Age-not sex or gender-makes the case of Ellie Anderson Complex.

In 'The Complex Case of Ellie Anderson', Joona Rasanen and Anna Smajdor raise several ethical questions about the case. One question asks, but does not answer, whether Ellie faced discrimination for being transgender when her mother was not allowed access to Ellie's sperm following her death. In raising the question, the authors imply anti-trans bias may have influenced this determination. However, this inference is not supported by current ethical and legal guidance for posthumous use of gametes, with which Ellie's case is consistent. We consider the authors' responses to their other ethical queries, and how their suggestions for what options might have been available to Ellie and her family are instructive for addressing attempts in the USA and UK to restrict minors' access to gender-affirming medical treatment, including puberty-blocking therapy.

LGBT testimony and the limits of trust.

In, 'Forever young: the ethics of ongoing puberty suppression (OPS) for non-binary adults,' Notini et al discuss the risks, harms and benefits of treating non-binary patients via identity-affirming OPS. Notini et al's article makes a strong case for OPS's permissibility, and their conclusion will not be disputed here. Instead, I directly focus on issues that their article addressed only indirectly. This article will use a hypothetical case study to show that while Notini et al's ethical conclusion might be spot on, that perhaps the method they took to get there was superfluous. If the medical community is to take LGBT testimony seriously (as they should) then it is no longer the job of physicians to do their own weighing of the costs and benefits of transition-related care. Assuming the patient is informed and competent, then only the patient can make this assessment, because only the patient has access to the true weight of transition-related benefits. Moreover, taking LGBT patient testimony seriously also means that parents should lose veto power over most transition-related paediatric care.

Are conscientious objectors morally obligated to refer?

In this paper, we argue that providers who conscientiously refuse to provide legal and professionally accepted medical care are not always morally required to refer their patients to willing providers. Indeed, we will argue that refusing to refer is morally admirable in certain instances. In making the case, we show that belief in a sweeping moral duty to refer depends on an implicit assumption that the procedures sanctioned by legal and professional norms are ethically permissible. Focusing on examples of female genital cutting, clitoridectomy and 'normalizing' surgery for children with intersex traits, we argue that this assumption is untenable and that providers are not morally required to refer when refusing to perform genuinely unethical procedures. The fact that acceptance of our thesis would force us to face the challenge of distinguishing between ethical and unethical medical practices is a virtue. This is the central task of medical ethics, and we must confront it rather than evade it.

Placement of long-acting reversible contraception for minors who are mothers should not require parental consent.

Decreasing unintended teenage pregnancy, especially repeat teenage pregnancy, is an important public health goal. Unfortunately, legal barriers in the USA impede this goal as all minors are unable to consent for birth control in 24 states, and only 10 of those states allow consent after the minor has given birth according to state statutory law. Placement of long-acting reversible contraception (LARC) is one of the most effective methods of preventing rapid repeat pregnancies. However, restrictions are placed on adolescents who may not have the option of parental consent if the parents are unwilling, or not present, to give consent. A predicament arises when healthcare professionals are willing to place the contraceptive for the patient, but cannot due to the restrictions and guidelines outlined by each state. Even though these adolescents are legally viewed as minors, adolescent mothers should be able to consent to the placement of LARC. Notably, adolescents have the legal ability to give consent for the healthcare of their child starting in the prenatal period. I argue that this ability should be extended to include adolescent consent for their own healthcare. Additionally, the procedure to place LARC is relatively low risk and highly effective, which is an opportune situation to allow minors to consent. Allowing adolescents to consent to LARC after delivery is a simple and effective way to decrease rapid repeat pregnancy rates in the USA.

Gender dysphoria in adolescents: can adolescents or parents give valid consent to puberty blockers?

