[The presumed consent legislation - A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts]. / Die Widerspruchslösung ­ Erfolgs- oder Störfaktor für die Gewebespende? Eine qualitative Studie auf Basis multidisziplinärer Expert*inneninterviews.

INTRODUCTION: Tissue transplantation can improve the quality of life of patients in a very wide range of applications. In 2021, around 900 people in Germany agreed to donate organs after death - the number of tissue donors was significantly higher. Nevertheless, there is a shortage of organs and tissues in Germany. In order to counteract this, the introduction of a presumed consent legislation has been discussed time and again. However, the debates focused on possible positive effects for organ donation, whereas potential consequences for tissue donation have so far not been considered in the political discourse or in research. Using an exploratory approach, this paper aims to contribute to closing this research gap: Multidisciplinary interviews with experts were conducted to investigate whether the presumed consent legislation is a key success factor for increasing the number of tissue donors in Germany and which other approaches might be promising. METHODS: We conducted qualitative interviews with 14 experts who worked as employees in different positions in tissue banks/networks, ophthalmologists performing corneal transplantation, medical ethicists, lawyers or scientists. These interviews were evaluated using the structuring content analysis according to Mayring. In reporting, we followed the Standards for Reporting Qualitative Research (SQRQ). RESULTS: The majority of experts did not consider presumed consent legislation to be a key factor in increasing the donation rate in Germany. Instead, an improvement of processes and structures in tissue donation was cited as the most important optimization potential. Furthermore, communication measures were postulated to create transparency about the characteristics of tissue donation as distinct from organ donation. These should address not only the general population, but also the professional groups involved in the tissue donation process. CONCLUSION: The present study indicates that the presumed consent legislation is not a success factor for increasing the number of tissue donors in Germany. It would be far more effective to improve structures and processes in order to identify the large number of potential tissue donors and to be able to conduct informed conversations with their relatives. Information measures for the general public and professionals, which clearly differentiate between tissue donation and organ donation, are also more promising than fruitless debates about the introduction of the presumed consent legislation.

The toll of COVID-19 on organ donation and kidney transplantation in Europe: Do legislative defaults matter?

This study investigates the cascading effects of COVID-19 pandemic on organ donation and transplantation in Europe. We also check whether legislative defaults for organ donation have a role in these outcomes. For this purpose, we used data from 32 European countries, between 2010 and 2021, and estimated pooled OLS regressions. We find that COVID-19 pandemic reduced deceased organ donation rates by 23.4%, deceased kidney transplantation rates by 27.9% and live kidney transplantation rates by 31.1% after accounting for health system capacity indicators. While our study finds that presumed consent legislation under normal circumstances leads to notable benefits in terms of deceased kidney transplantation and organ donation rates, the legislative defaults did not have a significant impact during the pandemic. Additionally, our findings indicate a trade-off between living and deceased transplantation that is influenced by the legislative default.

How clinicians discuss patients' donor registrations of consent and presumed consent in donor conversations in an opt-out system: a qualitative embedded multiple-case study.

BACKGROUND: The Netherlands introduced an opt-out donor system in 2020. While the default in (presumed) consent cases is donation, family involvement adds a crucial layer of influence when applying this default in clinical practice. We explored how clinicians discuss patients' donor registrations of (presumed) consent in donor conversations in the first years of the opt-out system. METHODS: A qualitative embedded multiple-case study in eight Dutch hospitals. We performed a thematic analysis based on audio recordings and direct observations of donor conversations (n = 15, 7 consent and 8 presumed consent) and interviews with the clinicians involved (n = 16). RESULTS: Clinicians' personal considerations, their prior experiences with the family and contextual factors in the clinicians' profession defined their points of departure for the conversations. Four routes to discuss patients' donor registrations were constructed. In the Consent route (A), clinicians followed patients' explicit donation wishes. With presumed consent, increased uncertainty in interpreting the donation wish appeared and prompted clinicians to refer to "the law" as a conversation starter and verify patients' wishes multiple times with the family. In the Presumed consent route (B), clinicians followed the law intending to effectuate donation, which was more easily achieved when families recognised and agreed with the registration. In the Consensus route (C), clinicians provided families some participation in decision-making, while in the Family consent route (D), families were given full decisional capacity to pursue optimal grief processing. CONCLUSION: Donor conversations in an opt-out system are a complex interplay between seemingly straightforward donor registrations and clinician-family interactions. When clinicians are left with concerns regarding patients' consent or families' coping, families are given a larger role in the decision. A strict uniform application of the opt-out system is unfeasible. We suggest incorporating the four previously described routes in clinical training, stimulating discussions across cases, and encouraging public conversations about donation.

