Organ transplantation from living related donors in Bangladesh first began in October 1982, and became commonplace in 1988. Cornea transplantation from posthumous donors began in 1984 and living related liver and bone marrow donor transplantation began in 2010 and 2014 respectively. The Human Organ Transplantation Act officially came into effect in Bangladesh on 13th April 1999, allowing organ donation from both brain-dead and related living donors for transplantation. Before the legislation, religious leaders (...) issued fatwa, or religious rulings, in favor of organ transplantation. The Act was amended by the Parliament on 8th January, 2018 with the changes coming into effect shortly afterwards on 28th January. However, aside from a few posthumous corneal donations, transplantation of vital organs, such as the kidney, liver, heart, pancreas, and other body parts or organs from deceased donors, has remained absent in Bangladesh. The major question addressed in this article is why the transplantation of vital organs from deceased donors is absent in Bangladesh. In addition to the collection of secondary documents, interviews were conducted with senior transplant physicians, patients and their relatives, and the public, to learn about posthumous organ donation for transplantation. Interviews were also conducted with a medical student and two grief counselors to understand the process of counseling the families and obtaining consent to obtain posthumous cornea donations from brain-dead patients. An interview was conducted with a professional anatomist to understand the processes behind body donation for the purposes of medical study and research. Their narrative reveals that transplant physicians may be reticent to declare brain death as the stipulations of the 1999 act were unclear and vague. This study finds that Bangladeshis have strong family ties and experience anxiety around permitting separating body parts of dead relatives for organ donation for transplantation, or donating the dead body for medical study and research purposes. Posthumous organ donation for transplantation is commonly viewed as a wrong deed from a religious point of view. Religious scholars who have been consulted by the government have approved posthumous organ donation for transplantation on the grounds of necessity to save lives even though violating the human body is generally forbidden in Islam. An assessment of the dynamics of biomedicine, religion and culture leads to the conclusion that barriers to posthumous organ donation for transplantation that are perceived to be religious may actually stem from cultural attitudes. The interplay of faith, belief, religion, social norms, rituals and wider cultural attitudes with biomedicine and posthumous organ donation and transplantation is very complex. Although overcoming the barriers to organ donation for transplantation is challenging, initiation of transplantation of vital organs from deceased donors is necessary within Bangladesh. This will ensure improved healthcare outcomes, prevent poor people from being coerced into selling their organs to rich recipients, and protect the solidarity and progeny of Bangladeshi families. (shrink)

Achieving valid informed consent from a human research participant involves an ongoing process designed to protect the participant and ensure their rights, safety, and well-being are not compromise...

Transplantation research on samples and organs from deceased donors in England, Wales and Northern Ireland is under threat. The key problems relate to difficulties encountered in gaining consent for research projects, as distinct from consent to donation for clinical transplantation. They are due partly to the terms of the Human Tissue Act 2004 (the 2004 Act), and partly to its interpretation by the Human Tissue Authority (HTA). They include excessive interaction with donor representatives regarding ‘informed consent’ (...) to research projects, uncertainty as to the scope and duration of a donor's ‘authority’ over an organ, and restrictions caused by the apparent need for licensing of transplantation research under the 2004 Act, combined with lack of certainty, or guidance, as to the distinction between ‘research’, which requires a licence, and ‘service development’, which does not. In our view this confusion hinders and deters Specialist Nurses for Organ Donation in approaching donor representatives and discussing possible research projects with them. It has also, as we have reported elsewhere, led to abandonment of research projects for fear of liability, despite both Research Ethics Committee (REC) approval and donor consent. Such problems do not seem to occur under the transplant laws of most other comparable jurisdictions. The Transplantation Ethics Symposium, ‘The ethics of organ retrieval: goals, rights and responsibilities’, hosted by the MRC Centre for Transplantation at King's College London in December 2010, revealed that many senior clinicians and researchers, administrators, and lawyers are both unclear and in disagreement concerning the effects of the 2004 Act and the extent to which it is adhered to or ignored in practice. In this paper we examine the difficulties encountered and suggest solutions based on a less restrictive interpretation of the 2004 Act, or, more probably, a regulatory change under its authority. We propose that, in the long term, a law which includes consent for REC-approved research within the general consent for organ donation and transplantation seems preferable to the present system, both ethically and in practical terms. (shrink)

Background Several ethical issues are associated with providing living organ transplantation services, and there is limited information on these issues faced by the teams providing service to refugees or asylum seekers. Aim To determine the challenges healthcare professionals face in organ transplant centers providing services to Syrians under temporary protection status and discern whether these difficulties align with ethical issues in living organ transplantation. Research design This study employed a qualitative design and conducted individual (...) semi-structured, in-depth interviews with 18 transplant team members in Istanbul between September and November 2022. Data analysis was based on Braun and Clarke’s thematic analysis. Participants and research context The participants comprised 18 healthcare professionals, including 6 physicians and 12 nurses working in organ transplant teams in Istanbul. Ethical considerations The University’s Ethics Committee provided approval. Participants were informed regarding confidentiality and signed an informed consent form. Results Three themes emerged from the data on ethical issues faced by organ transplantation services to Syrians: (a) beneficence or double equipoise, (b) autonomy, and (c) justice. Transplant teams experience problems related to preserving double equipoise in the provision of living donor organ transplantation because of language barriers, poor socioeconomic conditions, and cultural factors, which increases transplant teams’ individual and indirect social burden. Although problems arise from the language barrier when obtaining informed consent in the autonomy theme, institutional and national policies in preventing donor abuse have a comforting effect. Health workers had the least problems with the justice theme, wherein national health policies are determined. Conclusion Fewer issues related to autonomy and justice were reported in providing organ transplantation services to Syrians, with the most intense reported issues being maintaining double equipoise. The results revealed the need to develop institutional, national, and international policies with individual solutions to prevent difficulties healthcare professionals face in this process. (shrink)