This article considers the claim that gender diverse minors and their families should not be able to consent to hormonal treatment for gender dysphoria. The claim refers particularly to hormonal treatment with so-called 'blockers', analogues that suspend temporarily pubertal development. We discuss particularly four reasons why consent may be deemed invalid in these cases: (1) the decision is too complex; (2) the decision-makers are too emotionally involved; (3) the decision-makers are on a 'conveyor belt'; (4) the possibility of detransitioning. We examine each of these reasons and we show that none of these stand up to scrutiny, and that some are based on a misunderstanding of the nature and purposes of this stage of treatment and of the circumstances in which it is usually prescribed. Moreover, accepting these claims at face value could have serious negative implications, not just for gender diverse youth, but for many other minors and families and in a much broader range of healthcare settings.

Terrible choices in the septic child: a response to the PALOH trial round table authors.

In this response article, we challenge a core assumption that lies at the centre of a round table discussion regarding the Pharmacogenetics to Avoid Loss of Hearing trial. The round table regards a genetic test for a variant (mt.1555A>G) that increases the risk of deafness if a carrier is given the antibiotic gentamicin. The idea is that rapid testing can identify neonates at risk, providing an opportunity to prevent giving an antibiotic that might cause deafness. We challenge the assumption that a positive test unequivocally guides antibiotic choice because, aside from the risk of deafness, all antibiotics for neonatal sepsis are equivalent. We argue that this assumption is faulty and has particularly troubling moral consequences. We claim that giving an alternative to gentamicin is potentially providing inferior treatment and thereby may increase the risk of death. Parents and doctors are faced with a terrible choice as a result of positive point-of-care testing (POCT): give gold-standard treatment and risk deafness or give second line care and risk death. While we do not indicate an answer to this choice, what we do argue is that such a deep and difficult choice is one that may make parents wish genetic testing was never undertaken, and therefore, contra some authors in the round table, provides a reason to gain specific consent for POCT.

Using a biomarker acutely to identify babies at risk of serious adverse effects from antibiotics: where is the 'Terrible Moral and Medical Dilemma'?

We thank Parker and Wright for engaging in this roundtable debate in such a spirited way. The 'Pharmacogenetic [test] to Avoid Loss of Hearing' (PALOH) Trial is the first time a genetic point of care test has been applied in the acute neonatal setting; therefore, it is not surprising that questions have been raised which require debate, discussion and clarification. Parker and Wright misattribute several assumptions to the roundtable authors, which we would like to clarify here. Since they raise wider questions about the PALOH trial itself, several of the roundtable discussants have made a joint response.

Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees.

BACKGROUND: This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs' service to the subject of the clinical trial. METHODS: We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC's files and electronic archives. RESULTS: Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval. CONCLUSIONS: Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials' final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.

Consent in children's intensive care: the voices of the parents of critically ill children and those caring for them.

Despite its invasive nature, specific consent for general anaesthesia is rarely sought-rather consent processes for associated procedures include explanation of risk/benefits. In adult intensive care, because no one can consent to treatments provided to incapacitated adults, standardised consent processes have not developed. In paediatric intensive care, despite the ready availability of those who can provide consent, no tradition of seeking it exists, arguably due to the specialty's evolution from anaesthesia and adult intensive care. With the current Montgomery-related focus on consent, this seems untenable. We undertook a qualitative study in a specialist children's hospital colocated paediatric/neonatal intensive care (same medical team) in which parental acceptance of admission and entailed procedures is considered implied by virtue of that admission. Semistructured interviews were carried out with both staff and parents to investigate their views about consent, the current system and a proposed blanket consent system, in which parents actively consent at admission to routine procedures. Divergent views emerged: staff were worried that requiring consent at admission might prove a further emotional burden, whereas parents found providing consent a way of coping, feeling empowered and maintaining control. Inconsistencies were found in the way consent is obtained for your routine procedures. Practice does seem inconsistent with contemporary consent standards for medical intervention. Our findings support the introduction of a blanket consent system at admission together with ongoing bedside dialogue to ensure continuing consent. Both parents and staff expressed concern about avoiding possible harmful delays to children due to parental emotional overload and language difficulties.

Three scenarios illustrating ethical concerns when considering bariatric surgery in obese adolescents with Prader-Willi syndrome.

