Allen Buchanan and Daniel Brock, in a widely influential account, Deciding for Others (1990), advocate a sliding scale approach to the determination of whether a patient is competent to make a decision regarding his/her health care. An analysis of two critiques of their position (Beauchamp and Childress (1994), Wicclair (1991 a,b)) reveals a tacit presumption by all of these authors that the greater cognitive challenge often posed by high risk therapies constitutes grounds for an elevated standard of competence. This presumption (...) cannot be consistently maintained in cases where the patient's decision involves experimental therapies. It implies either that informed consent can never take place in such situations, or, perhaps even more counter-intuitively, that a lower standard of competency should be used than when the patient is asked to choose only among standard therapies. (shrink)

In _Pharmaceutical Freedom_ Professor Flanigan argues we ought to grant people self-medication rights for the same reasons we respect people’s right to give (or refuse to give) informed consent to treatment. Despite being the most comprehensive argument in favour of self-medication written to date, Flanigan’s _Pharmaceutical Freedom_ leaves a number of questions unanswered, making it unclear how the safe-guards Flanigan incorporates to protect people from harming themselves would work in practice. In this paper, I extend Professor Flanigan’s account by discussing (...) a hypothetical case to illustrate how these safe-guards could work together to protect people from harms caused by their own ignorance or incompetence. (shrink)

In light of the variety of uses of the term autonomy in recent bioethics literature, in this paper, I suggest that competence, not being as contested, is better placed to play the anti-paternalistic role currently assigned to autonomy. The demonstration of competence, I will argue, can provide individuals with robust spheres of non-interference in which they can pursue their lives in accordance with their own values. This protection from paternalism is achieved by granting individuals rights to non-interference upon demonstration of (...) competence. In this paper, I present a risk-sensitive account of competence as a means of grounding rights to non-interference. On a risk-sensitive account of competence individuals demonstrate their competence by exercising three capacities to the extent necessary to meet a threshold determined by the riskiness of the decision. These three capacities are the capacity to acquire knowledge, use instrumental rationality, and form and revise a life plan. (shrink)

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and (...) Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. (shrink)

If a person is competent to consent to a treatment, is that person necessarily competent to refuse the very same treatment? Risk relativists answer no to this question. If the refusal of a treatment is risky, we may demand a higher level of decision-making capacity to choose this option. The position is known as asymmetry. Risk relativity rests on the possibility of setting variable levels of competence by reference to variable levels of risk. In an excellent 2016 article inJournal of (...) Medical Ethics(JME), Rob Lawlor defends asymmetry of this kind by defending risk relativity, using and developing arguments and approaches found in earlier work such as that of Wilks. He offers what we call the two-scale approach: a scale of risk is to be used to set a standard of competence on a scale of decision-making difficulty. However, can this be done in any rational way? We argue it cannot, and in this sense, and to this extent, risk relativity is a nonsense. (shrink)

Should the assessment of decision‐making capacity (DMC) be risk sensitive, that is, should the threshold for DMC vary with risk? The debate over this question is now nearly five decades old. To many, the idea that DMC assessments should be risk sensitive is intuitive and commonsense. To others, the idea is paternalistic or incoherent, or both; they argue that the riskiness of a given decision should increase the epistemic scrutiny in the evaluation of DMC, not increase the threshold for DMC. (...) We respond to the critics’ main concerns by providing a comprehensive account of how risk‐sensitive DMC is coherent, avoids paternalism, and best fulfills the epistemic goal of DMC evaluations. (shrink)

