Presumed consent for organ donation: an incoherent justification / Presunción del consentimiento para la donación de órganos: una justificación incoherente / Consentimento presumido na dação de órgãos: uma justificação incoerente

Abstract: 15. The difference between supply and demand of transplantable organs is a global problem, and one of the most discussed measures aiming to solve it is the implementation of a presumed consent (opt-out) policy in cadaveric organ donation. This type of system is controversial when it comes to its direct effects on organ donation rates as well as its ethical base. We aim to present the latest perspectives concerning the ethical implications of the policy, especially regarding consent: its need, the coherence of presuming it and the policy's capacity to fulfill its requirements. From a community perspective, we advocate a default change in societies with an opt-out system, with a strong population education in that direction. The potential rights of family objection are also approached as well as the differences between theoretical discussion and concrete application of public policy.

Resumen: 19. El desfase entre la oferta y la demanda de órganos para trasplantes es un problema mundial, y una de las medidas más discutidas para solucionarlo es la aplicación de una política de consientimiento presumido (opt-out) de la donación de órganos de cadáveres. Este tipo de sistema es controvertido teniendo en cuenta sus efectos directos sobre las tasas de donación de órganos, así como su base ética. Nuestro objetivo es presentar las últimas perspectivas sobre las implicaciones éticas, especialmente en lo que respecta al consentimiento: su necesidad, la consistencia de su presunción y la capacidad de cumplir sus requisitos. Desde el punto de vista comunitario, abogamos por un cambio por defecto en las sociedades con un sistema de opt-out, con una fuerte educación de la población a tal efecto. También se abordan los posibles derechos de la objeción familiar, así como las diferencias entre el debate teórico y la aplicación concreta de las políticas públicas.

Resumo: 23. A diferença entre a oferta e a procura de órgãos para transplantação é um problema global, e uma das medidas mais discutidas com vista à sua resolução é a implementação de uma política de consentimento presumido (opt-out) na doação de órgãos de cadáver. Este tipo de sistema é controverso ponderando os seus efeitos diretos nas taxas de doação de órgãos, bem como da sua base ética. O nosso objetivo é apresentar as últimas perspetivas relativas às implicações éticas, especialmente no que diz respeito ao consentimento: a sua necessidade, a coerência da sua presunção e a capacidade em cumprir os seus requisitos. Numa perspetiva comunitária, defendemos uma mudança de default nas sociedades com um sistema opt-out, com uma forte educação da população nesse sentido. Os direitos potenciais da objeção familiar também são abordados, bem como as diferenças entre a discussão teórica e a aplicação concreta da política pública.

Effect of Opt-out System for Organ Donation After Brain Death on Ethical Legitimacy and Potential Efficacy in a Mathematical Model.

OBJECTIVES: We aimed to compare the possible outcomes of the current (opt-in) system and an opt-out system for organ donation in South Korea using a mathematical model. MATERIALS AND METHODS: A structured questionnaire was used to investigate the decision on organ donation and family consent after brain death under the current system and an opt-out system. The survey was conducted in August 2018 by means of a voluntary survey of 100 opposite-sex married couples. RESULTS: Sixty-three percent of participants wished to self-donate their organs after brain death: 69.5% were positive and 30.5% were negative regarding the implementation of the opt-out system. Among 200 participants, the total number of possible donors increased from 110 (55.0%) in the current system to 139 (69.5%) in the opt-out system. Positive autonomy was defined as obtainment of consent from the donor and the spouse, and negative autonomy was defined as concordaence of refusal between the donor and the spouse. Comparisons between the systems showed that the rate of autonomy increased from 57.0% in the current system to 61.5% in the opt-out system. Although the achievement of positive autonomy increased from 59.5% in the current system to 74.6% in the opt-out system, the achievement of negative autonomy decreased from 52.7% in the current system to 39.2% in the opt-out system. CONCLUSIONS: An opt-out system can increase the number of organ donors; however, achievement of negative autonomy can decrease.

[An ethical evaluation of presumed consent for organ donation in Switzerland]. / Une évaluation éthique du consentement présumé pour le don d'organes en Suisse.

