Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.

Inconsistency between the Circulatory and the Brain Criteria of Death in the Uniform Determination of Death Act.

The Uniform Determination of Death Act (UDDA) provides that "an individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead." We show that the UDDA contains two conflicting interpretations of the phrase "cessation of functions." By one interpretation, what matters for the determination of death is the cessation of spontaneous functions only, regardless of their generation by artificial means. By the other, what matters is the cessation of both spontaneous and artificially supported functions. Because each UDDA criterion uses a different interpretation, the law is conceptually inconsistent. A single consistent interpretation would lead to the conclusion that conscious individuals whose respiratory and circulatory functions are artificially supported are actually dead, or that individuals whose brain is entirely and irreversibly destroyed may be alive. We explore solutions to mitigate the inconsistency.

End-of-life practices: An ethical framework for clinicians.

Most hospitalized patients die following a decision to forgo life-sustaining treatment and/or focus on comfort care. Since "Do not kill" is a general ethical norm, many healthcare professionals (HCPs) are uncertain or troubled by such decisions. We propose an ethical framework to help clinicians to understand better their own ethical perspectives about four end-of-life practices: lethal injections, the withdrawal of life-sustaining therapies, the withholding of life-sustaining therapies, and the injection of sedatives and/or analgesics for comfort care. This framework identifies three broad ethical perspectives that may permit HCPs to examine their own attitudes and intentions. According to moral perspective A (absolutist), it is never morally permissible to be causally involved in the occurrence of death. According to moral perspective B (agential), it may be morally permissible to be causally involved in the occurrence of death, if HCPs do not have the intention to terminate the patient's life and if, among other conditions, they ensure respect for the person. Three of the four end-of-life practices, but not lethal injection, may be morally permitted. According to moral perspective C (consequentialist), all four end-of-life practices may be morally permissible if, among other conditions, respect for persons is ensured, even if one intends to hasten the dying process. This structured ethical framework may help to mitigate moral distress among HCPs by helping them to understand better their own fundamental ethical perspectives, as well as those of their patients and colleagues.

Inequitable Access to Transplants: Adults With Impaired Decision-Making Capacity.

Inequitable access to deceased donor organs for transplantation has received considerable scrutiny in recent years. Emerging evidence suggests patients with impaired decision-making capacity (IDC) face inequitable access to transplantation. The "Ethical and Legal Issues" working group of the European Society of Transplantation undertook an expert consensus process. Literature relating to transplantation in patients with IDC was examined and collated to investigate whether IDC is associated with inferior transplant outcomes and the legitimacy of this healthcare inequality was examined. Even though the available evidence of inferior transplant outcomes in these patients is limited, the working group concluded that access to transplantation in patients with IDC may be inequitable. Consequently, we argue that IDC should not in and of itself be considered as a barrier to either registration on the transplant waiting list or allocation of an organ. Strategies for non-discrimination should focus on ensuring eligibility is based upon sound evidence and outcomes without reference to non-medical criteria. Recommendations to support policy makers and healthcare providers to reduce unintended inequity and inadvertent discrimination are set out. We call upon transplant centres and national bodies to include data on decision-making capacity in routine reporting schedules in order to improve the evidence base upon which organ policy decisions are made going forward.

The ethics of semantics in medicine.

In this paper, we discuss the largely neglected topic of semantics in medicine and the associated ethical issues. We analyse several key medical terms from the informed perspective of the healthcare professional, the lay perspective of the patient and the patient's family, and the descriptive perspective of what the term actually signifies objectively. The choice of a particular medical term may deliver different meanings when viewed from these differing perspectives. Consequently, several ethical issues may arise. Technical terms that are not commonly understood by lay people may be used by physicians, consciously or not, and may obscure the understanding of the situation by lay people. The choice of particular medical terms may be accidental use of jargon, an attempt to ease the communication of psychologically difficult information, or an attempt to justify a preferred course of action and/or to manipulate the decision-making process.

Addressing ethical confusion in deceased donation and transplantation research: the need for dedicated guidance.

Innovative research in deceased donation and transplantation often presents ethical challenges for researchers and those responsible for ethical governance of research. These challenges have been recognized as potential barriers to the conduct of research. We review the literature to identify and describe ethical considerations that may cause confusion or uncertainty in the context of research involving potential deceased donors or deceased donor transplantation. We normatively examine these considerations and discuss their implications for the ethical conduct of research. In addition to the complexities of research involving critically ill, dying or recently deceased individuals, uncertainty may arise regarding the ethical status of various individuals who may be involved in research aimed at improving availability and outcomes of organ transplantation. Consequently, routine ethical guidelines for clinical research may fail to provide clear guidance with regards to the design, conduct and governance of some deceased donation or transplantation studies. Ethical uncertainty may result in delays or barriers to research, or neglect of important ethical considerations. Specific ethical guidance is needed to support research in deceased donation and transplantation as the ethical considerations that arise in the design and conduct of such research may not be addressed in the existing guidelines for human research.

Inconsistencies Between the Criterion and Tests for Brain Death.