Opt-out paradigms for deceased organ donation are ethically incoherent.

The Organ Donation Act 2019 has introduced an opt-out organ donor register in England, meaning that consent to the donation of organs upon death is presumed unless an objection during life was actively expressed. By assessing the rights of the dead over their organs, the sick to those same organs, and the role of consent in their requisition, this paper interrogates whether such paradigms for deceased organ donation are ethically justifiable. Where legal considerations are applicable, I focus on the recent changes in England as a case in point; however, this paper ultimately challenges the justifiability of opt-out systems in any form, concluding that ethical solutions to organ shortage do not lie in opt-out systems of deceased organ procurement.

'Take my kidneys but not my corneas'-Selective preferences as a hidden problem for 'opt-out' organ donation policy.

With aims to both increase organ supply and better reflect individual donation preferences, many nations worldwide have shifted from 'opt-in' to 'opt-out' systems for post-mortem organ donation (PMOD). In such countries, while a prospective donor's willingness to donate their organs/tissues for PMOD was previously ascertained-at least partially-by their having recorded positive donation preferences on an official register prior to death, this willingness is now presumed or inferred-at least partially-from their not having recorded an objection to PMOD-on an official organ donation register. Using evidence regarding the presence and prevalence of selective donation preferences, and via exploration of how appeals to donation preferences are used to both motivate and legitimate shifts to opt-out frameworks, this paper draws attention to a set of previously unexplored problems for opt-out organ donation arising in contexts where: (a) individuals demonstrate selective post-mortem organ/tissue donation preferences, (b) legislation provides prospective donors with the opportunity to selectively permit/refuse the donation of certain organs/tissues in line with these preferences. While selective preferences pose few problems for opt-in systems where a selective occasion is built into the process of signing the donor register, this is not the case for opt-out systems. The loss of this selective occasion can cause significant problems where appeals to preferences motivate/legitimate shifts to opt-out but evidence regarding variable preferences does not feed into determinations regarding organ/tissue exclusions. The nature of these problems depends on how the authorization aspect of 'opt-out' systems is framed (e.g. as presumed consent, deemed consent or, given the role of familial consent in many jurisdictions as consent in name only).

Ethical reflection support for potential organ donors' relatives: A narrative review.

BACKGROUND: Even in countries with an opt-out or presumed consent system, relatives have a considerable influence on the post-mortem organ harvesting decision. However, their reflection capacity may be compromised by grief, and they are, therefore, often prone to choose refusal as default option. Quite often, it results in late remorse and dissatisfaction. So, a high-quality reflection support seems critical to enable them to gain a stable position and a long-term peace of mind, and also avoid undue loss of potential grafts. In practice, recent studies have shown that the ethical aspects of reflection are rarely and often poorly discussed with relatives and that no or incomplete guidance is offered. No review of the literature is available to date, although it could be of value to improve the quality of the daily practice. OBJECTIVES: The objective was to review and synthesize the main concepts and approaches, theories and practices of ethical reflection support of the relatives or surrogates of potential post-mortem organ donors. RESEARCH DESIGN: A narrative review was performed in the medical, psychological and ethical fields using PubMed, PsycArticles and Web of Science databases (1980-2020). RESULTS: Out of 150 papers, 25 were finally retained. Four themes were drawn: the moral status of the potential post-mortem organ donor, the principlistic approach with its limits and critics, the narrative approach and the transcendental approach. DISCUSSION: This review suggests an extension of psychological support towards ethical reflection support. The process of helping relatives in their ethical exploration of post-mortem organ donation is psychologically and morally characterized. The need for specialized professionals educated and experienced both in clinical psychology and in health ethics to carry out this task is discussed. PRACTICAL IMPACT: This review could contribute to optimize the quality of the ethical reflection support by initiating an evolution from an empirical, partial and individual-dependent support to a more systematized, professionalized and exhaustive support.

