Legislation and Policy Recommendations on Organ and Tissue Donation and Transplantation From an International Consensus Forum.

There is a shared global commitment to improving baseline donation and transplantation performance metrics in a manner consistent with ethics and local cultural and social factors. The law is one tool that can help improve these metrics. Although legal systems vary across jurisdictions, our objective was to create expert, consensus guidance for law and policymakers on foundational issues underlying organ and tissue donation and transplantation (OTDT) systems around the world. Methods: Using the nominal group technique, a group composed of legal academics, a transplant coordinator/clinician, and a patient partner identified topic areas and recommendations on foundational legal issues. The recommendations were informed by narrative literature reviews conducted by group members based on their areas of expertise, which yielded a range of academic articles, policy documents, and sources of law. Best practices were identified from relevant sources in each subtopic, which formed the basis of the recommendations contained herein. Results: We reached consensus on 12 recommendations grouped into 5 subtopics: (i) legal definitions and legislative scope, (ii) consent requirements for donation' (iii) allocation of organs and tissue' (iv) operation of OTDT systems' and (v) travel for transplant and organ trafficking. We have differentiated between those foundational legal principles for which there is a firm basis of support with those requiring further consideration and resolution. Seven such areas of controversy are identified and discussed alongside relevant recommendations. Conclusions: Our recommendations encompass some principles staunchly enshrined in the OTDT landscape (eg, the dead donor rule), whereas others reflect more recent developments in practice (eg, mandatory referral). Although some principles are widely accepted, there is not always consensus as to how they ought to be implemented. As the OTDT landscape continues to evolve, recommendations must be reconsidered for the law to keep pace with developments in knowledge, technology, and practice.

Legal considerations for the definition of death in the 2023 Canadian Brain-Based Definition of Death Clinical Practice Guideline.

PURPOSE: The new 2023 Canadian Brain-Based Definition of Death Clinical Practice Guideline provides a new definition of death as well as clear procedures for the determination of death (i.e., when that definition is met). Since physicians must practice in accordance with existing laws, this legal analysis describes the existing legal definitions of death in Canada and considers whether the new Guideline is consistent with those definitions. It also considers how religious freedom and equality in the Canadian Charter of Rights and Freedoms might apply to the diagnosis of brain death. METHOD: We performed a legal analysis in accordance with standard procedures of legal research and analysis-including reviews of statutory law, case law, and secondary legal literature. The draft paper was discussed by the Legal-Ethical Working Subgroup and presented to the larger Guideline project team for comment. RESULTS AND CONCLUSION: There are some differences between the wording of the new Guideline and existing legal definitions. To reduce confusion, these should be addressed through revising the legal definitions. In addition, future challenges to brain death based on the Charter of Rights and Freedoms can be anticipated. Facilities should consider and adopt policies that identify what types of accommodation of religious objection and what limits to accommodation are reasonable and well-justified.

RéSUMé: OBJECTIF: Les nouvelles Lignes directrices canadiennes de pratique clinique pour la détermination du décès cérébral de 2023 fournissent une nouvelle définition du décès ainsi que des procédures claires pour la détermination du décès (c.-à-d. lorsque cette définition est respectée). Étant donné que les médecins doivent exercer conformément aux lois en vigueur, la présente analyse juridique décrit les définitions juridiques existantes du décès au Canada et vise à déterminer si les nouvelles Lignes directrices sont conformes à ces définitions. Cette analyse examine également comment la liberté de religion et l'égalité dans la Charte canadienne des droits et libertés pourraient s'appliquer au diagnostic de mort cérébrale. MéTHODE: Nous avons effectué une analyse juridique conformément aux procédures habituelles de recherche et d'analyse juridiques, y compris l'examen du droit écrit, de la jurisprudence et de la littérature juridique secondaire. L'ébauche du document a été examinée par le sous-groupe de travail juridico-éthique et présentée à l'équipe élargie du projet des Lignes directrices pour commentaires. RéSULTATS ET CONCLUSIONS: Il existe certaines différences entre le libellé des nouvelles Lignes directrices et les définitions juridiques existantes. Pour réduire la confusion, il convient de remédier à ces problèmes en révisant les définitions juridiques. De plus, les défis futurs à la mort cérébrale fondés sur la Charte des droits et libertés peuvent être anticipés. Les établissements devraient envisager et adopter des politiques qui précisent quels types d'accommodement d'objection religieuse et quelles limites d'accommodement sont raisonnables et bien justifiés.

