Vic Larcher

Making decisions to limit treatment in life-limiting and life-threatening conditions in children: a framework for practice

It is now more than 18 years since the late Professor David Baum wrote the foreword to the first Withholding and Withdrawing Life Saving Treatment in Children document. Since then the practice of paediatrics has changed radically. We are now seeing increased survival rates for infants born between 22 and 25 weeks gestation, new gene therapies stretching the boundaries of possibility, and advances in paediatric surgical techniques unimaginable in the last millennium. Against this backdrop, we are in an era of ubiquitous access to the internet and widespread use of social media. Children, young people, their parents and carers have very different knowledge and expectations of a condition and its treatment. Children and young people rightly expect to be fully involved in decisions about their treatment options wherever this is feasible and we must be able to communicate those options clearly and honestly. In this extraordinary world of medical miracles, one thing has not changed; the complexity, challenge and pain of that most difficult of decisions: is the treatment we are providing no longer in the best interests of the child? There is no technology to help us here—only guidance, discussion, and adequate time and information for truly shared decision making. Our commitment to the childs best interests must start before birth and continue through to palliative and end of life care. Even after death, a duty to provide bereavement support for parents and siblings is the natural conclusion to the difficult decisions we have made with them in the preceding weeks and months. This latest guidance on arguably the most difficult aspect of paediatric care has updated the decision making framework and incorporated more extensive advice on the direct involvement of children and young people. It also takes account of the broader possibilities flowing from developments in paediatric palliative care. This …

Emergency research in children: options for ethical recruitment

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.

Organ donation from children: time for legal, ethical and cultural change.

Successful transplantation has lead to increasing need for donated organs from children; however, contemporaneously decreased brain‐death rates means optimization of donation processes is crucial. Although excellent palliative care and organ donation are compatible, discrepancies exist both between and within European countries in abilities to offer families donation opportunities. Change will require address of legal, ethical and cultural barriers, and this review aims to explore such changes pertinent to both dead and living organ donation.

Lest we forget… research ethics in children: perhaps onerous, yet absolutely necessary

Medical research involving children is essential for advancing child health and well-being.1 Research involving children and their families still attracts controversy. In a recent article published in this journal, there has been concern voiced at the layers of bureaucracy that attended the ethical review of a seemingly straightforward but important piece of research on the follow-up of children with cardiac disease.2 To some extent, the frustrations encountered by the researchers should now have been lessened by the implementation of the findings of the Warner report3 and the establishment of a National Research Ethics Service. Nevertheless, the ethics of medical research involving children remains a matter of balancing protection against access.4 Some have suggested that a recent domination of protection has contributed to a situation in which children are ‘therapeutic orphans,’5 this term reflecting the lack of significant evidence for many aspects of current paediatric therapeutics. For example, in emergency childhood situations, the paucity of evidence for treatment regimes, due to the lack of randomised control trials in emergency medicine and paediatric intensive care compared with other areas of medicine, means that the very sickest children are subjected to evolved, anecdotal, medical practice. Similar non-evidence-based practice in adult medicine allowed lignocaine prophylaxis postmyocardial infarction and routine episiotomies until recent well-designed randomised controlled trials exposed their dangers! However, the recent welcome address of this imbalance with strategies such as increased funding for paediatric research, legislation to encourage—and occasionally enforce—pharmaceutical companies to test drugs in children, and the setting up of UK MCRN have led some to question whether the pendulum may have swung too far away from protection of the weak and vulnerable.4 This is especially troubling as increasing globalisation affords greater research access to less empowered populations.6 Thomas Percival, a physician from Warrington composed …

The ethical obligation to preserve fertility in the face of all therapies that might adversely affect it

