In Working Virtue: Virtue Ethics and Contemporary Moral Problems, leading figures in the fields of virtue ethics and ethics come together to present the first ...

An anthology of essays by up-and-coming feminist and gay writers reevaluates the objectives and philosophy of the feminist movement, calling for more emphasis on liberating women than on guarding their sexual behavior.

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...) sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

This essay explores three issues in respect for autonomy that pose unfinished business for the concept. By this, I mean that the dialogue over them is ongoing and essentially unresolved. These are: whether we ought to respect persons or their autonomous choices; the role of relational autonomy; and whether nonhuman animals can be autonomous. In attending to this particular set of unfinished business, I highlight some critical moral work left aside by the concept of respect for autonomy as understood in (...) Beauchamp and Childress’ Principles of Biomedical Ethics. Specifically, while significant pragmatic traction is gained by the authors’ focus on autonomous choice, carving such a focus out from the broader questions of moral respect and the autonomy of the person leaves aside a number of questions that we might have thought a view about respect for autonomy in biomedicine ought to answer. These include: How should physicians respond when autonomous patients make decisions that appear nonautonomous? What is the impact of the view that autonomy is “relational” for cross-cultural differences in how autonomy is respected? If chimpanzees can be autonomous, what does that mean for how they should be treated? (shrink)

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing. Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. Despite their differences, these ethics frameworks traditionally share a central concern for individual rights. We examine two putative individual rights—the right not to know, and the child’s (...) right to an open future—frequently invoked in discussions of predictive genetic testing, in order to explore their potential contribution to evaluating this new practice. Ultimately, we conclude that traditional clinical and public health ethics frameworks, and these two rights in particular, should be complemented by a social justice perspective in order adequately to characterize the ethical dimensions of general population PGS programs. (shrink)

In their Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” Lynch et al. propose a framework for ethical payment to research participants and apply it to the c...

Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is true. Without explicit (...) justification, it is not clear why or whether this should be the case. Ethics regulations guiding human subject research include principles such as respect for persons—and related duties—that are required as a matter of justice while regulations guiding animal subject research attend only to highly circumscribed considerations of welfare. Further, the regulations guiding research on animals discount any consideration of animal welfare relative to comparable human welfare. This paper explores two of the most promising justifications for these differences␣between the two sets of regulations. The first potential justification points to lesser moral status for animals on the basis of their lesser capacities. The second potential justification relies on a claim about the permissibility of moral partiality as␣found in common morality. While neither potential justification is sufficient to justify the regulatory difference as it stands, there is possible common ground between supporters of some regulatory difference and those rejecting the current difference. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their (...) body is a valued commodity in clinical trials research". It is perhaps surprising, then, that commodification is little discussed in the bioethics literature on phase I... (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

Should monkeys be used in painful and often deadly infectious disease research that may save many human lives? This is the challenging question that Anne Barnhill, Steven Joffe, and Franklin G. Miller take on in their carefully argued and compelling article “The Ethics of Infection Challenges in Primates.” The authors offer a nuanced and even-handed position that takes philosophical worries about nonhuman primate moral status seriously and still appreciates the very real value of such research for human welfare. Overall, they (...) argue for an extension and revision of the recommendations regarding chimpanzee research offered by the Institute of Medicine in 2011; the practical upshot of their argument would allow for infection challenge research for promising interventions for Ebola and Marburg virus diseases but not for smallpox or the common cold. The IOM recommendations regarding chimpanzee research put in motion an exceptionalist policy for this great ape population. Barnhill and colleagues’ proposal would enlarge the scope of that exceptionalism to embrace NHPs other than great apes. But is such exceptionalism warranted? It is not obvious to me either that the more sophisticated capacities of a species as a whole give it greater ethical protections or that less intellectually or socially sophisticated animals ought to therefore receive less protection when it comes to painful experimental interventions. (shrink)

While bioethics as a field has concerned itself with methodological issues since the early years, there has been no systematic examination of how ethics is incorporated into research on the Ethical, Legal and Social Implications of the Human Genome Project. Yet ELSI research may bear a particular burden of investigating and substantiating its methods given public funding, an explicitly cross-disciplinary approach, and the perceived significance of adequate responsiveness to advances in genomics. We undertook a qualitative content analysis of a sample (...) of ELSI publications appearing between 2003 and 2008 with the aim of better understanding the methods, aims, and approaches to ethics that ELSI researchers employ. We found that the aims of ethics within ELSI are largely prescriptive and address multiple groups. We also found that the bioethics methods used in the ELSI literature are both diverse between publications and multiple within publications, but are usually not themselves discussed or employed as suggested by bioethics method proponents. Ethics in ELSI is also sometimes undistinguished from related inquiries. (shrink)

From the late 1950s through the early 1970s, Harry F. Harlow's primate laboratory at the University of Wisconsin–Madison undertook a series of studies on infant rhesus macaque monkeys that gained the attention of both animal welfare advocates and the scientific community.1 Establishing one of the first primate research laboratories in 1932, Harlow began his career as a primate researcher by studying primate learning capabilities and shredding previous assumptions within psychology that primates were restricted to the conditioned learning of a rat. (...) As his need for subjects in particular age ranges and easily susceptible to study grew in the 1950s, he again broke research ground by establishing a captive breeding... (shrink)

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria, were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression program through the (...) National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression. (shrink)

In this brief, we argue that there is a diversity of ways in which humans (Homo sapiens) are ‘persons’ and there are no non-arbitrary conceptions of ‘personhood’ that can include all humans and exclude all nonhuman animals. To do so we describe and assess the four most prominent conceptions of ‘personhood’ that can be found in the rulings concerning Kiko and Tommy, with particular focus on the most recent decision, Nonhuman Rights Project, Inc v Lavery.

