Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...

On July 2, 2001, a medical milestone was reached when Robert Tools received a total artificial heart implant at Jewish Hospital in Louisville, Kentucky. Tools was implanted with an AbioCor artificial heart, one of several brands of new-generation artificial hearts that has been approved by the U.S. Food and Drug Administration for clinical trial. The AbioCor heart was developed by Abiomed of Danvers, Massachusetts.Following the surgery, physicians were guardedly enthusiastic about the device and (...) optimistic about the patient’s future. Tools, 59, has had a history of numerous heart attacks and by-pass surgery, as well as diabetes and kidney problems. He met the requirements of the AbioCor protocol because he was not a candidate for transplant, death was otherwise probable within thirty days, and other interventions were deemed ineffective. Researchers hope that strengthening his heart function will result in increased function of his other vital organs, thus prolonging the patient's life and increasing his energy. But because the device is experimental, nothing can be promised. (shrink)

Public discussion of new medical trials is desirable, but not moment‐by‐moment disclosure of patients' ups and down. Nor is such disclosure necessary: the public is not entitled to all information about a trial as soon as it is available. What should be given the press, and what withheld, cannot be decided without appreciating the surprising number and intricate interrelations of the parties' needs and interests.

Automation is inherently tied to ethical challenges because of its potential involvement in morally loaded decisions. In the present research, participants (n = 34) took part in a moral multi-trial dilemma-based task where the agent (human vs. machine) and the behavior (action vs. inaction) factors were randomized. Self-report measures, in terms of morality, consciousness, responsibility, intentionality, and emotional impact evaluation were gathered, together with electroencephalography (delta, theta, beta, upper and lower alpha, and gamma powers) and peripheral autonomic (electrodermal activity, (...) heart rate variability) data. Data showed that moral schemata vary as a function of the involved decider, and when the agent and behavior factors are crossed. Subjects did not consider machines full moral deciders to the same degree as humans and tend to morally better accept human active behavior and machine inaction. Moreover, the autonomic physiological activity might support the a-posteriori moral evaluation. In the evaluation of the agent’s consciousness, a beta ventrolateral prefrontal synchronization was detected for human action and machine inaction, while a generalized gamma synchronization occurred in artificial agent trials while rating the emotional impact of the decider’s behavior. The detected differences might point to a potential explicit and implicit asymmetry in moral reasoning toward artificial and human agents. (shrink)

On July 2, 2001, a medical milestone was reached when Robert Tools received a total artificial heart implant at Jewish Hospital in Louisville, Kentucky. Tools was implanted with an AbioCor artificial heart, one of several brands of new-generation artificial hearts that has been approved by the U.S. Food and Drug Administration for clinical trial. The AbioCor heart was developed by Abiomed of Danvers, Massachusetts.Following the surgery, physicians were guardedly enthusiastic about the device and (...) optimistic about the patient’s future. Tools, 59, has had a history of numerous heart attacks and by-pass surgery, as well as diabetes and kidney problems. He met the requirements of the AbioCor protocol because he was not a candidate for transplant, death was otherwise probable within thirty days, and other interventions were deemed ineffective. Researchers hope that strengthening his heart function will result in increased function of his other vital organs, thus prolonging the patient's life and increasing his energy. But because the device is experimental, nothing can be promised. (shrink)

On July 2, 2001, a medical milestone was reached when Robert Tools received a total artificial heart implant at Jewish Hospital in Louisville, Kentucky. Tools was implanted with an AbioCor artificial heart, one of several brands of new-generation artificial hearts that has been approved by the U.S. Food and Drug Administration for clinical trial. The AbioCor heart was developed by Abiomed of Danvers, Massachusetts.Following the surgery, physicians were guardedly enthusiastic about the device and (...) optimistic about the patient’s future. Tools, 59, has had a history of numerous heart attacks and by-pass surgery, as well as diabetes and kidney problems. He met the requirements of the AbioCor protocol because he was not a candidate for transplant, death was otherwise probable within thirty days, and other interventions were deemed ineffective. Researchers hope that strengthening his heart function will result in increased function of his other vital organs, thus prolonging the patient's life and increasing his energy. But because the device is experimental, nothing can be promised. (shrink)

It is widely believed to be permissible for a physician to discontinue any treatment upon the request of a competent patient. Many also believe it is never permissible for a physician to intentionally kill a patient. I argue that the prospect of deactivating a patient’s artificial heart presents us with a dilemma: either the first belief just mentioned is false or the second one is. Whichever horn of the dilemma we choose has significant implications for contemporary medical ethics.

