Ethical dilemmas related to living donor liver transplantation in Asia.

Living donor liver transplantation (LDLT) has evolved rapidly in Asia with good outcomes for both donor and recipient. Nonetheless, LDLT remains a highly demanding technique and complex surgery. The potential risks to the donors provide the basis for many of the ethical dilemmas associated with LDLT. The transplant team must have a good knowledge of the principles of bioethics in order to handle these matters. To look after the need, donor's safety and the chance for good recipient outcomes, the principles of respect for the donor's autonomy, beneficence, and non-maleficence should be practiced. In accordance with the concept of equipoise, the risk to the donor must balance the benefit to the recipient. The transplant center should have adequate experience and proven expertise in LDLT. There are concerns regarding the validity of informed consent given by the donor. While donations to non-relative patients may, at first sight, indicate radical altruism, it is important to apply careful scrutiny. Though organ trading is strictly prohibited by the law, there seems to be an inherent risk with directed donations to strangers. Transplant tourism has flourished in some countries in spite of the existence of strict laws. There are reservations regarding transplantation done by foreign visiting teams. Donor websites facilitating patients and donors and Facebook pages bear no responsibility for the outcomes of their matches and cannot ensure sufficient and accurate information about donation, transplantation, and post-operation life. Telemedicine and virtual consultations appeared to work better when the clinician and the patient know and trust each other.

Opinions of Health Care Personnel Regarding Disincentives and Incentives for Living Kidney Donation at a Single Center.

BACKGROUND: Transplant societies continue to actively concentrate on increasing rates of living kidney donation (LKD) to bridge the gap between individuals awaiting transplantation and the number of kidneys available. A widely discussed strategy to increase living donation rates is the provision of incentives and removal of disincentives. Though opinions of the public regarding this strategy have been studied, the opinions of health care providers, including younger professionals, are less clear. We studied the opinions of medical students and other health care providers on strategies to increase LKD to determine if opinions were different among those < 25 or ≥ 25 years of age. METHODS: A simple cross-sectional survey was conducted at an academic medical center. Participants included medical students and employees in Internal Medicine, General Surgery, and the Organ Transplantation Center. Pearson's χ2 and Fisher's exact test were conducted on the responses regarding disincentives and incentives to determine whether opinions differed based on age. RESULTS: Six hundred and twenty-four participants completed the survey. There was no statistical difference in opinions between groups on reimbursing transportation costs, loss of wages, or childcare costs, but those aged ≥ 25 were more agreeable with covering food/lodging costs compared to those < 25 (96.5% vs 90.7%, P = .009). Respondents < 25 years old were more willing to donate a kidney for a financial incentive (P = .0002) accepting a median amount of $25,000. CONCLUSIONS: Health care personnel broadly support removing financial disincentives for living kidney donation, and those ≥ 25 were more in favor of covering food/lodging costs compared to those < 25. Those < 25 years old were more likely to accept financial incentives towards donating their kidney compared to those ≥ 25 years.

A review of the possibility of adopting financially driven live donor kidney transplantation

ABSTRACT Kidney transplantation for end-stage renal disease remains the preferred solution due to its survival advantage, enhanced quality of life and cost-effectiveness. The main obstacle worldwide with this modality of treatment is the scarcity of organs. The demand has always exceeded the supply resulting in different types of donations. Kidney donation includes pure living related donors, deceased donors, living unrelated donors (altruistic), paired kidney donation and more recently compensated kidney donation. Ethical considerations in live donor kidney transplantation have always created a debate especially when rewarding unrelated donors. In this paper, we examine the problems of financially driven kidney transplantation, the ethical legitimacy of this practice, and propose some innovative methods and policies that could be adopted to ensure a better practice with accepted ethical guidelines.

Ethical disputes over living organ transplant and the applicable solutions to these disputes in China / Disputas éticas sobre el trasplante de órganos vivos y soluciones aplicables a esta disputas en China / Disputas éticas sobre transplante de órgãos vivos e as soluções aplicáveis a estas disputas na China

Objectives: In this study, we examine the ethical issues concerning living organ transplant in China. We attempt to review and analyze the ethical disputes that the living organ transplant faces in China and try to find applicable solutions to these disputes. Design: Ethical Analysis. Setting: Living organ transplant in China. Results: The ideal approaches to solving the ethical disputes involve (1) preventing disease, strengthening physical fitness, and improving the health of the national citizen; (2) encouraging the citizens to donate their organs after death; and (3) developing new technologies for organ transplant. Realistic approaches to addressing the ethical disputes over the living organ transplant include choosing the lesser of two evils, reducing the harm to the donor as much as possible and improving the transplant quality. Conclusions: The living organ transplant in China is an expedient measure instead of an ideal option and should be conducted under strict laws and regulations.

