Joan McGregor

Recovery of transplantable organs after cardiac or circulatory death: Transforming the paradigm for the ethics of organ donation

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donors autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination.

Scientific, legal, and ethical challenges of end-of-life organ procurement in emergency medicine

AIM We review (1) scientific evidence questioning the validity of declaring death and procuring organs in heart-beating (i.e., neurological standard of death) and non-heart-beating (i.e., circulatory-respiratory standard of death) donation; (2) consequences of collaborative programs realigning hospital policies to maximize access of procurement coordinators to critically and terminally ill patients as potential donors on arrival in emergency departments; and (3) ethical and legal ramifications of current practices of organ procurement on patients and their families. DATA SOURCES Relevant publications in peer-reviewed journals and government websites. RESULTS Scientific evidence undermines the biological criteria of death that underpin the definition of death in heart-beating (i.e., neurological standard) and non-heart-beating (i.e., circulatory-respiratory standard) donation. Philosophical reinterpretation of the neurological and circulatory-respiratory standards in the death statute, to avoid the appearance of organ procurement as an active life-ending intervention, lacks public and medical consensus. Collaborative programs bundle procurement coordinators together with hospital staff for a team-huddle and implement a quality improvement tool for a Rapid Assessment of Hospital Procurement Barriers in Donation. Procurement coordinators have access to critically ill patients during the course of medical treatment with no donation consent and with family or surrogates unaware of their roles. How these programs affect the medical care of these patients has not been studied. CONCLUSIONS Policies enforcing end-of-life organ procurement can have unintended consequences: (1) erosion of care in the patients best interests, (2) lack of transparency, and (3) ethical and legal ramifications of flawed standards of declaring death.

Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

BackgroundRequirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent.MethodsAn analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent.ResultsThere were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing.ConclusionThe Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

Organ Procurement After Cardiocirculatory Death: A Critical Analysis

To shorten the transplantation waiting time in the United States, federal regulations have been introduced requiring hospitals to develop policies for organ donation after cardiac (or circulatory) death (DCD). The practice of DCD is invoked based on the validity of the University of Pittsburgh Medical Center (UPMC) protocol and relies on the accuracy of the University of Wisconsin (UW) evaluation tool to appropriately identify organ donors. There is little evidence to support the position that the criteria for organ procurement adopted from the UPMC protocol complies with the dead donor rule. A high false-positive rate of the UW evaluation tool can expose many dying patients to unnecessary perimortem interventions because of donation failure. The medications and/or interventions for the sole purpose of maintaining organ viability can have unintended negative consequences on the timing and quality of end-of-life care offered to organ donors. It is essential to address and manage the evolving conflict between optimal end-of-life care and the necessary sacrifices for the procurement of transplantable organs from the terminally ill. The recipients of marginal organs recovered from DCD can also suffer higher mortality and morbidity than recipients of other types of donated organs. Finally, transparent disclosure to the public of the risks involved to both organ donors and recipients may contribute to open societal debate on the ethical acceptability of DCD.

Mass media campaigns and organ donation: managing conflicting messages and interests

Mass media campaigns are widely and successfully used to change health decisions and behaviors for better or for worse in society. In the United States, media campaigns have been launched at local offices of the states’ department of motor vehicles to promote citizens’ willingness to organ donation and donor registration. We analyze interventional studies of multimedia communication campaigns to encourage organ-donor registration at local offices of states’ department of motor vehicles. The media campaigns include the use of multifaceted communication tools and provide training to desk clerks in the use of scripted messages for the purpose of optimizing enrollment in organ-donor registries. Scripted messages are communicated to customers through mass audiovisual entertainment media, print materials and interpersonal interaction at the offices of departments of motor vehicles. These campaigns give rise to three serious concerns: (1) bias in communicating information with scripted messages without verification of the scientific accuracy of information, (2) the provision of misinformation to future donors that may result in them suffering unintended consequences from consenting to medical procedures before death (e.g, organ preservation and suitability for transplantation), and (3) the unmanaged conflict of interests for organizations charged with implementing these campaigns, (i.e, dual advocacy for transplant recipients and donors). We conclude the following: (1) media campaigns about healthcare should communicate accurate information to the general public and disclose factual materials with the least amount of bias; (2) conflicting interests in media campaigns should be managed with full public transparency; (3) media campaigns should disclose the practical implications of procurement as well as acknowledge the medical, legal, and religious controversies of determining death in organ donation; (4) organ-donor registration must satisfy the criteria of informed consent; (5) media campaigns should serve as a means of public education about organ donation and should not be a form of propaganda.