ZusammenfassungDie Bestimmung der Einwilligungsfähigkeit von Patienten beinhaltet weitreichende ethische und rechtliche Implikationen. Ausreichende Klärung des Begriffs ist daher unerlässlich. Solche Bemühungen gelten vorwiegend der Definition von Kriterien hinsichtlich relevanter mentaler Fähigkeiten. Grundlegendere Aspekte werden kaum explizit besprochen, so die Frage, ob Einwilligungsfähigkeit eher eine inhärente Fähigkeit oder ein ethisches Urteil bezeichnet. Zentral bei dieser Unterscheidung ist der Stellenwert ethischer Überlegungen die Zulässigkeit fürsorglicher Bevormundung betreffend. Geht man von einer inhärenten Fähigkeit aus, schließen solche Überlegungen an die Beurteilung von Einwilligungsfähigkeit an. (...) Im Fall eines Urteils sind diese konstitutiv für das Verständnis und die Bestimmung von Einwilligungsfähigkeit. Obwohl Einwilligungsfähigkeit idealerweise als inhärente Fähigkeit gedacht wird, weist die tatsächliche Herangehensweise eher in die Richtung, sie als ethisches Urteil zu verstehen. Diese verschiedenen Tendenzen sind für konzeptuelle Kontroversen hinsichtlich des Stellenwerts risiko-relativer Beurteilungen verantwortlich. Des Weiteren muss sich die Bestimmung von Einwilligungsfähigkeit – konzipiert man sie als ethisches Urteil – nicht rigide an einer bestimmten Definition des Begriffs der Autonomiefähigkeit orientieren und vermag so mit dessen definitorischen Unklarheiten besser umzugehen. (shrink)

Decision-making capacity (DMC) plays an important role in clinical practice—determining, on the basis of a patient’s decisional abilities, whether they are entitled to make their own medical decisions or whether a surrogate must be secured to participate in decisions on their behalf. As a result, it’s critical that we get things right—that our conceptual framework be well-suited to the task of helping practitioners systematically sort through the relevant ethical considerations in a way that reliably and transparently delivers correct verdicts about (...) who should and should not have the authority to make their own medical decisions. Unfortunately, however, the standard approach to DMC does not get things right. It is of virtually no help in identifying and clarifying the relevant ethical considerations. And, embedded in the prevailing anti-paternalist paradigm, DMC assessments obfuscate and distort the underlying ethical justification for granting or withholding decisional authority. Here, we describe the core commitments of the standard approach to DMC and then highlight three problems with it. We then argue that these problems are significant enough that they call for more than merely tinkering and fine tuning—variations of the standard approach cannot adequately address them. Instead, we should ditch DMC. (shrink)

Whereas indirect euthanasia is a common clinical practice, active euthanasia remains forbidden in most countries. The reason for this differentiation is usually seen in the principle of double-effect (PDE). PDE states that there is a morally relevant difference between the intended consequences of an action and merely foreseen, unintended side-effects. This article discloses the fundamental assumptions presenting the basis for this application of the PDE and examines whether these assumptions are compatible with the PDE. It is shown that neither a (...) liberal nor a utilitarian point of view makes the utilization of the PDE possible. In accordance with philosophical tradition, only within the doctrine of the sanctity of life does the PDE seem to be applicable. By analysing the premises of this doctrine, and comparing them with those of the PDE, the inconsistency of this idea is demonstrated. It is suggested that the role of the PDE in the current discussion on euthanasia is largely exaggerated. (shrink)

Editorial introduction to series of papers resulting from a European Commission Project on mental capacity.

In many Western jurisdictions, the law presumes that adult persons, and sometimes children that meet certain criteria, are capable of making their own health care decisions; for example, consenting to a particular medical treatment, or consenting to participate in a research trial. But what exactly does it mean to say that a subject has or lacks the requisite capacity to decide? This last question has to do with what is commonly called “decisional capacity,” a central concept in health care law (...) and ethics, and increasingly an independent topic of philosophical inquiry. (shrink)

Decision-Making Capacity First published Tue Jan 15, 2008; substantive revision Fri Aug 14, 2020 In many Western jurisdictions the law presumes that adult persons, and sometimes children that meet certain criteria, are capable of making their own medical decisions; for example, consenting to a particular medical treatment, or consenting to participate in a research trial. But what exactly does it mean to say that a subject has or lacks the requisite capacity to decide? This question has to do with what (...) is commonly called “decisional capacity”, a central concept in health care law and ethics, and increasingly an independent topic of philosophical inquiry. -/- Decisional capacity can be defined as the ability of subjects to make their own medical decisions. Somewhat similar questions of capacity arise in other contexts, such as capacity to stand trial in a court of law and the ability to make decisions that relate to personal care and finances. However, the history behind the more general legal notions of capacity to stand trial and capacity to manage one’s life is different and operates somewhat differently in law (Roth, Meisel, & Litz 1977; Zapf & Roesch 2005). For the purposes of this discussion the notion of decisional capacity will be limited to medical contexts only; most notably, those where decisions to consent or to refuse treatment or participation in clinical research are concerned. (shrink)