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.

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)

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)

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)

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.

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)

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...

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)

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.

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)

It may be the case that the most challenging moral problem of the twenty‐first century will be the relationship between the individual moral agent and the practices and institutions in which the moral agent is embedded. In this paper, we continue the efforts that one of us, Joan Liaschenko, first called for in 1993, that of using feminist ethics as a lens for viewing the relationship between individual nurses as moral agents and the highly complex institutions in which (...) they do the work of nursing. Feminist ethics, with its emphasis on the inextricable relationship between ethics and politics, provides a useful lens to understand the work of nurses in context. Using Margaret Urban Walker's and Hilde Lindemann's concepts of identity, relationships, values, and moral agency, we argue that health care institutions can be moral communities and profoundly affect the work and identity and, therefore, the moral agency of all who work within those structures, including nurses. Nurses are not only shaped by these organizations but also have the power to shape them. Because moral agency is intimately connected to one's identity, moral identity work is essential for nurses to exercise their moral agency and to foster moral community in health care organizations. We first provide a brief history of nursing's morally problematic relationship with institutions and examine the impact institutional master narratives and corporatism exert today on nurses’ moral identities and agency. We close by emphasizing the significance of ongoing dialogue in creating and sustaining moral communities, repairing moral identities, and strengthening moral agency. (shrink)

One of the most significant changes in modern healthcare delivery has been the evolution of the paper record to the electronic health record (EHR). In this paper we argue that the primary change has been a shift in the focus of documentation from monitoring individual patient progress to recording data pertinent to Institutional Priorities (IPs). The specific IPs to which we refer include: finance/reimbursement; risk management/legal considerations; quality improvement/safety initiatives; meeting regulatory and accreditation standards; and patient care delivery/evidence based practice. (...) Following a brief history of the transition from the paper record to the EHR, the authors discuss unintended or contested consequences resulting from this change. These changes primarily reflect changes in the organization and amount of clinician work and clinician‐patient relationships. The paper is not a research report but was informed by an institutional ethnography the aim of which was to understand how the EHR impacted clinicians and administrators in a large, urban hospital in the United States. The paper was also informed by other sources, including the philosophies of Jacques Ellul, Don Idhe, and Langdon Winner. (shrink)

Artificial persons are those who speak and act for others. Nurses speak and act for patients as well as for physicians and institutions, or, more aptly, institutionalized medicine. Yet, acting for institutionalized medicine can be harmful to nurses, due to the psychological experience of moral distress and the loss of integrity of their practice. This paper illustrates the harm to nurses as expressed in narratives of their practice, and suggests some initial steps we might take in resisting the artificial personhood (...) imposed by institutionalized medicine. (shrink)

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.

Moral distress has been covered extensively in the nursing literature and increasingly in the literature of other health professions. Cases that cause nurses’ moral distress that are mentioned most frequently are those concerned with prolonging the dying process. Given the standard of aggressive treatment that is typical in intensive care units (ICUs), much of the existing moral distress research focuses on the experiences of critical care nurses. However, moral distress does not automatically occur in all end-of-life circumstances, nor does every (...) critical care nurse suffer its damaging effects. What are the practices of these nurses? What specifically do they do to navigate around or through the distressing situations? The nursing literature is lacking an answer to these questions. This article reports a study that used narrative analysis to explore the reported practices of experienced critical care nurses who are skilled at and comfortable working with families and physicians regarding the withdrawal of aggressive treatment. A major finding was that these nurses did not report experiencing the dam-Moral Agency, Moral Imagination, and Moral Community: Antidotes to Moral Distress Terri Traudt, Joan Liaschenko, and Cynthia Peden-McAlpine Terri Traudt, MBC, MA, is a Communications Consultant specializing in bioethics at the Center for Bioethics at the University of Minnesota, in Minneapolis. [email protected] Joan Liaschenko, PhD, RN, FAAN, is a Professor at the Center for Bioethics and Nursing at the University of Minnesota. Cynthia Peden-McAlpine, PhD, ACNS, BC, is an Associate Professor in the School of Nursing at the University of Minnesota. © 2016 by The Journal of Clinical Ethics. All rights reserved. aging effects of moral distress as described in the nursing literature. The verbal communication and stated practices relevant to this finding are organized under three major themes: (1) moral agency, (2) moral imagination, and (3) moral community. Further, a total of eight subthemes are identified. The practices that constitute these themes and subthemes are further detailed and discussed in this article. Understanding these practices can help mitigate critical care nurses’ moral distress. (shrink)

