Pediatric Assent in Clinical Practice: A Critical Scoping Review.

BACKGROUND: This study assesses how pediatric assent is conceptualized and justified within the therapeutic context. Pediatric ethicists generally agree that children should participate in medical care decisions in developmentally appropriate ways. Much attention has been paid to pediatric assent for research participation, but ambiguities persist in how assent is conceptualized and operationalized in the therapeutic context where countervailing considerations such as the child's best interest and parental permission must also be weighed. METHODS: Searches were conducted in 11 databases including PubMed, Embase, Cochrane Library, and Web of Science. Articles published between 2010 and 2020 were screened in COVIDENCE for meeting each of four criteria: (1) focusing on pediatric assent, (2) focusing on clinical care, (3) including normative claims, and (4) containing substantive statements about the meaning of pediatric assent. Full texts were abstracted for (1) operational definitions of assent, (2) discussion of the temporal nature of assent, (3) description of the concept of "understanding," and (4) ethical justifications for soliciting assent. These excerpts were coded and code patterns formed themes presented in the results. RESULTS: The final analytic data set contained 29 articles. Analysis yielded three key themes. First, valid assent varies by treatment, population (e.g., younger versus older), and geographic/cultural context. Second, assent represents two distinct longitudinal processes: One involves eliciting preferences over a disease course or care episode; the other focuses on children's developmental maturation. Third, ethical justifications for assent draw variously on instrumental and intrinsic reasons, but often remain ambiguous. CONCLUSIONS: There is widespread agreement that assent is morally valuable, but there remain substantial ambiguities or disagreements about its meaning, process, and ethical justification.

When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

Arguments for a ban on pediatric intersex surgery: A dis/analogy with Jehovah witness blood transfusion.

This article argues for a ban on the performance of medically unnecessary genital normalizing surgeries as part of assigning a binary sex/gender to infants with intersex conditions on the basis of autonomy, regardless of etiology. It does this via a dis/analogy with the classic case in bioethics of Jehovah Witness (JW) parents' inability to refuse life-saving blood transfusions for their minor children. Both cases address ethical medical practice in situations where parents are making irreversible medical decisions on the basis of values strongly held, identity, and relationship-shaping values-such as religious beliefs or beliefs regarding the inherent value of binary sex/gender-amidst ethical pluralism. Furthermore, it takes seriously-as we must in the intersex case-that the restriction of parents' right to choose will likely result in serious harms to potentially large percentage of patients, their families, and their larger communities. I address the objection that parents' capacity to choose is restricted in the JW case on the basis of the harm principle or a duty to nonmaleficence, given that the result of parent choice would be death. I provide evidence that this is mistaken from how we treat epistemic uncertainty in the JW case and from cases in which clinicians are ethically obligated to restrict the autonomy of nonminor patients. I conclude that we restrict the parents' right to choose in the JW case-and should in the case of pediatric intersex surgery-to secure patient's future autonomy.

No consent for brain death testing.

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court questioned whether the clinicians were even required to seek consent from the parents of a child at all.

Aspectos bioéticos sobre el consentimiento informado en el uso de las vacunas en Pediatría / Bioethical aspects of informed consent for the use of vaccines in Pediatrics

Introducción: El consentimiento informado en Pediatría, es un proceso de toma de decisiones progresivo, consensuado y dialogado, centrado en una relación tripartita (pediatra, niño y padres), en virtud de la cual, estos últimos, aceptan o no las acciones de vacunación, las cuales han mejorado la prevención de distintas enfermedades infecciosas que afectan la salud de la población infantil y provocan gran morbilidad, mortalidad y secuelas. Objetivo: Exponer los principales aspectos bioéticos relacionados con el consentimiento informado en el uso de las vacunas en Pediatría. Material y Métodos: Se realizó una revisión de la literatura en español e inglés acerca del tema utilizando motores de búsqueda como Google Académico, y se consultaron 42 artículos de libre acceso en las bases de datos SciELO y Pubmed. Se analizó la bibliografía de los últimos 20 años, fundamentalmente de los últimos 5 años, desde 2000 hasta 2020. Desarrollo: Las vacunas son intervenciones preventivas que tienen una historia centenaria que demuestra su bondad y su eficacia, pero han planteado problemas éticos desde su comienzo. El consentimiento informado para su administración no se implementa con el mismo rigor en todas las regiones del mundo. Conclusiones: La vacunación en Pediatría constituye una práctica frecuente, por lo que es necesario el uso del consentimiento informado debidamente redactado y autorizado por los tutores legales o el paciente, que incluya la explicación de los propósitos, los procedimientos a que será sometido, los posibles daños y beneficios, y los posibles resultados de la misma(AU)

