In this paper, the author questions whether the research ethics guidelines and procedures are robust enough to protect groups when conducting genetics research with socially identifiable populations, particularly with Native American groups. The author argues for a change in the federal guidelines in substance and procedures of conducting genetic research with socially identifiable groups.

The genetic revolution is well underway, with genetic research and knowledge expanding at an exponential rate. Much of the new genetics research is focused on population groups, and proponents of “population genomics” argue that such studies are necessary since genetic “variation” among human populations holds the most promise for technological innovations that can improve human health and lead to increased understanding of the origin of human populations. Population genomic research thus targets specific groups to discover variation that could lead to (...) knowledge about genetic disorders, possible cures, and the origin and migration patterns of distinctive peoples. Research on genetic differences among groups or populations, however, raises many pressing ethical and legal questions. For example, focus on biological differences of racial and ethnic groups has in the past lead to assumptions about superiority and inferiority between groups, and in practice resulted in stigmatization and discrimination. Consequently, attention on groups should raise legal and moral red flags and compel us to move cautiously in this area. Pragmatically, targeting population groups as the object of study requires the determination of the nature and scope of “population groups” for purposes of genetics research. (shrink)

We respond to Morgan and Feeley’s critique on our article “Mass Media in Organ Donation: Managing Conflicting Messages and Interests.” We noted that Morgan and Feeley agree with the position that the primary aims of media campaigns are: “to educate the general public about organ donation process” and “help individuals make informed decisions” about organ donation. For those reasons, the educational messages in media campaigns should not be restricted to “information from pilot work or focus groups” but should include evidence-based (...) facts resulting from a comprehensive literature research. We consider the controversial aspects about organ donation to be relevant, if not necessary, educational materials that must be disclosed in media campaigns to comply with the legal and moral requirements of informed consent. With that perspective in mind, we address the validity of Morgan and Feeley’s claim that media campaigns have no need for informing the public about the controversial nature of death determination in organ donation. Scientific evidence has proven that the criteria for death determination are inconsistent with the Uniform Determination of Death Act and therefore potentially harmful to donors. The decision by campaign designers to use the statutory definition of death without disclosing the current controversies surrounding that definition does not contribute to improved informed decision making. We argue that if Morgan and Feeley accept the important role of media campaigns to enhance informed decision making, then critical controversies should be disclosed. In support of that premise, we will outline: (1) the wide-spread scientific challenges to brain death as a concept of death; (2) the influence of the donor registry and team-huddling on the medical care of potential donors; (3) the use of authorization rather than informed consent for donor registration; (4) the contemporary religious controversy; and (5) the effects of training desk clerks as organ requestors at the Department of Motor Vehicles offices. We conclude that organ donation is a medical procedure subject to all the ethical obligations that the medical profession must uphold including that of transparency and truthfulness. (shrink)

Mass media campaigns are widely and successfully used to change health decisions and behaviors for better or for worse in society. In the United States, media campaigns have been launched at local offices of the states’ department of motor vehicles to promote citizens’ willingness to organ donation and donor registration. We analyze interventional studies of multimedia communication campaigns to encourage organ-donor registration at local offices of states’ department of motor vehicles. The media campaigns include the use of multifaceted communication tools (...) and provide training to desk clerks in the use of scripted messages for the purpose of optimizing enrollment in organ-donor registries. Scripted messages are communicated to customers through mass audiovisual entertainment media, print materials and interpersonal interaction at the offices of departments of motor vehicles. These campaigns give rise to three serious concerns: (1) bias in communicating information with scripted messages without verification of the scientific accuracy of information, (2) the provision of misinformation to future donors that may result in them suffering unintended consequences from consenting to medical procedures before death (e.g, organ preservation and suitability for transplantation), and (3) the unmanaged conflict of interests for organizations charged with implementing these campaigns, (i.e, dual advocacy for transplant recipients and donors). We conclude the following: (1) media campaigns about healthcare should communicate accurate information to the general public and disclose factual materials with the least amount of bias; (2) conflicting interests in media campaigns should be managed with full public transparency; (3) media campaigns should disclose the practical implications of procurement as well as acknowledge the medical, legal, and religious controversies of determining death in organ donation; (4) organ-donor registration must satisfy the criteria of informed consent; (5) media campaigns should serve as a means of public education about organ donation and should not be a form of propaganda. (shrink)

The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy (...) raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden. (shrink)

