Bioethical decision-making depends on presuppositions about the function and goal of bioethics. The authors in this issue of The Journal of Medicine and Philosophy share the assumption that bioethics is about resolving cases, not about moral theory, and that the best method of bioethical decision-making is that which produces useful answers. Because we have no universally agreed upon background moral theory which can serve as the basis for bioethical decision-making, they try to move bioethics away from theory. For them, a (...) good method of bioethical decision-making is one which resolves cases in ways that are justifiable to the parties involved, not necessarily in ways that bring us ‘close’ to the right and the true. The authors consider how the move away from theory and toward actual cases is best accomplished. In particular, the debate in this issue is about specification, specified principlism, and casuistry. (shrink)

The last two decades have witnessed intense debate over the ethical legitimacy of placebo controlled trials. Most of the arguments for and against the use of PCTs turn on one of the following issues: the compatibility of the obligations of clinicians and researchers with PCTs, the scientific merit of PCTs, and the influence of patients' and subjects' perceptions, ability to consent, expectations, and rights on the permissibility of PCTs. I introduce each of these categories and assess the principal arguments in (...) each group. I argue that, although some of the arguments against PCTs have limitations, they do inform the debate in significant ways by pointing to important constraints on PCTs. Those concerning patients' and subjects' perceptions, capacity to consent, expectations, and rights are particularly instructive. They do not, for the most part, sustain an absolute prohibition of PCTs, but they do suggest types of PCTs that are inappropriate and they indicate issues that must be addressed when PCTs are conducted. I argue that we should look to the reasonableness and permissibility of informed refusals of care to evaluate the extent to which a trial is a legitimate PCT ; to determine which potential subjects should be considered eligible to enroll in a PCT ; and to inform the language that should be used in describing the study as part of the informed consent process. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in (...) specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that occur when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging questions in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

Issues of institutional identity and integrity in Roman Catholic health care institutions have been addressed at the level of individual institutions as well as by organizations of Catholic health care providers and at various levels in the Church hierarchy. The papers by Carol Taylor, C.S.F.N, Thomas Shannon, Kevin O’Rourke, O.P., Gerard Magill in this volume provide a significant contribution to concerns of Roman Catholic health care institutions as they face the challenges of providing health care in a secular, pluralistic, market-driven (...) economy. One way to understand institutional integrity is as a measure of the coherence between what an institution identifies as its commitments (its stated moral character), what an institution does (its manifest moral character) and an institution’s fundamental moral commitments (its deep moral character). The essays in this volume support this model of integrity. Although it is not their explicit focus, the four essays together provide a vision of institutional integrity for Catholic health care institutions. Each author focuses on one of the three central aspects of integrity: what one identifies as one’s commitments (Taylor), how one's actions reflect one’s values (Shannon and Magill), and what one is or what one values at a deep level (O’Rourke). I will offer a brief overview of the ways in which the integrity of Catholic health care institutions has been addressed. Then I will consider the four essays and show how each offers an analysis of one of the three critical elements of integrity. (shrink)

This article addresses the impact of the potential conflict between the roles of physicians who are both clinicians and researchers on the recruitment of persons into research trials. It has been proposedthat a physician breaches inter-role confidentiality when he or she uses information gathered in his or her clinical role to inform patients about trials for which they may be eligible and that clinician-researchers should adopt a model of preliminary consent to be approached about research prior to commencing a clinical (...) relationship. This article argues that even if we grant the legitimacy of inter-role confidentiality (which is open to question), there are circumstances in which other obligations physicians bear override the obligation of inter-role confidentiality. Moreover, it is argued that the practice of preliminary consent is morally suspect and that such consent cannot be deemed valid. The article concludes with a series of recommendations of ways in which the legitimate concern regarding the conflicting roles of clinician-researchers can be addressed in the recruitment stage of research. (shrink)