Introduction: Informed consent in Pediatrics is a progressive, consensual and dialogue-based decision-making process focused on a tripartite relationship (pediatrician-child-parents), under which the latter accept or do not accept the actions towards vaccination that have improved the prevention of different infectious diseases that affect the health of the child population and cause great morbidity, mortality and sequelae. Objective: To state the main bioethical aspects related to informed consent for the use of vaccines in Pediatrics. Material and Methods: A review of literature on the topic in Spanish and English was carried out using search engines such as Google Scholar. Also, 42 open access articles were consulted in the SciELO and Pubmed databases. The bibliography of the last 20 years was analyzed. It mainly included articles published during the last 5 years (from 2000 to 2020). Development: Vaccines are preventive interventions that have a centuries-old history that demonstrates their goodness and effectiveness, but have posed ethical problems since the very beginning. Informed consent for their administration is not implemented with the same rigor in all regions of the world. Conclusions: Vaccination in Pediatrics is a frequent practice, so a duly drafted informed consent authorized by the legal guardians or the patient is necessary. It should include the explanation of the aims, the procedures to which the patient will be submitted, the possible damages and benefits, and the possible results(AU)

Can Parents Restrict Access to Their Adolescent's Voice?: Deciding About a Tracheostomy.

Parents are the default decision-makers for their infants and children. Their decisions should be based on the best interests of their children. Differing interpretations of children's best interests may be a source of conflict. Providers' biased evaluations of patients' quality of life may undermine medicine's trustworthiness. As children mature, they should participate in medical decision-making to the extent that is developmentally appropriate. In this month's Ethics Rounds, physicians, a philosopher, and a lawyer consider parents' demand, supported by the hospital's legal department, that their 17-year-old son be excluded from a potentially life-and-death medical decision.

Principles of ethical consideration required for clinical research involving children.

Ethical considerations are more stringent in pediatric clinical research than in research targeting adults. However, in Japan, clear guidelines have yet to be presented on the necessary ethical considerations for clinical research involving children. The "Principles of Ethical Consideration Required for Clinical Research Involving Children" provide guiding principles for ethical considerations and the essential ways of thinking that all involved in clinical research on children need to understand in advance.

For Victims of Fatal Child Abuse, Who Has the Right to Consent to Organ Donation?

In rare circumstances, children who have suffered traumatic brain injury from child abuse are declared dead by neurologic criteria and are eligible to donate organs. When the parents are the suspected abusers, there can be confusion about who has the legal right to authorize organ donation. Furthermore, organ donation may interfere with the collection of forensic evidence that is necessary to evaluate the abuse. Under those circumstances, particularly in the context of a child homicide investigation, the goals of organ donation and collection and preservation of critical forensic evidence may seem mutually exclusive. In this Ethics Rounds, we discuss such a case and suggest ways to resolve the apparent conflicts between the desire to procure organs for donation and the need to thoroughly evaluate the evidence of abuse.

"The Hopkins Mongol Case": The Dawn of the Bioethics Movement.

One of the earliest controversies in the modern history of bioethics was known at the time as "the Hopkins Mongol case," involving an infant with Trisomy 21 and duodenal atresia whose parents declined to consent to surgery. Fluids and feeding were withheld, and the infant died of dehydration after 15 days. The child's short life had a profound impact on the author's career and that of several others and ultimately led to changes in the care of children and adults with disabilities and the way difficult end-of-life decisions are made in US hospitals today. It also contributed to the growth of the modern bioethics movement and scholarship focused on pediatric bioethics issues.

Uncertainty: An Uncomfortable Companion to Decision-making for Infants.

