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Purpose of Review: The controversial medical procedure of abortion is the subject of this article. It argues that for transplant patients, including recipients, abortion is ethical., Recent Findings: In June 2022, the United States Supreme Court overturned the long-standing decision of Roe v. Wade. This decision has led to a socio-legal environment where obtaining an abortion is impossible for some patients. However, the moral position relating to patients who have undergone transplants or are on a waiting list has been largely overlooked. End-stage renal, liver, and heart disease presents a hazardous situation for pregnancy, posing risks to both the fetus and the pregnant person. The abortion procedure is medically safer and allows a patient to proceed with a transplant. Limiting access to abortion or preventing it altogether will have a significant negative impact on transplant patients. The ethical analysis of abortion can be likened to compelling a relative or loved one of a transplant recipient to donate an organ to their family member or loved one., Summary: This article emphasizes the importance of maintaining the legal availability of abortion for transplant patients. Allowing abortions in transplant patients upholds ethical parity, as seen in the analogous situation of live organ donation., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Therapies derived from substances of human origin (SoHOs) such as organs, cells, and tissues provide life-saving or life-changing treatment for millions of people worldwide each year. However, many people lack timely access to SoHO-based therapies because of insufficient supplies of these exceptional health resources and/or broader barriers in access to healthcare. Despite well-established governmental commitments to promote health equity in general and equity of access to SoHOs in particular, information about inequities in access to most SoHO-based therapies is scarce. Furthermore, the issue of equitable allocation of SoHO-based therapies has received little attention from policymakers and ethicists, except in the context of organ allocation for transplantation. Consequently, the extent and nature of potential inequities within and between countries are largely unknown, and few sources of guidance are available to support progress toward equity in global access to SoHO-based therapies. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, organized in Santander, Spain. The group sought to assess potential gaps in knowledge about inequities involving SoHO-based therapies, to elucidate systemic factors that may influence access to these therapies, and to consider how policies and frameworks governing access to and allocation of SoHO-based therapies may promote equity when it is necessary to define boundaries in access because of insufficiency of supply. In discussing these challenges, we also outline several recommendations for action by governments and health authorities., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Establishing transparency and oversight of organ transplantation by regulatory agencies is of paramount importance to assure ethical, legal, and clinically robust transplantation practices. Registries reporting activity and outcome data of the donor and recipient, including donor source (living or deceased), must be developed for each transplant and should be a mandatory requirement to achieve accreditation to perform transplant surgeries. Collected data for the living organ donor must include the nationality, the nature of their relationship with the recipient, and the complications encountered by living donors that result in prolonged morbidity or mortality. Long-term patient and graft survival must be reported for the recipient with the underlying reasons for mortality or graft loss. To retain the authorization to perform organ transplantation, a facility must ensure that it reports this required information regarding every organ transplant., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Innovation is a hallmark of organ, tissue, and cell transplantation. The development of new treatments derived from these substances of human origin (SoHO) has rapidly evolved in recent years. Despite the great benefits that these innovative therapies could bring to patients, significant difficulties have arisen in making them equitably and widely accessible. Herein, we identify and address 4 challenges to promote innovation in this field in a collaborative, sustainable, and transparent manner and propose some concrete solutions applicable to SoHO-derived treatments, ranging from cell therapies to solid organ transplantation. Regulators, health policymakers, and government officials are recommended to incorporate specific elements into the regulatory frameworks of their respective jurisdictions, although regulatory convergence and equivalent quality and safety standards applicable to