“Evidence based medicine” is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. Since, when clinical practice guidelines are created, costs affect the content of EBM, (...) EBM inevitably becomes a form of rationing and adopts a public health point of view. This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism. (shrink)

There has been much discussion about how to obtain legitimacy at macro-level priority setting in health care by use of fair procedures, but how should we consider priority setting by individual clinicians or health workers at the micro-level? Despite the fact that just health care totally hinges upon their decisions, surprisingly little attention seems being paid to the legitimacy of these decisions. This paper addresses the following question: what are the conditions that have to be met in order to ensure (...) that individual claims on health care are well aligned with an overall concept of just health care? Drawing upon a distinction between individual and aggregated needs, I argue that even though we assume the legitimacy of macro-level guidelines, this legitimacy is not directly transferable to decisions at micro-level simply by adherence to the guidelines’ recommendation. Further, I argue that individual claims are subject to the formal principle of equality and the demands of vertical and horizontal equity in a way that gives context- and patient-related equity concerns precedence over equity concerns captured at the macro-level. I conclude that if we aim to achieve just health care, we need to develop a complementary framework for legitimising individual judgment of patients’ claims on health care resources. Moreover, I suggest the basic structure of such a framework. (shrink)

Background Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Method Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Results Three hundred thirty-nine reports from 38 (...) CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. Discussion In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. Conclusions The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance and risk (...) factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved. (shrink)

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of (...) ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

Translational research in medicine requires researchers to identify the steps to transfer basic scientific discoveries from laboratory benches to bedside decision-making, and eventually into clinical practice. On a parallel track, philosophical work in ethics has not been obliged to identify the steps to translate theoretical conclusions into adequate practice. The medical ethicist A. Cribb suggested some years ago that it is now time to debate ‘the business of translational’ in medical ethics. Despite the very interesting and useful perspective on the (...) field of medical ethics launched by Cribb, the debate is still missing. In this paper, I take up Cribb’s invitation and discuss further analytic distinctions needed to base an ethics aiming to translate between theory and practice. (shrink)

How may clinical ethics committees inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, (...) we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics. (shrink)

The overall aim of this article is to discuss the organization of limit setting in healthcare in terms of legitimacy. We argue there is a strong ethical demand that such processes should be arranged to provide adversely affected people well-justified reasons to confer legitimacy to the processes despite favouring a different decision-making outcome. Two increasingly popular approaches, Accountability for Reasonableness (A4R) and Multi-Criteria Decision Analysis (MCDA), can both be applied to support legitimate decision-making processes. However, the role played by ‘fair-minded (...) people’ in the A4R framework can be shown to undermine an adequate conceptualization of legitimacy according to the ethical demand. We discuss and specify conditions enabling A4R to meet this ethical demand when being implemented in a real-world setting without having to renounce the aim of striving for ‘reasonableness’ and impartiality. The methodological approach MCDA describes how to arrange for transparent resource allocation. This approach does not encompass any normative guidance on how to shape limit settings in terms of ‘reasonableness’; it basically promotes ‘rational’ decisions. We discuss how this practical methodology can be integrated with the theoretical A4R framework to meet the ethical demand while at the same time promoting politically required impartiality of healthcare limit setting. (shrink)

What are the criteria for reasonable clinical judgements? The reasonableness of macro-level decision-making has been much discussed, but little attention has been paid to the reasonableness of applying guidelines generated at a macro-level to individual cases. This paper considers a framework for reasonable clinical decision-making that will capture cases where relevant guidelines cannot reasonably be followed. There are three main sections. (1) Individual claims on healthcare from the point of view of concerns about equity are analysed. (2) The demands of (...) responsibility and equity on professional clinical performance are discussed, and how the combination of these demands emerges into seven requirements that constitute the framework is explored. Since this framework is developed to assist in reasonable clinical decision-making, practical implications of all these requirements are also suggested. (3) Challenges concerning the framework are discussed. First, a crucial presumption that the framework relies upon is considered—namely, clinicians’ willingness to justify their decisions as requested. Then how public deliberation may influence clinical decision-making is discussed. Next is a consideration of how clinicians’ need to have confidence in their own judgements in order to perform in a manner worthy of trust would be compatible with adherence to the framework supported by public deliberation. It is concluded that fair distribution in the interplay between macro- and micro-level considerations can be secured by legitimising procedures on each level, by ensuring well-organised and continuing public debate and by basing individual clinical judgements upon well-justified and principled normative bases. (shrink)