Survival after solid-organ transplantation has improved significantly, and many contemporary transplant recipients are of childbearing potential. There are limited data to guide decision-making surrounding pregnancy after transplantation, variations in clinical practice, and significant knowledge gaps, all of which raise significant ethical issues. Post-transplant pregnancy is associated with an increased risk of maternal and fetal complications. Shared decision-making is a central aspect of patient counselling but is complicated by significant knowledge gaps. Stakeholder interests can be in conflict; exploring (...) these tensions can help patients to evaluate their options and inform their deliberations. We argue that uniform, evidence-based recommendations for pregnancy after solid organ transplantation are needed. Conducting research, including patient-engaged studies, in this area should be priority for the transplant community. (shrink)

This collection features comprehensive overviews of the various ethical challenges in organ transplantation. International readings well-grounded in the latest developments in the life sciences are organized into systematic sections and engage with one another, offering complementary views. All core issues in the global ethical debate are covered: donating and procuring organs, allocating and receiving organs, as well as considering alternatives. Due to its systematic structure, the volume provides an excellent orientation for researchers, students, and practitioners alike to enable (...) a deeper understanding of some of the most controversial issues in modern medicine. (shrink)

Emerging biotechnology may soon allow the creation of genetically human organs inside animals, with non-human primates and pigs being the best candidate species. This prospect raises the question of whether creating organs in primates in order to then transplant them into humans would be more acceptable than using them for research. In this paper, we examine the validity of the purported moral distinction between primates and other animals, and analyze the ethical acceptability of using primates to create organs for (...) human use. (shrink)

Written by a sociologist and a biologist and science historian, this text considers the social aspects of organ transplantation and chronic hemodialysis. Their research, begun in 1968, focused on the experience of research physicians engaged in this work, the "gift- exchange" social dimensions of these practices, and the impact of these technologies on society as a whole. This reprint of the 1978 edition includes a new introduction by the authors. c. Book News Inc.

While solid organ transplantation for patients with substance use issues has attracted ethical discussion, a typology of the ethics themes has not been articulated in the literature. We conducted a scoping review of peer-reviewed literature on solid organ transplantation and substance use published between January 1997 and April 2016. We aimed to identify and develop a typology of the main ethical themes discussed in this literature and to identify gaps worthy of future research. Seventy articles (...) met inclusion criteria and underwent inductive content analysis. Four main ethical themes were identified: (1) personal responsibility; (2) utility; (3) moral character; and (4) fairness. Each theme had multiple sub-themes and there was substantial overlap between themes. This scoping review identified a disproportionate emphasis in the literature regarding personal responsibility, which was referenced by each of the other themes, and a narrow focus on alcohol and liver. We recommend future research further investigate these connections between ethical themes and focus on ethical issues associated with transplants from organ groups other than liver for patients who use substances other than alcohol. (shrink)

In patients with schizophrenia, consent postmortem for organ donation for transplantation and research is usually obtained from relatives. By means of a questionnaire, the authors investigate whether patients with schizophrenia would agree to family members making such decisions for them as well as compare decisions regarding postmortem organ transplantation and brain donation between patients and significant family members. Study results indicate while most patients would not agree to transplantation or brain donation for research, (...) a proportion would agree. Among patients who declined organ donation for transplantation or brain research, almost half of family members would have agreed to brain donation for research and over 40% to organ transplantation. Male relatives are more likely to agree to organ donation from their deceased relatives for both transplantation and research. The authors argue that it is important to respect autonomy and interests of research subjects even if mentally ill and even if no longer living. Consent may be assisted by appropriate educational interventions prior to patient death. (shrink)

The field of human organ transplantation, and most particularly that of heart transplantation where the donor is always deceased, is one in which the rhetoric of hope leaves little room for any exploration or understanding of the more negative emotions and affects that recipients may experience. Where a donated heart is commonly referred to as the ‘gift of life’, both in lay discourse and by those engaged in transplantation procedures, how does this imbricate with the alternative (...) clinical term of a ‘graft’? For recipients of donor organs, the experience of living on in the face of otherwise certain death is fraught with complex emotions, not only about the self and the now dead other, but the persistence of the other within the self. In contrast to our expectations of the feel-good narrative of the gift of life, recipients are often significantly troubled by the aftermath of the procedure, which may fundamentally challenge notions of personal identity, as well as having deep implications for our understanding of the relation between death and ‘staying alive’. Drawing on recent research into heart transplantation, I shall theorise the field through a reflection – drawing on both Mauss and Derrida – on the meaning of the gift, before moving on to consider whether a Deleuzian approach to both the assemblage and the ‘event’ of death might offer a more productive framework. (shrink)