SoHO at a global level would be needed. An innovation-driven regulatory environment, respectful with the human origin and in accordance with the altruistic donation of SoHO, should be encouraged to improve the safety, effectiveness, accessibility, and affordability of SoHO and to promote collaboration between countries and between public and private sectors. This overview is the outcome of a working group focused on "Innovation in the donation and clinical application of SoHO" as part of the international Summit "Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight" convened by the Organización Nacional de Trasplantes under the Spanish Presidency of the Council of the European Union in November 2023 and cosponsored by the Council of Europe, the World Health Organization, the Transplantation Society, and the European Society for Organ Transplantation., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Trafficking in human organs, cells, and tissues has long been a source of concern for health authorities and professionals, and several international ethical guidance documents and national laws have affirmed the prohibition of trade in these substances of human origin (SoHOs). However, despite considerable attention to the issue of organ trafficking, this remains a substantial and widespread problem internationally. In contrast, trafficking in cells, tissues, and medical products derived from SoHOs has received comparatively little attention, and the extent and nature of such trafficking remain largely unknown. Consequently, as part of the 2023 Global Summit on Convergence in Transplantation held in Santander, Spain, an ethics working group was assigned the task of formulating actionable recommendations to support the prevention of trafficking in all SoHOs. In reporting on this work, we review factors that may influence the persistent trafficking of SoHOs, explore the potential difficulties associated with the collection and reporting of data about suspected trafficking activities, and argue that more practical and consistent guidance, training, and regulatory frameworks are needed internationally to support effective reporting, sharing of data, and collaborative responses to suspected trafficking cases. We also discuss the importance of psychosocial evaluation of living donors as a strategy to detect and prevent organ trafficking and strive to advance the implementation of this well-established recommendation by outlining minimum standards for psychosocial evaluation of living donors., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The American Society of Transplant Surgeons convened a multidisciplinary working group to address operational, ethical, and legal considerations surrounding normothermic regional perfusion (NRP) procurement., Methods: The working group, comprising members from American Society of Transplant Surgeons and AST across various disciplines including transplant surgery, hepatology, critical care, and bioethics, collaborated to formulate recommendations and guidance for NRP procurement., Results: The following topics were identified by the group as essential standards that need to be addressed for ethical, legal, and operational conformance: terminology; conceptualization of death in the context of NRP; and communication, logistics, and training and competency., Conclusions: Fourteen recommendations that support the ethical and legal acceptability of NRP in the United States and set expectations for the conduct of NRP procedures are provided., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Global conflicts and humanitarian crises have resulted in an unprecedented number of refugees and migrants. This challenges the limited resources of health care systems and jeopardizes the availability of transplant care for these deserving migrants and refugees. This was the basis for a workshop held during the Congress of the Transplantation Society (Buenos Aires, 2022). We elaborate on the proceedings of the workshop entitled "Transplantation in the Context of Migration and Refugees," organized by the Ethics Committee of The Transplantation Society and Declaration of Istanbul Custodian Group. Transplant providers from around the world shared strategies of how each region has responded to providing access to care for refugees and migrants in need of transplant services. The potential exploitation of this vulnerable group leading to illicit organ removal was addressed for each region. The Transplantation Society, Declaration of Istanbul Custodian Group, and global transplant community should continue to focus on the status of refugees and migrants and collaborate on strategies to provide access to transplant care for this deserving population. Global cooperation will be essential to provide vigilant oversight to prevent exploitation of this vulnerable population., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: The author declares no funding or conflicts of interest.