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a persons autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death.

Population genomics and research ethics with socially identifable groups.

In this paper, the author questions whether the research ethics guidelines and procedures are robust enough to protect groups when conducting genetics research with socially identifiable populations, particularly with Native American groups. The author argues for a change in the federal guidelines in substance and procedures of conducting genetic research with socially identifiable groups.

Why When She Says No She Doesn't Mean Maybe and Doesn't Mean Yes: A Critical Reconstruction of Consent, Sex, and The Law

A little more than two years ago, a Texas woman, faced with a knife-wielding intruder demanding sex from her, tried to talk her attacker into wearing a condom to protect herself against the possibility of contracting AIDS. A grand jury refused to indict the man because jurors believed that the womans act of self-protection implied that she had consented to sex.

Recovery of transplantable organs after cardiac or circulatory death: the end justifying the means.

To the Editor: DuBois and DeVita (1) argue that every health policy group or professional association that has studied donation after cardiac or circulatory death (DCD) has come out in favor of the procedure. They should also inform readers that the different study groups—including the Institute of Medicine (IOM)—shared medical and ethics advisors charged with DCD implementation in the United States and therefore have consistently reached the same favorable conclusions. The IOM reports provided the pivotal thrust for legal, ethical, and medical justification for DCD (1). Federal regulations were introduced to enforce DCD in U.S. hospitals (2, 3). In September 2006, the President’s Council on Bioethics appointed an independent group to reanalyze and provide comprehensive and balanced interpretation of the DCD issues (4). The Council paper reached conclusions different from those of DuBois and DeVita (1). The Council noted conflicting evidence for the original assumptions for DCD and expressed ethical, legal, and moral uncertainty of the acceptability of DCD in the medical community and society at large. First assumption: Organ procurement is not the act causing the donor’s death (i.e., “the dead donor rule”). Dubois and DeVita claimed that “those concerned that the patient may not be dead may be uninformed of the near consensus in the literature on death determination” (1). The IOM endorsement of 5 mins of loss of cardiorespiratory activity for DCD death criteria was based on incomplete literature analysis (5). The DCD death criteria did not fulfill the irreversibility requirement for the Uniform Determination of Death Act (5). The IOM overlooked delayed spontaneous autoresuscitation with neurologic recovery in humans (called the Lazarus phenomenon) even though the Maastricht DCD protocol (University of Zurich, Switzerland) had acknowledged that phenomenon and required 10 mins after death before organ procurement (5–8). Also, the IOM expanded DCD to neurologically intact individuals after cardiorespiratory death (1, 9). Artificial circulatory and ventilatory support performed upon death to maintain organ viability for procurement could initiate spontaneous cardiac and neurologic activities and occasionally survival to discharge from hospital (5). In the DCD donors, reanimation or return of life would be actively suppressed by mechanical and pharmacologic interventions during the procurement process (10). The legal importance of being dead during the procurement process has been emphasized so that DCD would not become an act of “homicide” (5). Second assumption: The act of donation does not influence the donor’s medical or end-of-life (EOL) care. The variability of EOL practice raises the possibility of conflicted decision making on medical futility within institutions with transplant programs (11). The pressure to recover transplantable organs from DCD candidates can influence healthcare professionals’ decisions on medical futility and EOL (11). The deleterious consequences of donor management critical pathways on the quality of EOL care also have been downplayed and thus misinformed donors and their families on the trade-off in DCD (4, 9). Third assumption: A person’s right to donate is congruent with respect for autonomy and protected through an informed consent. Organ procurement organizations or affiliates are the designated entities to obtain consent; they also have administrative and financial interests to increase organ recovery rate (2). The organ procurement organizations’ conflict of interest and self-serving bias become apparent as they obtain donation consent, reinforcing the motivation to consent, while avoiding the discussion on the trade-off in EOL care (12). The information imbalance invalidates the notion that donation consent is truly based on complete and unbiased disclosure (4). Fourth assumption: Euthanasia is not permitted for the recovery of transplantable organs. To successfully procure organs in DCD, the warm ischemia time must be kept to a minimum and surgical recovery must begin within 60–90 mins after withdrawal of life support. The inaccuracy of predicting the time of death can be overcome by the use of large doses of opiates and sedatives to shorten the warm ischemia interval and fulfill the necessary criteria to begin the procurement process in a timely manner (9). Many healthcare providers who are directly involved with DCD have expressed euthanasia as a major concern and cause for moral distress toward such practice (1). In spite of the fallibility of DCD assumptions, its supporters, on behalf of the entire medical community and the public, have declared its ethical acceptability beyond any further debate because of its altruistic notion: It saves lives. The unilateral decision to invoke DCD, without widespread public awareness, impedes informed societal debate and participation (13). The absence of societal consensus can lead to a backlash re-igniting public distrust and jeopardizing the integrity of the entire process of deceased organ donation. The authors have not disclosed any affiliation or financial involvement with organizations or entities with a direct financial interest in the subject matter or materials discussed in the manuscript.

