Search

A decision to withdraw life-sustaining treatment (WLST) is derived by a conclusion that further treatment will not enable a patient to survive or will not produce a functional outcome with acceptable quality of life that the patient and the treating team regard as beneficial. Although many hospitalized patients die under such circumstances, controlled donation after the circulatory determination of death (cDCDD) programs have been developed only in a reduced number of countries. This International Collaborative Statement aims at expanding cDCDD in the world to help countries progress towards self-sufficiency in transplantation and offer more patients the opportunity of organ donation. The Statement addresses three fundamental aspects of the cDCDD pathway. First, it describes the process of determining a prognosis that justifies the WLST, a decision that should be prior to and independent of any consideration of organ donation and in which transplant professionals must not participate. Second, the Statement establishes the permanent cessation of circulation to the brain as the standard to determine death by circulatory criteria. Death may be declared after an elapsed observation period of 5 min without circulation to the brain, which confirms that the absence of circulation to the brain is permanent. Finally, the Statement highlights the value of perfusion repair for increasing the success of cDCDD organ transplantation. cDCDD protocols may utilize either in situ or ex situ perfusion consistent with the practice of each country. Methods to accomplish the in situ normothermic reperfusion of organs must preclude the restoration of brain perfusion to not invalidate the determination of death. Supplementary Information The online version contains supplementary material available at 10.1007/s00134-020-06341-7.

Introduction:Unfavorable attitudes and insufficient knowledge about donation after cardiac death among critical care providers can have important consequences for the appropriate identification of potential donors, consistent implementation of donation after cardiac death policies, and relative strength of support for this type of donation. The lack of reliable and valid assessment measures has hampered research to capture providers’ attitudes.Design and Research Aims:Using stakeholder engagement and an iterative process, we developed a questionnaire to measure attitudes of donation after cardiac death in critical care providers (n = 112) and examined its psychometric properties. Exploratory factor analysis, internal consistency, and validity analyses were conducted to examine the measure.Results:A 34-item questionnaire consisting of 4 factors (Personal Comfort, Process Satisfaction, Family Comfort, and System Trust) provided the most parsimonious fit. Internal consistency was acceptable for each of the subscales and the total questionnaire (Cronbach α > .70). A strong association between more favorable attitudes overall and knowledge ( r = .43, P < .001) provides evidence of convergent validity. Multivariable regression analyses showed that white race ( P = .002) and more experience with donation after cardiac death ( P < .001) were significant predictors of more favorable attitudes.Conclusion:Study findings support the utility, reliability, and validity of a questionnaire for measuring attitudes in critical care providers and for isolating targets for additional education on donation after cardiac death.

Vascularized composite allograft (VCA) transplantation has emerged as a groundbreaking surgical intervention to return identity and function following traumatic injury, congenital deformity, or disfigurement. While public attitudes toward traditional organ/tissue donation are favorable, little is known about attitudes toward VCA donation and transplantation. A survey was conducted of 1485 U.S. residents in August 2016 to assess VCA donation attitudes. Participants also completed the Revised Health Care System Distrust Scale. Most respondents were willing to donate hands/forearms (67.4%) and legs (66.8%), and almost half (48.0%) were willing to donate the face. Three-quarters (74.4%) of women were willing to donate the uterus; 54.4% of men were willing to donate the penis. VCA donation willingness was more likely among whites and Hispanics (p < 0.001), registered organ/tissue donors (p < 0.001), and those with less health care system distrust (p < 0.001) and media exposure to VCA transplantation (p = 0.003). Many who opposed VCA donation expressed concerns about psychological discomfort, mutilation, identity loss, and the reaction of others to seeing familiar body parts on a stranger. Attitudes toward VCA donation are favorable overall, despite limited exposure to VCA messaging and confusion about how VCA donation occurs. These findings may help guide the development and implementation of VCA public education campaigns.