Permanent implants of artificial hearts have been halted by bad results, but questions about fairness and informed consent have failed to stop manufacturers, surgeons, and hospitals from using mechanical hearts as bridges to transplant.

A member of the two federal advisory panels on artificial hearts reflects that the nuclear‐powered artificial heart, had it been developed, would have posed a physical threat to others. Today's artificial heart poses a different threat. Because of the high costs, many people may be deprived of access to other forms of medical care and other social goods.

Nancy Scheper-Hughes is one of the most prominent critics of markets in human organs. Unfortunately, Scheper-Hughes rejects the view that markets should be used to solve the current shortage of transplant organs without engaging with the arguments in favour of them. Scheper-Hughes’s rejection of such markets is of especial concern, given her influence over their future, for she holds, among other positions, the status of an adviser to the World Health Organization on issues related to global transplantation. Given her influence, (...) it is important that Scheper-Hughes’s moral condemnation of markets in human organs be subject to critical assessment. Such critical assessment, however, has not generally been forthcoming. A careful examination of Scheper-Hughes’s anti-market stance shows that it is based on serious mischaracterisations of both the pro-market position and the medical and economic realities that underlie it. In this paper, the author will expose and correct these mischaracterisations and, in so doing, show that her objections to markets in human organs are unfounded. (shrink)

Artificial devices that functionally replace internal organs are likely to be more common in the future. They are becoming more and more technologically feasible, increases in chronic diseases that can compromise various organs are anticipated, and donor organs will remain necessarily limited. More people in the future may have bodies that are partly nonorganic. How might artificial organs affect how we experience and conceptualize our bodies and how we understand the relation of the body to the experiencing, acting (...) subject, or self? Here, I focus on artificial heart devices (AHDs), including total artificial hearts (TAHs) and ventricular assist devices (VADs). While other devices, such as pacemakers and implantable cardiac defibrillators, assist the heart, I focus on devices that replace rather than assist organic function. AHDs, I argue, may have two opposing effects. On the one hand, having an AHD could alter experience, seemingly confirming that selves are shaped by the specifics of embodiment. On the other hand, AHDs are likely to encourage people to regard bodies as machines that are separable from the self. AHDs thus both confirm and undermine a body-self dualism. People with these devices may come to regard their bodies as machinelike even while having an artificial part alters their subjective experience. (shrink)

When the manufacturer of a medical device alone bears the responsibility for alerting recipients that the device may be defective, there is a certain temptation to gloss over the risk. The story of the Bjork‐Shiley Convexo‐Concave heart valve is a case in point.

De Bie et al. (2023) propose an organizing framework for different stages of human gestational development from conception to the viable premature. They also identify ethical considerations and con...

The lead article in this January‐February 2021 issue—the first of the Hastings Center Report's fiftieth year of publication—does not set out to change medicine. It tries instead to understand it. In “A Heart without Life: Artificial Organs and the Lived Body,” Mary Jean Walker draws on work in phenomenology and on empirical research with people who have received artificial heart devices to argue that such devices may have two very different effects on how a patient experiences (...) the body and the self. Several other pieces in this issue address the ongoing slew of patient care and health policy problems surrounding the Covid‐19 pandemic, and a special report titled Democracy in Crisis: Civic Learning and the Reconstruction of Common Purpose considers the requirements for public involvement in policy‐making about bioethical issues. (shrink)

This essay examines a challenge to common literary representations of female mental illness in the Early Modern period—the hysterical woman—in a collection of French short stories contemporary to Vesalius's De Fabrica: Jeanne Flore's Tales and Trials of Love. Jeanne Flore's tales depict several mentally disturbed female protagonists, young women prone to paroxysms of madness and self-mutilation. This study maintains that while Tales and Trials of Love superficially participates in the literary tradition that grew out of those accepted social and medical (...) beliefs, it also questions the long-accepted paradigm of female hysteria and points to a shift in the socio-medical climate. Jeanne Flore's fictional narratives suggest that mental illness no longer consists in the realignment of a uterine imbalance, but rather in the telling of personal stories, a precursor to psychoanalysis and narrative medicine. (shrink)

