To what extent should we use technological advances to try to make better human beings? Leading philosophers debate the possibility of enhancing human cognition, mood, personality, and physical performance, and controlling aging. Would this take us beyond the bounds of human nature? These are questions that need to be answered now.

In order to protect patients against medical paternalism, patients have been granted the right to respect of their autonomy. This right is operationalized first and foremost through the phenomenon of informed consent. If the patient withholds consent, medical treatment, including life-saving treatment, may not be provided. However, there is one proviso: The patient must be competent to realize his autonomy and reach a decision about his own care that reflects that autonomy. Since one of the most important patient rights hinges (...) on the patient's competence, it is crucially important that patient decision making incompetence is clearly defined and can be diagnosed with the greatest possible degree of sensitivity and, even more important, specificity. Unfortunately, the reality is quite different. There is little consensus in the scientific literature and even less among clinicians and in the law as to what competence exactly means, let alone how it can be diagnosed reliably. And yet, patients are deemed incompetent on a daily basis, losing the right to respect of their autonomy. In this article, we set out to fill that hiatus by beginning at the very beginning, the literal meaning of the term competence. We suggest a generic definition of competence and derive four necessary conditions of competence. We then transpose this definition to the health care context and discuss patient decision making competence. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Linking the process of rational decision making to emotions, an award-winning scientist who has done extensive research with brain-damaged patients notes the dependence of thought processes on feelings and the body's survival-oriented regulators. 50,000 first printing.

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)

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of the researcher to make (...) such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research. (shrink)

Cognitive enhancement takes many and diverse forms. Various methods of cognitive enhancement have implications for the near future. At the same time, these technologies raise a range of ethical issues. For example, they interact with notions of authenticity, the good life, and the role of medicine in our lives. Present and anticipated methods for cognitive enhancement also create challenges for public policy and regulation.

ABSTRACT Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information provided. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There (...) has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk. (shrink)

I will argue that the fairly common assumption that brain imaging may compromise people’s privacy in an undesirable way only if moral crimes are committed is false. Sometimes persons’ privacy is compromised because of failures of privacy. A normal emotional reaction to failures of privacy is embarrassment and shame, not moral resentment like in the cases of violations of right to privacy. I will claim that if (1) neuroimaging will provide all kinds of information about persons’ inner life and not (...) only information that is intentionally searched for, and (2) there will be more and more application fields of fMRI and more and more people whose brains will be scanned (without any coercion), then, in the future, shame may be an unfortunately common feeling in our culture. This is because failures of privacy may dramatically increase. A person may feel shame strongly and long, especially if his failure is witnessed by people who he considers relatively important, but less than perfectly trustworthy. (shrink)

An updated and expanded successor to Culver and Gert's Philosophy in Medicine, this book integrates moral philosophy with clinical medicine to present a comprehensive summary of the theory, concepts, and lines of reasoning underlying the ...

We would not be far wide of the mark if we suggested that the prevailing social ideology is structured round the presumption that interpersonal and political relationships ought to be, and for the most part are, based on the mutual consent of the parties involved. Liberal democratic theory has secured for consent a crucial role in the justification of political obligation and authority. In law, the maximvolenti non fit injuria,to the one who consents no wrong is done, constitutes a defence (...) in cases where one person invades the interests of another. In the bioethical field, there is a preoccupation with the formulation of a standard of ‘informed consent’ in patient-doctor and subject-researcher relationships. And in the broader domain of ethical theory there is an influential view that consensual acts do not differ in moral quality from selfregarding behaviour. (shrink)

Available methods such as technology assessment and risk analysis have failed to predict the effects of technological choices. We need to give up the futile predictive ambitions of previous approaches and instead base decisions on systematic studies of alternative future developments. It will then be necessary to cope with mere possibility arguments, i.e., arguments in which a conclusion is drawn from a mere possibility that a course of action may have certain consequences. A five-step procedure is proposed for the assessment (...) of such arguments. It includes a search for mere possibility arguments pointing in different directions, a scientific evaluation that may lead to the specification or refutation of some of these arguments, two symmetry tests, evaluation of the seriousness of the arguments in terms of novelty, spatio-temporal unlimitedness and interference with complex systems, and hypothetical retrospection that aims at finding a course of action that will be defensible in retrospect. (shrink)

Discusses 2 automated choice heuristics: choosing by liking ; and choosing by default. These 2 automated choice heuristics are akin to the judgment heuristics of the heuristic and biases literature. They are governed by rapid and intuitive processes, they are relatively immune to introspection, and their associated biases may not be recognized by the people who use them.

Progress in neuroscience will allow us to reveal the neuronal correlates of psychological processes involved in ethically relevant notions such as informed consent. Informed consent involves decision making, the psychological and neural processes of which have been investigated extensively in neuroscience. The neuroscience of decision making may be able to contribute to an ethics of informed consent by providing empirical and thus descriptive criteria. Since, however, descriptive criteria must be distinguished from normative criteria, the neuroscience of decision making cannot replace (...) the ethics of informed consent. Instead, the neuroscience of decision making could complement the current ethics, resulting in what can be called neuroethics of informed consent. It is concluded that current progress in the neurosciences could complement and change the way in which we approach ethical problems in neuropsychiatry. (shrink)

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may alter his or her cognitive abilities and (...) compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (shrink)