Living Donor Kidney Transplantation in Older Individuals: An Ethical Legal and Psychological Aspects of Transplantation (ELPAT) View.

Living donor transplantation is the optimal treatment for suitable patients with end-stage kidney disease. There are particular advantages for older individuals in terms of elective surgery, timely transplantation, and early graft function. Yet, despite the superiority of living donor transplantation especially for this cohort, older patients are significantly less likely to access this treatment modality than younger age groups. However, given the changing population demographic in recent decades, there are increasing numbers of older but otherwise healthy individuals with kidney disease who could benefit from living donor transplantation. The complex reasons for this inequity of access are explored, including conscious and unconscious age-related bias by healthcare professionals, concerns relating to older living donors, ethical anxieties related to younger adults donating to aging patients, unwillingness of potential older recipients to consider living donation, and the relevant legislation. There is a legal and moral duty to consider the inequity of access to living donor transplantation, recognising both the potential disparity between chronological and physiological age in older patients, and benefits of this treatment for individuals as well as society.

Inequitable Access to Transplants: Adults With Impaired Decision-Making Capacity.

Inequitable access to deceased donor organs for transplantation has received considerable scrutiny in recent years. Emerging evidence suggests patients with impaired decision-making capacity (IDC) face inequitable access to transplantation. The "Ethical and Legal Issues" working group of the European Society of Transplantation undertook an expert consensus process. Literature relating to transplantation in patients with IDC was examined and collated to investigate whether IDC is associated with inferior transplant outcomes and the legitimacy of this healthcare inequality was examined. Even though the available evidence of inferior transplant outcomes in these patients is limited, the working group concluded that access to transplantation in patients with IDC may be inequitable. Consequently, we argue that IDC should not in and of itself be considered as a barrier to either registration on the transplant waiting list or allocation of an organ. Strategies for non-discrimination should focus on ensuring eligibility is based upon sound evidence and outcomes without reference to non-medical criteria. Recommendations to support policy makers and healthcare providers to reduce unintended inequity and inadvertent discrimination are set out. We call upon transplant centres and national bodies to include data on decision-making capacity in routine reporting schedules in order to improve the evidence base upon which organ policy decisions are made going forward.

Donor Autonomy and Self-Sacrifice in Living Organ Donation: An Ethical Legal and Psychological Aspects of Transplantation (ELPAT) View.

Clinical teams understandably wish to minimise risks to living kidney donors undergoing surgery, but are often faced with uncertainty about the extent of risk, or donors who wish to proceed despite those risks. Here we explore how these difficult decisions may be approached and consider the conflicts between autonomy and paternalism, the place of self-sacrifice and consideration of risks and benefits. Donor autonomy should be considered as in the context of the depth and strength of feeling, understanding risk and competing influences. Discussion of risks could be improved by using absolute risk, supra-regional MDMs and including the risks to the clinical team as well as the donor. The psychological effects on the donor of poor outcomes for the untransplanted recipient should also be taken into account. There is a lack of detailed data on the risks to the donor who has significant co-morbidities.

Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey.

BACKGROUND: European countries are increasingly harmonising their organ donation and transplantation policies. Although a growing number of nations are moving to presumed consent to deceased organ donation, no attempts have been made to harmonise policies on individual consent and the role of the family in the decision-making process. Little is known about public awareness of and attitudes towards the role of the family in their own country and European harmonisation on these health policy dimensions. To improve understanding of these issues, we examined what university students think about the role of the family in decision-making in deceased organ donation and about harmonising consent policies within Europe. METHODS: Using LimeSurvey© software, we conducted a comparative cross-sectional international survey of 2193 university students of health sciences and humanities/social sciences from Austria (339), Belgium (439), Denmark (230), Germany (424), Greece (159), Romania (190), Slovenia (190), and Spain (222). RESULTS: Participants from opt-in countries may have a better awareness of the family's legal role than those from opt-out countries. Most respondents opposed the family veto, but they were more ambivalent towards the role of the family as a surrogate decision-maker. The majority of participants were satisfied with the family's legal role. However, those who were unsatisfied preferred to limit family involvement. Overall, participants were opposed to the idea of national sovereignty over consent policies. They favoured an opt-out policy harmonisation and were divided over opt-in. Their views on harmonisation of family involvement were consistent with their personal preferences. CONCLUSIONS: There is overall division on whether families should have a surrogate role, and substantial opposition to granting them sole authority over decision-making. If European countries were to harmonise their policies on consent for organ donation, an opt-out system that grants families a surrogate decision-making role may enjoy the widest public support.