Race or ethnic identity, despite its imprecise categorization, is a useful means of identifying population differences in mechanisms of disease and treatment effects. Therefore, race and other arbitrary demographic and physiological variables have appropriately served as a helpful guide to clinical management and to clinical trial participation. The African-American Heart Failure Trial was carried out in African-Americans with heart failure because prior data had demonstrated a uniquely favorable effect in this subpopulation of the drug combination in (...) BiDil. The remarkable effect of the drug in reducing mortality in this study has illuminated an important new mechanism of therapy for heart failure. Application of these findings need not be confined to the population studied, but the observation highlights the need for more precise ways to identify individual responsiveness to therapy. (shrink)

The heart has a high‐metabolic rate, and its “around‐the‐clock” vital role to sustain life sets it apart in a regenerative setting from other organs and appendages. The landscape of vertebrate species known to perform intrinsic heart regeneration is strongly biased toward ectotherms—for example, fish, salamanders, and embryonic/neonatal ectothermic mammals. It is hypothesized that intrinsic heart regeneration is exclusively limited to the low‐metabolic hearts of ectotherms. The biomedical field of regenerative medicine seeks to devise biologically inspired regenerative therapies (...) to diseased human hearts. Falsification of the ectothermy dependency for heart regeneration hypothesis may be a crucial prerequisite to meaningfully seek inspiration in established ectothermic regenerative animal models. Otherwise, engineering approaches to construct artificial heart components may constitute a more viable path toward regenerative therapies. A more strict definition of regenerative phenomena is generated and several testable sub‐hypotheses and experimental avenues are put forward to elucidate the link between heart regeneration and metabolism. Also see the video abstract here https://youtu.be/fZcanaOT5z8. (shrink)

In 2017 and 2019, two research teams claimed ‘proof of principle’ for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research–treatment distinction, pervasive in (...) regulation worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue that there is a tendency in the literature to conceptualize AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a ‘beneficial treatment’. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico‐legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed. (shrink)

This paper explores and ultimately affirms the surprising claim that artificial intelligence (AI) can become part of the person, in a robust sense, and examines three ethical and legal implications. The argument is based on a rich, legally inspired conception of persons as free and independent rightholders and objects of heightened protection, but it is construed so broadly that it should also apply to mainstream philosophical conceptions of personhood. The claim is exemplified by a specific technology, devices that connect (...) human brains with computers and operate by AI-algorithms. Under philosophically reasonable and empirically realistic conditions, these devices and the AI running them become parts of the person, in the same way as arms, hearts, or mental capacities are. This transformation shall be called empersonification. It has normative and especially legal consequences because people have broader and stronger duties regarding other persons (and parts of them) than regarding things. Three consequences with practical implications are: (i) AI-devices cease to exist as independent legal entities and come to enjoy the special legal protection of persons; (ii) therefore, third parties such as manufacturers or authors of software lose (intellectual) property rights in device and software; (iii) persons become responsible for the outputs of the empersonified AI-devices to the same degree that they are for desires or intentions arising from the depths of their unconscious. More generally, empersonification marks a new step in the long history of human–machine interaction that deserves critical ethical reflection and calls for a stronger value-aligned development of these technologies. (shrink)