The whole-brain criterion of death provides that a person who has irreversibly lost all clinical functions of the brain is dead. Bedside brain death (BD) tests permit physicians to determine BD by showing that the whole-brain criterion of death has been fulfilled. In a nonsystematic literature review, we identified and analyzed case reports of a mismatch between the whole-brain criterion of death and bedside BD tests. We found examples of patients diagnosed as BD who showed (1) neurologic signs compatible with retained brain functions, (2) neurologic signs of uncertain origin, and (3) an inconsistency between standard BD tests and ancillary tests for BD. Two actions can resolve the mismatch between the whole-brain criterion of death and BD tests: (1) loosen the whole-brain criterion of death by requiring only the irreversible cessation of relevant brain functions and (2) tighten BD tests by requiring an ancillary test proving the cessation of intracranial blood flow. Because no one knows the precise brain functions whose loss is necessary to fulfill the whole-brain criterion of death, we advocate tightening BD tests by requiring the absence of intracranial blood flow.

The ethical obligation of the dead donor rule.

The dead donor rule (DDR) originally stated that organ donors must not be killed by and for organ donation. Scholars later added the requirement that vital organs should not be procured before death. Some now argue that the DDR is breached in donation after circulatory determination of death (DCDD) programs. DCDD programs do not breach the original version of the DDR because vital organs are procured only after circulation has ceased permanently as a consequence of withdrawal of life-sustaining therapy. We hold that the original rendition of the DDR banning killing by and for organ donation is the fundamental norm that should be maintained in transplantation ethics. We propose separating the DDR from two other fundamental normative rules: the duties to prevent harm and to obtain informed consent.

Intensive care for organ preservation: A four-stage pathway.

OBJECTIVE: Intensive care for organ preservation (ICOP) is defined as the initiation or pursuit of intensive care not to save the patient's life, but to protect and optimize organs for transplantation. ANALYSIS: When a patient has devastating brain injury that might progress to organ donation this can be conceptualized as evolving through four consecutive stages: (1) instability, (2) stability, (3) futility and (4) finality. ICOP might be applied at any of these stages, raising different ethical issues. Only in the stage of finality is the switch from neurointensive care to ICOP ethically justified. CONCLUSION: The difference between the stages is that during instability, stability and futility the focus must be neurointensive care which seeks the patient's recovery or an accurate neurological prognostication, while finality focuses on withdrawal of life-sustaining therapy and commencement of comfort care, which may include ICOP for deceased donation.

Aligning the Criterion and Tests for Brain Death.

Disturbing cases continue to be published of patients declared brain dead who later were found to have a few intact brain functions. We address the reasons for the mismatch between the whole-brain criterion and brain death tests, and suggest solutions. Many of the cases result from diagnostic errors in brain death determination. Others probably result from a tiny amount of residual blood flow to the brain despite intracranial circulatory arrest. Strategies to lessen the mismatch include improving brain death determination training for physicians, mandating a test showing complete intracranial circulatory arrest, or revising the whole-brain criterion.

Positive HIV Test Results from Deceased Organ Donors: Should We Disclose to Next of Kin?

In the context of deceased organ donation, donors are routinely tested for HIV, to check for suitability for organ donation. This article examines whether a donor's HIV status should be disclosed to the donor's next of kin. On the one hand, confidentiality requires that sensitive information not be disclosed, and a duty to respect confidentiality may persist after death. On the other hand, breaching confidentiality may benefit third parties at risk of having been infected by the organ donor, as it may permit them to be tested for HIV and seek treatment in case of positive results. We conclude that the duty to warn third parties surpasses the duty to respect confidentiality. However, in order to minimize risks linked to the breach of confidentiality, information should be restrained to only concerned third parties, that is, those susceptible to having been infected by the donor.

Uncontrolled Donation After Circulatory Determination of Death: A Systematic Ethical Analysis.

Uncontrolled donation after circulatory determination of death (uDCDD) refers to organ donation after a refractory cardiac arrest. We analyzed ethical issues raised by the uDCDD protocols of France, Madrid, and New York City. We recommend: (1) Termination of resuscitation (TOR) guidelines need refinement, particularly the minimal duration of resuscitation efforts before considering TOR; (2) Before enrolling in an uDCDD protocol, physicians must ascertain that additional resuscitation efforts would be ineffective; (3) Inclusion in an uDCDD protocol should not be made in the outpatient setting to avoid error and conflicts of interest; (4) The patient's condition should be reassessed at the hospital and reversible causes treated; (5) A no-touch period of at least 10 minutes should be respected to avoid the risk of autoresuscitation; (6) Once death has been determined, no procedure that may resume brain circulation should be used, including cardiopulmonary resuscitation, artificial ventilation, and extracorporeal membrane oxygenation; (7) Specific consent is required prior to entry into an uDCDD protocol; (8) Family members should be informed about the goals, risks, and benefits of planned uDCDD procedures; and (9) Public information on uDCDD is desirable because it promotes public trust and confidence in the organ donation system.