'Capacity for Discernment' and Euthanasia on Minors in Belgium.

In 2014, the Belgian Euthanasia Law was amended so as to extend the possibility of obtaining euthanasia to minors who have the capacity for discernment. The amendment led to considerable debate among Belgian legal experts, health care professionals and ethicists, in large part due to concerns about the scope and assessment of the minor's 'capacity for discernment', a concept first introduced in Belgian medical law by the amendment. This article offers a critical legal analysis of the concept of 'capacity for discernment' and its implications for euthanasia practice in Belgium. We do so by focusing on a ruling of the Belgian Constitutional Court of 29 October 2015, where the concept figured prominently in the examination of the constitutionality of the amendment. This approach also allows us to shed light on the interpretation of several core aspects of the original 2002 Euthanasia Law and its 2014 amendment.

Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies.

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' "foundational" nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.

Where are we heading? The legality of human body transplants examined.

In this article the authors examine the legality of human body transplantation under the current state of medical knowledge. The article first analyzes under what conditions an experimental medical procedure may be legitimately performed under international and national law. Then it examines the legal requirements for prior ethics approval and considers the possible civil and criminal liability claims and disciplinary sanctions that may arise if such a procedure would fail. Subsequently, it applies this analysis to investigate whether body transplants would currently be legally allowed. The authors conclude that it is very unlikely that prior ethics approval would be obtained, and emphasize that physicians are likely to be found liable for medical malpractice if body transplantation is performed. If body transplantation results in the death of the patient, the physicians involved would run a considerable risk of being held criminally liable for negligent homicide. The participating physicians also risk severe disciplinary sanctions for professional misconduct, with a real possibility that they will be suspended or even banned from medical practice for life.

Governing the postmortem procurement of human body material for research.

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent.

Pediatric priority in kidney allocation: challenging its acceptability.

Any organ which is allocated to one individual represents a missed opportunity for someone else. Given the important repercussions which organ allocation policies inevitably have for certain people, any prioritization policy should rest on a solid argumentative basis. In this study, we analyze the widespread practice of prioritizing pediatric patients in the allocation of kidneys. While official policy documents offer no arguments in support of pediatric priority, such arguments can be found in the academic literature on pediatric renal transplantation. Our study is the first to bring together and critically analyze these. We identify five commonly cited arguments and show that none of these succeeds in justifying pediatric priority policies. We argue that the legitimacy of such policies may be further undermined by their potential adverse effects on both adults and children.

Living organ procurement from the mentally incompetent: the need for more appropriate guidelines.

With the case of Belgium as a negative example, this paper will evaluate the legitimacy of using mentally incompetents as organ sources. The first section examines the underlying moral dilemma that results from the necessity of balancing the principle of respect for persons with the obligation to help people in desperate need. We argue for the rejection of a radical utilitarian approach but also question the appropriateness of a categorical prohibition. Section two aims to strike a fair balance between the competing interests at stake and to define the conditions under which organ harvest from mentally incompetents might be morally acceptable. To this end, we morally assess the main requirements that have been put forward to allow organ removal from incompetent donors. We conclude that the current Belgian legislation is far too permissive and that national regulations that do not permit the harvest of non-regenerable organs from mentally incompetents in exceptional circumstances are too restrictive. On the basis of this discussion, we propose a number of guiding principles for decision-making in this area.

Should minors be considered as potential living liver donors?