Although parents are typically the most appropriate decision-makers for their children, there are limits to this authority. Medical providers may be ethically obligated to seek state intervention against a parental decision if the parent places a child at significant and imminent risk of serious harm. When parents make medical decisions for their children, they assess both the projected benefits and risks of their choices for their family. These assessments are impacted by uncertainty, which is a common feature of neonatal intensive care. The relative presence or absence of uncertainty may impact perceptions of parental decisions and a medical provider's decision to seek state intervention to overrule parents. In this article, we propose a model integrating prognostic uncertainty into pediatric decision-making that may aid providers in such assessments. We will demonstrate how to apply this model to 3 neonatal cases and propose that the presence of greater uncertainty ought to permit parents greater latitude to incorporate family values into their decision-making even if these decisions are contradictory to the recommendations of the medical team.

When Does A Minor's Legal Competence To Make Health Care Decisions Matter?

In this article, I examine the role of minors' competence for medical decision-making in modern American law. The doctrine of parental consent remains the default legal and bioethical framework for health care decisions on behalf of children, complemented by a complex array of exceptions. Some of those exceptions vest decisional authority in the minors themselves. Yet, in American law, judgments of minors' competence do not typically trigger shifts in decision-making authority from adults to minors. Rather, minors' decisional capacity becomes relevant only after legislatures or courts determine that the default of parental discretion does not achieve important policy goals or protect implicated constitutional rights in a particular health care context and that those goals can best be achieved or rights best protected by authorizing capable minors to choose for themselves. It is at that point that psychological and neuroscientific evidence plays an important role in informing the legal inquiry as to whether minors whose health is at issue are legally competent to decide.

Ethical Issues Raised by the Media Portrayal of Adolescent Transplant Refusals.

Cases of adolescents in organ failure who refuse solid organ transplant are not common, but several have been discussed in the media in the United States and the United Kingdom. Using the framework developed by Buchanan and Brock for surrogate decision-making, I examine what role the adolescent should morally play when deciding about therapy for life-threatening conditions. I argue that the greater the efficacy of treatment, the less voice the adolescent (and the parent) should have. I then consider how refusals of highly effective transplant cases are similar to and different from refusals of other lifesaving therapies (eg, chemotherapy for leukemia), which is more commonly discussed in the media and medical literature. I examine whether organ scarcity and the need for lifelong immunosuppression justify differences in whether the state intervenes when an adolescent and his or her parents refuse a transplant. I argue that the state, as parens patriae, has an obligation to provide the social supports needed for a successful transplant and follow-up treatment plan, although family refusals may be permissible when the transplant is experimental or of low efficacy because of comorbidities or other factors. I conclude by discussing the need to limit media coverage of pediatric treatment refusals.

Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations.

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is "too immature" and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or limit adolescent participation, jeopardizing study findings' validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible.

Can a Parent Refuse the Brain Death Examination?

The American Academy of Neurology believes that doctors have the right to do tests to evaluate whether a patient is brain dead even if the family does not consent. They argue that physicians have "both the moral authority and professional responsibility" to do such evaluations, just as they have the authority and responsibility to declare someone dead by circulatory criteria. Not everyone agrees. Truog and Tasker argue that apnea testing to confirm brain death has risks and that, for some families, those risks may outweigh the benefits. So, what should doctors do when caring for a patient whom they believe to be brain dead but whose parents refuse to allow testing to confirm that the patient meets neurologic criteria for death? In this article, we analyze the issues that arise when parents refuse such testing.

Long-term Puberty Suppression for a Nonbinary Teenager.

Many transgender and gender-diverse people have a gender identity that does not conform to the binary categories of male or female; they have a nonbinary gender. Some nonbinary individuals are most comfortable with an androgynous gender expression. For those who have not yet fully progressed through puberty, puberty suppression with gonadotrophin-releasing hormone agonists can support an androgynous appearance. Although such treatment is shown to ameliorate the gender dysphoria and serious mental health issues commonly seen in transgender and gender-diverse young people, long-term use of puberty-suppressing medications carries physical health risks and raises various ethical dilemmas. In this Ethics Rounds, we analyze a case that raised issues about prolonged pubertal suppression for a patient with a nonbinary gender.