Competing Interests: The author declares no funding or conflicts of interest

Alcohol and cannabis use as a contraindication to organ transplantation is a controversial issue. Until recently, patients in Canada with alcohol-associated liver disease were required to demonstrate abstinence for 6 mo to receive a liver transplant. There is no equivalent rule that is applied consistently for cannabis use. There is some evidence that alcohol and cannabis use disorder pretransplant could be associated with worse outcomes posttransplantation. However, early liver transplantation for patients with alcohol-associated liver disease in France and in the United States has led to challenges of the 6-mo abstinence rule in Canada in the media. It has also resulted in several legal challenges arguing that the rule violates human rights laws regarding discrimination in the provision of medical services and that the rule is also unconstitutional (this challenge is still before the court). Recent legalization of cannabis use for adults in Canada has led to questions about the appropriateness of limiting transplant access based on cannabis use. The ethics committee of the Canadian Society of Transplantation was asked to provide an ethical analysis of cannabis and alcohol abstinence policies. Our conclusions were as follows: neither cannabis use nor the 6-mo abstinence rule for alcohol use should be an absolute contraindication to transplantation, and transplant could be offered to selected patients, further research should be conducted to ensure evidence-based policies; and the transplant community has a duty not to perpetuate stigma associated with alcohol and cannabis use disorders., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Cannabis, or marijuana, comprises many compounds with varying effects. It has become a treatment option for chronic diseases and debilitating symptoms, and evidence suggests that it has immunomodulatory and antiinflammatory properties. Transplant centers are more frequently facing issues about cannabis, as indications and legalization expand. As of February 2020, 33 states and the District of Columbia have legalized medical cannabis, and 14 have legalized recreational cannabis. Moreover, 8 states have passed legislation prohibiting the denial of transplant listing solely based on cannabis use. Studies demonstrate the potential for significant pharmacokinetic and pharmacodynamic interactions between cannabis and immunosuppression. Additionally, safety concerns include increased risk of myocardial infarction, ischemic stroke, tachyarrhythmias, malignancy, neurocognitive deficits, psychosis, other neuropsychiatric disorders, cannabis use disorder, respiratory symptoms, and infection. A recent retrospective database study found a negative association between documented cannabis use disorder and graft survival, but little additional evidence exists evaluating this relationship. In the absence of robust clinical data, transplant centers need a clear, reasoned, and systematic approach to cannabis. The results of our national survey, unfortunately, found little consensus among institutions. As both recreational and medicinal cannabis become more ubiquitous nationwide, transplant centers will need to develop comprehensive policies to address its use., Competing Interests: L.J.B. has served on an advisory board for Veloxis Pharmaceuticals and currently serves on their Speaker’s Bureau. The other authors declare no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Uncontrolled donation after circulatory death (uDCD) refers to donation from persons who die following an unexpected and unsuccessfully resuscitated cardiac arrest. Despite the large potential for uDCD, programs of this kind only exist in a reduced number of countries with a limited activity. Barriers to uDCD are of a logistical and ethical-legal nature, as well as arising from the lack of confidence in the results of transplants from uDCD donors. The procedure needs to be designed to reduce and limit the impact of the prolonged warm ischemia inherent to the uDCD process, and to deal with the ethical issues that this practice poses: termination of advanced cardiopulmonary resuscitation, extension of advanced cardiopulmonary resuscitation beyond futility for organ preservation, moment to approach families to discuss donation opportunities, criteria for the determination of death, or the use of normothermic regional perfusion for the in situ preservation of organs. Although the incidence of primary nonfunction and delayed graft function is higher with organs obtained from uDCD donors, overall patient and graft survival is acceptable in kidney, liver, and lung transplantation, with a proper selection and management of both donors and recipients. Normothermic regional perfusion has shown to be critical to achieve optimal outcomes in uDCD kidney and liver transplantation. However, the role of ex situ preservation with machine perfusion is still to be elucidated. uDCD is a unique opportunity to improve patient access to transplantation therapies and to offer more patients the chance to donate organs after death, if this is consistent with their wishes and values.

: With current antiretroviral therapy, the lifespan of newly diagnosed persons with HIV (PWH) approaches that of uninfected persons. However, metabolic abnormalities related to both the disease and the virus itself, along with comorbidities of aging, have resulted in end-organ disease and organ failure as a major cause of morbidity and mortality. Solid organ transplantation is a life-saving therapy for PWH who have organ failure, and the approval of the HIV Organ Policy Equity Act has opened and expanded opportunities for PWH to donate and receive organs. The current environment of organ transplantation for PWH will be reviewed and future directions of research and treatment will be discussed.