A brain-based definition of death and criteria for its determination after arrest of circulation or neurologic function in Canada: a 2023 clinical practice guideline.

This 2023 Clinical Practice Guideline provides the biomedical definition of death based on permanent cessation of brain function that applies to all persons, as well as recommendations for death determination by circulatory criteria for potential organ donors and death determination by neurologic criteria for all mechanically ventilated patients regardless of organ donation potential. This Guideline is endorsed by the Canadian Critical Care Society, the Canadian Medical Association, the Canadian Association of Critical Care Nurses, Canadian Anesthesiologists' Society, the Canadian Neurological Sciences Federation (representing the Canadian Neurological Society, Canadian Neurosurgical Society, Canadian Society of Clinical Neurophysiologists, Canadian Association of Child Neurology, Canadian Society of Neuroradiology, and Canadian Stroke Consortium), Canadian Blood Services, the Canadian Donation and Transplantation Research Program, the Canadian Association of Emergency Physicians, the Nurse Practitioners Association of Canada, and the Canadian Cardiovascular Critical Care Society.

RéSUMé: Ces Lignes directrices de pratique clinique 2023 Lignes directrices de pratique clinique dicale du décès basée sur l'arrêt permanent de la fonction cérébrale qui s'applique à toute personne, ainsi que des recommandations pour la détermination du décès par des critères circulatoires pour des donneurs d'organes potentiels et des recommandations pour la détermination du décès par des critères neurologiques pour tous les patients sous ventilation mécanique, indépendamment de leur potentiel de donneur d'organes. Les présentes Lignes directrices sont approuvées par la Société canadienne de soins intensifs, l'Association médicale canadienne, l'Association canadienne des infirmiers/infirmières en soins intensifs, la Société canadienne des anesthésiologistes, la Fédération des sciences neurologiques du Canada (représentant la Société canadienne de neurologie, la Société canadienne de neurochirurgie, la Société canadienne de neurophysiologie clinique, l'Association canadienne de neurologie pédiatrique, la Société canadienne de neuroradiologie et le Consortium neurovasculaire canadien), la Société canadienne du sang, le Programme de recherche en don et transplantation du Canada, l'Association canadienne des médecins d'urgence, l'Association des infirmières et infirmiers praticiens du Canada, et la Société canadienne de soins intensifs cardiovasculaires (CANCARE) et la Société canadienne de pédiatrie.

Rationale for revisions to the definition of death and criteria for its determination in Canada.

Clarity regarding the biomedical definition of death and the criteria for its determination is critical to inform practices in clinical care, medical research, law, and organ donation. While best practices for death determination by neurologic criteria and circulatory criteria were previously outlined in Canadian medical guidelines, several issues have arisen to force their reappraisal. Ongoing scientific discovery, corresponding changes in medical practice, and legal and ethical challenges compel a comprehensive update. Accordingly, the A Brain-Based Definition of Death and Criteria for its Determination After Arrest of Neurologic or Circulatory Function in Canada project was undertaken to a develop a unified brain-based definition of death, and to establish criteria for its determination after devastating brain injury and/or circulatory arrest. Specifically, the project had three objectives: (1) to clarify that death is defined in terms of brain functions; (2) to clarify how a brain-based definition of death is articulated; and (3) to clarify the criteria for determining if the brain-based definition is met. The updated death determination guideline therefore defines death as the permanent cessation of brain function and describes corresponding circulatory and neurologic criteria to ascertain the permanent cessation of brain function. This article explores the challenges that prompted revisions to the biomedical definition of death and the criteria for its determination and outlines the rationales underpinning the project's three objectives. By clarifying that all death is defined in terms of brain function, the project seeks to align guidelines with contemporary medicolegal understandings of the biological basis of death.