Issues in bioethics often turn, at least in part, on the law and regulatory requirements. Consisting of chapters that address particular bioethics topics from the law’s perspective, this fascinating book includes: an introduction to the American legal system papers identifying the principal ways in which the law influences discussions and decisions concerning each of the topics highlighted supplemental papers on certain areas that address the influence and status of the law in countries other than the United States. Covering traditional topics (...) in bioethics, such as determinations of death and health care decisions for vulnerable groups, this study also explores emerging areas such as conflicts of interest in research, genetics, and privacy and confidentiality in the electronic age. Incisive and thought-provoking, this volume provides readers with a rich context for understanding the intersection between the law on bioethics and the central issues in bioethics. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in (...) specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

: Four principal arguments have been offered in support of requiring public and private third-party payers to help fund medical research: (1) many of the costs associated with clinical trial participation are for routine care that would be reimbursed if delivered outside of a trial; (2) there is a need to promote scientific research and medical progress and lack of coverage is an impediment to enrollment; (3) to cover the costs of trials expands health care and treatment options for the (...) sick; and (4) it is beneficial for private insurers to cover the costs associated with cancer clinical trials because doing so makes such companies more attractive to consumers. Although many see third-party-payer coverage as a victory for patients and for the future of research, requiring coverage of services provided in a trial beyond those that would be provided to a comparable patient outside the research context raises a number of concerns. (shrink)

This chapter contains sections titled: The Conceptual Geography Some Teleological Approaches to Distributing Health Care Hypothetical Contractor Theory Libertarian Approaches: Autonomy by Default Conclusion.

ABSTRACT In establishing National Bioethics Organisations (NBOs), liberal democracies seek to acknowledge the diversity of strongly held ethical positions and the imperative to engage in public debate about important bioethical decisions. NBOs are typically given a range of responsibilities, including contributing to and stimulating public debate; providing expert opinion on relevant issues for policy deliberations; and developing public policy. The state is now found to have an interest in areas previously thought to be a matter of individual choice. NBOs can (...) provide one way of opening up public debate to allow the diversity of views to be heard in a manner that is well‐informed, articulate and responsive to both expert and ‘lay’ public views. We draw on debates in political theory about democratic decision‐making and on the policy making roles of some key NBOs. We are particularly interested in examining the capacity of NBOs to meet the democratic ideal of effective participation by the public, or citizenry, especially by those who are directly affected by the policies, in the development of effective public policy. We provide a basic framework for policy development involving NBOs that can begin to meet this ideal, a process of ‘contested deliberation’. (shrink)

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public’s health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to (...) be expanded in two ways to reflect a ‘public health notion of post-market effectiveness’, which incorporates normative public health considerations: effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize a vaccine’s effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense. (shrink)

The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation, to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity (...) in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this “knowing” or “being better at judging” is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts. (shrink)

The nature, possibility, and implications of ethics expertise in general and of bioethics expertise in particular has been the focus of extensive debate for over thirty years. What is ethics expertise and what does it enable experts to do? Knowing what ethics expertise is can help answer another important question: What, if anything, makes a claim of expertise legitimate? In other words, how does someone earn the appellation “ethics expert?” There remains deep disagreement on whether ethics expertise is possible, and (...) if so, what constitutes such expertise and what it entails and legitimates. Discussion of bioethics expertise has become particularly important given the growing presence of bioethicists in the clinical setting as well as efforts to professionalize bioethics through codes of ethics and certification efforts. Unlike in the law or in engineering, where there may be a body of knowledge that professional organizations or others have articulated as important for education and training of experts, ethics expertise admits of no such body of knowledge or required experience. Nor is there an entity seen as having the authority to articulate the necessary scope of knowledge. Questions about whether there is such a body of knowledge for particular areas within bioethics have emerged and played a central role in professionalization efforts in recent years, especially in the area of clinical ethics. (shrink)

Volume 20, Issue 7, July 2020, Page 139-141.

