Background: An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. Methods: We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and (...) were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Results: Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. Conclusions: The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature. (shrink)

Managed care is evolving in ways that pose unique ethical challenges to those interested in the intersection of clinical and organizational ethics. For example, Disease Management is a form of managed care that has emerged in response to chronic illness. DM is a healthcare management tool that coordinates resources across an entire health care delivery system and throughout the life cycle of chronic disease. Health Maintenance Organizations have reduced some costs in the delivery of acute care, but real cost savings (...) will result only with greater efficiencies in the delivery of costly chronic care. DM is a systematic, population-based approach that identifies persons at risk of chronic ailment, intervenes with specific programs of care, measures clinical and other outcomes, and provides continuous quality improvement. Characterized as a movement to patient-driven services, DM involves a complex web of provider relations. (shrink)

Objectives—To assess whether UK and US health care professionals share the views of medical ethicists about medical futility, withdrawing/withholding treatment, ordinary/extraordinary interventions, and the doctrine of double effectDesign, subjects and setting–A 138-item attitudinal questionnaire completed by 469 UK nurses studying the Open University course on “Death and Dying” was compared with a similar questionnaire administered to 759 US nurses and 687 US doctors taking the Hastings Center course on “Decisions near the End of Life”.Results–Practitioners accept the relevance of concepts widely (...) disparaged by bioethicists: double effect, medical futility, and the distinctions between heroic/ordinary interventions and withholding/ withdrawing treatment. Within the UK nurses' group a “rationalist” axis of respondents who describe themselves as having “no religion” are closer to the bioethics consensus on withholding and withdrawing treatment.Conclusions—Professionals' beliefs differ substantially from the recommendations of their professional bodies and from majority opinion in bioethics. Bioethicists should be cautious about assuming that their opinions will be readily accepted by practitioners. (shrink)

Decisions about allocation of limited healthcare resources are frequently controversial. These decisions are usually based on careful analysis of medical, scientific and health economic evidence. Yet, decisions are also necessarily based on value judgements. There may be differing views among health professionals about how to allocate resources or how to evaluate existing evidence. In specific cases, professionals may have strong personal views (contrary to professional or societal norms) that treatment should or should not be provided. Could these disagreements rise to (...) the level of a conscientious objection? If so, should conscientious objections to existing allocation decisions be accommodated? In the first part of this paper, I assess whether resource allocation could be a matter of conscience. I analyse conceptual and normative models of conscientious objection and argue that rationing could be a matter for conscience. I distinguish between negative and positive forms: conscientious non-treatment and conscientious treatment. In the second part of the paper, I identify distinctive challenges for conscientious objections to resource allocation. Such objections are almost always inappropriate. (shrink)

Patients and physicians often perceive the current health care system to be unfair, in part because of the ways in which coverage decisions appear to be made. To address this problem the Ethical Force Program, a collaborative effort to create quality improvement tools for ethics in health care, has developed five content areas specifying ethical criteria for fair health care benefits design and administration. Each content area includes concrete recommendations and measurable expectations for performance improvement, which can be used by (...) those organizations involved in the design and administration of health benefits packages, such as purchasers, health plans, benefits consultants, and practitioner groups. (shrink)

Patients and physicians often perceive the current health care system to be unfair, in part because of the ways in which coverage decisions appear to be made. To address this problem the Ethical Force Program, a collaborative effort to create quality improvement tools for ethics in health care, has developed five content areas specifying ethical criteria for fair health care benefits design and administration. Each content area includes concrete recommendations and measurable expectations for performance improvement, which can be used by (...) those organizations involved in the design and administration of health benefits packages, such as purchasers, health plans, benefits consultants, and practitioner groups. (shrink)

is a review of 5 ethically based healthcare funding models discussed in the literature that are currently used to justify funding choices. If healthcare professionals and managers are better informed about the ethical reasoning behind funding choices, they could better determine which resource allocation alternatives to support. But where should we spend our resources? Although healthcare professionals have a duty to advocate for all healthcare recipients to receive a fair share of resources, the author concludes that our greater duty as (...) a profession is to the good of society as a whole. Balancing allocation decisions by considering all of the competing healthcare funding models and the ethical bases for them is suggested rather than to advocate too strongly for favored models.... (shrink)