Presumed Dissent? Opt-out Organ Donation and the Exclusion of Organs and Tissues.

It is often claimed that a legitimate approach to organ donation is an opt-out system, also known as 'presumed consent', 'deemed consent', or 'deemed authorisation', whereby individuals are presumed or deemed willing to donate at least some of their organs and tissues after death unless they have explicitly refused permission. While sharing a default in favour of donation, such systems differ in several key respects, such as the role and importance assigned to the family members of prospective donors and their preferences, and exclusions and safeguards which often specify the demographic groups, purposes, or organs and tissues that will remain outside the scope of the opt-out system. Using the recent shift to opt-out in England, Scotland, and Northern Ireland as case studies, and by reference to the key goals motivating this shift across the UK, this article asks whether and, if so, why, and how, opt-out systems for post-mortem organ donation should restrict the types of organs and tissues for which consent is deemed. In other words, ought opt-out systems for PMOD presume dissent regarding the donation of certain organs and tissues?

Applying utilitarianism to the presumed consent system for organ donation to consider the moral pros and cons.

In May 2020, England adopted an opt-out approach for organ donation, also referred to as the deemed consent system, with the aim of alleviating the demand for organs in the UK. This system dictates that those who have not opted out will have their organs donated following their death, with the exception of those meeting certain criteria. This article applies the philosophical theory of utilitarianism to the deemed consent system for organ donation, focusing particularly on topics such as that of informed consent and family refusal. Utilitarianism is a consequentialist theory that attempts to determine whether an action is morally right or wrong based on whether or not it maximises the preferences of the greatest number of people, with each person's satisfaction being considered as equal to another's.

General public's view on opt-in, opt-out, and mandated choice organ donation policies: a qualitative study involving Swiss French-speaking citizens favourably disposed towards organ donation.

BACKGROUND: All over the world, patients die while waiting for a transplant. Facing this difficulty, countries struggle to find efficient procedures and policies. One policy that has recently been enforced in many countries is the presumed consent (opt-out) system for organ donation. In such a system, every individual is considered as a potential organ donor except in cases of expressed refusal during her or his lifetime. Based on the input of a citizen's initiative, the Swiss parliament has made a proposal for a soft presumed consent policy.It was accepted by both chambers at the national level, but will possibly be challenged by a referendum, and give rise to a public vote. OBJECTIVE: Ahead of the democratic debate, our aim was to sound out what issues are perceived as relevant by ordinary citizens when they evaluate different policies regulating organ donation. What are their main worries and decision criteria? METHODS: We conducted semi-structured taped interviews with ordinary citizens during which we asked their views on three different systems: the current opt-in system, the opt-out presumed consent system described in a soft and in a hard version, and the mandatory decision system. We analysed transcripts by coding, and grouping code families up to four levels. We achieved saturation with fifteenth interviews. RESULTS: All our participants happened to be favourably disposed towards organ donation. Participants considered it important to choose a policy that contributes to overcoming the current shortage of organs, but not by any means. They were mostly concerned about individual rights and liberties, and more specifically about the importance of respecting the deceased's will and to promote lifetime advanced directives on organ donation. The role and rights of relatives were recurrent topics on which participants expressed divergent opinions. Participants often concluded that no legal system is perfect and spent much time discussing elements that were relevant to organ donation in general but not specifically linked to a given legal system. CONCLUSION: This study provides useful information about citizens' concerns regarding organ donation. In preparation of public debates on an opt-out policy, our results reveal what issues are likely to tilt the public opinion.

A Multiethnic Asian Perspective of Presumed Consent for Organ Donation: A Population-Based Perception Study.

