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.

La presunción de la donación de órganos en Colombia: reflexiones para el debate / The presumption of organ donation in Colombia: reflections for the debate / A presunção da doação de órgãos na Colômbia: reflexões para a discussão

Resumen La legislación sobre presunción de consentimiento es considerada como una medida efectiva para mejorar las tasas de donación de órganos. En el caso colombiano, este modelo institucional existe desde 1988; sin embargo, en 2016 las leyes de donación han sido reformadas para ratificar el modelo de presunción en una versión fuerte que garantice su implementación, y las nuevas disposiciones evitan que la familia pueda oponerse a la donación de órganos. El presente documento plantea que dicha estrategia no está libre de riesgos y su éxito depende de garantizar la transparencia de la información. Se presenta evidencia empírica y reflexiones teóricas que indican que la relación entre presunción de donación y mayor disponibilidad de órganos no es inequívoca, pues la decisión de donar es muy sensible a la información disponible en el entorno. Se concluye que si la información y los incentivos no son claros los individuos pueden manifestar su negativa a la donación de órganos y, en consecuencia, el sentido de solidaridad en el interior de la comunidad podría ser sacrificado.

Abstract The presumed consent legislation is considered as an effective measure to improve organ donation rates. In the Colombian case, this institutional model exists since 1988; however, in 2016 the donation laws were reformed to ratify the model of presumption in a powerful version to ensure its implementation, and the new provisions prevent the family from opposing organ donation. This paper states that such strategy is not risk-free, and that its success depends on ensuring the transparency of the information. We present empirical evidence and theoretical reflections that indicate that the relation between presumed consent legislation and major availability of organs is not unequivocal, since the decision of donation is very sensitive to the available information in the environment. It is concluded that if the information and the incentives are not clear, individuals can express their refusal to the donation of organs and, consequently, the sense of solidarity within the community could be sacrificed.

Resumo: A legislação sobre presunção de consentimento é considerada como uma medida eficaz para melhorar as taxas de doação de órgãos. No caso da Colômbia, este modelo institucional existe desde 1988; no entanto, em 2016 as leis de doação tem sido reformadas para ratificar o modelo de presunção em uma versão forte para garantir a sua implementação, as novas disposições impedem que a família possa opor-se à doação de órgãos. O presente artigo argumenta que esta estratégia não é isenta de riscos e seu sucesso depende de garantir a transparência das informações. Há evidência empírica e reflexões teóricas que indicam que a relação entre a presunção de doação e o aumento da disponibilidade de órgãos não é inequívoca, pois a decisão de doação de órgão é muito sensível à informação disponível no ambiente; se a informação e os incentivos não são claros os individuos podem expressar a sua recusa à doação de órgãos e, portanto, o sentido de solidariedade no interior da comunidade poderia ser sacrificado.

Study on Cultural Adaptability of Presumed Consent Principle in Organ Donation / 中国医学伦理学

The presumed consent principle in organ donation as one of the legal systems to obtain organs has a-chieved some success in practice.However,it is controversial in the ethical and legal aspects.Some Chinese scholars express concern about the implementation of presumed consent in the context of Chinese culture.In order to explicit whether the principle of presumed consent in organ donation is suitable for the Chinese culture,this pa-per considered that there are positive factors in promoting organ donation in Chinese culture through the study of the relationship among the types of presumed consent,the presumed consent and informed consent and the ethical prin-ciple of respect for autonomy.Under the regulation and promotion of state law,the principle of presumed consent can also play the positive role in promoting organ donation in the context of Chinese culture.

El consentimiento presunto y la reciprocidad como mecanismos para aumentar la donación de órganos / Presumed consent and reciprocity as means to increase organ availability for transplantation

Chile became the third country in the world (after Israel and Singapore) to introduce the rule of reciprocity to receive an allograft. This means that if an individual opts for not being an organ donor, loses priority to receive a transplant. Despite the difficulties associated with its implementation, the recent Chilean reform that also incorporated the presumed consent, should be studied by those countries that are trying to overcome the severe lack of organ availability for transplantation.

Family response to presume consent system on organ donation from a review of literature

Background: Most countries around the world have experienced a shortage in organs needed for transplantation. Organ donation performance is widely attributed to two important factors: the legislation and the role of the family. Thus, this literature review aims to examine the willingness of people for organ donation while highlighting the importance of having a presumed consent system. Methodology: In this study, we explored many papers of which 10 articles were studied to gain conclusive understanding of the two factors and their interactions. Results: Our analysis of literature regarding the legislation and family response showed that the presumed consent system for organ donation accounted for 21 – 30% higher organ donation rates than the informed consent system. We also found a gap between the willingness of people to donate their own and their relatives’ organs. The ratio of people willing to donate their organs after death was estimated to be 10 – 12% higher than the ratio of those willing to donate their relatives’ organs. Furthermore, the study revealed the importance of a presumed consent system in raising the willingness of the people and their relatives for donation, but that did not eliminate the gap. Conclusion: Countries seeking to overcome organ shortage and increase organ donation rates by moving towards the presumed consent system should consider the importance of providing families with proper information about this system. The fact that a gap between the willingness of the people to donate their own as well as their deceased relatives’ organs exists, has to be conveyed to the governments, which will be helpful in optimising organ donation rates.

