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- Sheila McLean (2010). Autonomy, Consent and the Law. Routledge-Cavendish.
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This essay explores some concerns about the quality of informed consent in patients whose autonomy is diminished by fatal illness. It argues that patients with diminished autonomy cannot give free and voluntary consent, and that recruitment of such patients as subjects in human experimentation exploits their vulnerability in a morally objectionable way. Two options are given to overcome this objection: (i) recruit only those patients who desire to contribute to medical knowledge, rather than gain access to experimental treatment, or (ii) provide prospective subjects the choice to participate in standard doubleblind study or receive the experimental treatment. Either option would guarantee that patients in desperate conditions are given a more meaningful choice and a richer freedom, and thus a higher quality of informed consent, than under standard randomized trials. Keywords: autonomy, double-blind trials, prerandomized and randomized trials, informed consent CiteULike Connotea Del.icio.us What's this?
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest.
This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.
Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better.
Machine generated contents note: 1. Introduction: why focus on informed consent?; 2. Deciding who decides: capacity and consent; 3. Putting the informed into 'informed consent': information and decision-making; 4. Freedom of expression: the voluntary nature of consent; 5. A patient's prerogative? The continuing nature of consent; 6. Concluding words about consent; Index.
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Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a principle of respect for patient autonomy is presented as being vacuous.
Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy.
Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model.
Patients belonging to ethnic, racial, and religious minorities have been all but excluded from the legal academy's on-going conversation about informed consent. This article repairs that egregious omission. It begins by observing the narrowing of ethical justifications that underlie our informed consent law, tracing the ethical literature from the ancients to modern formulations of autonomy-centered models. Next, this article reviews the vast body of empirical data available in social science literature, that demonstrates how distinct from the autonomy model the broad range of values and priorities held by patients from racial, ethnic, and religious minority groups is. The conclusion that informed consent's focus on the western notion of autonomy affirmatively harms minority patients is inescapable. The article concludes by offering a fiduciary model of informed consent law that could improve the quality of health care for more than 100 million minority patients, potentially at risk under current law while also regulating the informed consent procedure and practice in a way that will bring balance and justice to all American patients and providers.
Informed consent to therapy is the legal doctrine which imposes on a physician the duty to explain the nature and risks of a proposed treatment so the patient can make an informed decision whether to undergo the treatment. The doctrine has spawned tremendous controversy in the legal and medical professions.In this paper I examine the doctrine of informed consent as developed by the courts. The thrust of my criticism is that as the doctrine has been developed, it significantly undercuts individual autonomy. Several modifications are suggested which would provide more support for autonomy interests.
The received view in medical contexts is that informed consent is both necessary and sufficient for patient autonomy. This paper argues that informed consent is not sufficient for patient autonomy, at least when autonomy is understood as a "relational" concept. Relational conceptions of autonomy, which have become prominent in the contemporary literature, draw on themes in the thought of Charles Taylor. I first identify four themes in Taylor's work that together constitute a picture of human agency corresponding to the notion of agency implicit in relational accounts of autonomy. Drawing on these themes, I sketch two arguments against the position that informed consent secures autonomy. The first is that informed consent is an "opportunity" concept whereas autonomy is an "exercise" concept; the second is that informed consent requires merely weak evaluation and not strong evaluation. On Taylor's analysis of agency, strong evaluation is required for agency and for autonomy.
In contemporary Western biomedical ethics, informed consent practices are commonly justified in terms of the intrinsic value of patient autonomy. James Stacey Taylor maintains that this conception of the moral grounding of medical informed consent is mistaken. On the basis of his reasoning to that effect, Taylor argues that medical informed consent is justified by the instrumental value of personal autonomy. In this article, I examine whether Taylor's justification of medical informed consent is plausible.
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