This paper explores and ultimately affirms the surprising claim that artificial intelligence (AI) can become part of the person, in a robust sense, and examines three ethical and legal implications. The argument is based on a rich, legally inspired conception of persons as free and independent rightholders and objects of heightened protection, but it is construed so broadly that it should also apply to mainstream philosophical conceptions of personhood. The claim is exemplified by a specific technology, devices that connect (...) human brains with computers and operate by AI-algorithms. Under philosophically reasonable and empirically realistic conditions, these devices and the AI running them become parts of the person, in the same way as arms, hearts, or mental capacities are. This transformation shall be called empersonification. It has normative and especially legal consequences because people have broader and stronger duties regarding other persons (and parts of them) than regarding things. Three consequences with practical implications are: (i) AI-devices cease to exist as independent legal entities and come to enjoy the special legal protection of persons; (ii) therefore, third parties such as manufacturers or authors of software lose (intellectual) property rights in device and software; (iii) persons become responsible for the outputs of the empersonified AI-devices to the same degree that they are for desires or intentions arising from the depths of their unconscious. More generally, empersonification marks a new step in the long history of human–machine interaction that deserves critical ethical reflection and calls for a stronger value-aligned development of these technologies. (shrink)

The practice of using race or ethnic origin as a distinguishing feature of populations or individuals seeking health care is a universal and well-accepted custom in medicine. Although the origin of this practice may, in part, reflect past prejudicial attitudes, its use today can certainly be defended as a useful means of improving diagnostic and therapeutic efforts. Indeed, the tradition of dividing populations by some racial distinction in clinical research has nearly always revealed differences in mechanisms of disease and disease (...) frequency that can enhance diagnostic and therapeutic precision.At the conference occasioning this symposium, Professors Duster and Rotimi provided persuasive evidence that so-called race is not an accurate way to distinguish populations and that identification by race has led to serious prejudice. Professor Cho pleaded that race should never be used to characterize population differences. (shrink)

Background The Patient Right to Autonomy Act (PRAA), implemented in Taiwan in 2019, enables the creation of advance decisions (AD) through advance care planning (ACP). This legal framework allows for the withholding and withdrawal of life-sustaining treatment (LST) or artificial nutrition and hydration (ANH) in situations like irreversible coma, vegetative state, severe dementia, or unbearable pain. This study aims to investigate preferences for LST or ANH across various clinical conditions, variations in participant preferences, and factors influencing these preferences among (...) urban residents. Methods Employing a survey of legally structured AD documents and convenience sampling for data collection, individuals were enlisted from Taipei City Hospital, serving as the primary trial and demonstration facility for ACP in Taiwan since the commencement of the PRAA in its inaugural year. The study examined ADs and ACP consultation records, documenting gender, age, welfare entitlement, disease conditions, family caregiving experience, location of ACP consultation, participation of second-degree relatives, and the intention to participate in ACP. Results Data from 2337 participants were extracted from electronic records. There was high consistency in the willingness to refuse LST and ANH, with significant differences noted between terminal diseases and extremely severe dementia. Additionally, ANH was widely accepted as a time-limited treatment, and there was a prevalent trend of authorizing a health care agent (HCA) to make decisions on behalf of participants. Gender differences were observed, with females more inclined to decline LST and ANH, while males tended towards accepting full or time-limited treatment. Age also played a role, with younger participants more open to treatment and authorizing HCA, and older participants more prone to refusal. Conclusion Diverse preferences in LST and ANH were shaped by the public’s current understanding of different clinical states, gender, age, and cultural factors. Our study reveals nuanced end-of-life preferences, evolving ADs, and socio-demographic influences. Further research could explore evolving preferences over time and healthcare professionals’ perspectives on LST and ANH decisions for neurological patients.. (shrink)

In this paper, we explore how the prospect of artificial placenta technology (nearing clinical trials in human subjects) should encourage further consideration of the loss experienced by individuals when their pregnancy ends unexpectedly. Discussions of pregnancy loss are intertwined with procreative loss, whereby the gestated entity has died when the pregnancy ends. However, we demonstrate how pregnancy loss can and does exist separate to procreative loss in circumstances where the gestated entity survives the premature ending of the pregnancy. In (...) outlining the value that can be attached to pregnancy beyond fetal-centric narratives, we illustrate how pregnancy loss, separate to procreative loss, can be experienced. This loss has already been recognised among parents who have experienced an unexpected early ending of their pregnancy, resulting in their child being cared for in neonatal intensive care unit. Artificial placentas, however, may exacerbate these feelings and make pregnancy loss (without procreative loss) more visible. We argue that pregnancy is an embodied state in which gestation is facilitated by the body but gestation itself should be recognised as a process—and one that could be separable from pregnancy. In demarcating the two, we explore the different ways in which pregnancy loss can be understood. Our objective in this paper goes beyond contributing to our philosophical understanding of pregnancy towards practical-orientated conclusions regarding the care pathways surrounding the artificial placenta. We make recommendations including the need for counselling and careful consideration of the language used when an artificial placenta is used. (shrink)