Prader-Willi syndrome (PWS) is one of the 25 syndromic forms of obesity, in which patients present-in addition to different degrees of obesity-intellectual disability, endocrine disturbs, hyperphagia and/or other signs of hypothalamic dysfunction. In front of a severe/extreme obesity and the failure of non-invasive treatments, bariatric surgery is proposed as a therapeutic option. The complexity of the clinical condition, which could affect the long-term effects of bariatric surgery, and the frequent association with a mild to severe intellectual disability raise some ethical concerns in the treatment of obese PWS adolescents. This article analyses these issues referring to the principles of healthcare ethics: beneficence/non-maleficence (proportionality of treatments; minimisation of risks); respect of autonomy; justice. Based on these principles, three hypothetical scenarios are defined: (1) obese PWS adolescent, capable of making an autonomous decision; (2) obese PWS adolescent with a severe intellectual disability, whose parents agree with bariatric surgery; (3) obese PWS adolescent with a life-threatening condition and a severe intellectual disability, whose parents do not agree with bariatric surgery. The currently available evidence on efficacy and safety of bariatric surgery in PWS adolescents with extreme or severe obesity and the lack of adequate long-term follow-up suggests great caution even in a very life-threatening condition. Clinicians must always obtain a full IQ assessment of patients by psychologists. A multidisciplinary team is needed to analyse the clinical, psychological, social and ethical aspects and organise support for patient and parents, involving also the hospital ethical committee or, if necessary, legal authorities.

Ethically incentivising healthy behaviours: views of parents and adolescents with type 1 diabetes.

BACKGROUND: To assess ethical concerns associated with participation in a financial incentive (FI) programme to help adolescents with type 1 diabetes improve diabetes self-management. METHODS: Focus groups with 46 adolescents with type 1 diabetes ages 12-17 and 38 of their parents were conducted in the Seattle, Washington metropolitan area. Semistructured focus group guides addressed ethical concerns related to the use of FI to promote change in diabetes self-management. Qualitative data were analysed and emergent themes identified. RESULTS: We identified three themes related to the ethical issues adolescents and parents anticipated with FI programme participation. First, FI programmes may variably change pressure and conflict in different families in ways that are not necessarily problematic. Second, the pressure to share FIs in some families and how FI payments are structured may lead to unfairness in some cases. Third, some adolescents may be likely to fabricate information in any circumstances, not simply because of FIs, but this could compromise the integrity of FI programmes relying on measures that cannot be externally verified. CONCLUSIONS: Many adolescents with type 1 diabetes and their parents see positive potential of FIs to help adolescents improve their self-management. However, ethical concerns about unfairness, potentially harmful increases in conflict/pressure and dishonesty should be addressed in the design and evaluation of FI programmes.

Paediatric deep brain stimulation: ethical considerations in malignant Tourette syndrome.

Gilles de la Tourette syndrome (TS) is a childhood neuropsychiatric disorder characterised by the presence of motor and vocal tics. Patients with malignant TS experience severe disease sequelae; risking morbidity and mortality due to tics, self-harm, psychiatric comorbidities and suicide. By definition, those cases termed 'malignant' are refractory to all conventional psychiatric and pharmacological regimens. In these instances, deep brain stimulation (DBS) may be efficacious. Current 2015 guidelines recommend a 6-month period absent of suicidal ideation before DBS is offered to patients with TS. We therefore wondered whether it may be ethically justifiable to offer DBS to a minor with malignant TS. We begin with a discussion of non-maleficence and beneficence. New evidence suggests that suicide risk in young patients with TS has been underestimated. In turn, DBS may represent an invaluable opportunity for children with malignant TS to secure future safety, independence and fulfilment. Postponing treatment is associated with additional risks. Ultimately, we assert this unique risk-benefit calculus justifies offering DBS to paediatric patients with malignant TS. A multidisciplinary team of clinicians must determine whether DBS is in the best interest of their individual patients. We conclude with a suggestion for future TS-DBS guidelines regarding suicidal ideation. The importance of informed consent and assent is underscored.

Minority report: can minor parents refuse treatment for their child?