Transplantation programs commonly rely on clinicians’ judgments about patients’ social support (care from friends or family) when deciding whether to list them for organ transplantation. We examine whether using social support to make listing decisions for adults seeking transplantation is morally legitimate, drawing on recent data about the evidence-base, implementation, and potential impacts of the criterion on underserved and diverse populations. We demonstrate that the rationale for the social support criterion, based in the principle of utility, (...) is undermined by its reliance on tenuous evidence. Moreover, social support requirements may reinforce transplant inequities, interfere in patients’ personal relationships, and contribute to biased and inconsistent listing procedures. As such, accommodating the needs of patients with limited social support would better balance ethical commitments to equity, utility, and respect for persons in transplantation. We suggest steps for researchers, transplantation programs, and policymakers to improve fair use of social support in transplantation. (shrink)

Abstract:This symposium includes thirteen personal narratives from people who have received at least one organ transplant from a living or deceased donor. These narratives foster better understanding of the experiences of life-saving organ recipients and their families, including post-transplant difficulties experienced—sometimes requiring multiple transplants. This issue also includes three commentaries by Macey L. Levan, Heather Lannon, and Vidya Fleetwood, Roslyn B. Mannon & Krista L. Lentine. Dr. Levan is a living kidney donor and associate professor of surgery and (...) population health. She writes and teaches on organ transplant and has expertise and experience in governance at the federal level as a member of the board of directors for the U.S. Organ Procurement and Transplantation Network. Dr. Lannon is a social worker and transplant advocate. Her work and interest in the topic were inspired by her husband who needed a heart transplant. Dr. Fleetwood is a surgeon specializing in liver transplantation, pancreas transplantation, kidney transplantation, as well as living donor nephrectomy. Dr. Mannon is a nephrologist and professor of medicine, pathology and microbiology. Her work focuses on understanding and improving long-term kidney transplant outcomes for patients, donors, and caregivers. Dr. Lentine is a nephrologist specializing in treatment of adult patients with kidney disease. She is a researcher and co-chaired the international work group that developed guidelines for living donor kidney transplantation. (shrink)

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications (...) fail when unethical practices are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians. (shrink)

Interventional research on deceased organ donors and donor organs prior to transplant holds the promise of reducing the number of patients who die waiting for an organ by expanding the pool of transplantable organs and improving transplant outcomes. However, one of the key challenges researchers face is an assumption that someone who receives an organ that was part of an interventional research protocol is always a human subject of that same study. The consequences of this (...) assumption include the need for oversight by an institutional review board and for research-level informed consent from transplant recipients, all within the complex practical realities of the organ donation and transplantation process in the United States. The current national focus on this issue provides an opportunity to think critically about the policy goals of the human subjects regulations and their application to the nascent field of deceased organ donor intervention research. We propose that for donor research where the transplant recipient does not fall under the definition of human subject, the clinical consent model—rather than the consent model used for human research subjects—best facilitates the policy objectives of balancing clinical innovation, transparency, and protection of patients in an ethically responsible and legally compliant manner. (shrink)

Background Health advocacy is crucial for both patients and healthcare professionals. However, nurses who recognize the importance of health advocacy may experience heightened moral distress, particularly in complex donation and transplantation cases where patient autonomy, respect, and advocacy are paramount. Aim To identify the factors contributing to moral distress among nurses working in solid organ transplant units at a university hospital in São Paulo, with a focus on health advocacy. Research Design This descriptive, cross-sectional study employs both (...) quantitative and qualitative methods. For this, the quantitative phase of the study was conducted utilizing the Moral Distress Scale, while the qualitative phase was executed through focus group discussions. Participants and Research Context The quantitative phase involved 15 nurses using the Moral Distress Scale. The qualitative phase consisted of a focus group with 5 nurse managers/coordinators from the transplant units. Quantitative data were analyzed using R® software, while qualitative data were analyzed using Bardin’s Content Analysis. Ethical Considerations The study was approved by the Research Ethics Committee of the Ribeirão Preto College of Nursing, University of São Paulo. Participation was voluntary and confidentiality was ensured. Results A significant correlation was found between moral distress and the factors of “disregard for patient autonomy” ( p =.0100) and “therapeutic obstinacy” ( p =.0492). Conclusion The primary determinants associated with moral distress in the context of health advocacy were identified as “disregard for patient autonomy” and “therapeutic obstinacy.”. (shrink)

The disclosure of information that identifies deceased organ donors and/or organ transplant recipients by organ donation agencies and transplant centres is regulated in Australia by state and territory legislation, yet a significant number of donor family members and transplant recipients independently establish contact with each other. To describe and synthesize Australian laws and guidelines on the disclosure of identifying information. Legislation and guidelines relevant to organ donation and transplantation were obtained following a search of government (...) and DonateLife network websites. Information about the regulation of identity disclosure was extracted and synthesised using a process guided by Walt and Gilson’s (1994) policy analysis framework. Nineteen documents were examined. Six guidelines refer to and were consistent with current legislation. Four documents did not address identity disclosure. All jurisdictions prohibit healthcare professionals from disclosing identifying information. In three states, the prohibition extends to all members of the public including donor family members and transplant recipients. Restrictions on identity disclosure have implications for public promotion of donation and transplantation where sharing of stories and images of organ donors and transplant recipients is common. Further research is required to understand the perspective of donor family members, transplant recipients, and healthcare professionals impacted by the current laws. (shrink)