Objetivos: Neste estudo, examinamos as questões éticas relativas ao transplante de órgãos vivos na China. Vamos tentar rever e analisar os conflitos éticos que o transplante de órgãos vivos enfrenta na China e tentar encontrar soluções aplicáveis a estas disputas. Projeto: Análise ética. Configuração: Transplante de órgão vivo na China. Resultados: As abordagens ideais para resolver os conflitos éticos envolvem (1) prevenção de doenças, fortalecimento da aptidão física e melhora da saúde do cidadão nacional; (2) incentivar os cidadãos a doar seus órgãos após a morte; e (3) desenvolvimento de novas tecnologias para transplante de órgão. Abordagens realistas para enfrentar as disputas éticas sobre o transplante de órgão vivos incluem escolher o menor de dois males, reduzindo o dano ao doador o máximo possível e melhorar a qualidade do transplante. Conclusões: Transplantes de órgãos vivos na China é uma medida conveniente ao invés de uma opção ideal e deve ser conduzida sob estritas leis e regulamentos.

O artigo traz à discussão a compreensão atual do comportamento ecológico do ser humano, a partir de uma relação de dominação utilitária do ambiente em contraste com a sua compreensão do ponto de vista ecológico, a qual responde a um modelo natural que faz parte de relações de seu funcionamento no ecossistema. A este respeito, é colocado em discussão o paradigma de crise ambiental, em que tal comportamento supõe um problema grave da sociedade. Para os autores, a questão está intimamente ligada ao sistema produtivo e econômico que promove a artificialização do ser humano, criando falsas necessidades que, por meio de seu consumo, garantam a sustentabilidade do modelo econômico. É realizada uma reflexão crítica a partir da educação, no sentido de uma nova compreensão do comportamento humano, cuja perspectiva ecológica impulsiona novas relações ecossistêmicas baseadas na cooperação.

Patient perspectives on compensation for biospecimen donation.

BACKGROUND: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensation and can potentially improve informed consent and recruitment practices. METHODS: Researchers asked patients undergoing surgical removal of tissue to donate biological materials to a biobank; the request was made at their presurgical appointment or in the preoperative clinic of the Emory University Hospital. We interviewed 126 biospecimen donors within 30 days post surgery regarding their perspective on compensation for biospecimen donation. RESULTS: In response to the question "Should you be paid for your participation in the tissue bank?," 95 (95/126, 75%) participants answered "No." Of these, 55 (55/95, 58%) indicated that donating biological materials should be about altruism, not gaining a monetary reward. Only 11 (11/126, 9%) participants unequivocally believed they should receive compensation, while 14 (14/126, 11%) felt entitled to compensation only under specific circumstances. Eleven (11/14) "Depends" participants indicated that donors should only be compensated when researchers perform for-profit research. Responses varied by race and income level, with whites more likely to not feel entitled to compensation and higher income participants more likely to respond "Depends." CONCLUSIONS: The majority of biospecimen donors stated they should not be paid for tissue bank participation. However, a minority believe they should be paid for donating tissue if the tissue is used in revenue-generating projects. These results provide some support for the current biobanking practice of not providing compensation.

Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers.

Commentators are concerned that broad consent may not provide biospecimen donors with sufficient information regarding possible future research uses of their tissue. We surveyed with interviews 302 cancer patients who had recently provided broad consent at four diverse academic medical centers. The majority of donors believed that the consent form provided them with sufficient information regarding future possible uses of their biospecimens. Donors expressed very positive views regarding tissue donation in general and endorsed the use of their biospecimens in future research across a wide range of contexts. Concerns regarding future uses were limited to for-profit research and research by investigators in other countries. These results support the use of broad consent to store and use biological samples in future research.

Toward a conditional approach to anonymity? An explorative multicenter longitudinal study among anonymous living kidney donors and recipients.

Anonymity between living donors and recipients is a topic of discussion among transplant professionals. This longitudinal study explored living kidney donors' and patients' perspectives on anonymity. Prior to surgery (T0) and 3 months afterward (T1), participants in unspecified or specified indirect donation programs completed a questionnaire on their experiences with and attitudes toward anonymity as well as demographic and medical characteristics. Nonparametric tests were used to assess group differences and associations. Participants were content with anonymity at T0 and T1. Fourteen and 23% wanted to meet at T0 and T1, respectively. If the other party expressed the wish to meet, 50% (T0) and 55% (T1) would be willing to meet. Most participants agreed that meeting should be allowed if both parties agree. Attitude toward anonymity did not differ between donors/recipients, nor between T0/T1 and unspecified/specified indirect donation programs. This study showed that most donors and recipients who participated in anonymous donation schemes are in favor of a conditional approach to anonymity. Guidelines on how to revoke anonymity if both parties agree are needed and should include education about pros and cons of (non-) anonymity and a logistical plan on how, when, where, and by whom anonymity should be revoked.

