical decision-making during the current pandemic - in Ghana and other African settings where hardly any rationing guidelines exist. (shrink)

Having a self is associated with important advantages for an organism.These advantages have been suggested to include mechanisms supporting elaborate capacities for planning, decision-making, and behavioral control. Acknowledging such functionality offers possibilities for obtaining traction on investigation of neural correlates of selfhood. A method that has potential for investigating some of the brain-based properties of self arising in behavioral contexts varying in requirements for such behavioral guidance and control is functional brain imaging. Data obtained with this method are beginning to (...) converge on a set of brain areas that appear to play a significant role in permitting conscious access to representational content having reference to self as an embodied and independent experiencer and agent. These areas have been identified in a variety of imaging contexts ranging from passive state conditions in which they appear to manifest ongoing activity associated with spontaneous and typically ‘self-related’ cognition, to tasks targeting explicitly experienced properties of self, to demanding task conditions where activity within them is attenuated in apparent redirection of cognitive resources in the service of task guidance and control. In this paper, these data will be reviewed and a hypothesis presented regarding a significant role for these areas in enabling degrees of self-awareness and participating in the management of such behavioral control. (shrink)

This essay examines what it means to be embodied members of the Body of Christ, exploring the metaphor in 1 Corinthians 12:12–27 in terms of gender, race/ethnicity, variant embodiment, abused bodies, and sexual bodies.

This revised workbook is designed for patients' use as they work, either with a qualified mental health professional or on their own, to manage social anxiety. Based on the principles of cognitive-behavioral therapy, the treatment program described is evidence-based and proven effective. Complete with user-friendly forms and worksheets, as well as relatable case examples and chapter review questions, this workbook contains all the tools necessary to help patients manage their anxiety and improve their quality of life.

A selection of primary sources representing varying viewpoints on the subject of animal rights.

The aims of this study were to examine the effectiveness of a range of smartphone apps for managing symptoms of anxiety and depression and to assess the utility of a single-case research design for enhancing the evidence base for this mode of treatment delivery. The study was serendipitously impacted by the COVID-19 pandemic, which allowed for effectiveness to be additionally observed in the context of significant community distress. A pilot study was initially conducted using theSuperBetter app to evaluate the proposed (...) methodology, which proved successful with the four finishing participants. In the main study, 39 participants commenced, with 29 finishing the intervention phase and completing post-intervention measures. At 6-month follow-up, a further three participants could not be contacted. This study used a digitally enhanced, multiple baseline across-individuals single-case research design. Participants were randomly assigned to the following apps:SuperBetter,Smiling Mind,MoodMission,MindShift, andDestressify. Symptomatology and life functioning were measured at five different time points: pre-baseline/screening, baseline, intervention, 3-week post-intervention, and 6-month follow-up. Detailed individual perceptions and subjective ratings of the apps were also obtained from participants following the study’s completion. Data were analyzed using visual inspection, time-series analysis, and methods of statistical and clinical significance. Positive results were observed for all apps. Overall, more favorable outcomes were achieved by younger participants, those concurrently undertaking psychotherapy and/or psychotropic medication, those with anxiety and mixed anxiety and depression rather than stand-alone depression, and those with a shorter history of mental illness. Outcomes were generally maintained at 6-month follow-up. It was concluded that a diverse range of evidence-based therapies offered via apps can be effective in managing mental health and improving life functioning even during times of significant global unrest and, like all psychotherapies, are influenced by client features. Additionally, this single-case research design is a low-cost/high value means of assessing the effectiveness of mental health apps.Clinical Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry, which is a primary registry in the World Health Organization Registry Network, registration number ACTRN12619001302145p. (shrink)

This study employed a Discourse Ethicality survey instrument to analyze the legitimacy and ethicality of one of Dow Chemical's externally focused, rhetorical, crisis management strategies. A stratified random sample of the issues management bulletin The Point Is . . ., published over a ten year time period, was evaluated. The bulletins were divided into three time periods corresponding to significant events in Dow's history over the ten year period. Statistical and thematic analysis determined that perceived legitimacy and ethicality increased in (...) the bulletins over time. The results showed that at the height of external criticism from the media and public interest groups in the early 80's, Dow's response was characterized as antagonistic and focused on technological arguments. By the late 1980's, the bulletins range of issues had broadened considerably, were perceived as less antagonistic in tone, and focused more on issues and projects that may be described as socially conscious. (shrink)

From the most prominent thinkers in Latin American philosophy, literature, politics, and social science comes a challenge to conventional theories of globalization. The contributors to this volume imagine a discourse in which revolution requires no temporalized march of progress or takeovers of state power but instead aims at local control and the material conditions for human dignity.

Half of the 33.2 million people living with HIV today are women. Yet, responses to the epidemic are not adequately meeting the needs of women. This article critically evaluates how prevention of mother-to-child transmission (PMTCT) programs, the principal framework under which women's health is currently addressed in the global response to AIDS, have tended to focus on the prevention of HIV transmission from HIV-positive women to their infants. This paper concludes that more than ten years after their inception, PMTCT programs (...) still do not successfully ensure the adequate treatment, care and support of HIV-infected women. Of particular concern is the continued widespread use of single-dose nevirapine despite World Health Organization recommendations to employ more effective combination therapies that do not potentially jeopardize women's future treatment outcomes. In response, the article calls for a more comprehensive approach that places women's health needs at the centre of AIDS responses. This is critical in settings where the pandemic is generalized and there is a push to greatly expand PMTCT programs, as a more effective and equitable way of meeting the needs of women in the context of HIV. Without such a comprehensive approach, women will continue to be impacted disproportionately by the pandemic, and current strategies for prevention, including PMTCT, and treatment will not be as effective and responsive as they need to be. (shrink)