Decision-making Capacity matters to whether a patient’s decision should determine her treatment. But why it matters in this way isn’t clear. The standard story is that dmc matters because autonomy matters. And this is thought to justify dmc as a gatekeeper for autonomy – whereby autonomy concerns arise if but only if a patient has dmc. But appeals to autonomy invoke two distinct concerns: concern for authenticity – concern that a choice is consistent with an individual’s commitments; and concern for (...) sovereignty – concern that an individual exercises control over that which is hers to control. Here, I argue, neither concern can alone explain why dmc matters. Instead, dmc matters because it indicates a harmony between the two concerns – the demands of each concern are more likely to agree if a patient has dmc. This vindicates the standard story, but also makes clear that dmc is an inappropriate gatekeeper for autonomy. (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)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (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)

In 2016, this Journal published an article by Rob Lawlor1 on what we might call the acceptance-refusal asymmetry in competence requirements. This is the view that there can be cases in which a patient is sufficiently competent to accept a treatment, but not sufficiently competent to refuse it. Though the main purpose of Lawlor’s paper was to distinguish this asymmetry from various other asymmetries with which it has sometimes been confused,1 Lawlor also presented a brief case in favour of it. (...) Developing an earlier argument of Ian Wilks’,2 3 Lawlor argued that, when the risks associated with refusing a treatment are graver than those associated with accepting it, a higher level of competence may be required to refuse a treatment than to accept it. This claim could have important implications for the law, since determinations of competence often play a central role in determining the lawfulness of refusing or imposing a treatment. Indeed, the acceptance-refusal asymmetry in competence requirements, or something close to it, has played an important role in court judgments.2 However, Lawlor himself suggests that his conclusion will have practical implications only in a narrow range of cases.3 In this issue, Pickering, Giles Newton-Howes and Simon Walker respond to Lawlor’s piece.4 They deny that competence requirements should depend on the level of risk associated with a decision, and thus that there is any basis for the acceptance-refusal asymmetry in competence requirements. Part of the authors’ argument involves contesting the way in which Lawlor uses cases to support his view. In one case cited by Lawlor—and drawn from Wilks—we are invited to consider a whether …. (shrink)

In 2016, this Journal published an article by Rob Lawlor1 on what we might call the acceptance-refusal asymmetry in competence requirements. This is the view that there can be cases in which a patient is sufficiently competent to accept a treatment ( viz., to give consent to it), but not sufficiently competent to refuse it ( viz., to withhold consent to it). Though the main purpose of Lawlor’s paper was to distinguish this asymmetry from various other asymmetries with which it (...) has sometimes been confused,1 Lawlor also presented a brief case in favour of it. Developing an earlier argument of Ian Wilks’,2 3 Lawlor argued that, when the risks associated with refusing a treatment are graver than those associated with accepting it, a higher level of competence may be required to refuse a treatment than to accept it. This claim could have important implications for the law, since determinations of competence often play a central role in determining the lawfulness of refusing or imposing a treatment (eg, in England and Wales under the Mental Capacity Act 2005). Indeed, the acceptance-refusal asymmetry in competence requirements, or something close to it, has played an important role in court judgments.2 However, Lawlor himself suggests that his conclusion will have practical implications only in a narrow range of cases.3 In this issue, Pickering, Giles Newton-Howes and Simon Walker (henceforth ‘the authors’) respond to Lawlor’s piece.4 They deny that competence requirements should depend on the level of risk associated with a decision, and thus that there is any basis for the acceptance-refusal asymmetry in competence requirements. Part of the authors’ argument involves contesting the way in which Lawlor uses cases to support his view. In one case cited by Lawlor—and drawn from Wilks—we are invited to consider a whether …. (shrink)

Ethical and legal discourse pertaining to the ability to consent to treatment and research in England operates within a dualist framework of “competence” and “capacity”. This is confusing, as while there exists in England two possible senses of legal capacity – “first person” legal capacity and “delegable” legal capacity, currently neither is formulated to bear a necessary relationship with decision-making competence. Notwithstanding this, judges and academic commentators frequently invoke competence to consent in discussions involving the validity of offering or withholding (...) consent as a synonym for legal capacity to consent. I argue that this gives rise to a conflation, jeopardising clarity and consistency in law. This is somewhat less problematic in instances of “first-person” legal capacity that are heavily informed by criteria for decision-making competence than in the second sense of legal capacity, which is qualitatively different from decision-making competence, or with first-person legal capacity when defined in different terms from competence. The paper concludes by proposing that the soundest resolution to this problem is by making decision-making competence a necessary and sufficient condition of first-person legal capacity, affording a more scrupulous distinction between the two different forms of legal capacity that exist. (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)