Purpose of Review: There is a grave discordance between supply and demand for patients with failing organs largely due to an insufficient donor pool for transplantation. Xenotransplantation has been proposed as a solution to bridge this gap., Recent Findings: Recent success over the last decade in nonhuman primate models, due to emerging gene-editing technologies combined with novel immunosuppression regimens, has produced promising results in pancreatic islet cell, heart, lung, kidney and liver xenotransplantations., Summary: As the prospect of xenotransplantation is realized, safety and ethical considerations have come to the forefront of discussion. The WHO and World Health Assembly have encouraged member states to form regulatory bodies to govern human xenotransplantation studies with the highest standards. Here, we summarize the current regulatory landscape governing preclinical advances toward the first human clinical trials.

Since 2012, the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) has required transplant centers to record the citizenship residency status of patients undergoing transplantation in the United States. This policy replaced the 5% threshold of the non-US citizen/nonresidents (NC/NR) undergoing organ transplantation that could result in an audit of transplant center activity. Since April 1, 2015, the country of residence for the NC/NR on the waitlist has also been recorded. We analyzed the frequency of NC/NR deceased donor organ transplants and waitlist registrations at all US transplant centers by data provided by UNOS for that purpose to the UNOS Ad Hoc International Relations Committee. During the period of 2013 to 2016, 1176 deceased donor transplants (of all organs) were performed in non-US citizen/non-US resident (NC/NR) candidates (0.54% of the total number of transplants). We focused on high-volume NC/NR transplant centers that performed more than 5% of the deceased donor kidney or liver transplants in NC/NR or whose waitlist registrants exceeded 5% NC/NR. This report was prepared to fulfill the transparency policy of UNOS to assure a public trust in the distribution of organs. When viewed with a public awareness of deceased donor organ shortages, it suggests the need for a more comprehensive understanding of current NC/NR activity in the United States. Patterns of organ specific NC/NR registrations and transplantations at high-volume centers should prompt a review of transplant center practices to determine whether the deceased donor and center resources may be compromised for their US patients.

Purpose of Review: Despite over 60 years of progress in the field of since the first organ transplant, insufficient organ preservation capabilities still place profound constraints on transplantation. These constraints play multiple and compounding roles in the predominant limitations of the field: the severe shortages of transplant organs, short-term and long-term posttransplant outcomes and complications, the unmet global need for development of transplant infrastructures, and economic burdens that limit patient access to transplantation and contribute to increasing global healthcare costs. This review surveys ways that advancing preservation technologies can play a role in each of these areas, ultimately benefiting thousands if not millions of patients worldwide., Recent Findings: Preservation advances can create a wide range of benefits across many facets of organ transplantation, as well as related areas of transplant research. As these technologies mature, so will the policies around their use to maximize the benefits offered by organ preservation., Summary: Organ preservation advances stand to increase local and global access to transplantation, improve transplant outcomes, and accelerate progress in related areas such as immune tolerance induction and xenotransplantation. This area holds the potential to save the healthcare system many billions of dollars and reduce costs across many aspects of transplantation. Novel preservation technologies, along with other technologies facilitated by preservation advances, could potentially save millions of lives in the coming years.

Selected human immunodeficiency virus (HIV)-infected patients with end organ failure can safely receive an organ transplant from an HIV uninfected donor. Recent demonstration of the short term safety of organ transplantation between HIV-infected persons prompted a change in US American law to allow such transplantations. Prompted by the recent completion of the first organ transplantation between HIV-infected persons in Canada, we review Canadian law regarding the use of organs from HIV-infected donors, estimate the number of potential HIV-infected donors in Canada, and critically review considerations related to advancing organ transplantation from HIV-infected donors in Canada. Existing legislation allows organ transplantation from an HIV-infected donor under exceptional medical circumstances and therefore no change in legislation is required to increase utilization of organs from HIV-infected donors for transplantation in Canada. Among 335,793 hospital deaths between 2005 and 2009 in Canadian provinces excluding Quebec, 39 potential HIV-infected donors were identified. The actual number of HIV potential donors is estimated to be approximately 60% lower (3-5 potential donor per year), if the absence of viremia is required for transplantation. Although offering all Canadians the opportunity to donate organs is a laudable goal, further research to understand the need for HIV-positive donors and the willingness of HIV-positive recipients to accept organs from HIV-positive donors is needed to inform future policy regarding organ donation from HIV-infected persons in Canada.