Sterility (an inability to conceive without clinical intervention) and infertility (the inability to conceive after 1 year or more of unprotected intercourse) both produce psychological distress and reduced quality of life.1 ,2 Prevalence of sterility and infertility is variably increased after some types of cancer treatment, and similar adverse outcomes are reported among survivors.3 ,4 Despite the possibility of adoption and gamete/embryo donation, most adult patients with cancer prefer to have biological offspring5; advances in assisted reproduction technologies (ART) have made this possible.3 ,4 The provision of ART in these circumstances is grounded in the moral obligation to respect the autonomous choices of individuals, which is fundamental to a free society. In general we do not prevent adults from exercising freely made reproductive choices unless to do so poses serious risks of harm to the children conceived or to others. Considerations of reproductive medicine, with exceptions such as the provision of contraceptive advice in adolescents, have not historically formed a significant part of paediatric practice. Children may not possess—and may never develop—some or all of the characteristics that enable them to make autonomous reproductive choices. They may lack sufficient cognitive ability to use information; the presence of a coherent set of values in which such fundamental choices might be framed; and a sense of identity, developed over time, that enables them to formulate and implement life plans. But even if children lack these attributes there is evidence to suggest that parents are interested in fertility preservation on behalf of their children.3 Moreover infertility has adverse psychosocial consequences for the increasing number of adult survivors of childhood cancer.6,–,8 Concerns about fertility preservation are not the sole prerogative of patients with cancer in childhood.9 Others affected include …

Compassionate and innovative treatments in children: a proposal for an ethical framework

> Optimism is a good characteristic, but if carried to an excess, it becomes foolishness. Theodore Roosevelt1 We would define an innovative therapy as any newly introduced treatment, or a new modification to an existing therapy with unproven efficacy and side effect profile, which is being used in the best interests of a patient, often on an experimental and/or compassionate basis. Innovation in treating those who are suffering has been a driving force in the advancement of medical knowledge and treatment for many centuries. Many commonly accepted techniques, for example vaccination or transplant surgery, have developed from the use of innovation in response to human need. In critical care medicine, the need for innovation is driven by the obligation to rescue, often in circumstances that do not permit prolonged deliberation. In contrast there exists an obligation to protect the weak and vulnerable from interventions that are unlikely to achieve their intended benefits, but which may be accepted because they provide hope in the face of an otherwise bleak outcome. When accepted and proven approaches are failing a critically ill or suffering child, and some promising experimental therapy exists, it may be argued that there is a moral obligation to strive to obtain that therapy for the patient. Whilst those using innovative therapies should remain mindful of that ubiquitous maxim associated with Hippocrates, primum non nocere (first, do no harm),2 perhaps an alternative ethos might be equally pertinent. If, as Plutarch suggested, “the omission of good is no less reprehensible than the commission of evil,”3 it might plausibly be argued that failure to use a therapy that has some chance of benefit, in this context, can be interpreted as failing to avoid harm. However, Silverman specifically expressed the contrary view in considering the “advances” in neonatal intensive care towards …

Medical Innovation in a Children's Hospital: ‘Diseases Desperate Grown by Desperate Appliance are Relieved, or Not at All’

A balance needs to be struck between facilitating compassionate access to innovative treatments for those in desperate need, and the duty to protect such vulnerable individuals from the harms of untested/unlicensed treatments. We introduced a principle-based framework (2009) to evaluate such requests and describe its application in the context of recently evolved UK, US and European regulatory processes. 24 referrals (20 individual; four group) were received by our quaternary childrens hospital Clinical Ethics Committee (CEC) over the 5-year period (2011-16). The CEC-rapid response group evaluated individual cases within 48-hours; the main referrers being haematology/oncology, immunology or transplant services (14). Most requests were for drug/vaccine/pre-trial access (13) or biological/cellular therapies (8). The majority of individual requests were approved (19/20); neutral or negative opinions were given in 5, including 3 group requests. Recently evolved regulatory processes share common criteria and conditions to our framework including: demonstration of clinical need; sound scientific basis with lack of viable alternative; risks-benefit/best interests evaluation; arrangements for fully informed consent; no compromise of arrangements to test treatment for licensing purposes; consideration of resource implications. There are differences between individual processes and with our framework, with respect to procedures, scope, application format, costs and obligation to make available all outcome data. Our experience has emphasized the need for an independent, principled, consistent, fair and transparent response to the increasing demand for innovative treatment on a compassionate basis. We believe that there is a need for harmonization of the recent proliferation of regulation and legislation in this area.

