In This Together: Navigating Ethical Challenges Posed by Family Clustering during the Covid-19 Pandemic.

Harrowing stories reported in the media describe Covid-19 ravaging through families. This essay reports professional experiences of this phenomenon, family clustering, as encountered during the pandemic's spread across Southern California. We identify three ethical challenges following from it: Family clustering impedes shared decision-making by reducing available surrogate decision-makers for incapacitated patients, increases the emotional burdens of surrogate decision-makers, and exacerbates health disparities for and the suffering of people of color at increased likelihood of experiencing family clustering. We propose that, in response to these challenges, efforts in advance care planning be expanded, emotional support offered to surrogates and family members be increased, more robust state guidance be issued on ethical decision-making for unrepresented patients, ethics consultation be increased in the setting of conflict following from family clustering dynamics, and health care professionals pay more attention to systemic and personal racial biases and inequities that affect patient care and the surrogate experience.

Observational study of parental opinion of deferred consent for neonatal research.

OBJECTIVE: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent. DESIGN: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent. SETTING: Tertiary-level neonatal intensive care unit, Melbourne, Australia. RESULTS: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming. CONCLUSION: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

[Action before ethical dilemmas in the consultation after divorce. Role of the minor according to age and level of maturity]. / Actuación ante los dilemas éticos en la consulta tras divorcio. Papel del menor según edad y nivel de madurez.

Lately, number of divorces is increasing, nevertheless, a parents' divorce can become a traumatic problem for paediatric patients. Consequently, the aim of this study was to analyze the ethical conflicts that appear in the relationship between physician/parents/son/daughter, and more specifically those that a divorce generates. A descriptive study was developed through a survey composed by 39 items. Previously, an exhaustive bibliographic analysis was carried out. Our results show that only 35% of paediatricians interviewed have been educated in bioethics although this issue is important in daily practice. Other items show that 57,5% would not cancel a pharmacological treatment in order to improve quality of life. Also, they would react against a wrong parents' decision (82,5%). They give low value to the minor`s decision (6,05%), and rarely inform exclusively to adolescents (5%). In contrast, paediatricians sometimes ask to adolescents (20%) in first place and involved them to decide in 90% of cases. Besides, there are differences in the relation with fathers and mothers, 17,5% of mothers are informed exclusively, a fact that never happens with fathers. Ethics has an intrinsic value very important in daily clinical decisions in order to respect the rules and to adapt them to the situation of every paediatric patient. When an important ethical conflict become, as a divorce is, it is essential to know who must be informed and the rights everyone has to make a decision. It is complicated to the paediatricians yet to develop 41/2002 law for Patient's autonomy.

Dental Radiographs for Age Estimation in US Asylum Seekers: Methodological, Ethical, and Health Issues.

Unaccompanied migrant children seeking asylum status in the United States are often forced to undergo dental radiographs, or x-rays, to verify that they are younger than 18 years.The application of third molar dental radiographs is methodologically flawed and should not be employed as a determinant of chronological age. Furthermore, the use of such tests without obtaining informed consent from either the youth or an objective advocate is unethical.Finally, the legal and health consequences of these inappropriately applied tests are severe and jeopardize the safety and security of these vulnerable minors.

COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic.

The current coronavirus disease 2019 (COVID-19) pandemic has triggered an intense global research effort to inform the life-saving work of frontline clinicians who need reliable information as soon as possible. Yet research done in pressured circumstances can lead to ethical dilemmas, especially for vulnerable research subjects. We present the case of a child with neurocognitive impairment who is diagnosed with COVID-19 infection after presenting with fever and a seizure. The child lives in a group home and is in the custody of the state; her parents lost parental rights many years ago. Some members of the health care team want to enroll her in a randomized clinical trial evaluating an experimental treatment of COVID-19. For minor patients to enroll in this clinical trial, the institutional review board requires assent of patients and consent of guardians. An ethics consult is called to help identify relevant concerns in enrollment. In the accompanying case discussion, we address historical perspectives on research involving people with disabilities; proper management of research participation for people with disabilities including consent by proxy, therapeutic misconception, and other threats to the ethical validity of clinical trials; and the potentially conflicting obligations of researchers and clinicians.

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.

Marginally Represented Patients and the Moral Authority of Surrogates.

Incapacitated adult patients are commonly divided into two groups for purposes of decision making; those with a surrogate and those without. Respectively, these groups are often referred to as represented and unrepresented, and the relative ethics of decision making between them raises two particular issues. The first issue involves the differential application of the best interests standard between groups. Second is the prevailing notion that representedness and unrepresentedness are categorical phenomena, though it is more aptly understood as a multidimensional and continuous variable based on relational moral authority. This paper examines the nature of representedness as it relates to ethical norms of surrogate decision making.

Against the family veto in organ procurement: Why the wishes of the dead should prevail when the living and the deceased disagree on organ donation.

The wishes of registered organ donors are regularly set aside when family members object to donation. This genuine overruling of the wishes of the deceased raises difficult ethical questions. A successful argument for providing the family with a veto must (a) provide reason to disregard the wishes of the dead, and (b) establish why the family should be allowed to decide. One branch of justification seeks to reconcile the family veto with important ideas about respecting property rights, preserving autonomy, and preventing harm. These arguments are ultimately unsuccessful. Another branch of arguments is consequentialist, pointing out the negative consequences of removing the veto. Whether construed as concerning family distress or as a potential drop in the organs available, these arguments are unsuccessful; the first fails to recognize the tremendous distress associated with waiting for an organ, while the second has little supporting evidence. A final section considers and rejects whether combining some of the arguments just examined could justify the family veto. We should thus remove the family veto in organ donation.