I argue that valid informed consent is ethically required for organ donation from individuals declared dead using neurological criteria. Current policies in the U.S. do not require this and, not surprisingly, current practices inhibit the possibility of informed consent. Relevant information is withheld, opportunities to ensure understanding and appreciation are extremely limited, and the ability to make and communicate a free and voluntary decision is hindered by incomplete disclosure and other practices. Current practices should be revised to facilitate valid informed (...) consent for organ donation. (shrink)

This volume brings together a set of critical essays on the thought of Professor Doctor H. Tristram Engelhardt Jr., Co-Founding Editor of the Philosophy and Medicine book series. Amongst the founders of bioethics, Professor Engelhardt, looms large. Many of his books and articles have appeared in multiple languages, including Italian, Romanian, Portuguese, Spanish, and Chinese. The essays in this book focus critically on a wide swath of his work, in the process elucidating, critiquing, and/or commending the rigor and reach of (...) his thought. This volume compasses analyses of many different aspects of Engelhardt's work, including social and political philosophy, biopolitics, the philosophy of medicine, and bioethics. It brings together internationally known scholars to assess key elements of Engelhardt's work. (shrink)

Decisions regarding clinical procedures or research participation typically require the informed consent of individuals. When individuals are unable to give consent, the informed permission of a legally authorized representative or surrogate is required. Although many proposed procedures are aimed primarily at benefiting the individual, some are not. I argue that, particularly when individuals are asked to assume risks primarily or exclusively for the benefit of others, family members ought to be engaged in the informed consent process. Examples of procedures in (...) which individuals are asked to assume risks primarily or exclusively for the benefit of others include living organ donation and research participation. (shrink)

Questions concerning the role (or lack thereof) of God in morality are implicitly or explicitly important in Western philosophical ethics. I describe some of the different ways philosophers treat (or ignore) God and the foundations of morality more generally, and I highlight some of the implications of these approaches for bioethics. I demonstrate that the starting points we choose for morality set the course for fundamentally different accounts of what is permissible and impermissible, good and bad, and right and wrong.

Within and among societies, there are competing understandings of the status of children, including debates over whether they can bear rights and, if so, which rights they bear and against whom, and their capacity to make decisions and be held responsible and accountable for actions. There also are different understandings of what constitutes a family; what authority parents have over and regarding their children; and what should happen to children who are without parents because of death, desertion, or imprisonment. These (...) and other related debates reflect deep differences in worldviews, in how one understands the legitimate role of the state, in how one comes to know the proper way to raise children, and so on. The United Nations Convention on the Rights of the Child purports to reflect international convergence on the rights of children, on how decisions concerning children should be made, and on how children ought to be treated by the state and by their parents. This paper examines whether the Convention's framework for decision making concerning children is an appropriate framework for pediatric bioethics. Questions about how to make health care decisions for children ultimately are questions of who is in authority to make and judge such decisions. Establishing who is in authority, determining whether there are any limits to that authority and, if so, defining those limits should be the focus of efforts to develop and implement a pediatric decision-making framework. (shrink)

Plans to attempt what has been called a head transplant, a body transplant, and a head-to-body transplant in human beings raise numerous ethical, social, and legal questions, including the circumstances, if any, under which it would be ethically permissible to attempt whole-body transplantation (WBT) in human beings, the possible effect of WBT on family relationships, and how families should shape WBT decisions. Our assessment of many of these questions depends partially on how we respond to sometimes centuries-old philosophical thought experiments (...) about personal identity. As with so much in bioethics, it is impossible to escape, or at least inadvisable to try to bypass, the relevant foundational philosophical concerns. (shrink)

The 20th century eugenics movement in the USA and contemporary practices involving prenatal screening (PNS), prenatal diagnosis (PND), abortion and preimplantation genetic diagnosis (PGD) share important morally relevant similarities. I summarise some features of the 20th century eugenics movement; describe the contemporary standard of care in the USA regarding PNS, PND, abortion and PGD; and demonstrate that the ‘old eugenics’ the contemporary standard of care share the underlying view that social resources should be invested to prevent the birth of people (...) with certain characteristics. This comparison makes evident the difficulty of crafting moral arguments that treat some uses of PNS, PND, abortion and PGD as licit and others as illicit. (shrink)

Recent work calls for excluding clinical ethics consultants’ religious ethical commitments from formulating recommendations about particular cases and communicating those recommendations. I demonstrate that three arguments that call for excluding religious ethical commitments from this work logically imply that consultants may not use their secular ethical commitments in their work. The call to sever clinical ethics consultation from the ethical commitments of clinical ethics consultants has implications for the scope of work consultants may do and for the competencies required for (...) such work. (shrink)