Seeking to reconcile end-of-life organ procurement for transplantation with the uniform determination of death act.

To the Editor: Human death is a singular phenomenon characterized by simultaneous, irreversible cessation of all vital functions (circulation, respiration, and consciousness). Bernat et al (1) customize the criterion and standard of declaring death in nonheart-beating donation protocols to maximize procurement opportunities (including hearts). Variable (75 secs–5 mins) cardiac mechanical asystole (or absent arterial pulse) is the U.S. standard of declaring death in nonheart-beating donation (2). This standard is based on an analysis of published (1912–1970) case series (3). For the standard to be medically acceptable, the uniform determination of death act requires it to fulfill the criterion of irreversibility. Hearts recovered in nonheart-beating donation have normal native mechanical and electrical functions after transplantation. Therefore, mechanical asystole is reversible and, principally, fails medically or legally as a standard for determining circulatory–respiratory death. Additionally, residual brain activity can persist undetected by traditional clinical assessment several minutes after declaring pulseless patients dead (4). Nonheart-beating donation was renamed “donation after circulatory death,” further promoting public perception that organs are procured after true death. Bernat et al (1) reassure the general public that procuring organs in nonheartbeating donation is after death by novel reinterpretation of uniform determination of death act statutory language. They posit that in the uniform determination of death act, “permanence” has the intended meaning of “irreversibility.” They redefine the understanding of “permanence” (will not restore native vital functions spontaneously or because of intent and action not to resuscitate with currently available technology) and “irreversibility” (cannot restore native vital functions by resuscitation with currently available technology). But, by their definition, the ceased vital functions can be reversed. Did the President’s Commission intend for “irreversible” to have different meanings within the uniform determination of death act when determining death by a circulatory standard vs. a neurologic standard? Wherever this Commission used “permanent,” it was followed by a description of loss of function that cannot recover because of ischemia, damage, destruction, or necrosis (5). Neither intent nor action not to resuscitate was mentioned as contingencies qualifying “permanent” as “irreversible.” Furthermore, uniform determination of death act wording had consensus agreement of relevant professional organizations (5). State and federal judicial systems are the designated authorities for interpreting statutes. When advocacy groups and private professional organizations arbitrarily assume such roles there can be serious consequences. Bernat et al (1), in appropriating this role, implicitly reaffirm that organs are procured from living individuals declared dead by criteria convenient for transplantation practice. Organs are de facto procured in an active life-terminating intervention before legal death (i.e., homicide). Current state laws prohibit homicide by consent for or caused by organ procurement. By harvesting and transplanting normal-beating hearts, Bernat et al (1) also challenge existing federal regulations that specify that a “donor after cardiac death means an individual who donates after his or her heart has irreversibly stopped beating” (6). Despite evidence that resuscitation with extracorporeal membrane oxygenation followed by organ procurement is inconsistent with legal statutes, they claim that governmental agencies support the practice (1). If so, then we must ask: (1) does this utilitarian approach to procuring organs mean that society sanctions utilitarian homicide?; (2) should a practice that transgresses on individuals’ constitutional rights be supported by governmental agencies?; and (3) should federal funding for it be exempt from the congressional prohibition on support for other life-ending medical practices (e.g., euthanasia)? Arguing that determining death should be contingent on “an intent and action not to resuscitate” provides false moral certitude that organ-donating practices are consistent with the dead donor rule. In addition, as monotheistic religions uphold the sanctity of life and forbid ending a life to recover organs (7), the following questions arise: is it morally permissible to err on the side of ending a life to recover organs that will save lives, and is an immoral act justifiable if the intentions are good? The authors have not disclosed any potential conflicts of interest.