Legal and Ethical Considerations for Requiring Consent for Apnea Testing in Brain Death Determination.

The past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria (DNC). The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for requiring consent before apnea testing and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: (1) a justice-based objection to allocate scarce resources fairly and (2) a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors.

How Should Physicians Manage Organ Donation after the Circulatory Determination of Death in Patients with Extremely Poor Neurological Prognosis?

Organ donation after the circulatory determination of death (DCDD) accounts for a growing percentage of deceased organ donations. Although hospital DCDD protocols stipulate donor death determination, some do not adhere to national guidelines that require mechanical, not electrical, asystole. Surrogate decisions to withdraw life-sustaining therapy should be separated from decisions to donate organs. Donor families should be given sufficient information about the DCDD protocol and its impact on the dying process to provide informed consent, and donors should be given proper palliative care during dying. An unresolved ethical question is whether and how donor consent should be seen as authorizing manipulation of a living donor during the dying process solely for to benefit of the organ recipient.

From Healthcare to Warfare and Reverse: How Should We Regulate Dual-Use Neurotechnology?

Recent advances in military-funded neurotechnology and novel opportunities for misusing neurodevices show that the problem of dual use is inherent to neuroscience. This paper discusses how the neuroscience community should respond to these dilemmas and delineates a neuroscience-specific biosecurity framework. This neurosecurity framework involves calibrated regulation, (neuro)ethical guidelines, and awareness-raising activities within the scientific community.

[Non-heart-beating donors are ineligible]. / "Non-heart-beating donors" sind nicht geeignet.

The death of the donor is a mandatory prerequisite for organ transplantation (dead donor rule) worldwide. It is a medical, legal and ethical consensus to accept the concept of brain death, as first proposed in 1968 by the ad hoc committee of the Harvard Medical School, as a certain criterion of death. In isolated cases where the diagnosis of brain death was claimed to be wrong, it could be demonstrated that the diagnostic procedure for brain death had not been correctly performed. In March 2014 a joint statement by the German neuromedical societies emphasized that 1) the diagnosis of brain death is one of the safest diagnoses in medicine if performed according to accepted medical standards and criteria and 2) the concept of non-heart-beating donors (NHBD, i. e. organ donation after an arbitrarily defined duration of circulatory and cardiac arrest) practiced in some European countries must be absolutely rejected because it implicates a high risk of diagnostic error. According to the current literature it is unclear at what time cardiac and circulatory arrest is irreversible and leads to irreversible cessation of all functions of the entire brain including the brainstem, even though clinical signs of cessation of brain functions are always found after 10 min. Furthermore, is it often an arbitrary decision to exactly define the duration of cardiac arrest if continuous echocardiographic monitoring has not been carried out from the very beginning. Last but not least there are ethical concerns against the concept of NHBD because it might influence therapeutic efforts to resuscitate a patient with cardiac arrest. Therefore, the German Medical Council (BÄK) has repeatedly rejected the concept of NHBD for organ transplantation since 1995.

[Fourth update of the guidelines on determination of irreversible brain death. Procedural course and amendments]. / Vierte Fortschreibung der Richtlinie zur Feststellung des irreversiblen Hirnfunktionsausfalls. Verfahrensabläufe und Neuerungen.

In 2015 the fourth update of the directive for the determination of definitely irreversible loss of complete function of the cerebrum, cerebellum and brainstem was passed and came into force. This was preceded by several hearings of all professional societies and associations involved as well as a 2-year advisory process of an interdisciplinary working party. The directive is intended to determine irreversible brain death in the field of intensive care medicine and is independent of individual decisions about organ donation. Not only an update based on scientific data but also a clarification of the several procedures and a clear definition of the medical qualifications required were worked out. Furthermore, the technical procedures computed tomography (CT) angiography and duplex sonography were adopted for the diagnosis of cerebral circulatory arrest. The new directive including comprehensive explanatory notes was approved by the German Federal Ministry of Health and published by the German Medical Council (Bundesärztekammer).

