International Transplant Community Research Articles

Ethical and policy considerations for organ trafficking and transplant tourism: Based on the UK's first international case of human trafficking for the purpose of organ removal

AbstractThis study examines the UK's May 2023 judgment in an international organ trafficking and organ tourism case. Human trafficking for organ removal is one of the least understood but growing forms of trafficking worldwide. Countries in the Middle East, Asia, and the Americas are often widely criticized by the international transplant community as sites for organ trafficking. However, we believe that when discussing this issue, it is not just these areas that need to be addressed. What is particularly special is that this case not only involves transnational human trafficking, organ trafficking, and illegal organ transplantation interest chains but also involves the participation of national political officials and complex social and humanistic factors. This article focuses on the current ethical and policy issues involved in organ transplant tourism and organ trafficking and analyzes the implications of this case for our country's donation and transplantation work.

DCD kidney transplantation in Italy: Past, present, and future

The disproportion between the number of patients on the kidney transplant waiting list and the actual donors pool represents a primary issue for the international Transplant community. The development of donation after circulatory death (DCD) programs has been associated with a remarkable increase in organs procurement and transplants activities across the globe. However, effective DCD donation and transplantation require the resolution of several legal, ethical, deontological, logistical, and technical issues. In Italy, the major obstacle to this very specific type of dation was represented by the 20-minute no-touch period for the declaration of death by cardio-circulatory criteria established by the Italian legislation. Following the encouraging results obtained with the use of in situ Normothermic Regional Perfusion in the setting of a single-center exploratory trial performed between 2008 and 2013 (Alba project), the Comitato Nazionale per la Bioetica and the Centro Nazionale Trapianti eventually managed to start a national-scale controlled and uncontrolled DCD program. We herein describe the Italian DCD KT program with a special focus on the most crucial and peculiar aspects of the national organ donation and allocation process.

Experience with solid organ transplantation in patients with previous immunotherapy treatment is still limited but this is changing: The survey-based view of the global transplant society

BackgroundThe use of immunotherapy for cancer is increasing and is expected to continue growing. The outcomes after solid organ transplantation(SOT) in patients who received immunotherapy before SOT remain unclear. We evaluated the global transplant surgery community's attitude towards and experience with patients who received immunotherapy for malignancy before SOT. MethodsAn online-based survey was sent to North American transplant program directors in December-2020 and members of the International Liver Transplant Society in November-2021 evaluating experiences with and attitudes towards SOT in recipients with previous immunotherapy for cancer. ResultsA total of 119 respondents completed the survey(119/175;completion rate:68%), representing centers from North America, South America, Europe, Asia, and Australia. Seventy-one(62%) respondents would consider SOT in patients with a previous history of immunotherapy for cancer, whereas thirty-nine(34%) were aware of such immunotherapy-treated recipients being transplanted, with an increasing trend over the last few years(2016[n = 1]-2020[n = 14]). Institutional clinical management policies in this setting were lacking in most centers(n = 85[75%]). ConclusionsThe international transplant community is receptive to transplanting transplant candidates previously treated with immunotherapy for cancer, although experience is still limited. In this context, more centers have started to offer SOT to patients with a history of immunotherapy for cancer in recent years. However, support from clear and robust institutional policies in this endeavor is scant. Therefore, there is a high need for consensus guidelines to inform future clinical management, especially as immunotherapy for cancer is likely to continue to increase in the coming years.

Practice Patterns for the Acceptance of Medically Complex Living Kidney Donors with Hematuria, Sickle Cell Trait, Smoking, Illegal Drug Use, or Urological Issues: A Multinational Survey.

Background To review the practice patterns for the acceptance of medically complex living kidney donors (MCLKD) among the transplant providers of the international transplant community. Methods We distributed a survey globally, through major international transplantation societies, among nephrologists and transplant surgeons (TS). The survey contained questions regarding potential donors with microscopic hematuria, sickle cell trait, renal cysts, kidney stones, smoking, or illegal drug use. Results There were 239 respondents from 29 countries, including nephrologists (42%) and TS (58%). Although most respondents would investigate microscopic hematuria, one-third of them indicated they would decline these potential donors without investigation. Interestingly, most respondents accepted heavy smokers, intermittent illegal drug users (with advice to quit), and those with incidentally identified kidney stones, remote history of renal colic or simple renal cysts. We found multiple areas of consensus in practice with some interesting differences between nephrologists and TS. Conclusions This survey highlights the practice patterns of the acceptance of MCLKDs among the international community. In the absence of clear guidelines, this survey provides additional information to counsel kidney donors with microscopic hematuria, sickle cell trait, renal cysts, kidney stones, heavy smoking, or illegal drug use.

Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia: Who, When, and How?

Although the majority of patients with acute myeloid leukemia (AML) treated with intensive chemotherapy achieve a complete remission (CR), many are destined to relapse if treated with intensive chemotherapy alone. Allogeneic stem cell transplant (allo-SCT) represents a pivotally important treatment strategy in fit adults with AML because of its augmented anti-leukemic activity consequent upon dose intensification and the genesis of a potent graft-versus-leukemia effect. Increased donor availability coupled with the advent of reduced intensity conditioning (RIC) regimens has dramatically increased transplant access and consequently allo-SCT is now a key component of the treatment algorithm in both patients with AML in first CR (CR1) and advanced disease. Although transplant related mortality has fallen steadily over recent decades there has been no real progress in reducing the risk of disease relapse which remains the major cause of transplant failure and represents a major area of unmet need. A number of therapeutic approaches with the potential to reduce disease relapse, including advances in induction chemotherapy, the development of novel conditioning regimens and the emergence of the concept of post-transplant maintenance, are currently under development. Furthermore, the use of genetics and measurable residual disease technology in disease assessment has improved the identification of patients who are likely to benefit from an allo-SCT which now represents an increasingly personalized therapy. Future progress in optimizing transplant outcome will be dependent on the successful delivery by the international transplant community of randomized prospective clinical trials which permit examination of current and future transplant therapies with the same degree of rigor as is routinely adopted for non-transplant therapies.

Assessing Global Organ Donation Policies: Opt-In vs Opt-Out.

This paper argues that there is little difference between opt-in and opt-out organ donation systems for increasing donor numbers when used in isolation. Independently diverting to an opt-out system confers no obvious advantage and can harm efforts to bolster donations. Rather, it is essential to address barriers to organ donation on several levels along with a switch in system. Moreover, for many countries, it may be more beneficial to adequately capacitate the donation system already in place, rather than entertain a significant change with its attendant resource requirements. For decades, the international transplant community has been involved in vigorous debate as to the merits of moving from default opt-in systems to opt-out policies to grow organ donor numbers and better meet the ever-increasing demand for lifesaving transplants. Opt-out is certainly en vogue, with Wales, England and Nova Scotia recently switching over, Scotland due to become opt-out in March 2021 and Northern Ireland and Canada seriously considering a similar move. Thanks to several countries making the switch from opt-in to opt-out over the last 20–30 years, there are sets of robust longitudinal data that aid in analysing the efficacy of donation systems. However, these data are often contradictory and largely inconclusive, suggesting other factors may be in play. This paper reviews some emerging trends in opt-in versus opt-out organ donation policies and considers recent data that elucidates some of the main contentions across each. Ethical frameworks underpinning donation systems, such as informed consent, trust and transparency, are discussed in detail. Substantial time is also devoted to opt-in vs opt-out systems in developing countries, which tend to be excluded from many analyses, and where the challenges faced are magnified by socio-economic constraints. This constitutes a major gap in recently published literature, as developing countries often lag far behind their developed counterparts in donor and transplant numbers.

Ethical and Legal Considerations on Organ Procurement from Executed Prisoners in China

In the past several decades, due to the severe shortage of transplantable organs, organ procurement from executed prisoners have been used to transplant organs, which goes against international ethics standards. As of January 2015, China phased out the use of executed prisoner organs and embarked on its transplant reform. Since then, many efforts have been made to meet the international ethics guidelines on organ transplants. In this study, we aim to elaborate on the status quo of organ procurement from executed prisoners from the perspective of ethics and law. Although China has made great progress in organ donation and transplantation, some Western transplant surgeons and bioethicists still hold outdated views on organ donation and transplantation in China, which will not bring any benefits to its development and will alienate it from the international transplant community. In this study, we propose that both the international transplant society and Chinese transplant community, with mutual cooperation and trust, should jointly make efforts to advance the development of organ donation and transplantation in China.

The Declaration of Istanbul on Organ Trafficking and Transplant Tourism (2018 Edition) Introduction.