RéSUMé: Il est essentiel que la définition biomédicale du décès et les critères de sa détermination soient précis afin d'éclairer les pratiques en matière de soins cliniques, de recherche médicale, de droit et de don d'organes. Alors que les meilleures pratiques pour la détermination du décès par des critères neurologiques et circulatoires ont déjà été décrites dans les lignes directrices médicales canadiennes, plusieurs problèmes ont été soulevés, lesquels ont motivé leur réévaluation. Les découvertes scientifiques en cours, les changements correspondants dans la pratique médicale et les défis juridiques et éthiques imposent une mise à jour complète. Par conséquent, le projet d'Élaboration d'une définition uniformisée de la mort cérébrale et de critères fondés sur des données probantes pour sa détermination au Canada a été entrepris dans le but d'élaborer une définition uniformisée de la mort cérébrale et d'établir des critères pour sa détermination après une lésion cérébrale dévastatrice et/ou un arrêt circulatoire. Plus précisément, le projet avait trois objectifs : (1) clarifier que le décès est défini en termes de fonctions cérébrales; (2) clarifier la façon dont une définition cérébrale du décès est articulée; et (3) clarifier les critères permettant de déterminer si la définition de mort cérébrale est respectée. Les lignes directrices mises à jour sur la détermination du décès définissent donc le décès comme l'arrêt permanent de la fonction cérébrale et décrivent les critères circulatoires et neurologiques correspondants pour établir l'arrêt permanent de la fonction cérébrale. Cet article explore les défis qui ont motivé la révision de la définition biomédicale du décès et des critères de sa détermination et décrit les raisons d'être qui sous-tendent les trois objectifs du projet. En précisant que tout décès est défini en termes de fonction cérébrale, le projet cherche à aligner les lignes directrices sur les compréhensions médicolégales contemporaines des fondements biologiques de la mort.

Death determination by neurologic criteria-what do families understand?

PURPOSE: Currently, there is little empirical data on family understanding about brain death and death determination. The purpose of this study was to describe family members' (FMs') understanding of brain death and the process of determining death in the context of organ donation in Canadian intensive care units (ICUs). METHODS: We conducted a qualitative study using semistructured, in-depth interviews with FMs who were asked to make an organ donation decision on behalf of adult or pediatric patients with death determination by neurologic criteria (DNC) in Canadian ICUs. RESULTS: From interviews with 179 FMs, six main themes emerged: 1) state of mind, 2) communication, 3) DNC may be counterintuitive, 4) preparation for the DNC clinical assessment, 5) DNC clinical assessment, and 6) time of death. Recommendations on how clinicians can help FMs to understand and accept DNC through communication at key moments were described including preparing FMs for death determination, allowing FMs to be present, and explaining the legal time of death, combined with multimodal strategies. For many FMs, understanding of DNC unfolded over time, facilitated with repeated encounters and explanation, rather than during a single meeting. CONCLUSION: Family members' understanding of brain death and death determination represented a journey that they reported in sequential meeting with health care providers, most notably physicians. Modifiable factors to improve communication and bereavement outcomes during DNC include attention to the state of mind of the family, pacing and repeating discussions according to families' expressed understanding, and preparing and inviting families to be present for the clinical determination including apnea testing. We have provided family-generated recommendations that are pragmatic and can be easily implemented.

RéSUMé: OBJECTIF: À l'heure actuelle, il y a peu de données empiriques sur la compréhension des familles de la mort cérébrale et de la détermination du décès. Le but de cette étude était de décrire la compréhension des membres de la famille de la mort cérébrale et du processus de détermination du décès dans le contexte du don d'organes dans les unités de soins intensifs (USI) canadiennes. MéTHODE: Nous avons mené une étude qualitative à l'aide d'entrevues semi-structurées et approfondies avec des membres de la famille à qui on a demandé de prendre une décision de don d'organes au nom de patients adultes ou pédiatriques dont le décès avait été déterminé selon des critères neurologiques (DCN) dans les unités de soins intensifs canadiennes. RéSULTATS: Sur la base d'entrevues avec 179 membres de la famille, six thèmes principaux ont émergé : 1) l'état d'esprit, 2) la communication, 3) le DCN peut être contre-intuitif, 4) la préparation à l'évaluation clinique pour un DCN, 5) l'évaluation clinique pour un DCN et 6) le moment du décès. Des recommandations sur la façon dont les cliniciens peuvent aider les membres de la famille à comprendre et à accepter un DCN par la communication à des moments clés ont été décrites, y compris la préparation des membres de la famille à la détermination du décès, l'autorisation de la présence des membres de la famille et l'explication de l'heure légale du décès, combinées à des stratégies multimodales. Pour de nombreux membres de la famille, la compréhension du DCN s'est développée au fil du temps et a été facilitée par des rencontres et des explications répétées plutôt qu'au cours d'une seule rencontre. CONCLUSION: La compréhension qu'ont les membres de la famille de la mort cérébrale et de la détermination du décès représente un parcours qu'ils ont décrit lors de rencontres successives avec des acteurs de soins de santé, et particulièrement avec des médecins. Les facteurs modifiables pour améliorer la communication et les issues du deuil pendant un DCN comprennent l'attention portée à l'état d'esprit de la famille, le rythme et la répétition des discussions en fonction de la compréhension exprimée par les familles, ainsi que la préparation et l'invitation des familles à être présentes pour la détermination clinique, y compris pendant le test d'apnée. Nous avons fourni des recommandations familiales qui sont pragmatiques et peuvent être facilement mises en œuvre.

