ObjectiveCochlear explantation for purely elective (e.g. psychological and emotional) reasons is not well studied. Herein, we aim to provide data and expert commentary about elective cochlear implant (CI) removal that may help to guide clinical decision-making and formulate guidelines related to CI explantation.Data sourcesWe address these objectives via three approaches: case report of a patient who desired elective CI removal; review of literature and expert discussion by surgeon, audiologist, bioethicist, CI user and member of Deaf community.Review methodsA systematic review using (...) three scientific online databases was performed. Included articles addressed the benefits and/or complications of cochlear implantation in young children, CI explantation with or without revision surgery and the ethical debate between the medical and Deaf communities on cochlear implantation and explantation.ConclusionsThe medical and audiological perspectives identify a host of risks related to implant removal without reimplantation, including risk from surgery, general anaesthesia, cochlear ossification and poor audiometric outcomes. The member of the deaf community and bioethicist argue that physicians need to guide the principles of beneficence, non-maleficence and patient autonomy. Taken together, patient desires should be seen as paramount, if the patient is otherwise fit for surgery and well informed.Implications for practiceSimilar to the case of device implantation, device explantation should be a multidisciplinary and collaborative decision with the patient and the family’s desires at the centre. While every case is different, we offer a CI explantation discussion to assist in clinical decision-making, patient counselling and education. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to (...) care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

This article discusses the response of our ethics consultation service to an exceptional request by a patient to have his implantable cardioverter defibrillator removed. Despite assurances that the device had saved his life on at least two occasions, and cautions that without it he would almost certainly suffer a potentially lethal cardiac event within 2 years, the patient would not be swayed. Although the patient was judged to be competent, our protracted consultation process lasted more than 8 months as we (...) consulted, argued with, and otherwise cajoled him to change his mind, all to no avail. Justifying our at times aggressive paternalistic intervention helped us to reflect on the nature of autonomy and the dynamics of the legal, moral, and personal relationships in the clinical decision-making process. (shrink)

Disconnecting a patient from artificial life support, on their request, is often if not always a matter of letting them die, not killing them—and sometimes, permissibly doing so. Stopping a patient’s heart on request, by contrast, is a kind of killing, and rarely if ever a permissible one. The difference seems to be that procedures of the first kind remove an unwanted external support for bodily functioning, rather than intervening in the body itself. What should we say, however, about cases (...) at the boundary—procedures involving items that seem bodily in some respects, but not others? When, for instance, does deactivating an implanted device like a pacemaker count as killing, and when as letting die? Contra existing proposals, I argue that the boundaries of the body for this purpose are not drawn at the boundaries of the self, or (if this is different) the human organism. Nor should we determine when we are killing and when we are letting die by deferring to existing practices for distinguishing ongoing from completed treatment. Rather, I argue that whether something (organic or inorganic) counts as body part for purposes of this distinction depends on the results of a normative analysis of the particular character of our rights in it—particularly, whether and in what way these rights ought to be alienable. I conclude by arguing that there are likely good reasons to recognize distinctively “bodily” rights and restrictions in at least some implantable devices. (shrink)

Technological advances are making devices that functionally replace body parts—artificial organs and limbs—more widely used, and more capable of providing patients with lives that are close to “normal.” Some of the ethical issues this is likely to raise relate to how such prostheses are conceptualized. Prostheses are ambiguous between being inanimate objects and sharing in the status of human bodies—which already have an ambiguous status, as both objects and subjects. At the same time, the possibility of replacing body parts with (...) artificial objects puts pressure on the normative status typically accorded to human bodies, seemingly confirming that body parts are replaceable objects. The paper argues that bodies’ normative status relies on the relation of a body to a person and shows that persons could have similar relations to prostheses. This suggests that in approaching ethical issues surrounding prostheses, it is appropriate to regard them as more like body parts than like objects. (shrink)

This volume contains four versions of the lecture notes taken by Kant's students of his university courses in ethics given regularly over a period of some thirty years. The notes are very complete and expound not only Kant's views on ethics but many of his opinions on life and human nature. Much of this material has never before been translated into English. As with other volumes in the series, there are copious linguistic and explanatory notes and a glossary of key (...) terms. (shrink)

What makes something a part of my body, for moral purposes? Is the body defined naturalistically: by biological relations, or psychological relations, or some combination of the two? This paper approaches this question by considering a borderline case: the status of prostheses. I argue that extant accounts of the body fail to capture prostheses as genuine body parts. Nor, however, do they provide plausible grounds for excluding prostheses, without excluding some paradigm organic parts in the process. I conclude by suggesting (...) that embodiment is moralized all the way down: to be a body part is to be the sort of thing that ought to be protected, in a certain way, by social practices. (shrink)

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period (...) affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software—particularly software that can be remotely accessed—in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered. (shrink)

Whereas previous discussions on ownership of biological material have been much informed by the natural rights tradition, insufficient attention has been paid to the strand in liberal political theory represented by Felix Cohen, Tony Honoré, and others, which treats property relations as socially constructed bundles of rights. In accordance with that tradition, we propose that the primary normative issue is what combination of rights a person should have to a particular item of biological material. Whether that bundle qualifies to be (...) called “property” or “ownership” is a secondary, terminological issue. We suggest five principles of bodily rights and show how they can be applied to the construction of ethically appropriate bundles of rights to biological material. (shrink)

ABSTRACT When applying moral principles to concrete cases, we assume a background shared understanding of the boundaries of the persons to whom the principles apply. In most contexts, this assumption is unproblematic. However, in end‐of‐life contexts, when patients are receiving ‘artificial’ life‐support, judgments about where a person's self begins and ends can become controversial. To illustrate this possibility, this paper presents a case in which a decision must be made whether to deactivate a patient's pacemaker as a means to hasten (...) his death. After discussing some common moral principles that are often applied to resolve ethical problems at the end of life and after explaining why they are of no help here, the paper argues that the correct analysis of this case, and of cases of this sort, turns on considerations that relate to the constitution of the self. These considerations, the paper further argues, sometimes resist resolution. The constitution of the self is fixed in large measure by our concepts and social conventions, and these do not always provide determinate grounds for delimiting the boundaries of the self. (shrink)

It is difficult to study failed medical devices because of a lack of data. Routine device retrieval and analysis (DRA) is essential to performance evaluation, which, in turn, is essential to good patient care. We argue for the development of a national DRA program and medical device database and discuss the major ethical and policy issues associated with this proposal.