Infants are unable to make their own decisions or express their own wishes about medical procedures and treatments. They rely on surrogates to make decisions for them. Who should be the decision-maker when an infant's biological parents are also minors? In this paper, we analyse a case in which the biological mother is a child. The central questions raised by the case are whether minor parents should make medical decisions on behalf of an infant, and if so, what are the limits to this decision-making authority? In particular, can they refuse treatment that might be considered best for the infant? We examine different ethical arguments to underpin parental decision-making authority; we argue that provided that minor parents are capable of fulfilling their parental duties, they should have a right to make medical decisions for their infant. We then examine the ethical limits to minor parents' decision-making authority for their children. We argue that the restricted authority that teenagers are granted to make medical decisions for themselves looks very similar to the restricted autonomy of all parents. That is, they are permitted to make choices, but not harmful choices. Like all parents, minor parents must not abuse or neglect their children and must also promote their welfare. They have a moral right to make medical decisions for their infants within the same 'zone of parental discretion' that applies to adult parents. We conclude that adult and minor parents should have comparable decision-making authority for their infants.

Is 'best interests' the right standard in cases like that of Charlie Gard?

Savulescu and colleagues have provided interesting insights into how the UK public view the 'best interests' of children like Charlie Gard. But is best interests the right standard for evaluating these types of cases? In the USA, both clinical decisions and legal judgments tend to follow the 'harm principle', which holds that parental choices for their children should prevail unless their decisions subject the child to avoidable harm. The case of Charlie Gard, and others like it, show how the USA and the UK have strikingly different approaches for making decisions about the treatment of severely disabled children.

The best interest standard and children: clarifying a concept and responding to its critics.

This work clarifies the role of the best interest standard (BIS) as ethical principle in the medical care of children. It relates the BIS to the ethical framework of medical practice. The BIS is shown to be a general principle in medical ethics, providing grounding to prima facie obligations. The foundational BIS of Kopelman and Buchanan and Brock are reviewed and shown to be in agreement with the BIS here defended. Critics describe the BIS as being too demanding, narrow, opaque, not taking the family into account and not suitable as limiting principle. This work responds to these criticisms, showing that they do not stand up to scrutiny. They either do not apply to the BIS, only apply to misuses of the BIS or criticise a BIS that is not seriously defended in the literature.

Reasonable Parental and Medical Obligations in Pediatric Extraordinary Therapy.

The English cases of Charlie Gard and Alfie Evans involved a conflict between the desires of their parents to preserve their children's lives and judgments of their medical teams in pursuit of clinically appropriate therapy. The treatment the children required was clearly extraordinary, including a wide array of advanced life-sustaining technological support. The cases exemplify a clash of worldviews rooted in different philosophies of life and medical care. The article highlights the differing perspectives on parental authority in medical care in England, Canada, and the United States. Furthermore, it proposes a solution that accommodates for both reasonable parental desires and professional medical opinion. This is achieved by looking at concepts of extraordinary therapy, best interest, reasonable parenthood and medical objections. Summary: In cases where a child's treatment involves extraordinary therapy, there is often a conflict of opinion between the medical team and the parents with regard to the best course of action. The assumption should be that responsible, caring parents make reasonable and acceptable decisions for the good of their children. Rather than focusing on making a hypothetical best interest judgment, courts should in the first instance side with the parents. Only when parents act unreasonably or malevolently should their wishes be overridden. This should not affect the medics' right to conscientiously object towards carrying out procedures that they deem to be medically unnecessary or harmful.

A threshold of significant harm (f)or a viable alternative therapeutic option?

This article critically examines the legal arguments presented on behalf of Charlie Gard's parents, Connie Yates and Chris Gard, based on a threshold test of significant harm for intervention into the decisions made jointly by holders of parental responsibility. It argues that the legal basis of the argument, from the case of Ashya King, was tenuous. It sought to introduce different categories of cases concerning children's medical treatment when, despite the inevitable factual distinctions between individual cases, the duty of the judge in all cases to determine the best interests of the child is firmly established by the case law. It argues that the focus should not have been on a threshold for intervention but on whether his parents had established that the therapy they wanted was a viable alternative therapeutic option. In the April hearing, Charlie's parents relied on the offer of treatment from a US doctor; by July they had an independent panel of international experts supporting their case although by this time the medical evidence was that it was too late for Charlie. One of Charlie's legacies for future disputes may be that his case highlighted the need for evidence as to whether the treatment parents want for their child is a viable alternative therapeutic option before a court can determine which therapeutic option is in the best interests of the child.

