Emma Cave

Milgram and Tuskegee—Paradigm Research Projects in Bioethics

This paper discusses the use of the Milgram obedience experiments and the Tuskegee syphilis study in the bioethical literature. The two studies are presented and a variety of uses of them identified and discussed. It is argued that the use of these studies as paradigms of problematic research relies on a reduction of their complexity. What is discussed is thus often constructions of these studies that are closer to hypothetical examples than to the real studies.

Minors' capacity to refuse treatment: a reply to Gilmore and Herring.

Re R and Re W allow a parent to consent to treatment a competent minor refuses, but the cases have not been tested post-Human Rights Act 1998. Gilmore and Herring offer a means by which they might be distinguished or sidelined. They interpret Gillick to say that in order to consent a minor need only have a full understanding of the particular treatment. They argue that the minors in Re R and Re W were refusing all treatment which requires a separate assessment of capacity-an assessment which was not made. We fear that this distinction would not be workable in clinical practice and argue that their interpretation of Gillick is flawed. From a clinicians point of view, competence cannot always be judged in relation to a specific treatment, but instead must relate to the decision. We show that a decision can incorporate more than one treatment, and more than one decision might be made about one treatment. A minors understanding of a specific treatment is not always sufficient to demonstrate competence to make a decision. The result is that whilst there might be situations when a parent and a minor both have the power to consent to a particular treatment, they will not share concurrent powers in relation to the same decision. Consequently, a challenge to Re R and Re W, if forthcoming, would need to take a different form. We emphasise the necessity to minimise the dichotomy between legal consent and how consent works in medical practice.

Drink and Drugs in Pregnancy: Can the Law Prevent Avoidable Harm to the Future Child? :

Alcohol and drug misuse in pregnancy can cause long-term harm to the born-alive child. Where pregnant women decide to bring the foetus to term but resist medical treatment that will benefit them both, there are two ways in which the law might force it upon them. English courts have resisted the first option which is to grant the foetus a limited right to life under Article 2 of the Human Rights Act 1998. The second option is to utilise existing criminal, medical and mental health laws to compel pregnant women into treatment for their own good. Some states in the USA utilise such measures. This article considers the potential to do so in English law and the consequences for drug and alcohol dependent pregnant women and their children.

The ill-informed: Consent to medical treatment and the therapeutic exception

Affirming the doctrine of informed consent, the UK Supreme Court in Montgomery v Lanarkshire HB belatedly followed the Australian decision of Rogers v Whitaker, decoupling the duty to inform patients about the material risks of medical treatment from Bolam. The underlying commitment to patient autonomy coincides with a wider body of medical law that protects the right of capacitous adult patients to make treatment decisions, even if others consider those decisions bizarre and even if they will cause the patient serious harm. It is seemingly anomalous, therefore, that the Supreme Court in Montgomery referred to a ‘therapeutic exception’ (TE), as this suggests an underlying paternalistic approach. Contrary to this view, international examples suggest that a TE does not necessarily conflict with commitment to patient autonomy. In some countries, the exception mitigates the effects of a broadly objective test of materiality by enabling clinicians in exceptional circumstances to protect the autonomy interests of the particular patient. In others, it protects those incapable of an autonomous decision from harm. In England and Wales, however, alternative mechanisms can be interpreted to protect such patients from harm. On this basis, it is argued that the TE is obfuscatory, unnecessary and unjustified.

Competence and authority: adolescent treatment refusals for physical and mental health conditions

This article explores the relationship between competence and authority in relation to medical treatment refusals. Comparing provisions directed at adults and young people, the author explores the options before the court if a test case (called for by the British Medical Association and the Department of Health) is brought before the court to determine the extent of the minors autonomy rights to be involved in or make medical treatment decisions of common law. At present, the common law rights of competent adults and minors stand in stark contrast. Adults can refuse life-saving treatment against the advice of doctors, but minors (even if they pass the legal test for competence) cannot do so if a parent or the court provides the necessary consent in the childs ‘best interests’. Since the matter was last tested in court, childrens rights – including their autonomy rights – have evolved. In light of this, if a minor can demonstrate his autonomy in relation to the decision should he, like a competent adult, be given the legal authority to decide? Cave asserts that academic arguments against the different levels of competence required to consent to and refuse medical treatment should be distinguished from arguments about the respective authority a decision to consent and refuse may carry. A close examination of the law relating to adults reveals that their decisional authority is context-specific. There are circumstances where adults too are powerless to refuse medical treatment, regardless of their competence. Statutes enacted post-Human Rights Act 1998 which apply to competent minors take a similar approach. Deference to childrens autonomy rights does not necessarily require that their competent decisions are respected. In particular, the article considers mental health legislation, examining its aims and how they relate to the restrictions on competent adults and minors and the extent to which these provide examples which might be followed when the common law on adolescent treatment refusals is tested in court.