Déficit motor asociado a analgesia epidural en paciente con patología neurológica preexistente no conocida / No disponible

Existen múltiples estudios que afirman que las complicaciones neurológicas asociadas a la práctica de un bloqueo neuroaxial pueden tener una mayor incidencia en los pacientes que presentan enfermedades neurológicas preexistentes como la estenosis espinal. Esta incidencia puede ser especialmente relevante si no se cuenta con un diagnóstico previo de dichas patologías. En el presente trabajo describimos nuestra experiencia con una mujer de 60 años de edad, diagnosticada de isquemia crónica de miembro inferior derecho, que presentó un déficit motor importante tras la colocación de un catéter epidural para el manejo del dolor (AU)

There are many studies that suggest that the neurological complications associated with the practice of neuraxial blockade may have a higher incidence in patients with preexisting neurological conditions such as spinal stenosis. This effect may be particularly relevant if there is no previous diagnosis of these pathologies. We describe our experience with a 60-year-old woman diagnosed with chronic ischemia of the right leg which presented an important motor deficit following epidural catheter insertion for pain management (AU)

To provoke or not provoke: ethical considerations in the epilepsy monitoring unit.

Epilepsy is the second most common neurological disorder after migraines and headaches, with an economic burden of 15.5 billion dollars annually. Most patients with epilepsy can be controlled with antiepileptic drugs. Those who remain uncontrolled are considered refractory and are often admitted to an epilepsy monitoring unit for definitive diagnosis. Nonepileptic seizures are a common differential diagnosis in persons with refractory seizures. It is helpful for providers to witness the patients' seizures to make a definitive diagnosis for seizure classification. Frequently, unstandardized practice-provocation techniques are employed in an epilepsy monitoring unit setting. The purpose of these techniques is to elicit a seizure. A debate is occurring on whether the use of provocation techniques is ethical and necessary. This article will review the literature related to the current evidence and moral opinions swirling around this topic. It is important for the neuroscience nurse to be familiar with both sides of the seizure provocation debate as he or she will be on the front lines of shaping future policy and practice to come.

A touch of MS: therapeutic mislabeling.

When psychogenic symptomatology is at play, a spectrum of ethical problems and considerations arise when patients want, and at times, insist on being given an inaccurate neurologic diagnosis. We use the example of multiple sclerosis (MS) to highlight the value considerations for clinicians when they face these types of cases. Given the ambiguities involved in its diagnosis and the significant risks of its treatment, MS represents a rich case study. This discussion highlights the potential harms of mislabeling such patients with MS when the neurologist is confident they do not have MS and offers suggestions about how to approach and manage these patients. Despite being expedient and well-intentioned, labeling psychogenic symptoms with a medically inaccurate diagnosis, such as a "touch of MS," constitutes a "therapeutic mislabeling" and sacrifices ethically important values incommensurate with the benefits gained.

Neuroethics, neuroimaging, and disorders of consciousness: promise or peril?

The advent of powerful neuroimaging tools such as functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) has begun to redefine how we diagnose, define, and understand disorders of consciousness such as the vegetative and minimally conscious states. In my paper, I review how research using these methods is both elucidating these brain states and creating diagnostic dilemmas related to their classification as the specificity and sensitivity of traditional behavior-based assessments are weighed against sensitive but not yet fully validated neuroimaging data. I also consider how these methods are being studied as potential communication vectors for therapeutic use in subjects who heretofore have been thought to be unresponsive or minimally conscious. I conclude by considering the ethical challenges posed by novel diagnostic and therapeutic neuroimaging applications and contextualize these scientific developments against the broader needs of patients and families touched by severe brain injury.

Pain assessment: subjectivity, objectivity, and the use of neurotechnology.

