Quality improvement mechanisms increasingly use outcome measures to evaluate health care providers. This move toward outcome measures is a radical departure from the traditional focus on process measures. More radical still is the proposal to shift from relatively simple and proximal measures of outcome, such as mortality, to complex outcomes, such as quality of life. While the practical, scientific, and ethical issues associated with the use of outcomes such as mortality and morbidity to compare health care providers have been well (...) rehearsed, the specific concerns associated with the use of quality of life measures in quality of care research have received little attention. As with much research on quality of life there is a tendency to assume that the disadvantages are outweighed by the general virtue of “listening” to patients. In this paper we disagree with this assumption and argue that quality of life is a process, not an outcome. (shrink)

The National Institute for Health and Clinical Excellence (hereafter NICE) was created in 1998 to give guidance on which treatments should be provided by the British National Health Service, and to whom. So it has a crucial role as an agent of distributive justice. In this paper I argue that it is failing to adequately explain and justify its decisions in the public arena, particularly in terms of distributive justice; and that this weakens its legitimacy, to the detriment of the (...) National Health Service as a whole. I argue that this failure arises from the fact that NICE works within the frameworks of positivist science and liberal ethics, largely to the exclusion of other perspectives. This narrowness of view prevents NICE from properly connecting with the range of moral concerns represented in the population. I argue for NICE’s deliberations to become more inclusive, both in terms of epistemology, and also in terms of ethical perspectives. And I suggest a range of perspectives that could usefully be included. Finally I offer a framework of structures, philosophies and discussion process that will enable competing perspectives to be debated fairly and productively in this process. (shrink)

Decisions on which new health technologies to provide are controversial because of the scarcity of healthcare resources, the competing demands of payers, providers and patients and the uncertainty of the evidence base. Given this, additional information about new health technologies is often considered valuable. One response is to make access to a new health technology conditional on further research. Access can be restricted to patients who participate in a research study, such as a randomised controlled trial; alternatively, a new treatment (...) can be made generally available, but only on condition that further evidence is collected (eg, on long-term outcomes and adverse events, in patient registries). The National Institute for Health and Clinical Excellence (NICE), which provides guidance on which new health technologies to make available under the UK's NHS, for example, has made some research conditional recommendations, and the current interest in such options suggests that they are likely to become more prevalent in the future. This paper identifies and discusses the main ethical issues created by this distinctive range of recommendations. We argue that decisions to put research conditions on access to new technologies are compatible with widely accepted values, principles and practices relevant to resource allocation. However, there are important features of these distinctive judgements that must be taken into account by resource allocation decision-making bodies and research ethics committees, and that require new sorts of empirical data. (shrink)

Physicians frequently face ethical dilemmas when caring for patients. To help them to cope with these, biomedical ethics aims to implement moral norms for particular problems and contexts. As a means of studying the cognitive and neurobiological features underlying the respect for these norms, moral cognitive neuroscience could help us to understand and improve ethical questioning. The article reviews recent developments in the field and presents neurobiological arguments to highlight why some moral rules are universally shared and why some ethical (...) responses are very dependent on context. (shrink)

A rebuttal is provided to each of the arguments adduced by John Harris, an Editor-in-Chief of the Journal of Medical Ethics, in two editorials in the journal in support of the view that National Institute for Health and Clinical Excellence’s procedures and methods for making recommendations about healthcare procedures for use in the National Health Service in England and Wales are the product of “wickedness or folly or more likely both”, “ethically illiterate as well as socially divisive”, responsible for the (...) “perversion of science as well as of morality” and are “contrary to basic morality and contrary to human rights”. (shrink)

Many ethical theorists believe that a given distribution of healthcare is morally justified only if (1) it is cost-effective and (2) it does not discriminate against older adults and disabled people. However, if (3) cost-effectiveness involves maximizing the number of quality-adjusted life-years (QALYs) added by a given unit of healthcare resource, or cost, it seems the pursuit of cost-effectiveness will inevitably discriminate against older adults and disabled patients. I show why this trilemma is harder to escape than some theorists think. (...) We cannot avoid it by using age- or disability-weighted QALY scores, for example. I then explain why there is no sense of “discrimination” on which discrimination isbothunjust, and thus something healthcare rationing must avoid,andsomething cost-effective healthcare rationing inevitably involves. I go on to argue that many of the reasons we have for not favoring rationing that maximizes QALYs outside the healthcare context apply in healthcare as well. Thus, claim (1) above is dubious. (shrink)