Background: Organ shortage is still a world-wide problem, resulting in long waiting lists for kidney, liver, and heart transplant candidates across many transplant centers globally. This has resulted in the move toward presumed consent to increase deceased organ donation rates. However, there remains a paucity of literature on public attitude and barriers regarding the opt-out system, with existing studies limited to Western nations. Therefore, this study aimed to understand public sentiment and different barriers toward organ donation from the perspective of Singapore, a highly diverse and multiethnic Asian society. Methods: A cross-sectional community semi-structured interview was conducted in a public housing estate in Singapore. Pilot test was undertaken before participants were interviewed face-to-face by trained personnel. All statistical evaluations were conducted using Stata. The χ2-test compared subgroups based on patient characteristics while multivariable logistic regression identified predictors of willingness to donate/ assent. Effect estimates were quantified using odds ratio (OR). Findings: Out of 799 individuals, 85% were agreeable to organ donation after death and 81% were willing to assent to donations of family members' organs, which declined by 16% (p < 0.001) after a clinical scenario was presented. Demographic factors including ethnicity, education, marital, and employment status affected willingness to donate and assent. Knowledge correlated significantly with willingness to donate and assent. In particular, knowledge regarding brain death irreversibility had the strongest correlation (AOR 2.15; 95% CI 1.60-2.89). Conclusions: Organ donation rates remain low albeit presumed consent legislation, due to patient-level barriers, including but not limited to knowledge gaps, cultural values, religious backgrounds, and emotional impact at relatives' death. To effectively boost donor rates, it is crucial for policy makers to invest in public education and improve transplant provisions and family protocols.

Presumed post-mortem donors: the degree of information among university students.

BACKGROUND: Organ transplantation represents the most effective and acceptable therapy for end-stage organ failure. However, its frequent practice often leads to a shortage of organs worldwide. To solve this dilemma, some countries, such as Portugal, have switched from an opt-in to an opt-out system, which has raised concerns about respect for individual autonomy. We aimed to evaluate whether young university students are aware of this opt-out system so that they can make informed, autonomous and conscious decisions, as well as to identify the factors that determine a positive attitude toward post-mortem organ donation. METHODS: An observational, cross-sectional study was developed and a questionnaire was administered to first-year students from six faculties of the University of Porto. RESULTS: Of the 841 participants, 60% were unaware that Portugal had adopted an opt-out system. Among the informed individuals, their main sources of information included social media, internet, and family. Furthermore, only 48% of all participants agreed with the current opt-out system. Female sex (p = 0.049; OR 1.393), knowledge of the law (p < 0.001; OR 4.749) and family being the primary source of information (p < 0.001; OR 2.855) were independent factors associated with a positive attitude toward post-mortem organ donation law. CONCLUSIONS: There is a significant lack of knowledge among young university students regarding the presumed post-mortem organ donation law and how it works. Female sex, having family as a primary source of information and being aware of the presumed post-mortem organ donation law are the strongest independent factors that determine a positive attitude toward the opt-out system.

Ethical dilemmas and principles in organ transplantation in China / Dilemas y principios éticos en el trasplante de órganos en China / Dilemas e princípios éticos no transplante de órgãos na China

Abstract In medical clinical practice, organ transplantation is mainly applied to patients with end-stage organ lesions and organ failure. However, with the development of organ transplantation, many ethical issues and controversies have arisen. From the perspective of bioethics, the article compares the relevant ethical and legal regulations of organ transplantation in various countries. Due to the complexity of the real situation, many ethical dilemmas arise in organ transplantation in China. The article analyzes and researches three aspects of organ donation, distribution, and trading, and finds that there are various ethical problems in these three aspects of organ transplantation in China, such as whether the principle of presumed consent is ethical, whether brain death is legalized, the selection and determination of transplant patients, and whether human organ trading is legalized, etc. With the help of the four principles of bioethics and the current development of organ transplantation in China, the article proposes that organ transplantation in China should follow four ethical principles: the principle of respect for life, the principle of do no harm/benefit, the principle of respect for autonomy, and the principle of justice, in order to provide a defense for the legitimacy of organ transplantation.