Developing guidance for checking pregnancy status in adolescent girls before surgical, radiological or other procedures

Guidance on the conduct of pre-procedural checks of pregnancy status in UK women of child-bearing age has been developed to avert the risks of surgery and anaesthesia in a previously unidentified pregnancy. It was initially recommended that formal pregnancy testing should be selective in its application, depending on the risks posed by procedures. In response to 42 incidents, when pregnancy status was not established, the National Patient Safety Agency (NPSA) recommended: (a) tightening procedures to ensure that audited checking and recording of pregnancy status occurred; (b) consensual blanket testing of all menstruating women for pregnancy prior to surgical procedures.1 The NPSA acknowledged that ‘particular consideration applied to under 16-year-olds’, necessarily so since the mean age of menarche in the UK is 12.7 years, and UK teenage pregnancy rates remain high. Yet, as Donaldson et al report,2 knowledge and implementation of this guidance is incomplete and patchy. Consensual blanket testing of all under 16-year-olds prior to relevant procedures is a possible solution, but there are concerns as to whether this is a proportionate response, and how ethical and procedural issues should be addressed. Relatively few UK under 16-year-olds become pregnant, with 70%–75% pregnancies occurring in over 15-year-olds. This suggests that an age-targeted selective approach to testing may be appropriate. The risk to pregnancy posed by surgery, anaesthesia or ionising radiation in UK teenagers has not been defined and has to be seen in the context of higher incidence of pregnancy loss and …

Ethical issues in child protection

The management of child protection concerns arouses strong emotions and controversies and creates ethical tensions for all concerned. This paper provides a rational analysis of some of the issues involved and suggests responses to them. The ethical and legal duties of health-care professionals are to act in the best interests of the child by safeguarding children and reporting concerns. But this may involve conflicts with parents and produce reluctance of professionals to become involved, especially in controversial types of abuse. Mandatory reporting of concerns might overcome such reluctance, but may be ineffective in the face of diagnostic uncertainties. Assembly of a stronger diagnostic evidence base would seem ethically justified, but organization of the necessary case controlled studies might be problematic. Even with a comprehensive evidence base, individual diagnoses of abuse will always involve value judgements that should be underpinned by effective training and assessment of core competencies of professionals. These manoeuvres are unlikely to prevent both justified and vexatious complaints, often in relation to breaches in professional duties or concerning professional misconduct. The tendency to blame experts may have contributed to a reluctance of other professionals to become involved, despite proposals for reforms in the expert witness and court systems. Current approaches to child protection may neither promote greater understanding nor be in the best interests of children. A revised social contract for the effective protection of children could include: a duty of care that adequately addresses the primacy of the childs welfare; the acquisition of a sound evidence base; professional transparency and accountability (but with protection from malicious and vexatious complaints); and a shift emphasis towards a more inquisitorial system that embraced the principles of truth and reconciliation.

‘This House believes that we have gone too far in granting young people the responsibility for making decisions about their own healthcare’: record of a debate held in the Ethics and Law session of the RCPCH Annual Meeting, York 2009

The age at which children should be allowed to make decisions about their healthcare, and have those decisions honoured, remains controversial. Although some children under 16 years have similar levels of competency to adults, the extent to which they may use this to veto treatments is questionable. It is comparatively rare for young people to debate these issues themselves and have their comments recorded. This paper reports a debate held at the 2009 Royal College of Paediatrics and Child Health (RCPCH) Annual Meeting in York, in which members of the RCPCH Youth Advisory Panel presented arguments for and against the motion that ‘This House believes that we have gone too far in granting young people the responsibility for making decisions about their own healthcare’. The debate continues to have relevance and topicality and the young people involved marshalled many of the arguments that have been used in a wider context. Developing the latter produced much debate among the young people themselves and resulted in a series of sophisticated, informed and persuasive contributions that facilitated discussion by professionals and parents in the debate itself. A vote was held before and after the debate and, while the vote was overwhelming in the rejection of the motion on both occasions, a number of individuals changed their views or abstained on the second vote, suggesting that there are more discussions to be had. All those present acknowledged a need for greater dialogue and—irrespective of whether their views should be determinative in all situations—a greater involvement of children and young people in informed healthcare decision-making. The age at which children should be allowed to make significant and wide reaching decisions about their healthcare, and have those decisions honoured, remains controversial. In 1986 the Gillick judgement granted children under the age of 16 the right to …