It is 10 years since the Declaration of Istanbul (DOI) on Organ Trafficking and Transplant Tourism was developed. Although not a legally binding text, the DOI has been profoundly influential upon national legal frameworks and professional codes of practice. The DOI represented the position of the international transplant community against practices that violate the fundamental rights of the vulnerable and tarnish the reputation of transplantation medicine. An updated edition of the DOI was recently presented at the congress of The Transplantation Society in Madrid, Spain. The update was important after a decade of work, leading to a better understanding and conceptualization of these criminal practices. For example, in recent years, many groups have worked on updated definitions of organ trafficking and commercialization, with the most significant work produced by the Council of Europe, particularly its Convention on Action Against Trafficking in Human Organs. (https://rm.coe.int/16806dca3a). Because the DOI is now 10 years old, many of the definitions and issues need to be updated in the original document. Where the original document had 3 definitions of the terms, organ trafficking, transplant commercialism, and travel for transplantation/transplant tourism, the set of definitions in the 2018 edition has been expanded. Definitions now distinguish more clearly between organ trafficking and trafficking in persons for the purpose of organ removal. Furthermore, resident versus nonresident person is defined in the context of the declaration. The document also explains what is meant by self-sufficiency in transplantation and financial neutrality in organ donation. The definition of transplant commercialism has been removed because this concept is now more clearly defined in the context of the definition of organ trafficking. The set of 6 complex original principles has been revised and expanded to 11 more concise principles. Lastly, the section of the original text detailing proposals for potential implementation has been replaced by a separate commentary article in which the practical implications of the DOI are discussed and recommendations outlined in greater depth. The commentary article will be presented as a separate document to support the interpretation of principles and provide examples for their implementation in practice. This decision was made to make the actual document shorter and easier to read with a more detailed explanation in the commentary article. One important difference between the 2008 edition and the 2018 edition is the process in which this document was formed. The first iteration of the 2008 edition was developed by an international multidisciplinary steering committee, followed by a workshop attended by 158 global representatives, including government officials, social scientists, and ethicists. This meeting took place in Istanbul, Turkey, between April 30, 2008, and May 2, 2008. The 2018 edition similarly began with an updated document drafted by an international working group of 42 individuals convened by the Declaration of Istanbul Custodian Group's Executive. This document and an accompanying draft of the commentary article were then made available for public consultation via an online platform for a period of 2 months. All societies and organizations which had endorsed the DOI, as well as Declaration of Istanbul Custodian Group members, were directly invited to participate in the consultation. Complete responses were received from 245 individuals, representing more than 64 countries, including 65 responses on behalf of professional societies or organizations. Comments expressed a positive overall support for the updated text. All feedback received was reviewed before a final version of the document was produced by the working group. At a 1-day preconference workshop in Madrid, the document was presented to the stakeholders—a well-attended workshop with more than 120 delegates. The new edition of the DOI is more concise and provides greater conceptual clarity, which will enhance its value for those seeking to use it as a reference point for the development of ethical guidelines or policy at the local level. The 2018 document also aligns well with international norms and developments over the last 10 years. It remains an essential set of ethical standards articulating the responsibilities of health professionals and policy makers who must continue to combat unacceptable practices in donation and transplantation and strive to fufill the great promise of organ transplantation for people across the world.

Emerging arboviruses and implications for pediatric transplantation: A review.

Recent years have brought a rise in newly emergent viral infections, primarily in the form of previously known arthropod-transmitted viruses that have increased significantly in both incidence and geographical range. Of particular note are DENV, CHIKV, and ZIKV, which are transmitted mostly by Aedes species of mosquitoes that exhibit a wide and increasing global distribution. Being important pathogens for the general population, these viruses have the potential to be devastating in the international transplant community, with graft rejection and death as possible outcomes of infection. In this review, we discuss the current state of knowledge for these viruses as well as repercussions of infection in the solid organ and HSCT population, with a focus, when possible, on pediatric patients.

Current opinions in organ allocation.