The transplantation of porcine organs to humans could in the future be a solution to the worldwide organ shortage, but is to date still highly experimental. Further research on the potential effects of crossing the species barrier is essential before clinical application is acceptable. However, many crucial questions on efficacy and safety will ultimately only be answered by well designed and controlled solid organ xenotransplantation trials on humans. This paper is concerned with the question under which (...) conditions, given the risks involved and the ethical issues raised, such clinical trials should be resumed. An alternative means of overcoming the safety and ethical issues is suggested: willed body donation for scientific research in the case of permanent vegetative status. This paper argues that conducting trials on such bodies with prior consent is preferable to the use of human subjects without lack of brain function. (shrink)

Background Nonanonymized direct contact between organ recipients and donor families is a topic of international interest in the adult context. However, there is limited discussion about whether direct contact should be extended to pediatric settings due to clinician and researcher concerns of the potential harms to pediatric patients.Methods We interviewed pediatric organ recipients, their families, and donorfamilies in British Columbia, Canada, to determine their views on direct contact. Interviews were conducted in two stages, with those who were further (...) removed from the transplant process informing the approach to interviews with those who more recently went throughthe transplant process.Results Twenty-nine individuals participated in twenty in-depth interviews. The study included participants from three major organ systems: kidney, heart, and liver. Only five participants expressed that direct contact might cause harm or discomfort, while twenty-three indicated they saw significant potential for benefits. Nearly half focused on the harms to others rather than themselves, and nearly two-thirds focused on the benefits for others rather than themselves.Conclusion There appears to be a community desire for direct contact in pediatric organ transplant programs among those living in British Columbia, Canada. These results suggest a need to revisit the medical community’s assumptions around protection and paternalism in our practice as clinicians and researchers. (shrink)

Advancements in scientific research and technological development influence the practice of organ donation and organ transplantation. Many SRTD governance discourses put forward the need for multi-stakeholder engagements. We posit that staff employed by organ procurement organizations have a stake in the discussions around SRTD applicable to ODOT because SRTD is one factor that shapes ODOT and because staff are involved in ODOT education and awareness raising while acting as a nexus between donors and the public. (...) Therefore, we performed a content analysis of eight semi-structured in-depth interviews with staff of one Canadian organ procurement organization to ascertain the views that staff had on the use of SRTD in ODOT in general; specific SRTD envisioned to be used in the future in ODOT namely xenotransplantation, embryonic and non-embryonic stem cells, cloning, bionic/artificial organs, and 3-D printed organs; and the emerging ability of SRTD applicable in ODOT to enhance bodily abilities beyond the normal. We found that staff had views on the topics covered in this study, and staff acknowledged that they do not possess sufficient knowledge to be able to engage meaningfully in governance discussions of the SRTD covered and to educate others on these SRTDs. We recommend implementing continuous education for the staff on SRTD envisioned to be applied in ODOT as a capacity-building measure to enable their participation in the governance discussions of these SRTDs and to enhance their ability to educate others on ODOT applicable SRTD. (shrink)

The shortage of organs for transplantation has led researchers to look for new techniques to expand the donor pool. Preconditioning strategies have the potential to protect organs from transplant associated injury or may improve the function of substandard organs so that they become suitable for transplantation. Translating this type of technology to the clinical setting raises ethical issues, particularly relating to the deceased donor. It is important that society has the opportunity to discuss the issues raised by implementation (...) of preconditioning strategies before they are implemented rather than as a reaction to them. (shrink)

Background Transplant coordinators face ethical conflicts in various situations, such as deciding who should receive organ donations and how to consider patient costs and such conflicts are expected to be more frequent in Korea, as organ transplant coordinators in the country perform both organ acquisition and transplantation. Research Aim This study aims to develop an ethics education program to enhance organ transplant coordinators’ ethical competence and address the ethical conflicts faced by them during clinical (...) practice. Research design A descriptive study. Participants and research context An online survey was conducted from March 22 to May 28, 2021. The study was conducted among 160 registered members of the Korea Organ Transplant Coordinators Association. Ultimately, 87 participants agreed to participate in the study. Ethical considerations Permission to conduct the study was obtained from the Institutional Review Board. Results The study revealed variations in the degree of ethical conflict based on the participants' general characteristics. Furthermore, organ transplant coordinators exhibited high levels of ethical competence and expressed a need for ethics education. The findings also indicated a positive correlation between higher ethical competence and greater demand for ethics education. Conclusions Based on the findings, developing standardized ethics education programs tailored to organ transplant coordinators is recommended. These programs should focus on improving ethical decision-making skills and establishing professional ethics. The education provided should be practical, applicable in the clinical setting, and responsive to the participants’ awareness and concerns regarding ethics education. (shrink)