Consent for determination of death by neurologic criteria in Canada: an analysis of legal and ethical authorities, and consensus-based working group recommendations.

This article addresses the following question: should physicians obtain consent from the patient (through an advance directive) or their surrogate decision-maker to perform the assessments, evaluations, or tests necessary to determine whether death has occurred according to neurologic criteria? While legal bodies have not yet provided a definitive answer, significant legal and ethical authority holds that clinicians are not required to obtain family consent before making a death determination by neurologic criteria. There is a near consensus among available professional guidelines, statutes, and court decisions. Moreover, prevailing practice does not require consent to test for brain death. While arguments for requiring consent have some validity, proponents cannot surmount weightier considerations against imposing a consent requirement. Nevertheless, even though clinicians and hospitals may not be legally required to obtain consent, they should still notify families about their intent to determine death by neurologic criteria and offer temporary reasonable accommodations when feasible. This article was developed with the legal/ethics working group of the project, A Brain-Based Definition of Death and Criteria for its Determination After Arrest of Circulation or Neurologic Function in Canada developed in collaboration with the Canadian Critical Care Society, Canadian Blood Services, and the Canadian Medical Association. The article is meant to provide support and context for this project and is not intended to specifically advise physicians on legal risk, which in any event is likely jurisdiction dependent because of provincial or territorial variation in the laws. The article first reviews and analyzes ethical and legal authorities. It then offers consensus-based recommendations regarding consent for determination of death by neurologic criteria in Canada.

RéSUMé: Cet article répond à la question suivante : les médecins doivent-ils obtenir le consentement du patient (au moyen d'une directive médicale anticipée) ou de son mandataire spécial pour réaliser les examens, évaluations ou tests nécessaires pour déterminer si le décès est survenu selon des critères neurologiques? Bien que les organes juridiques n'aient pas encore fourni de réponse définitive, selon la jurisprudence et l'éthique, les cliniciens ne sont pas tenus d'obtenir le consentement de la famille avant de procéder à une détermination de décès selon des critères neurologiques. Il y a un quasi-consensus dans les lignes directrices professionnelles, les lois et les décisions judiciaires disponibles. De plus, la pratique courante n'exige pas le consentement pour procéder aux examens permettant de déterminer une mort cérébrale. Bien que les arguments en faveur de l'exigence d'un consentement aient une certaine validité, leurs défenseurs ne peuvent pas surmonter des considérations plus importantes contre l'imposition d'une exigence de consentement. Néanmoins, même si les cliniciens et les hôpitaux ne sont peut-être pas légalement tenus d'obtenir le consentement, ils devraient tout de même aviser les familles de leur intention de déterminer le décès selon des critères neurologiques et offrir des aménagements raisonnables temporaires lorsque cela est possible. Cet article a été mis au point en collaboration avec le groupe de travail sur les questions légales et éthiques du projet de Définition uniformisée de la mort cérébrale et de critères fondés sur des données probantes pour sa détermination au Canada et développé avec la Société canadienne de soins intensifs, la Société canadienne du sang et l'Association médicale canadienne. Cet article vise à étayer et fournir un contexte au projet et ne vise pas à conseiller spécifiquement les médecins sur le risque juridique qui, de toute façon, varie probablement en raison des différences légales provinciales et territoriales. L'article commence par passer en revue et analyser la jurisprudence et les considérations éthiques. Il propose ensuite des recommandations consensuelles concernant le consentement pour la détermination du décès selon des critères neurologiques au Canada.