Patient-centered care is no longer just a buzzword. It is now widely touted as a cornerstone in delivering quality care across all fields of medicine. However, patient-centered strategies and interventions necessitate evidence about patients' decision-making processes, values, priorities, and needs. Qualitative research is particularly well suited to understanding the experience and perspective of patients, donors, clinicians, and policy makers on a wide range of transplantation-related topics including organ donation and allocation, adherence to prescribed therapy, pretransplant and posttransplant care, implementation of clinical guidelines, and doctor-patient communication. In transplantation, evidence derived from qualitative research has been integrated into strategies for shared decision-making, patient educational resources, process evaluations of trials, clinical guidelines, and policies. The aim of this article is to outline key concepts and methods used in qualitative research, guide the appraisal of qualitative studies, and assist clinicians to understand how qualitative research may inform their practice and policy.

Background: Many nations are able to prosecute transplant-related crimes committed in their territory, but transplant recipients, organ sellers and brokers, and transplant professionals may escape prosecution by engaging in these practices in foreign locations where they judge the risk of criminal investigation and prosecution to be remote., Methods: The Declaration of Istanbul Custodian Group convened an international working group to evaluate the possible role of extraterritorial jurisdiction in strengthening the enforcement of existing laws governing transplant-related crimes across national boundaries. Potential practical and ethical concerns about the use of extraterritorial jurisdiction were examined, and possible responses were explored., Results: Extraterritorial jurisdiction is a legitimate tool to combat transplant-related crimes. Further, development of a global registry of transnational transplant activities in conjunction with a standardized international referral system for legitimate travel for transplantation is proposed as a mechanism to support enforcement of national and international legal tools., Conclusions: States are encouraged to include provisions on extraterritorial jurisdiction in their laws on transplant-related crimes and to collaborate with professionals and international authorities in the development of a global registry of transnational transplant activities. These actions would assist in the identification and evaluation of illicit activities and provide information that would help in developing strategies to deter and prevent them.

Background: Despite broad public support for organ donation, there is a chronic shortage of deceased donor organs. We sought to identify community preferences for features of organ donation policies., Methods: A discrete choice study was conducted using an online panel of Australian community respondents older than 18 years. Respondents were presented with scenarios comparing a "new" policy to the current policy. Tradeoffs between 8 policy aspects were quantified using mixed logit and latent class models: registration system, extent of donor family involvement, ease of registration, frequency of confirmation of intent, direct payment, and funeral expense reimbursement, priority for donor's family, and formal recognition of donation., Results: There were 2005 respondents (mean, 44.6 years). We found a strong preference for a new policy. Overall, respondents favored a policy that included: some involvement of the donor's family in the final decision, simple registration processes, less frequent reconfirmation of donation intent, direct payment or funeral expense reimbursement, and formal recognition of donation. However, there was significant preference heterogeneity across respondents, with various respondent groups valuing policy mechanisms differently. Respondents who viewed policy change negatively were also those who would be unlikely to be organ donors anyway, because they tended to hold negative views toward organ donation., Conclusions: Our results suggest that the Australian community are open to alternative organ donation policies including changes to: registration systems, family involvement, and financial and nonfinancial mechanisms. Future policy discussions should not be limited by preconceived notions of what is acceptable to the community, rather informed by actual community values and preferences.