Purpose: Organ donation and transplantation are practices that are supported by all of the world's major religions, including Sikhism, Christianity, Hinduism, and Judaism. Recent developments in the fields of organ donation and organ transplantation have sparked a renewed sense of optimism for the treatment of critical illnesses. The jurists permitted organ transplants on the basis of certain principles, including ownership and categories of property. On the other hand, moralists strive to deny the ownership of (...) human organs by using principles such as faith and Almighty Allah’s absolute authority. Then main objective of this research paper is on one hand to identify and emphasize arguments for and against organ donation and transplantation in the framework of scared provisions of Islam and its corresponding legal requirements and on the other hand to understand and teach the people that not only Islam allows organ donation but also encourage its followers to assist one another and make an effort to promote organ donations in society. Methodology: The doctrinal methodology. Explanatory and analytical research approaches are used in this work. It is worth mentioning that this research study is entirely based on library sources. Most of the sources are reputable and trustworthy textbooks, scholarly published and unpublished journal articles, law reports, and online websites related to the research area. Findings: According to the arguments as well as clear and explicit rulings, principles and authentic evidence from the Holy Quran, it is clear that the donation and transplantation of human body organs is permissible. The Holy religion of Islam persuades its followers to participate in charity, assist people, and donate organs to save the lives of those patients who are waiting for organ transplant. Recommendations: Theoretically, this work is very useful in contributing to the existing body of literature of knowledge. Practically, this work identifies the circumstances in which Muslim jurists not only allow but encourage its followers to assist one another and make an effort to promote organ donations in society in order to save people’s life. It is recommended that both the donor and the recipient of an organ must belong to the same nationality or legal jurisdiction in order to prevent the growth of an international organ trade, which would be far more difficult to regulate. Additionally, in order to protect the health of both the recipients and the donors, it is imperative that transplants from unknown sources be prohibited. (shrink)

Higgins’ et al recent paper1 presents a well-thought ethical analysis of the problems associated with the publication of unethical transplant research. More generally, research ethics committees never allow the use or reuse of data that has been collected without their required approval. Similarly, in many judicial settings, evidence is generally inadmissible when it is gathered illegally.2 Thus, journals and other publishers should follow in their footsteps and also roadblock any associated publications. Moreover, unethical organ donation and (...) class='Hi'>transplantation research is rife with integrity issues, which violate publication norms (eg, fabrication or falsification of the source of the donor organs; absent informed consent of living donors or donor families; funder conflict of interest). If these normally accepted exclusions3 are ignored, then publishers are turning off their moral compass and facilitating an attitude of ‘anything goes’ in the conduct of research. Table 1 presents a timeline of scholarly responses to the problem of publishing unethical transplant research. As shown, since 2007 there has been a slow evolution of changing publisher practices, yet more …. (shrink)

Often the only treatment available for patients suffering from diseased and injured organs is whole organ transplant. However, there is a severe shortage of donor organs for transplantation. The goal of organ engineering is to construct biological substitutes that will restore and maintain normal function in diseased and injured tissues. Recent progress in stem cell biology, biomaterials, and processes such as organ decellularization and electrospinning has resulted in the generation of bioengineered blood vessels, heart valves, livers, (...) kidneys, bladders, and airways. Future advances that may have a significant impact for the field include safe methods to reprogram a patient's own cells to directly differentiate into functional replacement cell types. The subsequent combination of these cells with natural, synthetic and/or decellularized organ materials to generate functional tissue substitutes is a real possibility. This essay reviews the current progress, developments, and challenges facing researchers in their goal to create replacement tissues and organs for patients. (shrink)

Non-consensual organ procurement from prisoners in China raises serious questions regarding the ethics of Chinese transplant research. In their article, published in this issue of JME, Higgins and colleagues address these questions through the lens of publication ethics. They argue that, ‘while there are potentially compelling justifications for use [of unethical research] under some circumstances, these justifications fail when unethical practices are ongoing’.1 Consequently, they recommend non-publication of Chinese transplant research and call for a mass retraction (...) of the articles identified in their review.2 To support their argument, Higgins and colleagues appeal to internationally recognised guidelines from the WHO3 and the World Medical Association, which assert that ‘executed prisoners must not be considered as organ and/or tissue donors’ due to the inability to acquire valid consent.4 Failing to declare an immediate publishing moratorium for transplant research involving prisoners in China, they argue, ‘undermines efforts to stop transplant-related human rights abuses, taints the evidence base, and renders those who publish and use the research complicit in the continuing harm’.5 We agree with Higgins and colleagues that non-consensual organ procurement from prisoners in China is a crime against humanity. Ongoing human rights violations in Chinese prisons are well documented and universally condemned. We also agree that the subsequent use of data acquired from unethical research is morally complex. Nonetheless, Higgins and colleagues’ arguments leave us with three …. (shrink)

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (...) (EU) Directive (2010) on standards of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research. (shrink)

Background: This research explores how public awareness and attitudes toward donation and transplantation policies may contribute to Spain's success in cadaveric organ donation. Materials and Methods: A representative sample of 813 people residing in Andalusia (Southern Spain) were surveyed by telephone or via Internet between October and December 2018. Results: Most participants trust Spain's donation and transplantation system (93%) and wish to donate their organs after death (76%). Among donors, a majority have expressed their consent (59%), (...) and few nondonors have expressed their refusal (14%). Only a minority are aware of the presumed consent system in force (28%) and feel sufficiently informed regarding the requirements needed to be an organ donor (16%). Participants mainly consider that relatives should represent the deceased's preferences and be consulted when the deceased's wishes are unknown, as is the case in Spain. Conclusion: Public trust in the transplant system may contribute to Spain's high performance in organ donation. High levels of societal support toward organ donation and transplantation do not correspond with similar levels of public awareness of donation and transplantation policies in Spain. (shrink)