EU Clinical Trials Regulation 2014: Fetter or facilitator?

European Union (EU) Clinical Trials Regulation 536/2014, expected to come into force in 2019, provides for a streamlined single EU application for cross-border clinical trials and enhanced transparency of results. The status of the Regulation in post-Brexit UK is uncertain. Matters of regulatory alignment will be covered by agreements on the future EU-UK relationship. In the short term, implementation of the Regulation in the United Kingdom depends on the Brexit model and timing of the Regulation’s implementation. The EU (Withdrawal) Act will convert EU law into UK law, including the vast array of EU life sciences regulation. However, the Regulation is likely to be implemented after the United Kingdom leaves the EU, but within the transition period. If the United Kingdom is not part of the legal framework governing clinical trials in the EU, then the United Kingdom will still need to comply with the global framework set out in the International Council on Harmonisation if it wants to be part of trials of medicinal products for which marketing authorization will be sought for licensing in the European Economic Area. This article extols the virtues of harmonization with the EU and attempts to counter some of the media focus on the advantages of a deregulated bespoke approach.

WHO KNOWS BEST (INTERESTS)? THE CASE OF CHARLIE GARD

When baby Charlie Gard was diagnosed with a rare mitochondrial disease, his parents located a Professor of Neurology in the USA willing to provide nucleoside therapy which offered a theoretical chance of improvement and successfully raised £1.3 million through crowd funding. The decision that unproven therapy was contrary to Charlie Gards best interests and that life-sustaining treatment should be withdrawn was devastating for his parents and difficult for their supporters to comprehend. The decision was upheld at three levels of appeal and Charlie died in July 2017 aged 11 months. This commentary provides a critical analysis of the legal principles surrounding unproven treatment and application of the best interests test in the different contexts of hospital and court. It draws attention to conflicting guidance and explores differences in approach in relation to unproven treatment for adults lacking capacity and children.

Voluntary Vaccination: The Pandemic Effect

Justification of a voluntary vaccination policy in England and Wales rests on tenuous foundations. Two arguments against voluntary vaccination are gaining ground. The first is that globalisation necessitates preparedness strategies for pandemics. Assuming sufficient supply, compulsory vaccination of adults and children constitutes a potential policy option in the context of a severe, vaccine‐preventable pandemic outbreak. The second argument is that children have a right to preventive medicine and thus to vaccination. The influence of the UN Convention on the Rights of the Child and its emphasis on parents as the trustees of their childrens best interests, and the increasingly global nature of our collective and individual responsibilities with respect to the transmission of vaccine‐preventable disease present challenges to the right to refuse vaccination on our own behalf and on behalf of our children. Exploring methods of compulsion and persuasion utilised across Europe, the USA and Australia, this paper argues that necessity and proportionality must be reassessed, and national public health law and policy setting out a graduated and proportionate approach to compulsory vaccination developed as a matter of priority.

Debating the future of mandatory vaccination

Mandatory vaccination should be debated before an epidemic or public health emergency to assure that public health law is graduated and proportionate.1 Mandated vaccination of children is not currently warranted in light of the current levels of herd immunity. Important historical lessons on the efficacy of legal mandate flow from …

Reforming the ethical review system: balancing the rights and interests of research participants with the duty to facilitate good research

Researchers have frequently complained that the NHS ethical review system stifles good research. At last measures are being put in place to address this criticism, but will they undermine the protection of research participants? The Declaration of Helsinki recognizes that medicine will not progress without good quality research, but also demands that the well-being of research participants takes precedence over the interests of science and society. This article examines the implications of the ongoing reform of the NHS research ethics review system for researchers, ethics committees and research participants.