The pain clinician is confronted with the formidable task of objectifying the subjective phenomenon of pain so as to determine the right treatments for both the pain syndrome and the patient in whom the pathology is expressed. However, the experience of pain - and its expression - remains enigmatic. Can currently available evaluative tools, questionnaires, and scales actually provide adequately objective information about the experiential dimensions of pain? Can, or will, current and future iterations of biotechnology - whether used singularly or in combination (with other technologies as well as observational-behavioral methods) - afford objective validation of pain? And what of the clinical, ethical, legal and social issues that arise in and from the use - and potential misuse - of these approaches? Subsequent trajectories of clinical care depend upon the findings gained through the use of these techniques and their inappropriate employment - or misinterpretation of the results they provide - can lead to misdiagnoses and incorrect treatment. This essay is the first of a two-part series that explicates how the intellectual tasks of knowing about pain and the assessment of its experience and expression in the pain patient are constituent to the moral responsibility of pain medicine. Herein, we discuss the problem of pain and its expression, and those methods, techniques, and technologies available to bridge the gap between subjective experience and objective evaluation. We address how these assessment approaches are fundamental to apprehend both pain as an objective, neurological event, and its impact upon the subjective experience, existence, and expectations of the person in pain. In this way, we argue that the right use of technology - together with inter-subjectivity, compassion, and insight - can sustain the good of pain care as both a therapeutic and moral enterprise.

Diagnosing consciousness: neuroimaging, law, and the vegetative state.

In this paper, we review recent neuroimaging investigations of disorders of consciousness and different disciplines' understanding of consciousness itself. We consider potential tests of consciousness, their legal significance, and how they map onto broader themes in U.S. statutory law pertaining to advance directives and surrogate decision-making. In the process, we outline a taxonomy of themes to illustrate and clarify the variance in state-law definitions of consciousness. Finally, we discuss broader scientific, ethical, and legal issues associated with the advent of neuroimaging for disorders of consciousness and conclude with policy recommendations that could help to mitigate confusion in this realm.

Perspectives of Canadian researchers on ethics review of neuroimaging research.

The current and potential uses of neuroimaging in healthcare and beyond have spurred discussion about the ethical issues related to neuroimaging and neuroimaging research. This study examined the perspectives of neuroimagers on ethical issues in their research and on the ethics review process. One hundred neuroimagers from 13 Canadian neuroscience centers completed an online survey and 35 semi-structured interviews were conducted. Neuroimagers felt that most ethical and social issues identified in the literature were dealt with adequately, well, and even very well by research ethics boards (REBs), but some issues such as incidental findings and transfer of knowledge were problematic. Neuroimagers reported a range of practical problems in the ethics review process. We aimed to gather perspectives from REB on the ethics review process, but insufficient participation by REBs prevented us from reporting their perspectives. Given shortcomings identified by neuroimagers as well as longstanding issues in Canadian ethics governance, we believe that substantial challenges exist in Canadian research ethics governance that jeopardize trust, communication, and the overall soundness of research ethics governance. Neuroimagers and REBs should consider their shared responsibilities in developing guidance to handle issues such as incidental findings, risk assessment, and knowledge transfer.

Epistemological considerations on neuroimaging--a crucial prerequisite for neuroethics.

PURPOSE: Whereas ethical considerations on imaging techniques and interpretations of neuroimaging results flourish, there is not much work on their preconditions. In this paper, therefore, we discuss epistemological considerations on neuroimaging and their implications for neuroethics. RESULTS: Neuroimaging uses indirect methods to generate data about surrogate parameters for mental processes, and there are many determinants influencing the results, including current hypotheses and the state of knowledge. This leads to an interdependence between hypotheses and data. Additionally, different levels of description are involved, especially when experiments are designed to answer questions pertaining to broad concepts like the self, empathy or moral intentions. Interdisciplinary theoretical frameworks are needed to integrate findings from the life sciences and the humanities and to translate between them. While these epistemological issues are not specific for neuroimaging, there are some reasons why they are of special importance in this context: Due to their inferential proximity, 'neuro-images' seem to be self-evident, suggesting directness of observation and objectivity. This has to be critically discussed to prevent overinterpretation. Additionally, there is a high level of attention to neuroimaging, leading to a high frequency of presentation of neuroimaging data and making the critical examination of their epistemological properties even more pressing. CONCLUSIONS: Epistemological considerations are an important prerequisite for neuroethics. The presentation and communication of the results of neuroimaging studies, the potential generation of new phenomena and new 'dysfunctions' through neuroimaging, and the influence on central concepts at the foundations of ethics will be important future topics for this discipline.