Biologists who work on the pig (_Sus scrofa_) take advantage of its similarity to humans by constructing the inferential and material means to traffic data, information and knowledge across the species barrier. Their research has been funded due to its perceived value for agriculture and medicine. Improving selective breeding practices, for instance, has been a driver of genomics research. The pig is also an animal model for biomedical research and practice, and is proposed as a source of (...) organs for cross-species transplantation: xenotransplantation. Genomics research has informed transplantation biology, which has itself motivated developments in genomics. Both have generated models of correspondences between the genomes of pigs and humans. Concerning genomics, I detail how researchers traverse species boundaries to develop representations of the pig genome, alongside ensuring that such representations are sufficiently porcine. In transplantation biology, the representations of the genomes of humans and pigs are used to detect and investigate immunologically-pertinent differences between the two species. These key differences can then be removed, to ‘humanise’ donor pigs so that they can become a safe and effective source of organs. In both of these endeavours, there is a tension between practices that ‘humanise’ the pig (or representations thereof) through using resources from human genomics, and the need to ‘dehumanise’ the pig to maintain distinctions for legal, ethical and scientific reasons. This paper assesses the ways in which this tension has been managed, observing the differences between its realisations across comparative pig genomics and transplantation biology, and considering the consequences of this. (shrink)

Background: Black, Asian and minority ethnic groups have a high need for organ transplantation but deceased donation is low. This restricts the availability of well-matched organs and results in relatively long waiting times for transplantation, with increased mortality risks. Objective: To identify barriers to organ donor registration and family consent among the BAME population, and to develop and evaluate a training intervention to enhance communication with ethnic minority families and identify impacts on family consent. Methods: Three-phase (...) programme comprising community-based research involving two systematic reviews examining attitudes and barriers to organ donation and effective interventions followed by 22 focus groups with minority ethnic groups; hospital-based research examining staff practices and influences on family consent through ethics discussion groups with staff, a study on intensive care units and interviews with bereaved ethnic minority families; and development and evaluation of a training package to enhance cultural competence among ICU staff. Setting: Community focus group study in eight London boroughs with high prevalence of ethnic minority populations. Hospital studies at five NHS hospital trusts. Participants: Community studies: 228 focus group participants; hospital studies: 35 nurses, 28 clinicians, 19 hospital chaplains, 25 members of local Organ Donation Committees, 17 bereaved family members; and evaluation: 66 health professionals. Data sources: Focus groups with community residents, systematic reviews, qualitative interviews and observation in ICUs, EDGs with ICU staff, bereaved family interviews and questionnaires for trial evaluation. Review methods: Systematic review and narrative synthesis. Results: Community studies: Organ Donor Register – different ethnic/faith and age groups were at varying points on the ‘pathway’ to organ donor registration, with large numbers lacking knowledge and remaining at a pre-contemplation stage. Key attitudinal barriers were uncertainties regarding religious permissibility, bodily concerns, lack of trust in health professionals and little priority given to registration, with the varying significance of these factors varying by ethnicity/faith and age. National campaigns focusing on ethnic minorities have had limited impact, whereas characteristics of effective educational interventions are being conducted in a familiar environment; addressing the groups’ particular concerns; delivery by trained members of the lay community; and providing immediate access to registration. Interventions are also required to target those at specific stages of the donation pathway. Hospital studies: family consent to donation – many ICU staff, especially junior nurses, described a lack of confidence in communication and supporting ethnic minority families, often reflecting differences in emotional expression, faith and cultural beliefs, and language difficulties. The continuing high proportion of family donation discussions that take place without the collaboration of a specialist nurse for organ donation reflected consultants’ views of their own role in family consent to donation, a lack of trust in SNODs and uncertainties surrounding controlled donations after circulatory death. Hospital chaplains differed in their involvement in ICUs, reflecting their availability/employment status, personal interests and the practices of ICU staff. Evaluation: professional development package – a digital versatile disk-based training package was developed to promote confidence and skills in cross-cultural communication. Initial evaluation produced positive feedback and significant affirmative attitudinal change but no significant difference in consent rate over the short follow-up period with requirements for longer-term evaluation. Limitations: Participants in the focus group study were mainly first-generation migrants of manual socioeconomic groups. It was not permitted to identify non-consenting families for interview with data regarding the consent process were therefore limited to consenting families. Conclusions: The research presents guidance for the effective targeting of donation campaigns focusing on minority ethnic groups and provides the first training package in cultural competence in the NHS. Future work: Greater evaluation is required of community interventions in the UK to enhance knowledge of effective practice and analysis of the experiences of non-consenting ethnic minority families. Funding: The National Institute for Health Research Programme Grants for Applied Research programme. (shrink)

The application of advanced biopreservation to organs donated for transplantation may make possible their indefinite storage and thereby improve the utility and equity they provide to patients. The technology is still at a preclinical stage, with many difficult, scientific issues that remain to be answered. At the moment, however, the actual capabilities of the technology are too indefinite to begin formulating the statutes, regulations, and ethical guidance that will be needed to obtain the benefits expected from its use.

