In the context of critically ill children, Baines contended that the best interests test was neither objective nor coherent, and thus of little applicability in making end-of-life decisions. In reply, Bridgeman attempted to refute these claims through legal analysis and contended that the doctrine allowed for responsive, fact-specific, context-sensitive and prudential reasoning. This paper is a response to Bridgeman, and argues that an examination of case law reveals the subjective and value-laden nature of the test. Courts must make decisions in (...) contested cases, but there is no reason to hold that a judge can divine the best interests of a critically ill child better than either parents or medical staff. This paper analyses a number of cases where judicial decisions appear at odds with the child's best interests, and argues that as the outcome depends upon the value system of the decision-maker the test is unhelpful in contested end-of-life cases. (shrink)

In 2008 the Human Fertilisation and Embryology Act amendments made deliberately choosing to bring disability into the world, using assisted reproduction, a criminal offence. This paper considers whether the legal prohibition above, should influence other policy areas concerning the welfare of future children such as new possibilities presented by foetal surgery and in utero gene therapy. If we have legal duties to avoid disability in one context should this influence our avoidance of disability in this other context? This paper investigates (...) whether the State might have a stake in wider promotion of practices to reduce the degree of disability in foetuses that will come to exist. Not selecting for disability does not affect the welfare of any future individual, whereas treating in utero abnormalities can optimize the eventual child’s welfare; antenatal interventions stand to improve clinical outcomes and welfare should that specific child be born. I explore why the State may want to intervene in the antenatal setting and to what extent, if at all; the State should implement these technologies. I argue that if the State is justified in intervening to outlaw the choosing to create disabled lives using assisted reproductive techniques, it is also justified in putting pressure on prospective parents to accept therapies in utero to help their child be born less disabled. However, I qualify this with the argument that the State is not justified in using force or the criminal law in this situation during pregnancy. (shrink)

Part of the standard protection of decisionally incapacitated research subjects is a prohibition against enrolling them unless surrogate decision makers authorize it. A common view is that surrogates primarily ought to make their decisions based on what the decisionally incapacitated subject would have wanted regarding research participation. However, empirical studies indicate that surrogate predictions about such preferences are not very accurate. The focus of this article is the significance of surrogate accuracy in the context of research that is not expected (...) to benefit the research subject. We identify three morally relevant asymmetries between being enrolled and not being enrolled in such non-beneficial research, and conclude that when there is a non-negligible probability that surrogates’ predictions are wrong, it will generally be better to err on the side of not authorizing enrollment. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

Das Wiskott-Aldrich-Syndrom (WAS), ein genetisch bedingter Immundefekt mit klinischer Manifestation im Kleinkindalter, wird voraussichtlich in näherer Zukunft erstmals versuchsweise durch eine somatische Gentherapie behandelt werden. Im vor- liegenden Beitrag werden die wichtigsten medizinisch-naturwissenschaftlichen Fakten dieses Krankheitsbildes sowie die bisherigen Erfahrungen mit somatischen Gentherapien bei anderen Immunmangelsyndromen ausführlich dargestellt. Sodann erfolgt eine ethische Analyse eines möglichen gentherapeutischen Eingriffs bei WAS-Patienten, bei der die spezifischen Aspekte des Wiskott-Aldrich-Syndroms – insbesondere die fast ausschließliche Betroffenheit von Kindern sowie die unterschiedlich aussichtsreiche Alter- nativoption einer (...) allogenen Knochenmarktransplantation–wesentliche Aspekte der Beurteilung sind. Im Ergebnis zeigt sich, dass ein gentherapeutischer Eingriff im vorliegenden Fall nicht im Rahmen einer Forschungsstudie, d.h. als Humanexperiment, gerechtfertigt werden kann, sondern allein als individueller Heilversuch. Gleichwohl las- sen die besonderen Risiken und die Innovativität eines solchen Eingriffs es notwendig erscheinen, diesen Heilversuch – anders als andere Heilbehandlungen mit bislang unerprobten Mitteln – in streng kontrollierter Form durchzuführen. Der neuartige Gedanke eines kontrollierten individuellen Heilversuchs zeichnet sich daher für den vorliegenden Fall, und womöglich auch für vergleichbare risikoreiche Behandlungsansätze namentlich im Bereich der Gentherapie, als geeignetes Instrument der Konzeption und Beurteilung ab. (shrink)