Following a current trend in European countries, Switzerland is about to decide to adopt (or reject) a presumed consent legislation for organ donation. In such a system, every citizen is considered as a potential organ donor except in case of expressed refusal during lifetime. The presumed consent system raises ethical and practical issues that need to be carefully understood and weighed before deciding on its fate. This article reviews the most pressing ethical issues and provides the empirical data necessary for assessing the presumed consent legislation in Switzerland. At the end of the analysis, the reader will be able to form her own informed opinion on the issue.

A l'image d'autres pays européens, la Suisse est sur le point de décider d'adopter (ou de rejeter) une législation du consentement présumé pour le don d'organes. Dans un tel système, tout citoyen est considéré comme donneur potentiel, sauf en cas de refus exprimé de son vivant. Le consentement présumé soulève des enjeux éthiques et pratiques qu'il importe de comprendre et pondérer soigneusement avant de statuer sur son sort. Cet article fournit les principales clefs d'analyse ainsi que les données empiriques nécessaires à cet exercice. Au terme de l'analyse, le lecteur pourra se forger une opinion informée et réfléchie sur le sujet.

The side effects of deemed consent: changing defaults in organ donation.

In this Current Controversy article, I describe and analyse the imminent move to a system of deemed consent for deceased organ donation in England and similar planned changes in Scotland, in light of evidence from Wales, where the system changed in 2015. Although the media has tended to focus on the potential benefits and ethical issues relating to the main change from an opt-in default to an opt-out one, other defaults will also change, while some will remain the same. Interaction of these other defaults with the principal one raise several ethical issues that may complicate efforts to use deemed consent to increase donation rates. Most significantly, changing the main default will have the effect of changing the default for patients' families, who play a vital role in the consent process.

Ethical understandings of proxy decision making for research involving adults lacking capacity: A systematic review (framework synthesis) of empirical research.

BACKGROUND: Research involving adults lacking mental capacity relies on the involvement of a proxy or surrogate, although this raises a number of ethical concerns. Empirical studies have examined attitudes towards proxy decision-making, proxies' authority as decision-makers, decision accuracy, and other relevant factors. However, a comprehensive evidence-based account of proxy decision-making is lacking. This systematic review provides a synthesis of the empirical data reporting the ethical issues surrounding decisions made by research proxies, and the development of a conceptual framework of proxy decision-making for research. METHODS: A systematic review was conducted according to PRISMA guidelines. Databases including MEDLINE, EMBASE, and CINAHL were searched using a combination of search terms, and empirical data from eligible studies were retrieved. The review followed the framework synthesis approach to refine and develop a conceptual framework. RESULTS: Thirty-four studies were included in the review. Two dimensions of proxy decision-making emerged. The ethical framing criteria of decision-making used by proxies: use of a substituted judgement, use of a best interests approach, combination of substituted judgement and best interests, and 'something else', and the active elements of proxy decision-making: 'knowing the person', patient-proxy relationship, accuracy of the decision, and balancing risks, benefits and burdens, and attitudes towards proxy decision-making. Interactions between the framing criteria and the elements of decision-making are complex and contextually-situated. CONCLUSIONS: The findings from this systematic review challenge the accepted reductionist account of proxy decision-making. Decision-making by research proxies is highly contextualized and multifactorial in nature. The choice of proxy and the relational features of decision-making play a fundamental role: both in providing the proxy's authority as decision-maker, and guiding the decision-making process. The conceptual framework describes the relationship between the framing criteria used by the proxy, and the active elements of decision-making. Further work to develop, and empirically test the proposed framework is needed.

Should Trauma Physicians Treat a Severely Injured Patient for the Sake of Elucidating Preferences about Organ Donation?

Organ donation potential is not a motivator of care in the trauma bay, and it is ethically problematic to consider organ donor potential during the active resuscitation of a trauma patient. Despite organ donation being a public good, the role of the trauma physician is to maintain focus on the patient as an individual and to respect a patient's right to life and autonomy. This tenet of medicine is the foundation of the trust that a community and individuals must have in order for the health care system to function. Fortunately, there are guidelines and systems in place to allow physicians to care for the patient in front of them while simultaneously making morally sound decisions regarding donation in the setting of the current organ shortage.

