Douglas Diekema influentially argues that interference with parental decisions is not in fact guided by the child’s best interests, but rather by a more permissive standard, which he calls the harm principle. This article first seeks to clarify this alternative position and defend it against certain existing criticisms, before offering a new criticism and alternative. This ‘harm principle’ has been criticized for (i) lack of adequate moral grounding, and (ii) being as indeterminate as the best interest standard that it seeks (...) to replace. I argue that these are not serious problems. I take Diekema’s negative point to be right—our actual standard for intervention is not literally the best interests of the child—but I disagree with his proposed replacement. First, Diekema’s proposed harm threshold should be more carefully distinguished from Mill’s harm principle. Second, there is no reason to assume that the standard for permissible intervention coincides with the threshold for harm (or serious harm). Thus, I propose that the best alternative to the best interests standard is not a harm principle, but rather a sufficiency threshold between adequate (or ‘good enough’) and inadequate (or ‘substandard’) parenting. (shrink)

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 to evaluate such requests and describe its application in the context of recently evolved UK, US and European regulatory processes. 24 referrals were received by our quaternary children's hospital Clinical Ethics Committee over the 5-year period. The CEC-rapid response group evaluated individual cases within (...) 48-hours; the main referrers being haematology/oncology, immunology or transplant services. Most requests were for drug/vaccine/pre-trial access or biological/cellular therapies. The majority of individual requests were approved ; 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. (shrink)

Dealing with situations where parents’ views about treatment for their child are strongly opposed to doctors’ views is one major area of ethical challenge in paediatric health care. The traditional approach focuses on the child’s best interests, but this is problematic for a number of reasons. The Harm Principle test is regarded by many ethicists as more appropriate than the best interests test. Despite this, use of the best interests test for intervening in parental decisions is still very common in (...) clinical settings and can lead to confusion. In this paper, I propose the Zone of Parental Discretion as a means of putting into practice the key ideas of the Harm Principle, in a clear, step-by-step process. The Zone of Parental Discretion provides a tool for ethical deliberation by clinicians and ethicists about all situations in which parents and doctors disagree about treatment of a child, whether parents are refusing medically recommended treatment, or requesting non-recommended treatment. (shrink)

Minors are generally considered incompetent to provide legally binding decisions regarding their health care, and parents or guardians are empowered to make those decisions on their behalf. Parental authority is not absolute, however, and when a parent acts contrary to the best interests of a child, the state may intervene. The best interests standard is the threshold most frequently employed in challenging a parent''s refusal to provide consent for a child''s medical care. In this paper, I will argue that the (...) best interest standard provides insufficient guidance for decision-making regarding children and does not reflect the actual standard used by medical providers and courts. Rather, I will suggest that the Harm Principle provides a more appropriate threshold for state intervention than the Best Interest standard. Finally, I will suggest a series of criteria that can be used in deciding whether the state should intervene in a parent''s decision to refuse medical care on behalf of a child. (shrink)

The pace of change and, indeed, the sheer number of clinical ethics committees has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital for Children (...) NHS Foundation Trust v MX, FX and X, [21]–[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK. (shrink)

This discussion paper considers how seldom recognised theories influence clinical ethics committees. A companion paper examined four major theories in social science: positivism, interpretivism, critical theory and functionalism, which can encourage legalistic ethics theories or practical living bioethics, which aims for theory–practice congruence. This paper develops the legalistic or living bioethics themes by relating the four theories to clinical ethics committee members’ reported aims and practices and approaches towards efficiency, power, intimidation, justice, equality and children’s interests and rights. Different approaches (...) to framing ethical questions are also considered. Being aware of the four theories’ influence can help when seeking to understand and possibly change clinical ethics committee routines. The paper is not a research report but is informed by a recent study in two London paediatric cardiac units. Forty-five practitioners and related experts were interviewed, including eight members of ethics committees, about the work of informing, preparing and supporting families during the extended process of consent to children’s elective heart surgery. The mosaic of multidisciplinary teamwork is reported in a series of papers about each profession, including this one on bioethics and law and clinical ethics committees’ influence on clinical practice. The qualitative social research was funded by the British Heart Foundation, in order that more may be known about the perioperative views and needs of all concerned. Questions included how disputes can be avoided, how high ethical standards and respectful cooperation between staff and families can be encouraged, and how minors’ consent or refusal may be respected, with the support of clinical ethics committees. (shrink)