Cardiff Law School, Museum Avenue, Cardiff CF10 3AX, UK. Tel: +44(0)2920875447, Fax: +44(0)2920874097; Email: Holms{at}cardiff.ac.uk ' + u + '@' + d + ' '//--> Abstract The paper presents a brief overview of current knowledge about (i) the link between parental behaviour and lifestyle and childhood obesity, (ii) the many other factors influencing overweight and obesity rates in children and (iii) the effectiveness of interventions in children who are already overweight and obese. On the basis of this, it is analysed (...) to what extent it is meaningful to attribute causal and moral responsibility to parents in theory and in practice. It is argued that although there is a sense in which many parents are causally and morally responsible for the obesity of their children, most parents are not blameworthy and the attribution of parental responsibility in most cases does not justify intervention in the family context by society on behalf of the children. In the analysis of the possible justification of more general interventions, parallels are drawn to the distinction between hard and soft forms of paternalism. Train up a child in the way he should go; and when he is old, he will not depart from it. (Proverbs 22: 6) For I have told him that I will judge his house for ever for the iniquity which he knoweth; because his sons made themselves vile, and he restrained them not. 1. (Samuel 3: 13) CiteULike Connotea Del.icio.us What's this? (shrink)

Current UK guidelines regarding clinical research on children permit research that is non-therapeutic from the perspective of that particular child. The guidelines permit research interventions that cause temporary pain, bruises or scars. It is argued here that such research conflicts with the Declaration of Helsinki according to which the interests of the research subject outweigh all other interests. Given this, in the context of clinical research, who is best placed to protect the child from this kind of exploitation? Is it (...) the medical researcher, the child’s parents or the nurse advocate? This article describes the problem, possible responses to it, and closes with a consideration of, and rejection of, a defence of current guidelines that claims moral parity between clinical research and clinical education. (shrink)

In this paper, we first briefly describe neuroimaging technology, our reasons for studying magnetic resonance imaging (MRI) technology, and then provide a discussion of what we have identified as priority issues for paediatric MRI research. We examine the issues of respectful involvement of children in the consent process as well as privacy and confidentiality for this group of MRI research participants. In addition, we explore the implications of unexpected findings for paediatric MRI research participants. Finally, we explore the ethical issues (...) concerning advances in functional MRI. This paper aims to provide a clear description of priority paediatric MRI research ethics issues to make some preliminary recommendations regarding next steps. (shrink)

We systematically reviewed contemporary literature to create an evidence-informed framework for research studies involving children and adolescents who can assent to participate. We searched seven citation indices to locate peer-reviewed research published in English language journals between 2000 and 2012. After screening 1,231 titles and abstracts for relevance, we assessed levels of evidence, extracted information, and analysed content from 87 articles. Most articles narrowly focused on paediatric assent barriers and facilitators for decision-making about research participation. No articles provided a single, (...) comprehensive ethical framework to guide the development and review of research assent protocols. We developed a 6-step framework that provides guidance to: prepare the child for the assent process; assess the child’s readiness to engage in decision making; discuss the elements of informed consent to the greatest extent possible; seek an initial assent decision; monitor and affirm assent; and respect the child’s role as a research participant. The PAeDS-MoRe framework also supports the creation of process models that address the unique, developmental needs of paediatric sub-groups, and guides the operationalization of jurisdictional requirements for ethical research involving children who are unable to provide free, informed and ongoing consent. (shrink)

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention as such. It has (...) been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)