The Organ Procurement and Transplantation Network (OPTN) Deceased Donor Potential Study, funded by the Health Resources and Services Administration, characterized the current pool of potential deceased donors and estimated changes through 2020. The goal was to inform policy development and suggest practice changes designed to increase the number of donors and organ transplants. Donor estimates used filtering methodologies applied to datasets from the OPTN, the National Center for Health Statistics, and the Agency for Healthcare Research and Quality and used these estimates with the number of actual donors to estimate the potential donor pool through 2020. Projected growth of the donor pool was 0.5% per year through 2020. Potential donor estimates suggested unrealized donor potential across all demographic groups, with the most significant unrealized potential (70%) in the 50-75-year-old age group and potential Donation after Circulatory Death (DCD) donors. Actual transplants that may be realized from potential donors in these categories are constrained by confounding medical comorbidities not identified in administrative databases and by limiting utilization practices for organs from DCD donors. Policy, regulatory, and practice changes encouraging organ procurement and transplantation of a broader population of potential donors may be required to increase transplant numbers in the United States.

Determination of death and provision of organ transplantation can result in controversy for the pediatric provider caring for a critically ill or injured child. Despite accepted legal definitions for death and guidelines for neurologic and circulatory determination of death, there remains an evolving and, at times, contentious dialogue among medical experts and the community. We provide the historical context and summarization of several legal and clinical aspects to define death and discussion of potential ethical controversies regarding death by neurologic and circulatory criteria. We highlight conflicts and controversies raised by both family and healthcare team members that are becoming increasingly prevalent in our practice of critical care medicine. We offer insight and proposed solutions into matters of autonomy, maleficence, non-beneficence, and the respectful, dignified care of the sick and dying child and their family.

Innovative deceased donor intervention strategies have the potential to increase the number and quality of transplantable organs. Yet there is confusion over regulatory and legal requirements, as well as ethical considerations. We surveyed transplant surgeons (n = 294), organ procurement organization (OPO) professionals (n = 83), and institutional review board (IRB) members (n = 317) and found wide variations in their perceptions about research classification, risk assessment for donors and organ transplant recipients, regulatory oversight requirements, and informed consent in the context of deceased donor intervention research. For instance, when presented with different research scenarios, IRB members were more likely than transplant surgeons and OPO professionals to feel that study review and oversight were necessary by the IRBs at the investigator, donor, and transplant center hospitals. Survey findings underscore the need to clarify ethical, legal, and regulatory requirements and their application to deceased donor intervention research to accelerate the pace of scientific discovery and facilitate more transplants.

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

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.

Although federal mandate prohibits the allocation of solid organs for transplantation based on “accidents of geography,” geographic variation of transplantable organs is well documented. This study explores regional differences in communication in requests for organ donation. Administrative data from 9 partnering Organ Procurement Organizations and interview data from 1,339 family decision makers (FDMs) were compared across 8 geographically distinct US donor service areas (DSA). Authorization to organ donation ranged from 60.4% to 98.1% across DSAs. FDMs from the three regions with the lowest authorization rates reported the lowest levels of satisfaction with the time spent discussing donation and with the request process; discussion of the least donation-related topics; the highest levels of pressure to donate; and, the least comfort with the donation decision. OPO region predicted authorization (Odds Ratios ranged from 8.14 to 0.24), as did time spent discussing donation (OR = 2.11), the number of donation-related topics discussed (OR = 1.14), and requesters’ communication skill (OR = 1.14). Standardized training for organ donation request staff is needed to ensure the highest quality communication during requests, optimize rates of family authorization to donation in all regions, and increase the supply of organs available for transplantation.

The legal framework governing organ donation in the United States is built on principles uniquely designed to support the system of transplantation. Understanding how the laws are designed and operate in practice provides insight into organ donation practices and performance and illuminates how the

Dr. Han writes a thoughtful perspective on the opioid epidemic and its evident impact on organ donation. While I too share his discomfort knowing that many of the overdose deaths are preventable, this narrative is not new. Suicides, homicides, car accidents, and other potentially preventable traumas

Case reports of kidney transplantation using HIV-positive (HIV+) donors in South Africa and advances in the clinical care of HIV+ transplant recipients have drawn attention to the legal prohibition of transplanting organs from HIV+ donors in the United States. For HIV+ transplant candidates, who face high barriers to transplant access, this prohibition violates beneficence by placing an unjustified limitation on the organ supply. However, transplanting HIV+ organs raises nonmaleficence concerns given limited data on recipient outcomes. Informed consent and careful monitoring of outcome data should mitigate these concerns, even in the rare circumstance when an HIV+ organ is intentionally transplanted into an HIV-negative recipient. For potential donors, the federal ban on transplanting HIV+ organs raises justice concerns. While in practice there are a number of medical criteria that preclude organ donation, only HIV+ status is singled out as a mandated exclusion to donation under the National Organ Transplant Act (NOTA). Operational objections could be addressed by adapting existing approaches used for organ donors with hepatitis. Center-specific outcomes should be adjusted for HIV donor and recipient status. In summary, transplant professionals should advocate for eliminating the ban on HIV+ organ donation and funding studies to determine outcomes after transplantation of these organs.