The organ donation and transplantation (ODT) system heavily relies on the willingness of individuals to donate their organs. While it is widely believed that public trust plays a crucial role in shaping donation rates, the empirical support for this assumption remains limited. In order to bridge this knowledge gap, this article takes a foundational approach by elucidating the concept of trust within the context of ODT. By examining the stakeholders involved, identifying influential factors, and mapping the intricate trust (...) relationships among trustors, trustees, and objects of trust, we aim to provide a comprehensive understanding of trust dynamics in ODT. We employ maps and graphs to illustrate the functioning of these trust relationships, enabling a visual representation of the complex interactions within the ODT system. Through this conceptual groundwork, we pave the way for future empirical research to investigate the link between trust and organ donation rates, informed by a clarified understanding of trust in ODT. This study can also provide valuable insights to inform interventions and policies aimed at enhancing organ donation rates. (shrink)

Background: The family interview context is permeated by numerous ethical issues which may generate conflicts and impact on organ donation process. Objective: This study aims to analyze the family interview process with a focus on principlist bioethics. Method: This exploratory, descriptive study uses a qualitative approach. The speeches were collected using the following prompt: “Talk about the family interview for the donation of organs and tissues for transplantation, from the preparation for the interview to the decision of the (...) family to donate or not.” For the treatment of qualitative data, we chose the method of content analysis and categorical thematic analysis. Participants: The study involved 18 nurses who worked in three municipal organ procurement organizations in São Paulo, Brazil, and who conducted family interviews for organ donation. Ethical considerations: The data were collected after approval of the study by the Research Ethics Committee of the School of Nursing of the University of São Paulo. Results: The results were classified into four categories and three subcategories. The categories are the principles adopted by principlist bioethics. Discussion: The principles of autonomy, beneficence, non-maleficence, and justice permeate the family interview and reveal their importance in the organs and tissues donation process for transplantation. Conclusion: The analysis of family interviews for the donation of organs and tissues for transplantation with a focus on principlist bioethics indicates that the process involves many ethical considerations. The elucidation of these aspects contributes to the discussion, training, and improvement of professionals, whether nurses or not, who work in organ procurement organizations and can improve the curriculum of existing training programs for transplant coordinators who pursue ethics in donation and transplantation as their foundation. (shrink)

Transplantation is becoming an increasingly more common approach to treatment of diseases of organ failure, making organ donation an important means of saving lives. Most world religions find organ donation for the purpose of transplantation to be acceptable, and some even encourage members to donate their organs as a gift of love to others. Recent developments, including artificial organs, transplants from nonhuman species, use of stem cells, and cloning, are impacting the field of transplantation. (...) These new approaches should be discussed with bioethical considerations in mind, particularly the notion of human beings as a unity of body and spirit. (shrink)

In the UK, the legal processes underpinning the procurement system for cadaveric organs for transplantation and research after death are under review. The review originated after media reports of hospitals, such as Alder Hey and Bristol, retaining organs after death without the full, informed consent of relatives. The organ procurement systems for research and transplantation are separate and distinct, but given that legal change will be applicable to both, some have argued now is the time (...) to introduce alternative organ transplant procurement systems such as presumed consent or incentive based schemes . Findings are reported in this paper from qualitative and quantitative research undertaken in Scotland in order to ascertain the public acceptability of different procurement systems. Nineteen in depth interviews carried out with donor families about their experiences of donating the organs of the deceased covered their views of organ retention, presumed consent, and financial incentives. This led onto a representative interview survey of 1009 members of the Scottish public. The originality of the triangulated qualitative and quantitative study offers exploration of alternative organ procurement systems from different “sides of the fence”. The findings suggest that the legal changes taking place are appropriate in clarifying the role of the family but can go further in strengthening the choice of the individual to donate. (shrink)

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve (...) functional outcomes. Studying manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)

Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ (...) transplants, it requires greater justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved—the patient, the donor and the potential child—as well as discuss the regulatory implications as research on uterus transplantations moves forward. (shrink)

Human allografts for life-threatening organ failure have been demonstrated to be lifesaving and are now considered to be standard of care for many conditions. Transplantation of non-vital anatomic body parts has also been accomplished. Hand transplantation after limb loss in adults has been shown to offer some promising benefits in both functional and psychological measures in preliminary studies. It has been suggested to expand eligibility criteria to include minors, with one such operation having already been performed. With (...) this in mind, we examine the current state of hand transplantation research in the context of available alternatives. We examine the ethics of carrying out these operations in minors, including under the protections of clinical research. We argue that children should not be considered for this surgery due to the substantial risks of immunosuppressive medication, the likelihood that the graft will need to be replaced during the patient’s lifetime and the lack of significant compensatory advantages over modern prosthetics. (shrink)

A dissociated area of medical research warrants bioethical consideration: a proposed transplantation of a donor’s entire body, except head, to a patient with a fatal degenerative disease. The seeming improbability of such an operation can only underscore the need for thorough bioethical assessment: Not assessing a case of such potential ethical import, by showing neglect instead of facing the issue, can only compound the ethical predicament, perhaps eroding public trust in ethical medicine. This article discusses the historical background (...) of full-body transplantation, documents the seriousness of its current pursuit, and builds an argument for why prima facie this type of transplant is bioethically distinct. Certainly, this examination can only be preliminary, indicating what should be a wide and vigorous discussion among practitioners and ethicists. It concludes with practical suggestions for how the medical and bioethics community may proceed with ethical assessment. (shrink)