For many patients, living donor liver transplantation represents their only hope of receiving a lifesaving graft. In certain (albeit rare) cases, a minor will be the only suitable donor. Living liver donation by minors has been reported in several countries. In the academic literature and professional guidelines, little attention is paid to the development of an ethical framework for this practice. The focus is frequently limited to the donation of regenerative tissues and kidneys. However, liver donation differs in important respects because of the increased medical risks and the lack of substitute therapies. Therefore, in this article, we assess whether living liver donation by minors is ethically appropriate. We argue that living liver donation by minors is justifiable only if minors possess the capacity to consent to donation or if the procedure is in their best interests. Although minors may possess adult-like levels of cognitive maturity, they lack sufficient psychosocial maturity to give valid consent to donation. In addition, living liver donation is generally not in a minor's best interests. With respect to the latter, the potential psychological benefits that a minor may experience as a result of living liver donation are insufficiently empirically supported and are unlikely to outweigh the short- and long-term medical and psychological risks. Therefore, we conclude that minors should not be considered as potential living liver donors.

Could minors be living kidney donors? A systematic review of guidelines, position papers and reports.

The purpose of this study is to systematically review guidelines, position papers, and reports on living kidney donation by minors. We systematically searched the databases such as Medline, Embase, ISI Web of knowledge, Google scholar as well as the websites of various bioethics committees, transplant organizations and societies. Guidelines were included if they provided recommendations for or against living kidney donation by minors. Data were analyzed using qualitative content analysis. We included 39 documents in this study. Twenty seven of these endorse an absolute prohibition of living kidney donation by minors, because of concerns regarding the decision-making capacity of minors, the impartiality of parental authorization, the best interests of the minor, and the necessity of the donation. Twelve guidelines, however, would exceptionally allow living kidney donation by minors, provided that adequate safeguards are put in place, including an assessment of the minor's autonomy and maturity, authorization by an independent body, assuring that the anticipated psychosocial benefits outweigh the medical and psychosocial risks for the donor and the restriction to situations of last resort. A more adequate medical and psychosocial follow-up of living kidney donors may likely contribute to a more unified approach towards living kidney donation by minors.

Improving control over euthanasia of persons with psychiatric illness: Lessons from the first Belgian criminal court case concerning euthanasia.

Background: Belgium is one of very few countries that legally allow euthanasia for suffering caused by psychiatric illness. In the first criminal trial in Belgium of physicians involved in euthanasia, three physicians recently faced the accusation of "murder by poisoning," for allegedly having failed to comply with several requirements of the Belgian Euthanasia Law in granting the euthanasia request a woman suffering from psychiatric illness. Although all three physicians were acquitted, the case generated much debate among policy makers, medical professionals, and the general public. Method: We use this trial as the starting point for a critical analysis of the adequacy of the three-level control system established in the Euthanasia Law, as it is applied in the evaluation of euthanasia requests from persons who suffer unbearably from a psychiatric illness. This analysis is based on information presented during the criminal trial as well as information on the euthanasia that was published in the press. Results: Our analysis highlights substantial problems in the assessment and granting of the euthanasia request. The patient was euthanized without it having been substantiated that her psychiatric illness had no prospect of improvement and that her suffering could not be alleviated. The three-step control system enshrined in the Law and promoted by the Federal Control and Evaluation Commission for Euthanasia appears to have failed at each level. Conclusion: To evaluate requests for euthanasia for mental suffering caused by psychiatric illness, the requirements of the Belgian Euthanasia Law should be complemented by mandating the advice of two psychiatrists, and face-to-face discussions between all physicians involved. In parallel with the process of evaluating the euthanasia request, a treatment track should be guaranteed where reasonable evidence-based treatments and recovery-oriented options are tried.

The Reality of Inadequate Patient Care and the Need for a Global Action Framework in Organ Donation and Transplantation.

BACKGROUND: Transplant therapy is considered the best and often the only available treatment for thousands of patients with organ failure that results from communicable and noncommunicable diseases. The number of annual organ transplants is insufficient for the worldwide need. METHODS: We elaborate the proceedings of the workshop entitled "The Role of Science in the Development of International Standards of Organ Donation and Transplantation," organized by the Pontifical Academy of Sciences and cosponsored by the World Health Organization in June 2021. RESULTS: We detail the urgency and importance of achieving national self-sufficiency in organ transplantation as a public health priority and an important contributor to reaching relevant targets of the United Nations Agenda for Sustainable Development. It details the elements of a global action framework intended for countries at every level of economic development to facilitate either the establishment or enhancement of transplant activity. It sets forth a proposed plan, by addressing the technical considerations for developing and optimizing organ transplantation from both deceased and living organ donors and the regulatory oversight of practices. CONCLUSIONS: This document can be used in governmental and policy circles as a call to action and as a checklist for actions needed to enable organ transplantation as treatment for organ failure.

