Ethical issues in implementation research: a discussion of the problems in achieving informed consent

Background: Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research. Discussion: The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research. Summary: While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees

The Market for Medical Ethics

At the core of Kenneth Arrow’s classic 1963 essay on medical uncertainty is a claim that has failed to carry the day among economists. This claim—that physician adherence to an anti-competitive ethic of fidelity to patients and suppression of pecuniary influences on clinical judgment pushes medical markets toward social optimality—has won Arrow near-iconic status among medical ethicists (and many physicians). Yet conventional wisdom among health economists, including several participants in this symposium, holds that this claim is either naïve or outdated. Health economists admire Arrow’s article for its path-breaking analysis of market failures resulting from information asymmetry, uncertainty, and moral hazard. But his suggestion that anticompetitive professional norms can compensate for these market failures is at odds with economists’ more typical treatment of professional norms as monopolistic constraints on contractual possibility. If the goal of health care policy and law is to maximize the social welfare yield from medical spending, consideration of the place of professional ethics norms in health policy requires that we pose three questions. First, how can we distinguish between professional norms that enhance social welfare (even if “anticompetitive” in some sense) and therefore merit our deference (and perhaps even some legal protection) and norms that reduce welfare? Second, when we conclude that a professional norm is socially undesirable, how should we go about choosing among regulatory and legal strategies and deference to markets as means for dissolving the norm? Third, when we conclude that a professional norm is socially desirable, how should we go about preserving it? Should we defer to market outcomes—and perhaps shield select forms of professional collusion from antitrust intervention? Or should we defend this norm actively, through legal and regulatory intervention? This essay focuses on the first of these three questions, since it is the subject of Arrow’s article. From a public policy perspective, however, the second and third are just as important. It is hardly obvious that a socially undesirable norm should be targeted by judges or regulators rather than left to wither in the marketplace; nor is it clear that a socially desirable norm needs legal or regulatory support to survive

Situating care in mainstream health economics: an ethical dilemma?

Standard health economics concentrates on the provision of care by medical professionals. Yet ‘care’ receives scant analysis; it is portrayed as a spillover effect or externality in the form of interdependent utility functions. In this context care can only be conceived as either acts of altruism or as social capital. Both conceptions are subject to considerable problems stemming from mainstream health economics’ reliance on a reductionist social model built around instrumental rationality and consequentialism. Subsequently, this implies a disregard for moral rules and duties and the compassionate aspects of behaviour. Care as an externality is a second-order concern relative to self-interested utility maximization, and is therefore crowded out by the parameters of the standard model. We outline an alternative relational approach to conceptualising care based on the social embeddedness of the individual that emphasises the ethical properties of care. The deontological dimension of care suggests that standard health economics is likely to undervalue the importance of care and caring in medicine

Equity - some theory and its policy implications

This essay seeks to characterise the essential features of an equitable health care system in terms of the classical Aristotelian concepts of horizontal and vertical equity, the common (but ill-defined) language of “need” and the economic notion of cost-effectiveness as a prelude to identifying some of the more important issues of value that policy-makers will have to decide for themselves; the characteristics of health (and what determines it) that can cause policy to be ineffective (or have undesired consequences); the information base that is required to support a policy directed at securing greater equity, and the kinds of research (theoretical and empirical) that are needed to underpin such a policy

Ethics and health care 'underfunding'

There are continual “crises” in health care systems worldwide as producer and patient groups unify and decry the “underfunding” of health care. Sometimes this cacophony is the self interest of profit seeking producers and often it is advocacy of unproven therapies. Such pressure is to be expected and needs careful management by explicit rationing criteria which determine who gets access to what health care. Science and rationality, however, are unfortunately, rarely the rules of conduct in the medical market-place