In 1968, the Harvard criteria equated irreversible coma and apnea with human death and later, the Uniform Determination of Death Act was enacted permitting organ procurement from heart-beating donors. Since then, clinical studies have defined a spectrum of states of impaired consciousness in human beings: coma, akinetic mutism, minimally conscious state, vegetative state and brain death. In this article, we argue against the validity of the Harvard criteria for equating brain death with human death. Brain death does not disrupt somatic (...) integrative unity and coordinated biological functioning of a living organism. Neurological criteria of human death fail to determine the precise moment of an organism’s death when death is established by circulatory criterion in other states of impaired consciousness for organ procurement with non-heart-beating donation protocols. The criterion of circulatory arrest 75 s to 5 min is too short for irreversible cessation of whole brain functions and respiration controlled by the brain stem. Brain -based criteria for determining death with a beating heart exclude relevant anthropologic, psychosocial, cultural, and religious aspects of death and dying in society. Clinical guidelines for determining brain death are not consistently validated by the presence of irreversible brain stem ischemic injury or necrosis on autopsy; therefore, they do not completely exclude reversible loss of integrated neurological functions in donors. The questionable reliability and varying compliance with these guidelines among institutions amplify the risk of determining reversible states of impaired consciousness as irreversible brain death. The scientific uncertainty of defining and determining states of impaired consciousness including brain death have been neither disclosed to the general public nor broadly debated by the medical community or by legal and religious scholars. Heart-beating or non-heart-beating organ procurement from patients with impaired consciousness is de facto a concealed practice of physician-assisted death, and therefore, violates both criminal law and the central tenet of medicine not to do harm to patients. Society must decide if physician-assisted death is permissible and desirable to resolve the conflict about procuring organs from patients with impaired consciousness within the context of the perceived need to enhance the supply of transplantable organs. (shrink)

Advance health care directives and informed consent remain the cornerstones of patients' right to self-determination regarding medical care and preferences at the end-of-life. However, the effectiveness and clinical applicability of advance health care directives to decision-making on the use of life support systems at the end-of-life is questionable. The Uniform Anatomical Gift Act (UAGA) has been revised in 2006 to permit the use of life support systems at or near death for the purpose of maximizing procurement opportunities of organs medically (...) suitable for transplantation. Some states have enacted the Revised UAGA (2006) and a few of those have included amendments while attempting to preserve the uniformity of the revised Act. Other states have introduced the Revised UAGA (2006) for legislation and remaining states are likely to follow soon. (shrink)

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's autonomy. (...) We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. (shrink)

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed (...) intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death. (shrink)

The ArgumentIt has long been apparent that in the nineteenth century, mathematics in France and England developed along different lines. The differences, which might well be labelled stylistic, are most easy to see on the foundational level. At first this may seem surprising because it is such a fundamental area, but, upon reflection, it is to be expected. Ultimately discussions about the foundations of mathematics turn on views about what mathematics is, and this is a question which is answered by (...) a variety of different groups including mathematicians, students, curricular planners, parents, etc. Mathematical practice rests on some kind of mixture of the answers to this fundamental question which come from these diverse groups. Comparing the cultural matrices which supported mathematics in France and Britain in the first decades of the nineteenth century sheds light on the real though often subtle differences in the ways the subject was pursued in the two countries. (shrink)

This paper presents research on the moral sensibility of six pre-service teachers in an undergraduate teacher education program. Using their reflective writing across their first two semesters of coursework as well as focus group interviews in their third semester as sources of data, the paper identifies and describes three distinctive types of moral sensibility and examines ways in which moral sensibility interacts with experiences in teacher education. Suggestions for explicitly incorporating the moral in pre-service teacher education are presented.