Deemed consent: assessing the new opt-out approach to organ procurement in Wales.

In December 2015, Wales became the first country in the UK to move away from an opt-in system in organ procurement. The new legislation introduces the concept of deemed consent whereby a person who neither opt in nor opt out is deemed to have consented to donation. The data released by the National Health Service (NHS) in July 2017 provide an excellent opportunity to assess this legislation in light of concerns that it would decrease procurement rates for living and deceased donation, as well as sparking an increase in family refusals. None of these concerns have come to pass, with Wales experiencing more registered donors, fewer family refusals and more living donations. However, as the number of actual donors has dropped slightly from a high level, the situation must be monitored closely in the years to come.

"Effective" Requesting: A Scoping Review of the Literature on Asking Families to Consent to Organ and Tissue Donation.

BACKGROUND: Families are often asked to consent to the donation of their deceased relative's organs or tissues. These end-of-life conversations are important because they affect consent rates as well as the psychological impact of the decision for families. This scoping review of the literature on requesting family consent was prepared to support of the development of leading practice recommendations for end-of-life conversations with families of potential donors. A scoping review maps research activity in a field across a range of commentary and empirical study designs but does not attempt meta-synthesis of empirical data or quality assessment. METHODS: We performed a scoping review of the peer-reviewed literature from January 2000 to February 2015 on the questions of what constitutes an "effective" request and the factors that affect consent rates and family satisfaction with their decision and the process. This review includes a final set of 168 articles addressing (a) whether, when, and how to ask families for consent to donation or (b) characteristics of families or decedents that affect families' decisions or family satisfaction with their decisions. RESULTS: Six main themes were identified: (1) the objectives of requesting and encouraging family consent to donation, (2) the effect of the donation decision on family well-being, (3) the process of requesting family consent, (4) the impact of the quality of the care for the deceased and for the family, (5) the content and manner of the request for family consent, and (6) the characteristics of the family and deceased that affect the request for family consent. CONCLUSION: This scoping review found that there is a large literature on how to modify the process and manner of the request to increase family consent rates. Another important line of inquiry focuses on the psychological impact of the decision on the family. Although a scoping review does not attempt to synthesize results or draw evidence-based conclusions, the literature generally supports the intuitive expectations that compassionate and respectful care for the deceased and family, listening for and addressing family concerns, and an attitude to donation that is positive (but not solely procurement-focused) and is best for both consent rates and family well-being. Although the presumption is often that the primary objective of asking for family consent is to secure consent and donation, some ethical commentary on requesting consent emphasizes that this objective must be balanced with the parallel obligation to protect the psychological well-being of families. This places some constraints on the approaches used in family consent discussions.

Presumed consent: licenses and limits inferred from the case of geriatric hip fractures.

BACKGROUND: Hip fractures are common and serious injuries in the geriatric population. Obtaining informed consent for surgery in geriatric patients can be difficult due to the high prevalence of comorbid cognitive impairment. Given that virtually all patients with hip fractures eventually undergo surgery, and given that delays in surgery are associated with increased mortality, we argue that there are select instances in which it may be ethically permissible, and indeed clinically preferable, to initiate surgical treatment in cognitively impaired patients under the doctrine of presumed consent. In this paper, we examine the boundaries of the license granted by presumed consent and use the example of geriatric hip fracture to build an ethical framework for understanding the doctrine of presumed consent. DISCUSSION: The license to act under presumed consent requires three factors: patient incapacity, clinical urgency and clarity on the correct course of action. All three can apply to geriatric hip fracture. The typical patient frequently lacks capacity. Delays in initiating surgical treatment are associated with markedly increased mortality rates. Last, there appears to be consensus that surgery is the preferred treatment. Nonetheless, because there is a window of safe delay during which treating physicians can stabilize the patient, address reversible causes of cognitive impairment and identify surrogate decision makers, presumed consent should be invoked only as a method of last resort. CONCLUSIONS: A medical situation need not be characterized by risk of imminent and certain death for presumed consent to be relevant. Rather, there are two distinct windows that must be considered: the time interval in which action may be delayed without danger, and the time interval needed to obtain a better form of consent. Presumed consent is appropriate only when the latter exceeds the former.