Resumen En la práctica clínica médica, el trasplante de órganos se aplica principalmente a los pacientes con lesiones orgánicas en fase terminal y con insuficiencia orgánica. Sin embargo, con el desarrollo del trasplante de órganos, han surgido muchas cuestiones éticas y controversias. Desde la perspectiva de la bioética, el artículo compara las normas éticas y jurídicas pertinentes del trasplante de órganos en varios países. Debido a la complejidad de la situación real, surgen muchos dilemas éticos en el trasplante de órganos en China. El artículo analiza e investiga tres aspectos de la donación, la distribución y el comercio de órganos, y constata que hay varios problemas éticos en estos tres aspectos del trasplante de órganos en China, como si el principio del consentimiento presunto es ético, si la muerte cerebral está legalizada, la selección y determinación de los pacientes de trasplante y si el comercio de órganos humanos está legalizado, etc. Con la ayuda de los cuatro principios de la bioética y el desarrollo actual del trasplante de órganos en China, el artículo propone que el trasplante de órganos en China debe seguir cuatro principios éticos: el principio de respeto a la vida, el principio de no hacer daño/beneficio, el principio de respeto a la autonomía y el principio de justicia, con el fin de proporcionar una defensa de la legitimidad del trasplante de órganos.

Resumo Na prática clínica médica, o transplante de órgãos é principalmente destinado a pacientes em estágio final de lesões e falência dos órgãos. Entretanto, com o desenvolvimento do transplante de órgãos, surgiram muitas questões e controvérsias éticas. O artigo compara, desde uma perspectiva bioética, as regulações éticas e legais relevantes sobre transplantes de órgãos em vários países. Devido à complexidade da situação real, muitos dilemas éticos surgiram no transplante de órgãos na China. O artigo analisa e investiga aspectos de doação, distribuição e comercialização de órgãos, e encontra que há vários problemas éticos nestes três aspectos do transplante de órgãos na China, tais como se o princípio do consentimento presumido é ético, se morte cerebral é legalizada, a seleção e determinação de pacientes que irão receber transplante, se a comercialização de órgãos humanos é legalizada, etc. O artigo propõe, com a ajuda de quatro princípios da bioética e o desenvolvimento atual de transplante de órgãos na China, que o transplante de órgãos na China deve seguir quatro princípios éticos: o princípio do respeito à vida, o princípio de beneficiar/não causar dano, o princípio do respeito pela autonomia e o princípio da justiça, de forma a possibilitar a defesa da legitimidade do transplante de órgãos.

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.

Fewer Mistakes and Presumed Consent.

"Opt-out" organ procurement policies based on presumed consent are typically advertised as being superior to "opt-in" policies based on explicit consent at securing organs for transplantation. However, Michael Gill (2004) has argued that presumed consent policies are also better than opt-in policies at respecting patient autonomy. According to Gill's Fewer Mistakes Argument, we ought to implement the procurement policy that results in the fewest frustrated wishes regarding organ donation. Given that the majority of Americans wish to donate their organs, it is plausible that a presumed consent policy would result in fewer frustrated wishes compared to the current opt-in policy. It follows that we ought to implement a policy of presumed consent. In this paper, I first consider and find wanting an objection to the Fewer Mistakes Argument developed recently by Douglas MacKay (2015). I also consider an objection put forth by James Taylor (2012) but argue that there is a methodological reason to prefer my own argument to Taylor's. Finally, I argue for two theses: first, that Gill's major argument in favor of the crucial premise of the Fewer Mistakes Argument is flawed, and second, that the major premise of the Fewer Mistakes Argument is false.

'Relative Consent' or 'Presumed Consent'? Organ donation attitudes and behaviour.

Legislation, in the form of presumed consent, has been argued to boost organ donation but most evidence disregards the practice of seeking relative's consent, which can either 'veto' donation decisions, or 'legitimize them', by removing any possible conflict with the donor's family. We study the effect of presumed consent alongside family consent on individuals' willingness to donate (WTD) one's own and relatives' organs, and on actual organ donation behaviours. Using data from 28 European countries for the period 2002-2010, we found that presumed consent (PC) policies are associated with increased willingness to donate organs, but this effect was attenuated once internal family discussions on organ donation were controlled for. Our findings indicate that relative's consent acts as a veto of donation intentions and attenuates the effect of regulation on actual donations. More specifically, PC increases WTD one's own and relatives' organs in countries where no family consent is required. Consistently, we find that family consent attenuates the influence of regulatory environment on actual donations. The effect is driven by the influence of family discussions which increased WTD, and in combination with presumed consent translated into higher organ donation rates.