Finding an effective microbicide that could substantially lower women’s risk of acquiring HIV infection is an ethical imperative. Women and girls continue to be disproportionally affected by HIV in sub-Saharan Africa. Ethics guidelines for conducting preventive HIV microbicide trials call for steps that intertwine biomedical research and public health. Ethical considerations include adequate studies of the safety of microbicides, the use of placebo controls in future trials once a microbicide is shown to be effective, whether leftover microbicide from a trial (...) that demonstrated efficacy should be made available to the public or used in the control group of a future trial, what preventive measures and treatment should be provided for trial participants during and after the research, and what constitute ‘fair benefits’ to the community or country when a trial is completed. The Global Campaign for Microbicides conducted a study of the benefits being provided to participants in microbicide trials and others, and found substantial evidence that researchers and sponsors are meeting the obligations stated in ethical guidelines. A cautionary tale of an HIV prevention trial that was prematurely halted demonstrates the need for engagement with the community where trials are carried out. (shrink)

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper assesses the (...) latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called "constrained pure procedural justice" best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions. (shrink)

Norman Daniels' and James Sabin's theory of “accountability for reasonableness” (A4R) is a much discussed account of due process for decision-making on health care priority setting. Central to the theory is the acceptance that people may justifiably disagree on what reasons it is relevant to consider when priorities are made, but that there is a core set of reasons, that all centre on fairness, on which there will be no disagreement. A4R is designed as an institutional decision process which will (...) ensure that only those reasons which everybody will agree are relevant and appropriate form part of decision-making. The argument which we will put forward in this paper questions whether it is a simple matter to delineate the core set of reasons and claims that it is a potential problem in A4R that it does not provide an indication of the exact content of this process. The paper first briefly outlines the content of A4R. It is argued that disagreement on what services should be high priorities cannot be resolved solely with a reference to “due process.” In order to retain consistency over time, decision-makers are required to agree and articulate what reasons qualify as relevant and how conflicting reasons are to be balanced in the course of the process. The second and main part of the paper then considers how the reason of “solidarity” can be handled within the A4R framework, and it is shown that deciding whether solidarity should be admitted to the core set of allowable reasons is not a simple matter. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)

Collision sports pose a high risk of concussion. How to respond to this risk is more ethically complex when considering children and adolescents due to a) incomplete evidence regarding the impact of concussion on developing brains, b) physiological and social vulnerability, and c) the young person’s reliance on proxy decision-makers, usually parents. There is also a lack of clear definitions of (a) collision sport (vs. contact sport) and (b) what constitutes a child or adolescent. We consider whether parents should be (...) free to allow their children/adolescents to play contact or collision sport. The article analyses the harms and benefits of collision sport and methods of determining risk, before outlining our support for the precautionary principle. We then consider whether the ‘best interests’ or ‘right to an open future’ framework ought to be applied to the issue of childhood participation in collision sport. Rather than supporting a ban of child/adolescent participation in collision sport, we argue that permissibility should be decided on a sport-by-sport basis. Moreover, we apply the ‘Accountability of Reasonableness’ framework to ensure that sound ethical values guide and support protections for this vulnerable group in the absence of high-quality evidence. (shrink)

Managed care is evolving in ways that pose unique ethical challenges to those interested in the intersection of clinical and organizational ethics. For example, Disease Management is a form of managed care that has emerged in response to chronic illness. DM is a healthcare management tool that coordinates resources across an entire health care delivery system and throughout the life cycle of chronic disease. Health Maintenance Organizations have reduced some costs in the delivery of acute care, but real cost savings (...) will result only with greater efficiencies in the delivery of costly chronic care. DM is a systematic, population-based approach that identifies persons at risk of chronic ailment, intervenes with specific programs of care, measures clinical and other outcomes, and provides continuous quality improvement. Characterized as a movement to patient-driven services, DM involves a complex web of provider relations. (shrink)