Surgical “buy-in” is an “informal contract between surgeon and patient in which the patient not only consents to the operative procedure but commits to the post-operative surgical care anticipated by the surgeon.”1 Surgeons routinely assume that patients wish to undergo treatment for operative complications so that the overall treatment course is “successful,” as in the treatment of a post-operative infection. This article examines occasions when patients buy-in to a treatment course that carries risk of complication, yet refuse treatment when complications (...) arise. We coin this counter-phenomenon “cashing-out.” Cashing-out may elicit negative feelings among careproviders. We question why patients or families may wish to cash-out. One reason may be the changing epistemological position of patients as they experience a complication. The shift from the hypothetical discussion of complications during the initial informed-consent process to the experience of having a complication represents new knowledge. Patients and families may use this knowledge as the basis to revoke consent for some or all of the remaining treatment course. This article seeks to understand cashing-out in terms of the patients’ experiences. We hope to prompt recognition of this phenomenon across medical contexts and to provide impetus for further work to understand why patients may wish to cash-out. (shrink)

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)

The controversy over the so-called Ashley Treatment (AT), a series of medical procedures that inhibited both growth and sexual development in the body of a profoundly intellectually impaired girl, usually centers either on Ashley’s rights, including a right to an intact, unaltered body, or on Ashley’s parents’ rights to make decisions for her. The claim made by her parents, that the procedure would improve their ability to care for her, is often dismissed as inappropriate or, at best, irrelevant. We argue, (...) however, that caregiving is a central issue in the controversy, as Ashley’s need for caregiving is a defining characteristic of her life. In this article, we analyze the ethics of the Ashley Treatment within the context of family caregiving. Through the physical and emotional work of caregiving, families participate in the formation and maintenance of personal identity, a process that Hilde Lindemann recently called “holding.” We argue that, in an intellectually disabled person such as Ashley, who depends on her family for every aspect of her care, the family’s contribution to identity is an essential source of personhood. We believe that the treatment can be justified if it is indeed an instance of appropriate family “holding” for Ashley. (shrink)

Advance care planning (ACP) is a process that seeks to elicit patients’ goals, values, and preferences for future medical care. While most commonly employed in adult patients, pediatric ACP is becoming a standard of practice for adolescent and young adult patients with potentially life-limiting illnesses. The majority of research has focused on patients and their families; little attention has been paid to the perspectives of healthcare providers (HCPs) regarding their perspectives on the process and its potential benefits and limitations. Focus (...) groups were conducted with 15 physicians as part of a larger study of adolescent and young adult ACP in hematopoietic stem cell transplant (HSCT) patients. This study identified two categories important to the utility of ACP in pediatric HSCT patients; (1) the temporal context of ACP and decision making and (2) the limitations of pediatric ACP, with subcategories identified as (a) embodied and witnessed knowing, (b) the impact of clinical cascades—when the treatment of one organ system creates complications in another system that needs to be treated—and a creation of a “new normal” following complications of illness and its treatment in the pediatric intensive care unit (PICU), (c) the balancing of adolescents’ autonomy with their capacity to make informed medical decisions, and (d) the epistemological frames that differ between HCP and patients and their families. These findings support ACP in adolescent and young adult HSCT patients, with a number of implications for practice as this process becomes more common. (shrink)

: Catholic teaching has no moral difficulties with research on stem cells derived from adult stem cells or fetal cord blood. The ethical problem comes with embryonic stem cells since their genesis involves the destruction of a human embryo. However, there seems to be significant promise of health benefits from such research. Although Catholic teaching does not permit any destruction of human embryos, the question remains whether researchers in a Catholic institution, or any researchers opposed to destruction of human embryos, (...) could participate in research on cultured embryonic stem cells, or whether a Catholic institution could use any therapy that ultimately results from such research. This position paper examines how such research could be conducted legitimately in a Catholic institution by using an ethical analysis involving a narrative context, the nature of the moral act, and the principle of material cooperation, along with references to significant ethical assessments. It also offers tentative guidelines that could be used by a Catholic institution in implementing such research. (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)

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.