Ethics of organ procurement from the unrepresented patient population.

The shortage of organs for transplantation by its nature prompts ethical dilemmas. For example, although there is an imperative to save human life and reduce suffering by maximising the supply of vital organs, there is an equally important obligation to ensure that the process by which we increase the supply respects the rights of all stakeholders. In a relatively unexamined practice in the USA, organs are procured from unrepresented decedents without their express consent. Unrepresented decedents have no known healthcare wishes or advance care planning document; they also lack a surrogate. The Revised Uniform Anatomical Gift Act (RUAGA) of 2006 sends a mixed message about the procurement of organs from this patient population and there are hospitals that authorise donation. In addition, in adopting the RUAGA, some states included provisions that clearly allow organ procurement from unrepresented decedents. An important unanswered question is whether this practice meets the canons of ethical permissibility. The current Brief Report presents two principled approaches to the topic as a way of highlighting some of the complexities involved. Concluding remarks offer suggestions for future research and discussion.

Speaking for Our Father.

A living will is a document in which an individual can communicate his or her health care choices to loved ones in the event that he or she is unable to do so directly. Many surrogate decision-makers use living wills as guides; however, the existence of such documents does not entirely relieve them of their burden. Surrogate decision-makers often need to consider the impact of the personal and family burdens entailed by their decisions, and the stress accompanying these burdens regularly creates high levels of anxiety and depression. This stress can be exacerbated when two surrogate decision-makers are at loggerheads as to the best way forward. This case study illustrates the effects of stress accompanying disagreement among surrogate decision-makers-here, the patient's adult sons-and demonstrates that a process of listening can help the bioethicist identify the values that are important to the patient and, consequently, to the surrogate as well, and use these values to help address the issue.

Five Things Clinicians Should Know When Caring for Unrepresented Patients.

Increasingly, clinicians confront patients who are incapacitated and have no available surrogate. Such unrepresented patients cannot consent to proposed health care, and nobody else is available who is authorized to consent on their behalf. Despite the challenge of decision making for unrepresented patients, few laws or professional organization policy statements offer a solution. This article helps fill this void by describing the top 5 things clinicians should know when they are caring for unrepresented patients: (1) realize that these patients are highly vulnerable; (2) confirm that the patient is incapacitated; (3) confirm that the patient is unrepresented; (4) appreciate variability among state law decision-making processes for unrepresented patients; (5) use guardianship only as a last resort.

Who Makes Decisions for Incapacitated Patients Who Have No Surrogate or Advance Directive?

Unrepresented patients are those who have no surrogate or advance directive to guide medical decision making for them when they become incapacitated. While there is no perfect solution to the problem of making medical decisions for such vulnerable patients, 3 different approaches are noted in the literature: a physician approach, an ethics committee approach, and a guardianship approach. Recent policies and laws have required an approach that is "tiered" with respect to both who is involved and the gravity of the medical treatment questions at issue. In a general sense, some variant of a tiered approach is likely the best possible solution for jurisdictions and health institutions-both those already with and those without a tiered approach-to the challenging puzzle of treating unrepresented patients.

Who Are "Unrepresented" Patients and What Count as "Important" Medical Decisions for Them?

Unrepresented patients are hospital patients who lack decision-making capacity but have no advance directive and no one to serve as a legally authorized surrogate. An important first step in efforts to change the law and develop organizational policies that help respond to these patients' needs is determining which patients should be considered unrepresented and which aspects of hospital care should receive attention. This article proposes working definitions of unrepresented patient and important medical decisions based on the work of one statewide initiative, the Unrepresented Patients Project for Illinois.

Should Long-Term Life-Sustaining Care Be Started in Emergency Settings?

Decision making on behalf of an incapacitated patient is challenging, particularly in the context of venoarterial extracorporeal membrane oxygenation (VA-ECMO), a medically complex, high-risk, and costly intervention that provides cardiopulmonary support. In the absence of a surrogate and an advance directive, the clinical team must make decisions for such patients. Because states vary in terms of which decisions clinicians can make, particularly at the end of life, the legal landscape is complicated. This commentary on a case of withdrawal of VA-ECMO in an unrepresented patient discusses Extracorporeal Life Support Organization guidelines for decision making, emphasizing the importance of proportionality in a benefits-to-burdens analysis.

Changing the Question.

Jack, who is seventy-five years old, is in the hospital with a terminal condition that has undermined his cognitive faculties. He has left no advance directive and has never had a conversation in which he made his treatment wishes remotely clear. Yet now, a treatment decision must be made, and in modern American medicine, the treatment decision for Jack is supposed to be made by a surrogate decision-maker, who is supposed to use a decision-making standard known as "substituted judgment." According to the substituted judgment standard, Jack's surrogate decision-maker, his wife, is supposed to decide on his treatment by determining what Jack would do if he did have decisional capacity. That is, she is supposed to answer the question, what would the patient choose? I will argue that this is the wrong question to ask because when the question has a determinate answer, that answer is sometimes not sufficiently connected to the value that is supposed to make the question morally salient, and because sometimes, perhaps often, there is no determinate answer to the question of what the patient would choose. Jointly, these two problems suggest the need for a different question.

Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research.

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.