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

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.

Families play an essential role in deceased organ procurement. As the person cannot directly communicate his or her wishes regarding donation, the family is often the only source of information regarding consent or refusal. We provide a systematic description and analysis of the different roles the family can play, and actions the family can take, in the organ procurement process across different jurisdictions and consent systems. First, families can inform or update healthcare professionals about a person’s donation wishes. Second, families can authorize organ procurement in the absence of deceased’s preferences and the default is not to remove organs, and oppose donation where there is no evidence of preference but the default is to presume consent; in both cases, the decision could be based on their own wishes or what they think the deceased would have wanted. Finally, families can overrule the known wishes of the deceased, which can mean preventing donation, or permitting donation when the deceased refused it. We propose a schema of 4 levels on which to map these possible family roles: no role, witness, surrogate, and full decisional authority. We conclude by mapping different jurisdictions onto this schema to provide a more comprehensive understanding of the consent system for organ donation and some important nuances about the role of families. This classificatory model aims to account for the majority of the world’s consent systems. It provides conceptual and methodological guidance that can be useful to researchers, professionals, and policymakers involved in organ procurement.

Despite continuing controversies regarding the vital status of both brain-dead donors and individuals who undergo donation after circulatory death (DCD), respecting the dead donor rule (DDR) remains the standard moral framework for organ procurement. The DDR increases organ supply without jeopardizing trust in transplantation systems, reassuring society that donors will not experience harm during organ procurement. While the assumption that individuals cannot be harmed once they are dead is reasonable in the case of brain-dead protocols, we argue that the DDR is not an acceptable strategy to protect donors from harm in DCD protocols. We propose a threefold alternative to justify organ procurement practices: (1) ensuring that donors are sufficiently protected from harm; (2) ensuring that they are respected through informed consent; and (3) ensuring that society is fully informed of the inherently debatable nature of any criterion to declare death.

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.