Future directions in psychiatric neurosurgery: Proceedings of the 2022 American Society for Stereotactic and Functional Neurosurgery meeting on surgical neuromodulation for psychiatric disorders.

OBJECTIVE: Despite advances in the treatment of psychiatric diseases, currently available therapies do not provide sufficient and durable relief for as many as 30-40% of patients. Neuromodulation, including deep brain stimulation (DBS), has emerged as a potential therapy for persistent disabling disease, however it has not yet gained widespread adoption. In 2016, the American Society for Stereotactic and Functional Neurosurgery (ASSFN) convened a meeting with leaders in the field to discuss a roadmap for the path forward. A follow-up meeting in 2022 aimed to review the current state of the field and to identify critical barriers and milestones for progress. DESIGN: The ASSFN convened a meeting on June 3, 2022 in Atlanta, Georgia and included leaders from the fields of neurology, neurosurgery, and psychiatry along with colleagues from industry, government, ethics, and law. The goal was to review the current state of the field, assess for advances or setbacks in the interim six years, and suggest a future path forward. The participants focused on five areas of interest: interdisciplinary engagement, regulatory pathways and trial design, disease biomarkers, ethics of psychiatric surgery, and resource allocation/prioritization. The proceedings are summarized here. CONCLUSION: The field of surgical psychiatry has made significant progress since our last expert meeting. Although weakness and threats to the development of novel surgical therapies exist, the identified strengths and opportunities promise to move the field through methodically rigorous and biologically-based approaches. The experts agree that ethics, law, patient engagement, and multidisciplinary teams will be critical to any potential growth in this area.

Inequities in organ and tissue donation and transplantation for sexual orientation and gender identity diverse people: A scoping review.

Sexual orientation and gender identity (SOGI)-diverse populations experience discrimination in organ and tissue donation and transplantation (OTDT) systems globally. We assembled a multidisciplinary group of clinical experts as well as SOGI-diverse patient and public partners and conducted a scoping review including citations on the experiences of SOGI-diverse persons in OTDT systems globally to identify and explore the inequities that exist with regards to living and deceased OTDT. Using scoping review methods, we conducted a systematic literature search of relevant electronic databases from 1970 to 2021 including a grey literature search. We identified and screened 2402 references and included 87 unique publications. Two researchers independently coded data in included publications in duplicate. We conducted a best-fit framework synthesis paired with an inductive thematic analysis to identify synthesized benefits, harms, inequities, justification of inequities, recommendations to mitigate inequities, laws and regulations, as well as knowledge and implementation gaps regarding SOGI-diverse identities in OTDT systems. We identified numerous harms and inequities for SOGI-diverse populations in OTDT systems. There were no published benefits of SOGI-diverse identities in OTDT systems. We summarized recommendations for the promotion of equity for SOGI-diverse populations and identified gaps that can serve as targets for action moving forward.

Two Views of Vulnerability in the Evolution of Canada's Medical Assistance in Dying Law.

Canada is six years into a new era of legalized medical assistance in dying (MAiD). The law continues to evolve, following a pattern in which Canadian courts rule that legal restrictions on eligibility for MAiD are unconstitutional and Parliament responds by gradually expanding eligibility for MAiD. The central tension underlying this dialogue between courts and government has focused on two conceptions of how to best promote and protect the interests of people who are vulnerable by virtue of intolerable and irremediable suffering due to an illness, disease, or disability. Do we, as a society, have a duty to protect vulnerable people from seeking certain medical procedures that are contrary to their interests, as those are perceived by others? Or do we have a duty to uphold their rights to autonomy, including the right to make choices within a range that may be constrained by many factors, some of which may be socially unjust? This is a recurrent problem in bioethics and medical law, which we explore through the lens of how Canadian courts and Parliament have grappled with defining eligibility for MAiD.

The experiences of family members of deceased organ donors and suggestions to improve the donation process: a qualitative study.