Background: Across Europe, transplant centers vary in the content of the psychosocial evaluation for eligible living organ donors. To identify whether a common framework underlies this variation in this evaluation, we studied which psychosocial screening items are most commonly used and considered as most important in current psychosocial screening programs of living organ donors., Methods: A multivariate analytic method, concept mapping, was used to generate a visual representation of the "psychosocial" screening items of living kidney and liver donors. A list of 75 potential screening items was derived from a systematic literature review and sorted and rated for their importance and commonness by multidisciplinary affiliated health care professionals from across Europe. Results were discussed and fine-tuned during a consensus meeting., Results: The analyses resulted in a 6-cluster solution. The following clusters on psychosocial screening items were identified, listed from most to least important: (1) personal resources, (2) motivation and decision making, (3) psychopathology, (4) social resources, (5) ethical and legal factors, and (6) information and risk processing., Conclusions: We provided a conceptual framework of the essential elements in psychosocial evaluation of living donors which can serve as a uniform basis for the selection of relevant psychosocial evaluation tools, which can be further tested in prospective studies.

There are a number of regulatory barriers both perceived and real that have hampered widespread clinical research in the field of donation and transplantation. This article sets forth a framework clarifying the existing legal requirements and their application to the conduct of research on deceased donors and donor organs within the United States. Recommendations are focused on resolving some of the ambiguity surrounding deceased donor authorization for research, Health Insurance Portability and Accountability Act requirements and the role of institutional review board oversight. The successful conduct of clinical research in the field of donation and transplantation requires an understanding of these regulatory nuances as well as identification of important ethical principles to consider. Facilitation of these concepts will ultimately provide support for innovative research designed to increase the availability of organs for transplantation. Further work identifying the optimal infrastructure for overview of clinical research in the field should be given priority.

With the recent transposition of Directive 2010/53/EU into the transplant regulation of EU Member States, the time is right to have a closer look at its implications for living organ donation practice. We first discuss the relevance of the Action Plan which forms the basis for the policy of the European Commission in the field of organ donation and transplantation. We then analyze the impact of Directive 2010/53/EU which was adopted to support the implementation of the Priority Actions set out in the Action Plan. We more specifically focus on the obligations of transplant centers engaged in living organ donation and highlight their significance for clinical practice. Finally, we point out some strengths and weaknesses of the Directive in addressing living organ donation.

Background: The disparity between patients awaiting transplantation and available organs has widened, and resultant organ shortage became a world crisis. The transplantation community has made considerable progress in national organ donation system in Korea, and significant growth in the number of deceased donors has been witnessed., Methods: After introduction of the Organ Transplant Act, which was enacted in 2000, transparency was established in organ allocation system in Korea. However, the number of deceased donor dwindled significantly from 162 in 1999 to 36 in 2002. To improve deceased donation, several strategies were pursued, and finally new national organ donation system was established through the amendment of the Organ Transplant Act., Results: Organ incentive system, which was introduced in 2003, failed to increase the number of deceased donors (68 in 2003, 86 in 2004, and 91 in 2005). Monetary incentive to the bereaved family was introduced in 2006 and slightly increased the number of deceased donor (141 in 2006). However, this effect was not long-lasting (148 in 2007). After enforcement of the new Organ Transplant Act, which included nationwide independent organ procurement organization and mandatory report of potential brain death, the number of deceased donors significantly increased, reaching 368 in 2011. The growth continued and the number of deceased donors reached 409 (8.03 pmp) in 2012., Conclusion: There has been a significant growth in the number of deceased donors in Korea since the appropriate deceased organ donation system was launched. A comprehensive national program is required to improve deceased donation and achieve self-sufficiency.

Although currently in the early clinical research phase, the first successful birth of a child after uterus transplant is an early step toward another reproductive option for women with uterine factor infertility. Uterus transplantation uniquely brings together the fields of assisted reproductive technology and transplant medicine and represents the world's first ephemeral transplant completed to improve quality of life rather than extending life. However, the ethical, legal, and social implications of uterus transplantation must be carefully analyzed for the donor, recipient, and resulting child before uterus transplant moves from clinical research to clinical practice.