The popularity and availability of global health experiences has increased, with organizations helping groups plan service trips and companies specializing in “voluntourism,” health care professionals volunteering their services through different organizations, and medical students participating in global health electives. Much has been written about global health experiences in resource poor settings, but the literature focuses primarily on the work of health care professionals and medical students. This paper focuses on undergraduate student involvement in short term medical volunteer work in resource (...) poor countries, a practice that has become popular among pre-health professions students. We argue that the participation of undergraduate students in global health experiences raises many of the ethical concerns associated with voluntourism and global health experiences for medical students. Some of these may be exacerbated by or emerge in unique ways when undergraduates volunteer. Guidelines and curricula for medical student engagement in global health experiences have been developed. Guidelines specific to undergraduate involvement in such trips and pre-departure curricula to prepare students should be developed and such training should be required of volunteers. We propose a framework for such guidelines and curricula, argue that universities should be the primary point of delivery even when universities are not organizing the trips, and recommend that curricula should be developed in light of additional data. (shrink)

There are competing accounts of the birth of bioethics. Despite the differences among them, these accounts share the claim that bioethics was not born in a single disciplinary home or in a single social space, but in numerous, including hospitals, doctors' offices, research laboratories, courtrooms, medical schools, churches and synagogues, and philosophy classrooms. This essay considers the interdisciplinarity of bioethics and the contribution of new disciplines to bioethics. It also explores the implications of interdisciplinarity for bioethics education. As bioethics develops, (...) it will be helpful to identify essential elements in the education of bioethicists and to distinguish between members of other disciplines who make important contributions to bioethics and bioethicists. (shrink)

In most, if not all, jurisdictions with active organ transplantation programs, there is a persistent desire to increase donation rates because the demand for transplantable organs exceeds the supply. China, in particular, faces an extraordinary gap between the number of organs donated by deceased donors and the number of people seeking one or more transplants. China might look to Western countries with higher donation rates to determine how best to introduce Western practices into the Chinese system. In attempting to increase (...) its organ donation rate, China must not only ensure that its organ donation system reflects different Chinese cultural values, but also that it avoids the ethical problems of the United States and of other Western systems. This article examines four such problems. They concern the family, obtaining permission for organ donation, the definition and diagnosis of “brain death,” and trust. Revisions to the Chinese system should involve a careful look to China and Chinese cultural resources rather than to Western models. (shrink)

The term ‘culture wars’ has been used to describe deep, apparently intractable, disagreements between groups for many years. In contemporary discourse, it refers to disputes regarding significant moral matters carried out in the public square and for which there appears to be no way to achieve consensus or compromise. One set of battle lines is drawn between those who hold traditional Christian commitments and those who do not. Christian bioethics is nested in a set of moral and metaphysical understandings that (...) collide with those of the dominant secular culture. The result is a gulf between a moral life and an approach to bioethics framed in the face of a transcendent God and a final judgment versus a moral life and an approach to bioethics framed as if the world were without ultimate meaning and as if death were the end of personal existence. These approaches are separated by a moral and metaphysical gulf that sustains incompatible life worlds and incompatible understandings of bioethics. Attempts to bridge the gulf with secular reason are ineffective because there is no shared conception of reason or standard of evidence. Efforts to use the state to enforce a particular set of metaphysical and moral commitments, whether secular or religious, lead to public disputes with a war-like character. (shrink)

Contemporary bioethics is, at least in part, the product of biomedical and sociopolitical changes in the middle to latter part of the 20th century. These changes prompted reflection on deep moral questions at a time when traditional sources of moral guidance no longer were widely respected and, in some cases, were being rejected. In light of this, scholars, policy makers, and clinicians sought to identify a common morality that could be used among persons with different moral commitments to resolve disputes (...) and guide clinical practice and health policy. The concept of the common morality remains important in bioethics. This essay considers the common morality in light of the work of H. Tristram Engelhardt, Jr. (shrink)

“Outsiders” addressing ethical issues in medicine—Strangers at the Bedside —became “bioethicists.” Bioethicists providing research ethics consultation have been described as “stranger...