Entrega de información y voluntariedad en el consentimiento presunto de la ley de donación de órganos en Chile / Information delivery and voluntariness in presumed consent in the Chilean organ donation law

A principios del año 2010 se reformó en Chile la antigua ley de donación y trasplante de órganos de 1996, instaurando una nueva forma de hacer donantes a los ciudadanos a través del llamado consentimiento presunto. A partir de lo anterior se analiza este concepto en relación a los pilares fundamentales del consentimiento informado; información, voluntariedad y capacidad, enfocado principalmente en los dos primeros. Respecto al principio de voluntariedad es claramente violado ya que actualmente no es necesario que la persona se manifieste para ser donante, sino que es posicionada automáticamente como tal a no ser que escoja lo contrario. Continuando con el análisis, se puede ver como la autoridad ha dejado de lado el principio de información, no poniendo énfasis en éste, a pesar de que la evidencia indica que es una forma efectiva de convencer a pacientes no donantes. La promulgación de la ley debe ser complementada con entrega de información y educación a los distintos sectores cívicos.

In early 2010, in Chile, the law of organ donation and transplantation from 1996 was amend ended, establishing a new form of organ donation to citizens through the presumed consent. From the above, this concept is analyzed according to the fundamental pillars of informed consent; information, voluntariness and capacity, mainly focused on the first two. Regarding the principle of voluntary it is clearly violated, as it is no longer necessary that the person chooses to be a donor if one does not manifest their willingness to not be one. Continuing with the analysis, it can be seen how the authority has neglected the principle of information, not emphasizing it, even though the evidence indicates that it is an effective way to convert non-donors. The enactment of the law must be supplemented by providing information and education to civic sectors.(AU)om the above, this concept is analyzed according to the fundamental pillars of informed consent; information, voluntariness and capacity, mainly focused on the first two. Regarding the principle of voluntary it is clearly violated, as it is no longer necessary that the person chooses to be a donor if one does not manifest their willingness to not be one. Continuing with the analysis, it can be seen how the authority has neglected the principle of information, not emphasizing it, even though the evidence indicates that it is an effective way to convert non-donors. The enactment of the law must be supplemented by providing information and education to civic sectors.

Organ Transplantation and Biomedical Ethics: An Analysis of Hospital Organ Transplantation Policy and a Proposal of Ethical Guideline / 대한이식학회지