Research teams have made considerable progress in treating absolute uterine factor infertility through uterus transplantation, though studies have differed on the choice of either deceased or living donors. While researchers continue to analyze the medical feasibility of both approaches, little attention has been paid to the ethics of using deceased versus living donors as well as the protections that must be in place for each. Both types of uterus donation also pose unique regulatory challenges, including how to allocate (...) donated organs; whether the donor / donor's family has any rights to the uterus and resulting child; how to manage contact between the donor / donor's family, recipient, and resulting child; and how to track outcomes moving forward. (shrink)

As a first step, the arguments for and against the use of animals for medical purposes in general were reviewed. These arguments are summarized briefly in the first part of the article; Secondly, even if people accept in principle the use of animals in medicine and medical research, their use in xenotransplantation mayraise particular difficulties. There are three key issues in the debate over the use of animals in xenotransplantation. The first is whether as a matter of principle, it (...) is considered to be morally acceptable to use animals as organ or tissue source; the second is the ethical acceptability of the use of primates to supply transplant material; the third is the ethical issues raised by the use of genetically modified animals to provide organs for xenotransplantation. If it is agreed to be acceptable in principle, there are then questions to address regarding the welfare of animals within any xenotransplantation program. Finally, the author makes an attempt to discuss these ethical issues in Chinese cultural context. (shrink)

Objectives: The introduction of the living donation in organ transplantation introduces important new psychological conflicts and ethical questions in the transplantation process. Operation related risks, as well as dependencies in the family structure, generate considerable pressure on potential donors. The aim of the study was to reconstruct the determinants of willingness to donate before transplantation.Methods: Evaluation of 20 taped and transcribed interviews oriented to current approaches in qualitative interview research. The approach used is based on (...) grounded theory, qualitative content analysis, and the concept of the ideal type.Results: Before surgery, “openly motivated” donors push for an operation, leaving no room for ambivalence in the evaluation process. They idealise the relationship with the recipient, and link their donation with the individual—partly in subconscious expectations and wishes. In contrast, “openly ambivalent” donors formulate their anxieties and express arguments against donation.Conclusions: Statements that claim ambivalence towards donation or utterance of arguments against donation indicate earlier coercion. Before transplantation, potential donors should have the opportunity to discuss their emotional situation to help their decision making process. (shrink)

In the wake of scandals about the unauthorised retention of organs following postmortem examination, the issue of valid consent has returned to the forefront. Emphasis is put on obtaining explicit authorisation from the patient or family prior to any medical intervention, including those involving the dead. Although the controversies in the UK arose from the retention of human material for education or research rather than therapy, concern has been expressed that public mistrust could also adversely affect organ donation (...) for transplantation. At the same time, however, the British Medical Association continues to call for a shift to a system of presumed consent for organ transplantation. This apparent inconsistency can be justified because valid distinctions exist between the reasons requiring explicit consent for retention and the acceptability of presumed consent for transplantation. This paper argues for introducing a system of presumed consent for organ donation, given the overwhelming expressions of public support for transplantation. Ongoing legislative review in the UK provides an ideal chance to alter the default position to one where potential donors can simply acquiesce or opt out of donation. Combined with consultation with their relatives, this could be a much better method of realising individuals’ wishes. It would also achieve a better balance between the duties owed to the deceased and those owed to people awaiting a transplant. (shrink)

This paper is an attempt to examine the traditional Yoruba beliefs about organ donation. Organ donation and transplantation remain a rare occurrence in African, this to a large extent can be as a result of the traditional African orientation on the one hand and the advancement in medical research that come with transplanting organ on the other. In this paper, we x-ray the problem of organ shortage in most African countries. We identified that apart (...) from lack of awareness on organ donation, Africans traditionally would not be willing to donate their organs after death. This paper critically examines beliefs in some African cultures and their relationship with organ donation. We analyze life after death in the Yoruba tradition and the belief in the continuation of the body after death. The paper concludes that the African belief in the continuation of the body in the afterlife contributes to the non-willingness of Africans to donate an organ after death. (shrink)

BackgroundOrgan donation following brain death has become an important way of supplying organs for transplantation in many countries. This practice is less common in Iran for different reasons. Therefore, this study aims to explore the obstacles to organ donation following brain death in Iran.MethodsThis qualitative research was conducted following the conventional content analysis method. The study population consisted of individuals with a history of brain death among their blood relatives who refused to donate the organs. Snowball sampling (...) was employed to select the participants. In-depth semi-structured interviews were conducted for data gathering. Theoretical saturation was achieved through 20 interviews. Data analysis was done following the steps proposed by Graneheim and Lundman. Lincoln and Guba’s criteria were used to ensure data rigor and transferability of the study.ResultsData analyses revealed 185 codes, 23 categories, and seven themes including, poor knowledge about brain death and organ transplantation from a dead body, cultural beliefs, religious beliefs, deficiencies of requesting process, fear and concerns, inability to make a decision, and social learning.ConclusionThere were several factors in families’ reluctance to donate organs of a brain-dead patient. Through improving knowledge and changing cultural beliefs in society, it is possible to take large steps towards promoting organ donation from brain-dead patients. (shrink)