The new Belgian law on biobanks: some comments from an ethical perspective.

On 19 December 2008 the Official Journal of Belgium published the 'Law regarding the procurement and use of human body material destined for human medical applications or for scientific research purposes'. This paper will comment on various aspects of the Law: its scope of application (what is understood by 'body material'?); its concept of 'residual human body material' (with far-reaching implications for the type of consent required for research); the nature of actions with and uses of human body material that are explicitly prohibited; the right of donors to be informed of relevant information revealed by the use of their body material; and the special responsibilities placed on hospital ethics committees. As will be argued in this paper, several of these provisions are highly problematic from an ethical point of view, especially those relating to consent. Meanwhile, the Minister of Public Health has asked the Belgian Advisory Committee on Bioethics for advice on the incorporation of the 'presumed consent' model, that applies to post mortem organ donation, into the biobank Law's provisions on post mortem removal and use of body material. This aspect of the Law effectively extends the 'presumed consent' regime, both from organs to body material in general, and from therapeutic uses to research uses.

COVID-19 vaccination for people with severe mental illness: why, what, and how?

Psychiatric disorders, and especially severe mental illness, are associated with an increased risk of severe acute respiratory syndrome coronavirus 2 infection and COVID-19-related morbidity and mortality. People with severe mental illness should therefore be prioritised in vaccine allocation strategies. Here, we discuss the risk for worse COVID-19 outcomes in this vulnerable group, the effect of severe mental illness and psychotropic medications on vaccination response, the attitudes of people with severe mental illness towards vaccination, and, the potential barriers to, and possible solutions for, an efficient vaccination programme in this population.

COVID-19-Related Mortality Risk in People With Severe Mental Illness: A Systematic and Critical Review.

Background: Increasing clinical evidence suggests that people with severe mental illness (SMI), including schizophrenia spectrum disorders, bipolar disorder (BD), and major depressive disorder (MDD), are at higher risk of dying from COVID-19. Several systematic reviews examining the association between psychiatric disorders and COVID-19-related mortality have recently been published. Although these reviews have been conducted thoroughly, certain methodological limitations may hinder the accuracy of their research findings. Methods: A systematic literature search, using the PubMed, Embase, Web of Science, and Scopus databases (from inception to July 23, 2021), was conducted for observational studies assessing the risk of death associated with COVID-19 infection in adult patients with pre-existing schizophrenia spectrum disorders, BD, or MDD. Methodological quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS). Results: Of 1,446 records screened, 13 articles investigating the rates of death in patients with pre-existing SMI were included in this systematic review. Quality assessment scores of the included studies ranged from moderate to high. Most results seem to indicate that patients with SMI, particularly patients with schizophrenia spectrum disorders, are at significantly higher risk of COVID-19-related mortality, as compared to patients without SMI. However, the extent of the variation in COVID-19-related mortality rates between studies including people with schizophrenia spectrum disorders was large because of a low level of precision of the estimated mortality outcome(s) in certain studies. Most studies on MDD and BD did not include specific information on the mood state or disease severity of patients. Due to a lack of data, it remains unknown to what extent patients with BD are at increased risk of COVID-19-related mortality. A variety of factors are likely to contribute to the increased mortality risk of COVID-19 in these patients. These include male sex, older age, somatic comorbidities (particularly cardiovascular diseases), as well as disease-specific characteristics. Conclusion: Methodological limitations hamper the accuracy of COVID-19-related mortality estimates for the main categories of SMIs. Nevertheless, evidence suggests that SMI is associated with excess COVID-19 mortality. Policy makers therefore must consider these vulnerable individuals as a high-risk group that should be given particular attention. This means that targeted interventions to maximize vaccination uptake among these patients are required to address the higher burden of COVID-19 infection in this already disadvantaged group.