BACKGROUND: Decisions about organ donation are stressful for family members of potential organ donors. We sought to comprehensively explore the donation process from interviews conducted with family members of patients admitted to pediatric and adult intensive care units in Canada. METHODS: We conducted a qualitative study using semistructured, in-depth interviews with 271 family members asked to make an organ donation decision. We recruited participants from all provinces with an organ donation organization (n = 10), and analyzed themes using a modified grounded theory approach. On the basis of these interviews, suggestions were made by researchers and family members on how to improve the process of organ donation. RESULTS: We identified 3 main themes and 9 subthemes. Families need more comprehensive support around the time of donation, including having access to someone with shared experiences, support during specific moments as needed and better support during critical transitions (e.g., when the donor body goes to the operating room). The theme of better connection to recipient(s) included receiving information about the donation surgery (e.g., which organs were recovered), establishing connection with recipients (e.g., via social networks or letters) and planned encounters. Support after donation, such as updates on organ transplantation, early mental health checks and continued connection to donor organizations, could be improved. We derived 20 suggestions for improving the organ donation process, derived from interviews with family members of pediatric and adult organ donors. INTERPRETATION: We found gaps in family support during end-of-life and donation care. Feelings of abandonment, lack of support and poor-to-little follow-up provide the empirical findings needed for hospitals and organ donor organizations to provide better support to donor families.

Brain Computer Interfaces and Communication Disabilities: Ethical, Legal, and Social Aspects of Decoding Speech From the Brain.

A brain-computer interface technology that can decode the neural signals associated with attempted but unarticulated speech could offer a future efficient means of communication for people with severe motor impairments. Recent demonstrations have validated this approach. Here we assume that it will be possible in future to decode imagined (i.e., attempted but unarticulated) speech in people with severe motor impairments, and we consider the characteristics that could maximize the social utility of a BCI for communication. As a social interaction, communication involves the needs and goals of both speaker and listener, particularly in contexts that have significant potential consequences. We explore three high-consequence legal situations in which neurally-decoded speech could have implications: Testimony, where decoded speech is used as evidence; Consent and Capacity, where it may be used as a means of agency and participation such as consent to medical treatment; and Harm, where such communications may be networked or may cause harm to others. We then illustrate how design choices might impact the social and legal acceptability of these technologies.

The COVID-19 pandemic and organ donation and transplantation: ethical issues.

BACKGROUND: The COVID-19 pandemic has had a significant impact on the health system worldwide. The organ and tissue donation and transplantation (OTDT) system is no exception and has had to face ethical challenges related to the pandemic, such as risks of infection and resource allocation. In this setting, many Canadian transplant programs halted their activities during the first wave of the pandemic. METHOD: To inform future ethical guidelines related to the COVID-19 pandemic or other public health emergencies of international concern, we conducted a literature review to summarize the ethical issues. RESULTS: This literature review identified three categories of ethical challenges. The first one describes the general ethical issues and challenges reported by OTDT organizations and transplantation programs, such as risks of COVID-19 transmission and infection to transplant recipients and healthcare professionals during the transplant process, risk of patient waitlist mortality or further resource strain where transplant procedures have been delayed or halted, and resource allocation. The second category describes ethical challenges related to informed consent in the context of uncertainty and virtual consent. Finally, the third category describes ethical issues related to organ allocation, such as social considerations in selecting transplant candidates. CONCLUSION: This literature review highlights the salient ethical issues related to OTDT during the current COVID-19 pandemic. As medical and scientific knowledge about COVID-19 increases, the uncertainties related to this disease will decrease and the associated ethical issues will continue to evolve.

Ethical considerations in the use of pre-mortem interventions to support deceased organ donation: A scoping review.

AIM: Pre-mortem interventions (PMIs) are performed on patients before the determination of death in order to preserve or enhance the possibility of organ donation. These interventions can be ethically controversial, and we thus undertook a scoping review of the ethical issues surrounding diverse PMIs. METHODS: Using modified scoping review methods, we executed a search strategy created by an information specialist. Screening and iterative coding of each article was done by two researchers using qualitative thematic analysis, and narrative summaries of coded themes were presented. RESULTS: We identified and screened 5365 references and coded 196 peer-reviewed publications. The most frequently cited issues were related to possible harms to the patient who is a potential donor, and legitimacy of consent. The most controversial issue was that PMIs may place patients at risk for physical harm, yet benefit is accrued mainly to recipients. Some authors argued that lack of direct medical benefit to the still living patient precluded valid consent from surrogate decision makers (SDMs), while many stated that some medical risk could be approved by SDMs if it aligns with non-medical benefits valued by the patient. CONCLUSION: PMIs require consensus that benefit includes concepts beyond medical benefit to the patient who is a potential donor. Informed consent must be confirmed for each PMI and not assumed to be part of general consent for donation. Risk must be proportionate to the potential benefit and newly proposed interventions should be reviewed carefully for medical efficacy and potential risks.