Existing methods of academic publication provide limited opportunity to obtain stakeholder input on issues of broad interest. This article reports the results of an experiment to produce a collaborative, crowdsourced article examining a current controversial issue in transplant medicine (hereby referred to as the "C4 Article"). The editorial team as a whole selected the topic of organ allocation, then divided into six sections, each supported by an individual editorial team. Widely promoted by the American Journal of Transplantation, the C4 Article was open for public comment for 1 month. The nonblinded editorial teams reviewed the contributions daily and interacted with contributors in near-real time to clarify and expand on the content received. Draft summaries of each section were posted and subsequently revised as new contributions were received. One hundred ninety-four individuals viewed the manuscript, and 107 individuals contributed to the manuscript during the submission period. The article engaged the international transplant community in producing a contemporary delineation of issues of agreement and controversy related to organ allocation and identified opportunities for new policy development. This initial experience successfully demonstrated the potential of a crowdsourced academic manuscript to advance a broad-based understanding of a complex issue.

Living Donation of Vascularized Composite Allografts.

Living donation has become a medically and ethically accepted practice in solid organ transplantation. Published proceedings from the international kidney transplant community and from the Ethics Committee of The Transplantation Society articulated the general principles and specific recommendations for living donation, which remain the backbone of Centers for Medicare and Medicaid Services and Organ Procurement and Transplantation Network requirements and policies. Meanwhile, there have been major advancements in another revolutionary field of transplant medicine: vascularized composite allotransplantation. Recent interventions have demonstrated potential for superior functional and aesthetic outcomes in a single operation when compared to staged conventional reconstructions. In view of these successes, the indications for vascularized composite allotransplantation are expected to broaden to include less extensive types of transplants, which would introduce the possibility of using living vascularized composite allotransplantation donors. In this article, the authors discuss the feasibility and ethics associated with living donation of vascularized composite allografts. The authors explore the current guidelines and policies set by the Organ Procurement and Transplantation Network regarding living organ donation. In addition, the authors provide several clinical scenarios in which living donation of vascularized composite allotransplantation could be used to augment the reconstructive ladder currently used by reconstructive surgeons to guide their reconstructive strategies.

Human Organ Trafficking

IntroductionGlobal human trafficking continues to be a major concern of the international transplant community. The paper presents findings of the analyses based on the interviews performed with 274 end-stage renal disease patients who have purchased a kidney in Egypt during the last decade.MethodsB

Missing Domains of Lung Transplant Patient Selection.

Although there is consensus regarding disease-specific indications for lung transplant, ambiguity remains regarding how patient-specific attributes should influence lung transplant candidacy. This study had 3 aims (1) to establish the missing domains of the interdisciplinary assessment of the lung transplant candidate, (2) to have these domains validated by an international panel of lung transplant experts, and (3) to recommend the next step for inclusion of these domains into the lung transplant candidate selection process. Three levels of evidence were reviewed. A search for standards and guidelines, a comprehensive literature review, and a validation of domains by experts were conducted. Seven domains of patient attributes were identified as relevant to lung transplant patient selection: cognitive performance, frailty, psychological factors, self-efficacy, social support, quality of life, and sociodemographic factors. Within each domain, several elements were identified to be incorporated in the process of patient assessment. Assessment of the missing domains and elements should be incorporated into the interdisciplinary lung transplant evaluation process. Standardized recognition and reporting of the patient-specific attributes will inform the work of individual transplant programs and the international transplant community. Further study is needed to associate these patient attributes with transplant outcomes. Improved understanding is needed regarding how nurses assess lung transplant candidates and how they communicate their findings within interdisciplinary settings.

Transplant Medicine in China: Need for Transparency and International Scrutiny Remains.

Previous publications have described unethical organ procurement procedures in the People's Republic of China. International awareness and condemnation contributed to the announcement abolishing the procurement of organs from executed prisoners starting from January 2015. Eighteen months after the announcement, and aligned with the upcoming International Congress of the Transplantation Society in Hong Kong, this paper revisits the topic and discusses whether the declared reform has indeed been implemented. China has neither addressed nor included in the reform a pledge to end the procurement of organs from prisoners of conscience, nor has the government initiated any legislative amendments. Recent reports have discussed an implausible discrepancy of officially reported steady annual transplant numbers and a steep expansion of the transplant infrastructure in China. This paper expresses the viewpoint that, in the current context, it is not possible to verify the veracity of the announced changes, and it thus remains premature to include China as an ethical partner in the international transplant community. Until we have independent and objective evidence of a complete cessation of unethical organ procurement from prisoners, the medical community has a professional responsibility to maintain the academic embargo on Chinese transplant professionals.

On Patients Who Purchase Organ Transplants Abroad.