AIMS: This study was done to develop an ethical guideline for organ transplatation, a life-saving treatment which helps improve the quality of life. METHODS: This study begins with a survey of the Korean current state of affairs concerning organ transplantation. This study used a survey questionnaire and received responses from 31 hospitals out of 45 hospitals where organ transplantation are being done. After this survey, followed by a discussion of ethical considerations in arranging organ transplants. Before proposing an ethical guideline, this study discusses a series of interesting ethical issues in transplanting(both living and cadaveric)organs including ethical foundations of organ transplantation, distributive justice and matters of donor's consent in organ transplatation. RESULTS: The foremost research for this study boils down to a survey paper titled, "An Analysis of the Current State of Affairs Concerning Organ Transplantation and Ethical Considerations in Domestic and International Hospitals." Based upon data collected from various hospitals, this work analyzes items, such as the frequency and types of organs transplanted in a hospital, the existence of organ transplant coordinator, the performance of the hospital ethics committee, and ethical considerations in obtaining consents from the living donor. Although thousands of organs are annually transplanted in domestic hospitals, virtually none of them are found to meet ethically proper standards. The paper points out the need to institutionalize a nationwide cadaveric organ distribution organization like UNOS(United Network for Organ Sharing) in the U.S., and proposes to stretch out the national health insurance to extensively cover transplanting expenses. "The Ethical Foundation of Organ Transplantation", the author counts three key ethical principles in organ transplantation: the principle of respect for autonomy; the principle of beneficence; and the principle of justice. He argues that in cases of living donor no principle should take precedence over the principle of respect for autonomy and thus it is very important for a hospital to obtain the donor's consent. As for cadaveric organ transplantation, he holds reservation because he is worried that serious shortage of organs for transplantation in conjunction with pure utilitarian considerations could change the definition of death so that the brain death gains more popularity than ever. In addition, the author claims that the proponent of organ transplantation must distinguish the moral dimension of the discussion from the legal one because otherwise she would hardly be able to defend herself from the slippery slope argument against organ transplantation. This paper concludes with a note that we must implement restrictions to avoid undesired effects if organ transplantation could ever be justified. "A Discussion of Distributive Justice in Organ Transplantation" comprises two parts. The first half delineates above mentioned ethical principles in the context of organ transplantation, while the second half goes generally over the UNOS Point System. This work is focused entirely upon cadaveric organ transplants, because the vast majority of organs available for transplants comes from cadavers and the number is still increasing. The UNOS allocates cadaveric organs based upon both medical and justice criteria. Following are summaries of the UNOS policy on organ distribution. Every potential recipient of organ transplants must be listed on the UNOS computer system waiting list. Allocation of cadaveric kidneys consider factors such as waiting time, six antigen match, panel reactive antibody, blood group and age. The UNOS Point System allocates livers to the local patients first, followed by regional and national patients respectively, in order to limit ischemic time. A recipient of liver transplant belongs to one of five(0~4) medical status levels where status 4 is the most medically urgent. At the regional and national levels pancreas are allocated first to patients with excellent HLA matches, while at the local level waiting time is the sole factor. The intestinal organ allocation system is based on two(1~2) patient status codes, ABO blood type identity and time waiting. In heart or lung tranplants ischemic time seriously matters. "A Biomedical Study of Informed Consent from the Organ Donor" investigates several topics: the relevance of the principle of respect for autonomy as the basic principle of informed consent; how the autonomy of the organ donor to be respected; and the role of the hospital ethics committee in obtaining informed consent from the donor. The author finds the principle of respect for patient's autonomy not sufficient for the basic principle of the living donor's informed consent because there is some danger in which the patient may be left uncared-for, and thus she suggests that the principle of nonmaleficence and the principle of care also be considered. That the principle of respect for autonomy turns out not sufficient even for cadaveric organ donation, and so judgment based upon the best interest of the deceased may seem appropriate for people from some special groups. A medical team must make efforts to identify the donor's competence and voluntariness, i.e., preconditions of informed consent. All the relevant medical information should be disclosed to the living donor. Once the donor makes a judgment, medical experts should respect the donor's decision. This article puts an emphasis on the role of the hospital ethics committee in such activities as identifying donor's voluntariness, confirming the disclosure, and evaluating the minority's benefit. The last work in this paper, "A Moral Theological Investigation of the Presumed Consent in Organ Transplantation" talk about Principium Riflexum(the principle of reflection) in an attempt to explain the possibility that we may harvest cadaveric organs from the deceased who while alive had never expressed their wishes concerning organ donation. To apply the principle in the context of presumed consent, the author, a Catholic priest, introduces two elements of the principle. Probabilismus allows us to feel free to choose when we face dubious matters(in dubio libetas), and by the rule of selection we are justified in choosing whatever our consciousness mandates. He takes both elements to support the presumed consent of the deceased because he believes the good that people may contribute to their neighbors by donating organs would obviously override opposing reasons. Although the author argues for the presumed consent from the deceased, he does not overlook the family grief in donating the cadaveric organs. He concludes with a suggestion that we should work to keep the public aware of cadaveric organ donation and to form public opinions education should play a key role. CONCLUSION: Researcher suggest an Ethical Guideline for Organ Transplantation as our study conclusion. 1) Body organs may be transplanted to protect the health and well-being of the patient, but not for the medical or scientific research. 2) Body organs may be taken for transplantation, only with the consent from the donor. In cases of cadaveric donors who have left no formal consent in the lifetime, they are to be presumed to refuse to donate body organs. 3) In principle, cadaveric transplantation is preferred. Living donors are limited to competent adults who have blood ties with the patient, e.g., parents, children, or siblings of the patient. However, reversible tissue like bone marrows donation may be an exception to this limitation. In particular, no living donors may be put under inappropriate pressure or influences. Body organs may be taken from the living donor only if based upon sufficient and easy-to-understand information provided, the donor voluntarily consents after (s)he deliberately balances benefits against harm. 4) Under no circumstances human bodies, organs, or tissues may be sold or purchased for transplantation. A physician should not participate in any transplanting operations if (s)he becomes to know that the transplant has been obtained through a transaction. 5) Recipients of organs for transplantation should be determined in accordance with the principle of justice on the allocation of limited medical resources. 6) When a vital, single organ is to be transplanted, the death of the donor shall have been determined by at least one physician other than the recipient's physician. 7) Transplant procedures of body organs should be undertaken (a) only by physicians who possess special medical knowledge and technical competence developed through special training, study, and laboratory experience and practice, and (b) in medical institutions with adequate facilities. 8) All decision procedures in transplanting body organs should be objective, open to parties involved, kept accurately on record, and maintained for a given period of time.