Charlie Gard and the weight of parental rights to seek experimental treatment.

The case of Charlie Gard, an infant with a genetic illness whose parents sought experimental treatment in the USA, brought important debates about the moral status of parents and children to the public eye. After setting out the facts of the case, this article considers some of these debates through the lens of parental rights. Parental rights are most commonly based on the promotion of a child's welfare; however, in Charlie's case, promotion of Charlie's welfare cannot explain every fact of the case. Indeed, some seem most logically to extend from intrinsic parental rights, that is, parental rights that exist independent of welfare promotion. I observe that a strong claim for intrinsic parental rights can be built on arguments for genetic propriety and children's limited personhood. Critique of these arguments suggests the scope of parental rights remains limited: property rights entail proper use; non-personhood includes only a small cohort of very young or seriously intellectually disabled children and the uniqueness of parental genetic connection is limited. Moreover, there are cogent arguments about parents' competence to make judgements, and public interest arguments against allowing access to experimental treatment. Nevertheless, while arguments based on propriety may raise concerns about the attitude involved in envisioning children as property, I conclude that these arguments do appear to offer a prima facie case for a parental right to seek experimental treatment in certain limited circumstances.

Consenting to invasive contraceptives: an ethical analysis of adolescent decision-making authority for long-acting reversible contraception.

Since USA constitutional precedent established in 1976, adolescents have increasingly been afforded the right to access contraception without first obtaining parental consent or authorisation. There is general agreement this ethically permissible. However, long-acting reversible contraception (LARC) methods have only recently been prescribed to the adolescent population. They are currently the most effective forms of contraception available and have high compliance and satisfaction rates. Yet unlike other contraceptives, LARCs are associated with special procedural risks because they must be inserted and removed by trained healthcare providers. It is unclear whether the unique invasive nature of LARC changes the traditional ethical calculus of permitting adolescent decision-making in the realm of contraception. To answer this question, we review the risk-benefit profile of adolescent LARC use. Traditional justifications for permitting adolescent contraception decision-making authority are then considered in the context of LARCs. Finally, analogous reasoning is used to evaluate potential differences between permitting adolescents to consent for LARC procedures versus for emergency and pregnancy termination procedures. Ultimately, we argue that the invasive nature of LARCs does not override adolescents' unique and compelling need for safe and effective forms of contraception. In fact, LARCs may oftentimes be in the best interest of adolescent patients who wish to prevent unintended pregnancy. We advocate for the specific enumeration of adolescents' ability to consent to both LARC insertion and removal procedures within state policies. Given the provider-dependent nature of LARCs and the stigma regarding adolescent sexuality, special political and procedural safeguards to protect adolescent autonomy are warranted.

Voices of moral authority: parents, doctors and what will actually help.

The public often believes that parents have a right to make medical decisions about their child. The idea that, in respect of children, doctors should do what parents tell them to do is problematic on the face of it. The effect of such a claim would be that a doctor who acted deliberately to harm a child would be making a morally correct decision, providing only that it is what the child's parents said they wanted. That is so obviously nonsense that it cannot be what people who claim it actually mean. In this paper, I suggest that the claim actually represents either or both of two misunderstandings. It can be a result of wrongly appealing to the principle of respect for autonomy, or a belief that doctors are not committed to acting in the interests of the child. In this paper, I show that, while neither belief is entirely justified, there are elements of truth in both. I argue that if ethically correct decisions are those that are directed to improving the quality of a child's existence, then neither parents nor doctors are in a position to make ethically correct decisions about a child except in discussion with one another. Where such discussion is not possible, I suggest there should be a national Children's Interests Panel to agree on the child's interests. The panel should include, but not be limited to, paediatricians and lawyers and its decisions should be legally binding on all parties.