Donation after circulatory determination of death (DCDD) has the potential to increase the number of organs available for transplantation. Because consent and management of potential donors must occur before death, DCDD raises unique ethical and policy issues.To develop an ethics and health policy statement on adult and pediatric DCDD relevant to critical care and transplantation stakeholders.A multidisciplinary panel of stakeholders was convened to develop an ethics and health policy statement. The panel consisted of representatives from the American Thoracic Society, Society of Critical Care Medicine, International Society for Heart and Lung Transplantation, Association of Organ Procurement Organizations, and the United Network of Organ Sharing. The panel reviewed the literature, discussed important ethics and health policy considerations, and developed a guiding framework for decision making by stakeholders.A framework to guide ethics and health policy statement was established, which addressed the consent process, pre- and post mortem interventions, the determination of death, provisions of end-of-life care, and pediatric DCDD.The information presented in this Statement is based on the current evidence, experience, and clinical rationale. New clinical research and the development and dissemination of new technologies will eventually necessitate an update of this Statement.

The principles of gift law establish a consistent international legal understanding of consent to donation under a range of regulatory systems. Gift law as the primary legal principle is important to both the foundation of systems that prevent organ sales and the consideration of strategies to increase organ donation for transplantation.

The clinical characteristics of all New England Organ Bank (NEOB) donors after circulatory death (DCD) donors were analyzed between July 1, 2009, and June 30, 2014. During that 5-year period, there were 494 authorized medically suitable potential DCDs that the NEOB evaluated, constituting more than 30% of deceased donors coordinated annually by the NEOB. From the cohort of 494 authorized potential DCDs, 331 (67%) became actual DCD, 82 (17%) were attempted as a DCD but did not progress to donation, and 81 (16%) transitioned to an actual donor after brain death (DBD). Two hundred seventy-six organs were transplanted from the 81 donors that transitioned from DCD to actual DBD, including 24 heart, 70 liver, 12 single and 14 bilateral lung, and 12 pancreas transplants. When patients with devastating brain injury admitted to the intensive care units are registered donors, the Organ Procurement Organization staff should share the patient's donation decision with the health care team and the patient's family, as early as possible after the comfort measures only discussion has been initiated. The experience of the NEOB becomes an important reference of the successful implementation of DCD that enables an expansion of deceased donation (inclusive of DBD).

Vascularized composite allograft (VCA) transplantation is a medically acceptable treatment for the reconstruction of major tissue loss. The advent of VCA transplantation has spurred regulatory and policy development in the United States to address the multiple clinical, ethical and legal issues that must be considered for the practice of VCA donation and transplantation to develop within the existing framework of public trust and transparency vital to the success of donation and transplantation.

This document was developed through the collaborative efforts of the Society of Critical Care Medicine, the American College of Chest Physicians, and the Association of Organ Procurement Organizations. Under the auspices of these societies, a multidisciplinary, multi-institutional task force was convened, incorporating expertise in critical care medicine, organ donor management, and transplantation. Members of the task force were divided into 13 subcommittees, each focused on one of the following general or organ-specific areas: death determination using neurologic criteria, donation after circulatory death determination, authorization process, general contraindications to donation, hemodynamic management, endocrine dysfunction and hormone replacement therapy, pediatric donor management, cardiac donation, lung donation, liver donation, kidney donation, small bowel donation, and pancreas donation. Subcommittees were charged with generating a series of management-related questions related to their topic. For each question, subcommittees provided a summary of relevant literature and specific recommendations. The specific recommendations were approved by all members of the task force and then assembled into a complete document. Because the available literature was overwhelmingly comprised of observational studies and case series, representing low-quality evidence, a decision was made that the document would assume the form of a consensus statement rather than a formally graded guideline. The goal of this document is to provide critical care practitioners with essential information and practical recommendations related to management of the potential organ donor, based on the available literature and expert consensus.