Purpose: We sought to examine the ethical, legal, and social implications (ELSI) literature research and scholarship types, topics, and contributing community fields of training as a first step to charting the broader ELSI community’s future priorities and goals. Methods: We categorized 642 articles and book chapters meeting inclusion criteria for content in both human genetics or genomics and ethics or ELSI during a 5-year period (2003–2008) according to research and scholarship types, topics, and the area of advanced training of the (...) first-listed author. Research and scholarship type categories were developed and characterized through in-depth review of 95 randomly sampled publications from the larger group. Results: There is a single dominant approach to ELSI, which focuses on ethical and other social issues “downstream” of advances in genomics, the contributors to which predominately have advanced training in medicine or science fields other than social science. A comparatively low percentage of publications primarily offer policy recommendations, and these are much more likely to be written by those with advanced training in law than is the case for the literature as a whole. Social science studies predominately employ qualitative methods and vary significantly with respect to the extent and types of recommendations offered. Two further types of ELSI research and scholarship offer alternative models for so-called “normative” work in this field. Conclusion: Considering topics, training, and types of ELSI research and scholarship from the most recent past allows for a baseline perspective that is sorely needed in charting this field’s future course. (shrink)

Recent advances in next generation sequencing along with high hopes for genomic medicine have inspired interest in genomic research with the newly dead. However, applicable law does not adequately determine ethical or policy responses to such research. In this paper we propose that such research stands at a crossroads between other more established biomedical clinical and research practices. In addressing the ethical and policy issues raised by a particular research project within our institution comparatively with these other practices, we illustrate (...) the moral significance of paying careful heed to where one looks for guidance in responding to ethical questions raised by a novel endeavor. (shrink)

Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease, suffering, and death arising, or potentially arising, from natural outbreaks or intentional deployment of some of the world’s most dreaded pathogens. Top priority research goals include finding vaccines to prevent, diagnostic tools to detect, and medicines for smallpox, plague, ebola, anthrax, tularemia, and viral hemorrhagic fevers, among many other pathogens (National Institute of Allergy and Infectious Diseases [NIAID] priority pathogens). To this end, increased funding for conducting (...) research, developing research facilities, and purchasing (stockpiling) developed vaccines, diagnostic tools, and therapeutics .. (shrink)

Background: Discussion of the influence of money on bioethics research seems particularly salient in the context of research on the ethical, legal, and social implications (ELSI) of human genomics, as this research may be financially supported by the ELSI Research Program. Empirical evidence regarding the funding of ELSI research and where such research is disseminated, in relation to the specific topics of the research and methods used, can help to further discussions regarding the appropriate influence of specific institutions and institutional (...) contexts on ELSI and other bioethics research agendas. Methods: We reviewed 642 ELSI publications (appearing between 2003 and 2008) for reported sources of funding, forum for dissemination, empirical and nonempirical methods, and topics of investigation. Results: Most ELSI research is independent of direct grant-based funding sources; 66% reported no such sources of funding. The National Human Genome Research Institute (NHGRI) is the most dominant source of funding; 16% of publications acknowledged at least one source of NHGRI grant funding. Funding is acknowledged more frequently in empirical than nonempirical publications and more frequently in publications in public health journals than in any other ELSI research dissemination forums. Dominant research topics vary by publication forum and by reported funding. Conclusions: ELSI research is surprisingly independent of direct grant-based funding, yet correlations are apparent between this type of funding and publication placement, topics addressed, and methods used, implying a not insignificant influence on ELSI research agenda setting. However, given the relatively low percentage of publications acknowledging external grant-based funding, as well as other significant correlations between publication placement and topics addressed, additional institutional contexts, perhaps related to professional advancement or valuation, may shape research agendas in ways that potentially exceed the direct influences of grant-based funding in this area. In some cases, grant-based funding may actually counter other potentially problematic institutional influences. (shrink)

"Amid ongoing debate about health care reform, the need for informed analyses of U.S. health policy is greater than ever. The twelve original essays in this volume show that common public debates routinely bypass complex ethical, sociocultural, historical, and political questions about how we should address ideals of justice and equality in health care. Integrating perspectives from the humanities, social sciences, medicine, and public health, the contributors illuminate the relationships between justice and health inequalities to complicate and enrich debates often (...) dominated by simplistic narratives"--. (shrink)

The article "Picking and Choosing Among Phase I Trials", written by Jill A. Fisher, Torin Monahan and Rebecca L. Walker, was originally published Online First without Open Access. After publication in volume 16, issue 4, page 535-549 the author decided to opt for Open Choice and to make the article an Open Access publication.