Heart Robot was a public engagement project funded by the Engineering and Physical Sciences Research Council. The aim of the project was to challenge cultural perceptions of robots, and to stimulate thought and debate in members of the general public around research in the field of social and emotional robotics. Fusing the traditions of Bunraku puppetry, the technology of animatronics and the field of artificial emotion and social intelligence, Heart Robot presented a series of entertaining, thought-provoking, and (...) moving performances at fourteen events in the south-west region of the UK between May and December 2008. This paper presents a summary of the independent evaluation of the project. Keywords: Robot, Puppet, Public Engagement, Social Robots, Science-art collaboration. (shrink)

Recent work in artificial intelligence has increasingly turned to argumentation as a rich, interdisciplinary area of research that can provide new methods related to evidence and reasoning in the area of law. Douglas Walton provides an introduction to basic concepts, tools and methods in argumentation theory and artificial intelligence as applied to the analysis and evaluation of witness testimony. He shows how witness testimony is by its nature inherently fallible and sometimes subject to disastrous failures. At the same (...) time such testimony can provide evidence that is not only necessary but inherently reasonable for logically guiding legal experts to accept or reject a claim. Walton shows how to overcome the traditional disdain for witness testimony as a type of evidence shown by logical positivists, and the views of trial sceptics who doubt that trial rules deal with witness testimony in a way that yields a rational decision-making process. (shrink)

BackgroundHealthcare providers have to make ethically complex clinical decisions which may be a source of stress. Researchers have recently introduced Artificial Intelligence (AI)-based applications to assist in clinical ethical decision-making. However, the use of such tools is controversial. This review aims to provide a comprehensive overview of the reasons given in the academic literature for and against their use.MethodsPubMed, Web of Science, Philpapers.org and Google Scholar were searched for all relevant publications. The resulting set of publications was title and (...) abstract screened according to defined inclusion and exclusion criteria, resulting in 44 papers whose full texts were analysed using the Kuckartz method of qualitative text analysis.ResultsArtificial Intelligence might increase patient autonomy by improving the accuracy of predictions and allowing patients to receive their preferred treatment. It is thought to increase beneficence by providing reliable information, thereby, supporting surrogate decision-making. Some authors fear that reducing ethical decision-making to statistical correlations may limit autonomy. Others argue that AI may not be able to replicate the process of ethical deliberation because it lacks human characteristics. Concerns have been raised about issues of justice, as AI may replicate existing biases in the decision-making process.ConclusionsThe prospective benefits of using AI in clinical ethical decision-making are manifold, but its development and use should be undertaken carefully to avoid ethical pitfalls. Several issues that are central to the discussion of Clinical Decision Support Systems, such as justice, explicability or human–machine interaction, have been neglected in the debate on AI for clinical ethics so far.Trial registrationThis review is registered at Open Science Framework (https://osf.io/wvcs9). (shrink)

Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. Methods An observational study of protocols of randomised trials of chronic therapies (...) for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. Results 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. Conclusions The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised. (shrink)

This interdisciplinary collection of classical and contemporary readings provides a clear and comprehensive guide to the many hotly-debated philosophical issues at the heart of artificial intelligence.

'if AI is outside your field, or you know something of the subject and would like to know more then Artificial Intelligence: The Basics is a brilliant primer.' - Nick Smith, Engineering and Technology Magazine November 2011 Artificial Intelligence: The Basics is a concise and cutting-edge introduction to the fast moving world of AI. The author Kevin Warwick, a pioneer in the field, examines issues of what it means to be man or machine and looks at advances in (...) robotics which have blurred the boundaries. Topics covered include: how intelligence can be defined whether machines can 'think' sensory input in machine systems the nature of consciousness the controversial culturing of human neurons. Exploring issues at the heart of the subject, this book is suitable for anyone interested in AI, and provides an illuminating and accessible introduction to this fascinating subject. (shrink)