Is an opt-out organ donation system desirable? Comments on a new law.

A law that introduces an opt-out system for organ donation has recently come into force in Wales. The debate surrounding the effectiveness and ethical acceptability of an opt-out system continues, though the available data have still not provided definitive proof that an opt-out system is more efficient than an opt-in system. Systems based on implied consent but with specific safeguards would appear more suitable and more respectful of ethical principles than those based on a more aggressive form of presumed consent.

Non-therapeutic intensive care for organ donation: A healthcare professionals' opinion survey.

BACKGROUND AND PURPOSE: Providing non-therapeutic intensive care for some patients in hopeless condition after cerebrovascular stroke in order to protect their organs for possible post-mortem organ donation after brain death is an effective but ethically tricky strategy to increase organ grafting. Finding out the feelings and opinion of the involved healthcare professionals and assessing the training needs before implementing such a strategy is critical to avoid backlash even in a presumed consent system. PARTICIPANTS AND METHODS: A single-centre opinion survey of healthcare professionals was conducted in 2013 in the potentially involved wards of a French University Hospital: the Neurosurgical, Surgical and Medical Intensive Care Units, the Stroke Unit and the Emergency Department. A questionnaire with multiple-choice questions and one open-ended question was made available in the different wards between February and May 2013. ETHICAL CONSIDERATIONS: The project was approved by the board of the Lorraine University Diploma in Medical Ethics. RESULTS: Of a total of 340 healthcare professionals, 51% filled the form. Only 21.8% received a specific education on brain death, and only 18% on potential donor's family approach and support. Most healthcare professionals (93%) think that non-therapeutic intensive care is the continuity of patient's care. But more than 75% of respondents think that the advance patient's consent and the consent of the family must be obtained despite the presumed consent rule regarding post-mortem organ donation in France. CONCLUSION: The acceptance by healthcare professionals of non-therapeutic intensive care for brain death organ donation seems fairly good, despite a suboptimal education regarding brain death, non-therapeutic intensive care and families' support. But they ask to require previously expressed patient's consent and family's approval. So, it seems that non-therapeutic intensive care should only remain an ethically sound mean of empowerment of organ donors and their families to make post-mortem donation happen as a full respect of individual autonomy.

[End-of-life decisions and practices in critically ill patients in the cardiac intensive care unit. A nationwide survey]. / Begrenzung und Abbruch lebenserhaltender Maßnahmen bei kritisch kranken kardiochirurgischen Patienten. Ergebnisse einer bundesweiten Umfrageaktion.

BACKGROUND: Ethical and medical criteria in the decision-making process of withholding or withdrawal of life support therapy in critically ill patients present a great challenge in intensive care medicine. OBJECTIVES: The purpose of this work was to assess medical and ethical criteria that influence the decision-making process for changing the aim of therapy in critically ill cardiac surgery patients. MATERIALS AND METHODS: A questionnaire was distributed to all German cardiac surgery centers (n = 79). All clinical directors, intensive care unit (ICU) consultants and ICU head nurses were asked to complete questionnaires (n = 237). RESULTS: In all, 86 of 237 (36.3 %) questionnaires were returned. Medical reasons which influence the decision-making process for changing the aim of therapy were cranial computed tomography (cCT) with poor prognosis (91.9 %), multi-organ failure (70.9 %), and failure of assist device therapy (69.8 %). Concerning ethical reasons, poor expected quality of life (48.8 %) and the presumed patient's wishes (40.7 %) were reported. There was a significant difference regarding the perception of the three different professional groups concerning medical and ethical criteria as well as the involvement in the decision-making process. CONCLUSION: In critically ill cardiac surgery patients, medical reasons which influence the decision-making process for changing the aim of therapy included cCT with poor prognosis, multi-organ failure, and failure of assist device therapy. Further studies are mandatory in order to be able to provide adequate answers to this difficult topic.

Historical development and current status of organ procurement from death-row prisoners in China.

BACKGROUND: In December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners. DISCUSSION: In the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to "voluntarily donate" organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards. CONCLUSIONS: Organ sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with "consent" are now simply labelled as "voluntarily donations from citizens". The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain.