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ObjectivesTo increase postmortem organ donation rates, several countries are adopting an opt-out (presumed consent) policy, meaning that individuals are deemed donors unless they expressly refused so. Although opt-out countries tend to have higher donation rates, there is no conclusive evidence that this is caused by the policy itself. The main objective of this study is to better assess the direct impact of consent policy defaults per se on deceased organ recovery rates when considering the role of the family in the decision-making process. This study does not take into account any indirect effects of defaults, such as potential psychological and behavioural effects on individuals and their relatives.DesignBased on previous work regarding consent policies, we created a conceptual model of the decision-making process for deceased organ recovery that included any scenario that could be directly influenced by opt-in or opt-out policies. We then applied this model to internationally published data of the consent process to determine how frequently policy defaults could apply.Main outcome measuresWe measure the direct impact that opt-in and opt-out policies have per se on deceased organ recovery.ResultsOur analysis shows that opt-in and opt-out have strictly identical outcomes in eight out of nine situations. They only differ when neither the deceased nor the family have expressed a preference and defaults therefore apply. The direct impact of consent policy defaults is typically circumscribed to a range of 0%–5% of all opportunities for organ recovery. Our study also shows that the intervention of the family improves organ retrieval under opt-in but hinders it under opt-out.ConclusionsThis study may warn policy makers that, by emphasising the need to introduce presumed consent to increase organ recovery rates, they might be overestimating the influence of the default and underestimating the power granted to families.

Consent policies for post-mortem organ procurement (OP) vary throughout Europe, and yet no studies have empirically evaluated the ethical implications of contrasting consent models. To fill this gap, we introduce a novel indicator of governance quality based on the ideal of informed support, and examine national differences on this measure through a quantitative survey of OP policy informedness and preferences in seven European countries. Between 2017-2019, we conducted a convenience sample survey of students (n = 2006) in Austria (AT), Belgium (BE), Denmark (DK), Germany (DE), Greece (GR), Slovenia (SI) and Spain (ES), asking participants about their donation preferences, as well as their beliefs and views about the policy in place. From these measures, we computed indices of informedness, policy support, and fulfilment of unexpressed preferences, which we compared across countries and consent systems. Our study introduces a tool for analyzing policy governance in the context of OP. Wide variation in policy awareness was observed: Most respondents in DK, DE, AT and BE correctly identified the policy in place, while those in SI, GR and ES did not. Respondents in opt-out countries (AT, BE, ES and GR) tended to support the policy in place (with one exception, i.e., SI), whereas those in opt-in countries (DE and DK) overwhelmingly opposed it. These results reveal stark differences in governance quality across countries and consent policies: We found a preponderance of informed opposition in opt-in countries and a general tendency towards support-either informed or uninformed-in opt-out countries. We also found informed divergence in opt-in countries and a tendency for convergence-either informed or uninformed-among opt-out countries. Our study offers a novel tool for analyzing governance quality and illustrates, in the context of OP, how the strengths and weaknesses of different policy implementations can be estimated and compared using quantitative survey data.

The debate over the determination of death has been raging for more than fifty years. Since then, objections against the diagnosis of brain death from family members of those diagnosed as dead-have been increasing and are causing some countries to take novel steps to accommodate people’s beliefs and preferences in the determination of death. This, coupled with criticism by some academics of the brain death criterion, raises some questions about the issues surrounding the determination of death. In this paper, we discuss some of the main approaches to death determination that have been theoretically proposed or currently put into practice and propose a new approach to death determination called \"weak pluralism\" as a reasonable ethical and political alternative to respect diversity in death determination.

Since the 1960s, scientists, engineers, and healthcare professionals have developed brain–computer interface (BCI) technologies, connecting the user’s brain activity to communication or motor devices. This new technology has also captured the imagination of publics, industry, and ethicists. Academic ethics has highlighted the ethical challenges of BCIs, although these conclusions often rely on speculative or conceptual methods rather than empirical evidence or public engagement. From a social science or empirical ethics perspective, this tendency could be considered problematic and even technocratic because of its disconnect from publics. In response, our trinational survey (Germany, Canada, and Spain) reports public attitudes toward BCIs (N = 1,403) on ethical issues that were carefully derived from academic ethics literature. The results show moderately high levels of concern toward agent-related issues (e.g., changing the user’s self) and consequence-related issues (e.g., new forms of hacking). Both facets of concern were higher among respondents who reported as female or as religious, while education, age, own and peer disability, and country of residence were associated with either agent-related or consequence-related concerns. These findings provide a first look at BCI attitudes across three national contexts, suggesting that the language and content of academic BCI ethics may resonate with some publics and their values.

It was only after James P. Lovette's death, in 2006, that I discovered that the twenty‐four‐year‐old colleague and friend with whom I had spent so many afternoons debating issues in organ transplantation had been the first successful child heart transplantee in the world and one of the longest‐living survivors of a second transplant. During the years we met, he never even hinted at the fact that three different hearts had beaten in his chest. The revelation that his life had been an almost uninterrupted chain of medical challenges suddenly made me appreciate his quirkiness in a whole new light. Organ transplantation crudely exemplifies a traditional moral dilemma between means and ends: in order to save a life, someone else has to die. Bioethicists involved in this field have the role of identifying the ethical issues surrounding organ donation and helping others to argue in an intelligible and convincing way. In my view, bioethicists have the obligation to foster a discussion as open and transparent as possible on these matters. Still, I sometimes fear that I may be helping to cause unnecessary harms to potential recipients who are desperately waiting for a vital organ. Scholars would be chillingly cold if their quest for truth systematically came at the cost of lives lost. Every life can be meaningful and provide meaning to many others. This is true even with organ recipients, who often have short lives full of considerable suffering.

The increasing application of artificial intelligence (AI) to healthcare raises both hope and ethical concerns. Some advanced machine learning methods provide accurate clinical predictions at the expense of a significant lack of explainability. Alex John London has defended that accuracy is a more important value than explainability in AI medicine. In this article, we locate the trade-off between accurate performance and explainable algorithms in the context of distributive justice. We acknowledge that accuracy is cardinal from outcome-oriented justice because it helps to maximize patients’ benefits and optimizes limited resources. However, we claim that the opaqueness of the algorithmic black box and its absence of explainability threatens core commitments of procedural fairness such as accountability, avoidance of bias, and transparency. To illustrate this, we discuss liver transplantation as a case of critical medical resources in which the lack of explainability in AI-based allocation algorithms is procedurally unfair. Finally, we provide a number of ethical recommendations for when considering the use of unexplainable algorithms in the distribution of health-related resources.

Background Immunosuppression after kidney transplantation is mainly guided via plasma tacrolimus trough level, which cannot sufficiently predict allograft rejection and infection. The plasma load of the non-pathogenic and highly prevalent torque teno virus (TTV) is associated with the immunosuppression of its host. Non-interventional studies suggest the use of TTV load to predict allograft rejection and infection. The primary objective of the current trial is to demonstrate the safety, tolerability and preliminary efficacy of TTV-guided immunosuppression. Methods For this purpose, a randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, investigator-driven phase II trial was designed. A total of 260 stable, low-immunological-risk adult recipients of a kidney graft with tacrolimus-based immunosuppression and TTV infection after month 3 post-transplantation will be recruited in 13 academic centres in six European countries. Subjects will be randomised in a 1:1 ratio (allocation concealment) to receive tacrolimus either guided by TTV load or according to the local centre standard for 9 months. The primary composite endpoint includes the occurrence of infections, biopsy-proven allograft rejection, graft loss, or death. The main secondary endpoints include estimated glomerular filtration rate, graft rejection detected by protocol biopsy at month 12 post-transplantation (including molecular microscopy), development of de novo donor-specific antibodies, health-related quality of life, and drug adherence. In parallel, a comprehensive biobank will be established including plasma, serum, urine and whole blood. The date of the first enrolment was August 2022 and the planned end is April 2025. Discussion The assessment of individual kidney transplant recipient immune function might enable clinicians to personalise immunosuppression, thereby reducing infection and rejection. Moreover, the trial might act as a proof of principle for TTV-guided immunosuppression and thus pave the way for broader clinical applications, including as guidance for immune modulators or disease-modifying agents. Trial registration EU CT-Number: 2022-500024-30-00

In this issue of the Report, James L. Bernat proposes an innovative and sophisticated distinction to justify the introduction of permanent cessation as a valid substitute standard for irreversible cessation in death determination. He differentiates two approaches to conceptualizing and determining death: the biological concept and the prevailing medical practice standard. While irreversibility is required by the biological concept, the weaker criterion of permanence, he claims, has always sufficed in the accepted standard medical practice to declare death. Bernat argues that the medical practice standard may be acceptable on the ground that proving circulatory or brain permanence is sufficient to assure complete accuracy for death diagnosis. The topic requires public deliberation: processes to survey people's opinions and mechanisms to channel their opinions into policy‐making. What is at stake is the nature of our society. Do we want an expertocracy, in which an enlightened few design policies for the greater good of the majority and exploit the lack of public knowledge to achieve compliance?

Non-conventional resuscitation involves several techniques, including thrombolysis treatment during CPR,3,8 transfer to the intensive care unit with induced mild hypothermia,5,6 ECMO as a bridge to extracorporeal life support devices in the intensive care unit,4 percutaneous coronary intervention in a catheterisation laboratory,9 and, if needed, insertion of an intra-aortic balloon pump.6 Emergency and intensive care services in many countries, including Austria, Sweden, Japan, France, and the USA, have reported that various combinations of these techniques are associated with promising survival rates with good neurological outcomes (cerebral performance categories scale 1-2) after discharge from hospital.3,5,9,10 As a result of increasing evidence to support the eff ectiveness of such interventions in selected patients, international resuscitation guidelines have been modifi ed and now recommend treatment of the known or suspected causes of refractory cardiac arrest before CPR is discontinued.11,12 Uncontrolled donation programmes that overlook this recommendation might be failing to off er the updated standard of treatment to certain patients with out-of-hospital cardiac arrest. [...] some interventions that are strictly intended to preserve the organs- eg, vasodilators, anticoagulants, and preservation fl uids- can actually compromise the patient's chances of survival.13 However, not all patients with out-ofhospital cardiac arrest are likely to benefi t from nonconventional resuscitation procedures.10 Criteria should be developed to classify patients as either entitled to these innovative therapies or suitable for organ donation.

The ever‐increasing demand for organs led Spain, France, and other European countries to promote uncontrolled donation after circulatory determination of death (uDCDD). For the same reason, New York City has recently developed its own uDCDD protocol, which differs from European programs in some key ways. The New York protocol incorporates a series of technical and management improvements that address some practical problems identified in response to European uDCDD protocols. However, the more fundamental issue of whether uDCDD donors are dead when organs are procured remains problematic for the New York City protocol and, indeed, for all uDCDD protocols. In the United States, two amendments to the legal criteria of death have been suggested to avoid a formal violation of the dead donor rule in DCDD protocols: first, replacing the requirement “irreversible” with the weaker term “permanent,” and second, using the term “circulatory” instead of “cardiac” to identify the key function that must be lost to declare death. While intended to facilitate controlled DCDD, these modifications create a problem for uDCDD protocols: if extracorporeal membrane oxygenation is introduced to preserve the organs, then circulation is restored after death is declared. In this issue of the Hastings Center Report, Kevin Munjal and colleagues call for a new ethical construct and policy so that uncontrolled and controlled DCDD can coexist.