This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.

Individuals with major depression may benefit from psychiatric treatment, yet they may refuse such treatment, sometimes because of their depression. Hence the question is raised whether such individuals are competent to refuse psychiatric treatment. The standard notion of competence to consent to treatment, which refers to expression of choice, understanding of medical information, appreciation of the personal relevance of this information, and logical reasoning, may be insufficient to address this question. This is so because major depression may not impair these (...) four abilities while it may disrupt coherence of personal preferences by changing them. Such change may be evaluated by comparing the treatment preferences of the individual during the depression to his or her treatment preferences during normal periods. If these preferences are consistent, they should be respected. If they are not consistent, or past treatment preferences that were arrived at competently cannot be established, treatment refusal may have to be overridden or ignored so as to alleviate the depression and then determine the competent treatment decision of the individual. Further study of the relation between depression and competence to refuse or consent to psychiatric treatment is required. (shrink)

Concepts of decision, choice, decision-maker, and decision-making are common practical tools in both social science and natural science, on which scientific knowledge, policy implications, and moral recommendations are based. In this article I address three questions. First, I look into how present-day social scientists and natural scientists use decision/choice concepts. What are they used for? Second, scientists may differ in the application of decision/choice to X, and they may explicitly disagree about the applicability of decision/choice to X. Where exactly do (...) these disagreements lie? Third, I ask how scientists should use decision/choice concepts. What are they correctly and incorrectly used for? I argue that scientists must responsibly attend to a methodological demand: you have to have a principled, non-ad hoc, well-argued-for way of telling where decision/choice applicability ends. Thus, I aim to minimize the risk of conceptual stretching and foster responsible conceptual practices in a large body of scientific work. (shrink)

There is an ongoing debate about loss of control in addiction: Some theorists say at least some addicts’ drug-directed desires are irresistible, while others insist that pursuing drugs is a choice. The debate is long-standing and has essentially reached a stalemate. This essay suggests a way forward. I propose an alternative model of loss of control in addiction, one based not on irresistibility, but rather fallibility. According to the model, on every occasion of use, self-control processes exhibit a low, but (...) non-zero, rate of failure due to error. When these processes confront highly recurrent drug-directed desires, the cumulative probability of a self-control lapse steadily grows. The model shows why the following statement—which has an air of paradox—can in fact be true: Each drug-directed desire the addict faces is fully resistible, but the addict nonetheless has significantly diminished control over eventually giving in. (shrink)

I argue that addiction is not a chronic, relapsing, neurobiological disease characterized by compulsive use of drugs or alcohol. Large-scale national survey data demonstrate that rates of substance dependence peak in adolescence and early adulthood and then decline steeply; addicts tend to “mature out” in their late twenties or early thirties. The exceptions are addicts who suffer from additional psychiatric disorders. I hypothesize that this difference in patterns of use and relapse between the general and psychiatric populations can be explained (...) by the purpose served by drugs and alcohol for patients. Drugs and alcohol alleviate the severe psychological distress typically experienced by patients with comorbid psychiatric disorders and associated problems. On this hypothesis, consumption is a chosen means to ends that are rational to desire: Use is not compulsive. The upshot of this explanation is that the orthodox view of addiction as a chronic, relapsing neurobiological disease is misguided. I delineate five folk psychological factors that together explain addiction as purposive action: strong and habitual desire; willpower; motivation; functional role; and decision and resolve. I conclude by drawing lessons for research and effective treatment. (shrink)

I take as my starting point the “one very simple principle” proclaimed by Mill in On Liberty … “That principle is, that the sole end for which mankind are warranted, individually or collectively, in interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. He cannot rightfully be compelled to do (...) or forbear because it will be better for him to do so, because it will make him happier, because, in the opinion of others, to do so would be wise, or even right.”. (shrink)

This book is the most comprehensive treatment available of one of the most urgent - and yet in some respects most neglected - problems in bioethics: decision-making for incompetents. Part I develops a general theory for making treatment and care decisions for patients who are not competent to decide for themselves. It provides an in-depth analysis of competence, articulates and defends a coherent set of principles to specify suitable surrogate decisionmakers and to guide their choices, examines the value of advance (...) directives, and investigates the role that considerations of cost ought to play in decisions concerning incompetents. Part II applies this theoretical framework to the distinctive problems of three important classes of individuals, many of whom are incompetent: minors, the elderly and psychiatric patients. The authors' approach combines a probing analysis of fundamental issues in ethical theory with a sensitive awareness of the concrete realities of health care institutions and the highly personal and individual character of difficult practical problems. Its broad scope will appeal to health professionals, moral philosophers and lawyers alike. (shrink)

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)