This paper is motivated by the increasing popularity of efficient designs for stated choice experiments. The objective in efficient designs is to create a stated choice experiment that minimizes the standard errors of the estimated parameters. In order to do so, such designs require specifying prior values for the parameters to be estimated. While there is significant literature demonstrating the efficiency improvements of employing efficient designs, the bulk of the literature tests conditions where the priors used to generate the efficient (...) design are assumed to be accurate. However, there is substantially less literature that compares how different design types perform under varying degree of error of the prior. The literature that does exist assumes small fractions are used, which is in contrast to computer-aided surveys that readily allow for large fractions. Further, the results in the literature are abstract in that there is no reference point to provide clear insight on the magnitude of any issue. Our objective is to analyze the robustness of different designs within a typical stated choice experiment context of a trade-off between price and quality. We use as an example transportation mode choice, where the key parameter to estimate is the value of time. Within this context, we test many designs to examine how robust efficient designs are against a misspecification of the prior parameters. The simple mode choice setting allows for insightful visualizations of the designs themselves and also an interpretable reference point for the range in which each design is robust. Not surprisingly, the D-efficient design is most efficient in the region where the true population VOT is near the prior used to generate the design: the prior is $20/h and the efficient range is $10–$30/h. However, the D-efficient design quickly becomes the most inefficient outside of this range, and the estimation significantly degrades above $50/h. The orthogonal and random designs are robust for a much larger range of VOT. The robustness of Bayesian efficient designs varies depending on the variance that the prior assumes. Implementing two-stage designs that first use a small sample to estimate priors are also not robust relative to uninformative designs. Arguably, the random design performs as well as any design, and it will perform even better if data cleaning is done to remove choice tasks where one alternative dominates the other. (shrink)

Joan McGregor argues that “colleges and universities should adopt as part of their core mission the development of skills of civil discourse” rather than engaging in the practice of restricting controversial speakers from making presentations on campuses. I agree with McGregor concerning the need for increased civil discourse. However, this does not mean universities should welcome speakers to publicly present any material they wish without restriction or oversight. In this paper, I make three main arguments: (i) Colleges (...) and universities have a duty to protect members of the campus community from the harm and exclusion resulting from hateful or harmful speech, in the same way that they must protect them from sexual assaults and concussions. (ii) In the vast majority of cases, this duty can be fulfilled by holding speakers to standards of discourse that prevail in academic debate, and insisting on a number of procedural requirements. (iii) We should be wary of conservative arguments framed in terms of free speech, because they can be deployed to undermine important functions of the university in a democratic society, namely, to teach students how to be discerning citizens, and to protect thinkers willing to be critical of the government and the ruling classes. (shrink)

ArgumentThis paper traces the changing fortunes of natural theology in two generations of an English family. The group is represented in the first generation by the Unitarian radical, William Frend, and in the second by the spiritualist Sophia Frend De Morgan and her husband, the mathematician Augustus De Morgan. The Frend/DeMorgans were distinguished from the naturalistic Darwins by their commitment to reason; they were a quintessentially urban group whose impulses to natural theology flowed from a God they encountered through their (...) minds. For William Frend, natural theology was rooted in a tightly disciplined, linguistic view of reason that linked theological and mathematical understandings; in the De Morgan's generation, however, understandings of mathematics and of language changed in ways that undercut the power of Frend's reasoned approach. In its rise and fall this family story of reasoned theology is co-temporal with the natural theology that was wrecked on the rocks of Darwinian evolutionary theory. (shrink)

Background: Although attention to healthcare ethics in rural areas has increased, specific focus on rural palliative care is still largely under-studied and under-theorized. The purpose of this study was to gain a deeper understanding of the values informing good palliative care from rural individuals' perspectives. Methods: We conducted a qualitative ethnographic study in four rural communities in Western Canada. Each community had a population of 10, 000 or less and was located at least a three hour travelling distance by car (...) from a specialist palliative care treatment centre. Data were collected over a 2-year period and included 95 interviews, 51 days of field work and 74 hours of direct participant observation where the researchers accompanied rural healthcare providers. Data were analyzed inductively to identify the most prevalent thematic values, and then coded using NVivo. Results: This study illuminated the core values of knowing and being known, being present and available, and community and mutuality that provide the foundation for ethically good rural palliative care. These values were congruent across the study communities and across the stakeholders involved in rural palliative care. Although these were highly prized values, each came with a corresponding ethical tension. Being known often resulted in a loss of privacy. Being available and present created a high degree of expectation and potential caregiver strain. The values of community and mutuality created entitlement issues, presenting daunting challenges for coordinated change. Conclusions: The values identified in this study offer the opportunity to better understand common ethical tensions that arise in rural healthcare and key differences between rural and urban palliative care. In particular, these values shed light on problematic health system and health policy changes. When initiatives violate deeply held values and hard won rural capacity to address the needs of their dying members is undermined, there are long lasting negative consequences. The social fabric of rural life is frayed. These findings offer one way to re-conceptualize healthcare decision making through consideration of critical values to support ethically good palliative care in rural settings. (shrink)