Severity as a Priority Setting Criterion: Setting a Challenging Research Agenda

Priority setting in health care is ubiquitous and health authorities are increasingly recognising the need for priority setting guidelines to ensure efficient, fair, and equitable resource allocation. While cost-effectiveness concerns seem to dominate many policies, the tension between utilitarian and deontological concerns is salient to many, and various severity criteria appear to fill this gap. Severity, then, must be subjected to rigorous ethical and philosophical analysis. Here we first give a brief history of the path to today’s severity criteria in Norway and Sweden. The Scandinavian perspective on severity might be conducive to the international discussion, given its long-standing use as a priority setting criterion, despite having reached rather different conclusions so far. We then argue that severity can be viewed as a multidimensional concept, drawing on accounts of need, urgency, fairness, duty to save lives, and human dignity. Such concerns will often be relative to local mores, and the weighting placed on the various dimensions cannot be expected to be fixed. Thirdly, we present what we think are the most pertinent questions to answer about severity in order to facilitate decision making in the coming years of increased scarcity, and to further the understanding of underlying assumptions and values that go into these decisions. We conclude that severity is poorly understood, and that the topic needs substantial further inquiry; thus we hope this article may set a challenging and important research agenda

Health professionals have an ethical duty

The British Medical Association (BMA) recently published guidance from its medical ethics committee on decision making concerning the withholding and withdrawing of life-prolonging medical treatment. It is a very thoughtful and thought-provoking document, the ramifications of which go far beyond the immediate situation it is addressing. The authors are clearly well aware of this.When considering a doctor’s ethical response to “contemporaneous requests for life-prolonging treatment” made by competent patients, the committee observes: “Although patients’ wishes should always be discussed with them, the fact that a patient has requested a particular treatment does not mean that it must always be provided.” They advance four propositions in support of this conclusion, namely: “(a) Health professionals are not obliged to provide any treatment which cannot produce the desired benefit”. “(b) There is no obligation to provide any treatment which is clearly contrary to an individual’s health interests. A life-prolonging treatment may, for example, prolong life but result in severe pain or loss of function so that overall it produces severe harm to the patient”. “(c) Except in an emergency situation, doctors are not obliged to treat contrary to their conscience (though they may be obliged to make an appropriate referral)”. “(d) Where resources are limited, it is inevitable that some patients will not receive all of the treatment they request even though such treatment could be potentially beneficial to them”. Towards the end of their commentary on the last of these propositions, they observe: “Health professionals have an ethical duty to make the best use of the available resources and this means that hard decisions must be made. Whilst this is a much broader issue than can be discussed thoroughly in this document, it is clear that doctors are not obliged to comply with patients’ requests for treatment when they make inequitable demands on scarce resources”. Later they come back to this issue in the context of patients who have lost or never attained competence. In that connection they observe: “Existing guidelines and court judgments have insisted that non-treatment decisions for people who lack the ability to make or communicate decisions should be based on considerations of benefit to the patient and not cost. It is obvious, however, that money spent caring for irreversibly and severely brain-damaged patients is money which cannot be used to treat other patients. This is an issue which needs to be acknowledged and addressed on a national scale as part of the debate on rationing and prioritising resources”

Can We Agree on What Robots Should be Allowed to Do? An Exercise in Rule Selection for Ethical Care Robots

Future Care Robots (CRs) should be able to balance a patient’s, often conflicting, rights without ongoing supervision. Many of the trade-offs faced by such a robot will require a degree of moral judgment. Some progress has been made on methods to guarantee robots comply with a predefined set of ethical rules. In contrast, methods for selecting these rules are lacking. Approaches departing from existing philosophical frameworks, often do not result in implementable robotic control rules. Machine learning approaches are sensitive to biases in the training data and suffer from opacity. Here, we propose an alternative, empirical, survey-based approach to rule selection. We suggest this approach has several advantages, including transparency and legitimacy. The major challenge for this approach, however, is that a workable solution, or social compromise, has to be found: it must be possible to obtain a consistent and agreed-upon set of rules to govern robotic behavior. In this article, we present an exercise in rule selection for a hypothetical CR to assess the feasibility of our approach. We assume the role of robot developers using a survey to evaluate which robot behavior potential users deem appropriate in a practically relevant setting, i.e., patient non-compliance. We evaluate whether it is possible to find such behaviors through a consensus. Assessing a set of potential robot behaviors, we surveyed the acceptability of robot actions that potentially violate a patient’s autonomy or privacy. Our data support the empirical approach as a promising and cost-effective way to query ethical intuitions, allowing us to select behavior for the hypothetical CR