Which Donor for Uterus Transplants: Brain-Dead Donor or Living Donor? A Systematic Review.

BACKGROUND: The aim of this systematic review was to evaluate and compare the pros and cons of using living donors or brain-dead donors in uterus transplantation programs, 2 years after the first worldwide live birth after uterus transplantation. METHODS: The Medline database and the Central Cochrane Library were used to locate uterine transplantation studies carried out in human or nonhuman primates. All types of articles (case reports, original studies, meta-analyses, reviews) in English or French were considered for inclusion. RESULTS: Overall, 92 articles were screened and 44 were retained for review. Proof of concept for human uterine transplantation was demonstrated in 2014 with a living donor. Compared with a brain-dead donor strategy, a living donor strategy offers greater possibilities for planning surgery and also decreases cold ischemia time, potentially translating into a higher success rate. However, this approach poses ethical problems, given that the donor is exposed to surgery risks but does not derive any direct benefit. A brain-dead donor strategy is more acceptable from an ethical viewpoint, but its feasibility is currently unproven, potentially owing to a lack of compatible donors, and is associated with a longer cold ischemia time and a potentially higher rejection rate. CONCLUSIONS: The systematic review demonstrates that uterine transplantation is a major surgical innovation for the treatment of absolute uterine factor infertility. Living and brain-dead donor strategies are not mutually exclusive and, in view of the current scarcity of uterine grafts and the anticipated future rise in demand, both will probably be necessary.

[Living kidney donation]. / Le donneur vivant de rein.

OBJECTIVES: To review ethical, legal and technical aspects of living kidney donor surgery. MATERIAL AND METHODS: An exhaustive systematic review of the scientific literature was performed in the Medline database (http://www.ncbi.nlm.nih.gov) and Embase (http://www.embase.com) using different associations of the following keywords: Donor nephrectomy; Kidney paired donation; Kidney transplantation; Laparoscopic nephrectomy; Living donor; Organs trafficking; Robotic assisted nephrectomy; Vaginal extraction. French legal documents have been reviewed using the government portal (http://www.legifrance.gouv.fr). Articles were selected according to methods, language of publication and relevance. A total of 6421 articles were identified; after careful selection, 161 publications were considered of interest and were eligible for our review. RESULTS: The ethical debate focuses on organ shortage, financial incentive, organ trafficking and the recent data suggesting a small but significant increase risk for late renal disease in donor population. Legal decisions aim to increase the number of kidneys available for donation, such as kidney-paired donation that faces several obstacles in France. Laparoscopic approach became widely used, while robotic-assisted donor nephrectomy failed to demonstrate improved outcome as compared with other minimal invasive techniques. CONCLUSION: Minimally invasive living donor nephrectomy aims to limit side effects in the donor without increasing the morbidity in this specific population of healthy persons; long term surveillance to prevent the onset of renal disease in mandatory.

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?

INTRODUCTION: Living kidney donors comprise a unique group of "patients", undergoing an operation for the benefit of others. The informed consent process is therefore valued differently. Although this is a team effort, the surgeon is responsible for performing the donor nephrectomy, and often the one held accountable, should adverse events occur. Although there is some consensus on how the informed consent procedure should be arranged, practices vary. The aim of this study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosure of complications. METHODS: A web-based survey was sent to all kidney transplant surgeons (n = 50) in eight transplant centers with questions regarding the local procedure and disclosure of specific details. RESULTS: Response rate was 98% (n = 49), of which 32 (65%) were involved in living donor education; overall, transplant- (50%), vascular- (31%), and abdominal surgeons (13%), and urologists (6%) performed donor nephrectomies in the eight centers. Informed consent procedures varied, ranging from assumed to signed consent. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 13 (41%), three surgeons (9%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied. CONCLUSION: Important complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended.

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

INTRODUCTION: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. METHODS AND ANALYSIS: The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. RESULTS: Outcome will be published in a scientific journal. TRIAL REGISTRATION NUMBER: NTR5374; Pre-results.

Advances in Ethical, Social, and Economic Aspects of Chronic Renal Disease in Bolivia.