As more same-sex couples enter into civil unions and domestic partnerships, the courts and other institutions are beginning to consider the implications of these partnerships in several areas of the law. A Georgia appeals court, for example, recently published the first opinion addressing this issue, ruling that a civil union of two women, obtained in Vermont, was not equivalent to a marriage for the purposes of interpreting a child custody agreement entered into in Georgia. As many observers predicted, the enactment of legislation recognizing same-sex partnerships has profound implications on the practice of family law, trust and estate law and healthcare law.This Article focuses on an area of healthcare law in which the legal status of a civil union or domestic partnership could have significant consequences—organ donations. In particular, it explores whether a civil union or domestic partner is an appropriate party to consent to an organ donation.

In the article “Geographic Disparities in Liver Availability: Accidents of geography or consequences of poor social policy” Ladin et al argue that those who live in underserved areas, with high rates of preventable deaths from gunshot wounds, motor vehicle accidents and reduced medical services, may have a “special claim” to local organs in order to adjust for the geographically based “poor social policies” that contribute to low access to healthcare (1). This article is protected by copyright. All rights reserved.

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.

Discovering the genetic basis of a particular disease is not only of great interest to the medical community; private health insurers are also anxiously awaiting the results of genetic linkage studies. Apart from the scientific value of DNA studies, the results of genetic linkage research are relevant to health care delivery in two principal ways. First, identifying the genetic origin of a disease may allow doctors to detect the disease earlier. If doctors know that an individual is genetically predisposed to a particular disease, then health care providers can increase screening efforts and watch for early symptoms. Second, if an individual has a genetic predisposition to a particular disease, health care providers may employ preventive or “prophylactic" measures to reduce or eliminate the risk of developing the disease or condition to which the individual is genetically predisposed. Genetic linkage studies will soon allow more individuals to learn of their own genetic predispositions to certain diseases. Currently genetic predisposition tests (both pedigrees of family history and DNA analysis) can indicate that an individual is at high risk for developing a disease.

The principles of gift law establish a consistent international legal understanding of consent to donation under a range of regulatory systems. Gift law as the primary legal principle is important to both the foundation of systems that prevent organ sales and the consideration of strategies to increase organ donation for transplantation.

Face transplantation, like many new experimental procedures, emerged into the field without clear regulatory oversight. New surgical techniques, squarely within the “practice of medicine,” are generally not regulated in the USA unless the surgical procedure involves a device for which FDA approval is required. Transplantation of organs and/or tissues, however, is one of the most highly regulated fields within medicine. Multiple federal agencies, national standards, and state laws and regulations provide a tight system of oversight for the donation and transplantation of organs and tissues. This chapter examines how face transplantation may be adopted into this framework based on previous experience with solid organs in the USA.

To the Editor: In a Perspective article in this issue of the Journal, Truog provides his views on organ donation, suggesting that the pendulum between the need for transplantable organs and the rights of potential donors' families “has swung too far in the direction of procuring organs.”1 Truog asserts that consent for organ donation is obtained “at the expense of commitments that are fundamental to the patient–physician relationship.” We disagree with this description because it does not reflect current consent practices. In practice, there is a confluence between the ethical commitments that Truog outlines: “that the desires of people who . . .

Alessandro Nanni Costa, J. M. Simon i Castellvi, Antonio G. Spagnolo, Nunziata Comoretto, Jean Laffitte, Hakan Gabel, Francis L. Delmonico, Ferdinand Muehlbacher, Walter Schaupp, Alexandra K. Glazier, Valter D. Garcia, Mario Abbud-Filho, Jose O. Medina-Pestana, Mariangela Gritta Grainer, Pier Paolo Donadio, Anna Guermani, Riccardo Bosco, Francesco Giordano, Blanca Martinez Lopez de Arroyabe, Marco Brunetti, Marti Manyalich, Gloria Paez, Ricardo Valero, Rafael Matesanz, Elisabeth Coll, Beatriz Dominguez-Gil, Beatriz Mahillo, Eduardo Martin Escobar, Gregorio Garrido, and Felix Cantarovich