Canadian Society of Transplantation White Paper: Ethical and Legal Considerations for Alcohol and Cannabis Use in Solid Organ Listing and Allocation.

Alcohol and cannabis use as a contraindication to organ transplantation is a controversial issue. Until recently, patients in Canada with alcohol-associated liver disease were required to demonstrate abstinence for 6 mo to receive a liver transplant. There is no equivalent rule that is applied consistently for cannabis use. There is some evidence that alcohol and cannabis use disorder pretransplant could be associated with worse outcomes posttransplantation. However, early liver transplantation for patients with alcohol-associated liver disease in France and in the United States has led to challenges of the 6-mo abstinence rule in Canada in the media. It has also resulted in several legal challenges arguing that the rule violates human rights laws regarding discrimination in the provision of medical services and that the rule is also unconstitutional (this challenge is still before the court). Recent legalization of cannabis use for adults in Canada has led to questions about the appropriateness of limiting transplant access based on cannabis use. The ethics committee of the Canadian Society of Transplantation was asked to provide an ethical analysis of cannabis and alcohol abstinence policies. Our conclusions were as follows: neither cannabis use nor the 6-mo abstinence rule for alcohol use should be an absolute contraindication to transplantation, and transplant could be offered to selected patients, further research should be conducted to ensure evidence-based policies; and the transplant community has a duty not to perpetuate stigma associated with alcohol and cannabis use disorders.

Resumption of Cardiac Activity after Withdrawal of Life-Sustaining Measures.

BACKGROUND: The minimum duration of pulselessness required before organ donation after circulatory determination of death has not been well studied. METHODS: We conducted a prospective observational study of the incidence and timing of resumption of cardiac electrical and pulsatile activity in adults who died after planned withdrawal of life-sustaining measures in 20 intensive care units in three countries. Patients were intended to be monitored for 30 minutes after determination of death. Clinicians at the bedside reported resumption of cardiac activity prospectively. Continuous blood-pressure and electrocardiographic (ECG) waveforms were recorded and reviewed retrospectively to confirm bedside observations and to determine whether there were additional instances of resumption of cardiac activity. RESULTS: A total of 1999 patients were screened, and 631 were included in the study. Clinically reported resumption of cardiac activity, respiratory movement, or both that was confirmed by waveform analysis occurred in 5 patients (1%). Retrospective analysis of ECG and blood-pressure waveforms from 480 patients identified 67 instances (14%) with resumption of cardiac activity after a period of pulselessness, including the 5 reported by bedside clinicians. The longest duration after pulselessness before resumption of cardiac activity was 4 minutes 20 seconds. The last QRS complex coincided with the last arterial pulse in 19% of the patients. CONCLUSIONS: After withdrawal of life-sustaining measures, transient resumption of at least one cycle of cardiac activity after pulselessness occurred in 14% of patients according to retrospective analysis of waveforms; only 1% of such resumptions were identified at the bedside. These events occurred within 4 minutes 20 seconds after a period of pulselessness. (Funded by the Canadian Institutes for Health Research and others.).

Ethics of Digital Mental Health During COVID-19: Crisis and Opportunities.

Social distancing measures due to the COVID-19 pandemic have accelerated the adoption and implementation of digital mental health tools. Psychiatry and therapy sessions are being conducted via videoconferencing platforms, and the use of digital mental health tools for monitoring and treatment has grown. This rapid shift to telehealth during the pandemic has given added urgency to the ethical challenges presented by digital mental health tools. Regulatory standards have been relaxed to allow this shift to socially distanced mental health care. It is imperative to ensure that the implementation of digital mental health tools, especially in the context of this crisis, is guided by ethical principles and abides by professional codes of conduct. This paper examines key areas for an ethical path forward in this digital mental health revolution: privacy and data protection, safety and accountability, and access and fairness.