Since 2005, great progress has been made in health care provision to patients with terminal renal failure in Bolivia. Access to dialysis and transplantation is regulated by the Ministry of Health, based on clinical criteria, applied equitably, without favoritism or discrimination based on race, sex, economic means, or political power. Until December 2013, there were no restrictions in dialysis and transplantation in Health Insurance institutions, but they covered only 30% of the population. Now the remaining 70% has access to free dialysis funded by the communities where patients live, with funds coming from the government and taxes on oil products. More than 2,231 people are getting dialysis, reaching a population growth of >60% annually. The number of hemodialysis units has increased by >200% (60 units), making access easier for end-stage renal failure patients. Treatment protocols have been drawn up to guarantee the best quality of life for the patients. The Law on Donation and Transplantation was enacted in 1996, and Supplementary Regulations were enacted in 1997 with various amendments over the past 5 years. A National Transplant Coordination Board, working under the National Renal Health Program, supervises and regulates transplants and promotes deceased-donor transplantation in an attempt to cover the demand for donors. Rules have been drawn up for accreditation of transplant centers and teams to guarantee the best possible conditions and maximum guaranties. Since January 2014, the National Renal Health Program has been providing free kidney transplants from living donors.

Is laparoscopic live donor hepatectomy justified ethically?

Live donor liver transplant (LDLT) was first reported in the 1990s and quickly raised ethical considerations, mainly related to the risk brought to the donor. The question of donor safety was even more accurate with the occurrence of laparoscopy, a technique which could allegedly increase the risk of severe intraoperative complications. Besides the questions of justice and autonomy, donor safety remains the main ethical debate of LDLT. Considering the lack of comparative assessment of postoperative outcomes, the Jury of the last Consensus meeting held in Japan in 2014 called for the creation of international registries to help to determine the benefit/risk ratio of laparoscopic donor hepatectomy. Since randomized studies are very unlikely to occur, benchmarking comparisons, between liver and kidney donors for instance, may also help to define standard practice. At last, donors' points of view should also be taken into account in the evaluation of those innovative procedures.

Kidney and liver transplantation in the elderly.

BACKGROUND: Transplant surgery is facing a shortage of deceased donor organs. In response, the criteria for organ donation have been extended, and an increasing number of organs from older donors are being used. For recipients, the benefits of transplantation are great, and the growing ageing population has led to increasing numbers of elderly patients being accepted for transplantation. METHODS: The literature was reviewed to investigate the impact of age of donors and recipients in abdominal organ transplantation, and to highlight aspects of the fine balance in donor and recipient selection and screening, as well as allocation policies fair to young and old alike. RESULTS: Overall, kidney and liver transplantation from older deceased donors have good outcomes, but are not as good as those from younger donors. Careful donor selection based on risk indices, and potentially biomarkers, special allocation schemes to match elderly donors with elderly recipients, and vigorous recipient selection, allows good outcomes with increasing age of both donors and recipients. The results of live kidney donation have been excellent for donor and recipient, and there is a trend towards inclusion of older donors. Future strategies, including personalized immunosuppression for older recipients as well as machine preservation and reconditioning of donor organs, are promising ways to improve the outcome of transplantation between older donors and older recipients. CONCLUSION: Kidney and liver transplantation in the elderly is a clinical reality. Outcomes are good, but can be optimized by using strategies that modify donor risk factors and recipient co-morbidities, and personalized approaches to organ allocation and immunosuppression.

Seriously ill patients as living unspecified kidney donors: rationale and justification.

BACKGROUND: Between 2000 and December 2013, 106 live donor nephrectomies from anonymous living-donors were performed at the Erasmus MC Rotterdam; five of the donors (5.4%) had a life-threatening disease. The aim of the present report is to give the rational and justification for this procedure. METHODS: All five donors underwent the national standard living-donor screening procedure. Additionally, motivation to donate and psychologic stability were assessed by a psychologist using in-depth interview techniques and a psychologic complaints questionnaire. Post-donor nephrectomy follow-up consisted of standard questionnaires and clinical check-ups. RESULTS: One patient had cerebral and caudal ependymomas, one had severe and progressive emphysema, two had Huntington's disease and one had a grade 2 oligodendroglioma. The psychologic screening revealed genuine motivation, adequate risk perception, and normal sense of reality. No contraindications for donation were found. The five donor nephrectomies made nine kidney transplantations possible. All donors were satisfied with the donation procedure. Three donors died during follow-up (0.6-4.9 years) as a result of their disease. CONCLUSION: In the absence of apparent additional health risks, medical, and psychologic contraindications, we consider it ethically justified to accept an offer from a cognitively competent patient with a life-threatening disease in view of their self-reported satisfaction during follow-up. Although based on a limited number of patients, we conclude that a stricter psychologic screening for seriously ill donors compared to healthy unspecified anonymous donors to unspecified patients is not necessary.

