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)

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)

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)

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)

: 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)

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)