The international transplant community portrays organ trade as a growing and serious crime involving large numbers of traveling patients who purchase organs. We present a systematic review about the published number of patients who purchased organs. With this information, we discuss whether the scientific literature reflects a substantial practice of organ purchase. Between 2000 and 2015, 86 studies were published. Seventy-six of these presented patients who traveled and 42 stated that the transplants were commercial. Only 11 studies reported that patients paid, and eight described to what or whom patients paid. In total, during a period of 42 years, 6002 patients have been reported to travel for transplantation. Of these, only 1238 were reported to have paid for their transplants. An additional unknown number of patients paid for their transplants in their native countries. We conclude that the scientific literature does not reflect a large number of patients buying organs. Organ purchases were more often assumed than determined. A reporting code for transplant professionals to report organ trafficking networks is a potential strategy to collect and quantify cases.

Improvement in kidney transplantation in the Balkans after the Istanbul Declaration: where do we stand today?

Due to the limited access to kidney transplantation (KTx) in developing countries, desperate patients have engaged in the purchase and sale of kidneys. In 2004, the World Health Assembly urged member states to protect the poor and vulnerable from being exploited through practices of illegal organ trafficking that had become widespread throughout the world. In 2008, the international transplant community convened a summit of transplant professionals, legal experts and ethicists to combat organ trafficking, transplant tourism and transplant commercialism that resulted in the Declaration of Istanbul (DOI). The South-Eastern Europe Health Network (SEEHN) represents a nine country multigovernmental collaboration on health systems. The Regional Health Development Centre on Organ Donation and Transplant Medicine (RHDC) was established in 2011 in Croatia to facilitate cooperation among south-eastern European countries to improve organ transplantation within the Balkan region. Since 2011, a collaboration between the RHDC, the Custodian Group of the DOI (DICG) and SEEHN professionals has enhanced strategic planning and definition of country-specific action plan priorities on organ donation and transplantation. Data of kidney transplantation provided in this report show a significant increase in transplantation activities in a 4-year period in Macedonia, Moldova, Bosnia and Hercegovina, Romania and Montenegro. The success of the donation and transplantation programmes was influenced by the engagement of key professionals and the establishment of organizational infrastructure with the implementation of an appropriate funding model. In conclusion, the DOI has provided an ethical framework for engagement of health professionals from south-eastern European countries. The newly established SEEHN RHDC as a technical coordinating body greatly contributed in building institutional capacity and strengthening regional collaboration between health authorities and professionals within these countries for improvement of transplant activities in the Balkans.

Organ Transplantation for Nonresidents of the United States: A Policy for Transparency

A policy proposal relating to transplantation of deceased donor organs into nonresidents of the United States was jointly sponsored by the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) International Relations and Ethics Committees and approved by the OPTN/UNOS Board in June 2012. The proposal followed prior acceptance by the Board of the definitions of "travel for transplantation" and "transplant tourism" and the introduction in March 2012 of revised data collection categories for transplant candidates who are neither citizens nor residents. The most important aspect of the new policy concerns replacement of the previous so-called "5% rule" with the review of all residency and citizenship data and the preparation of a public annual report. The new policy does not prohibit organ transplantation in nonresidents. However, the policy and public data report will ensure transparency and support transplant center responsibility to account for their practices. Since the adoption of the policy, the first 19 months of data show that less than 1% of new deceased donor waitlist additions and less than 1% of transplantation recipients were non-US citizen/nonresidents candidates who traveled to the United States for purposes of transplantation. By adopting this policy, the US transplant community promotes public trust and serves as an example to the international transplant community.

Open Letter to Xi Jinping, President of the People’s Republic of China

Open Letter to Xi Jinping, President of the People’s Republic of China

Organ transplantation is getting back its "true" luster in China.

Although a great success has been made in the field of organ transplantation in China, the practice of organ donation from executed prisoners has long been rebuked by the international transplant community. The "boycott" attitude of western countries has stifled the development of transplant science and medicine in China. With the efforts of the Chinese government and transplant community, a voluntary organ donation system has been successfully established. The medical authorities have committed that the practice of using organs from executed prisoners will be abandoned in the near future. It is time for a big hug from the international transplant community to its Chinese partner. And it is time for a rapid development of organ transplantation in China.

“No one really knows why they are alive until they know what they'd die for”: Lessons from the death of a living liver donor

“No one really knows why they are alive until they know what they'd die for”: Lessons from the death of a living liver donor