Children as hematopoietic cell donors in research: when is it approvable?

With increasing frequency, allogeneic hematopoietic cell transplantation involving children is being performed in the research setting. Allogeneic hematopoietic cell transplantation, however, cannot be performed without a hematopoietic stem cell (HSC) donor. This donor is often a sibling of the recipient and may also be a child. In such circumstances, it is unclear whether or how the federal regulations for pediatric research apply to the minor donors. This introductory paper reviews the issues to be considered while evaluating studies that use HSCs obtained from minor donors and identifies areas where further research is needed. In the era of increasing applicability for donor-derived cellular therapies, we provide a suggested framework for determining when minor donors qualify as human research subjects and when their participation can be approved under the federal regulations.

The ethics of a proposed study of hematopoietic stem cell transplant for children with "less severe" sickle cell disease.

Hematopoietic stem cell transplant (HSCT) is the only cure for sickle cell disease (SCD). HSCT using an HLA-identical sibling donor is currently an acceptable treatment option for children with severe SCD, with expected HSCT survival >95% and event-free survival >85%. HSCT for children with less severe SCD (children who have not yet suffered overt disease complications or only had mild problems) is controversial. It is important to consider the ethical issues of a proposed study comparing HLA-identical sibling HSCT to best supportive care for children with less severe SCD. In evaluating the principles of nonmaleficence, respect for individual autonomy, and justice, we conclude that a study of HLA-identical sibling HSCT for all children with SCD, particularly hemoglobin SS and Sß(0)-thalassemia disease, is ethically sound. Future work should explore the implementation of a large trial to help determine whether HSCT is a beneficial treatment of children with less severe SCD.

Ethical issues regarding related and nonrelated living organ donors.

The ethics of the clinical practice of transplanting human organs for end-stage organ disease is a fascinating topic. Who is the "owner" of the transplantable organs of a deceased, brain-dead patient? Who should have a right to receive these organs? Who set the boundaries between a living donor's autonomy and a "paternalistic" doctor? What constitutes a proper consent? These questions are only some of the ethical issues that have been discussed in the last 60 years. All of these ethical issues are intensified by the fact that supply of human organs does not match demand, and that, as a consequence, living-donor organ transplantation is widely utilized. The aim of this article is not to be exhaustive but to present the general ethical principles of beneficence, nonmaleficence, and justice as applied to organ transplantation. Moreover, the topic of reimbursement for organ donation is also discussed.

Financial incentives to increase Canadian organ donation: quick fix or fallacy?

Unlike the United States, the potential to increase organ donation in Canada may be sufficient to meet the need for transplantation. However, there has been no national coordinated effort to increase organ donation. Strategies that do not involve payment for organs, such as investment in health care resources to support deceased donor organ donation and introduction of a remuneration framework for the work of deceased organ donation, should be prioritized for implementation. Financial incentives that may be permitted under existing legislation and that pose little risk to existing donation sources should be advanced, including the following: payment of funeral expenses for potential donors who register their decision on organ donation during life (irrespective of the decision to donate or actual organ donation) and removal of disincentives for directed and paired exchange living donation, such as payment of wages, payment for pain and suffering related to the donor surgery, and payment of directed living kidney donors for participation in Canada's paired exchange program. In contrast, it would be premature to contemplate a regulated system of organ sales that would require a paradigm shift in the current approach to organ donation and legislative change to implement.

Written informed consent for living kidney donors: practices and compliance with CMS and OPTN requirements.

We sought to assess how written informed consent practices for candidate living kidney donors have changed over the last 5 years and to assess compliance with Centers for Medicare and Medicaid (CMS) and Organ Procurement and Transplantation Network (OPTN) regulations that took effect in 2007. We requested evaluation consent forms from US centers that performed >5 living kidney transplants during the prior year (n = 184). We received 148 consent forms; each was reviewed for information provided and inclusion of CMS- and OPTN-required elements. We found that nearly all transplant centers now obtain written consent for living kidney donor evaluation. However, most centers' evaluation consent forms do not include all CMS and OPTN requirements. Multiple items balancing donor and recipient interests and confidentiality were omitted. In addition, information about payment for routine follow-up care, complications related to surgery and other health problems following surgery were highly variable and frequently ambiguous. As centers revise their consent forms to address the 2013 OPTN policies, our findings may help them identify areas of potential deficiency. We propose that UNOS develop a uniform donor evaluation consent form to improve the clarity, consistency and efficiency of living donor consent.