A recent organ distribution scandal in Germany raises questions of general importance on which many thousands of lives may well depend. The scandal in Germany has produced reactions that are likely to occur whenever and wherever distribution irregularities occur and become public knowledge. After it had become known that physicians in three German hospitals were in the habit of manipulating records in order to fast-track their patients’ cases, the country experienced a decrease of available organs by a staggering 40% in (...) October 2012. Even though this loss of trust by donors and their families is understandable, and potentially a legitimate form of protest against wrongful distribution, the withdrawal of agreement to serve as a posthumous donor in response to irregularities also inevitably results in avoidable poor outcomes for highly vulnerable individuals. In this paper, we provide a moral analysis of such dilemmas and make recommendations as to the way forward. (shrink)

Background As the UK’s main healthcare priority-setter, the National Institute for Health and Care Excellence (NICE) has good reason to want to demonstrate that its decisions are morally justified. In doing so, it has tended to rely on the moral plausibility of its principle of cost-effectiveness and the assertion that it has adopted a fair procedure. But neither approach provides wholly satisfactory grounds for morally defending NICE’s decisions. In this study we adopt a complementary approach, based on the proposition that (...) a priority-setter's claim to moral justification can be assessed, in part, based on the coherence of its approach and that the reliability of any such claim is undermined by the presence of dissonance within its moral system. This study is the first to empirically assess the coherence of NICE’s formal approach and in doing so to generate evidence-based conclusions about the extent to which this approach is morally justified. Methods The study is grounded in the theory, methods and standards of empirical bioethics. Twenty NICE policy documents were coded to identify and classify the normative commitments contained within NICE technology appraisal policy as of 31 December 2021. Coherence was systematically assessed by attempting to bring these commitments into narrow reflective equilibrium (NRE) and by identifying sources of dissonance. Findings Much of NICE policy rests on coherent values that provide a strong foundation for morally justified decision-making. However, NICE’s formal approach also contains several instances of dissonance which undermine coherence and prevent NRE from being fully established. Dissonance arises primarily from four sources: i) NICE’s specification of the principle of cost-effectiveness; ii) its approach to prioritising the needs of particular groups; iii) its conception of reasonableness in the context of uncertainty, and iv) its concern for innovation as an independent value. Conclusion At the time of analysis, the level of coherence across NICE policy provides reason to question the extent to which its formal approach to technology appraisal is morally justified. Some thoughts are offered on why, given these findings, NICE has been able to maintain its legitimacy as a healthcare priority-setter and on what could be done to enhance coherence. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such as tissue (...) samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

This study used fMRI to investigate the neural substrates of moral cognition in health resource allocation decision problems. In particular, it investigated the cognitive and emotional processes that underpin utilitarian approaches to health care rationing such as Quality Adjusted Life Years. Participants viewed hypothetical medical and nonmedical resource allocation scenarios which described equal or unequal allocation of resources to different groups. In addition, participants were assigned to 1 of 2 treatments in which they either did or did not receive advanced (...) instructions about the principles of utilitarianism. In all cases, participants were asked to judged the proposed allocations as “fair” or “unfair.” More brain activity was observed within the superior parietal lobe, angular gyrus, middle temporal gyrus, and bilateral caudate nucleus when participants viewed scenarios depicting equal divisions of resources. Conversely, unequal resource divisions were associated with more activity in the inferior frontal gyrus and insula cortex. Furthermore, instructions about the principles of utilitarianism led to significant activation differences within the inferior frontal gyrus and the middle frontal gyrus. Significant differences in activity were also found within the inferior frontal cortex and anterior insula between medical and nonmedical scenarios. The implications for cognitive control mechanisms and the cognitive and neural bases of utilitarian ethical judgment are discussed. (shrink)