Law’s processes are likely always to be needed when particularly intractable conflicts arise in relation to the care of a critically ill child like Charlie Gard. Recourse to law has its merits, but it also imposes costs, and the courts’ decisions about the best interests of such children appear to suffer from uncertainty, unpredictability and insufficiency. The insufficiency arises from the courts’ apparent reluctance to enter into the ethical dimensions of such cases. Presuming that such reflection is warranted, this article (...) explores alternatives to the courts, and in particular the merits of specialist ethics support services, which appear to be on the rise in the UK. Such specialist services show promise, as they are less formal and adversarial than the courts and they appear capable of offering expert ethical advice. However, further research is needed into such services – and into generalist ethics support services – in order to gauge whether this is indeed a promising development. (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)

BackgroundThis 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.MethodsWe 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.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive 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. (shrink)

As support for clinical ethics committees in the UK grows, care must be taken to define their function, membership and method of working and the status of their decisions.The modern practice of medicine raises a plethora of complex issues—medical, ethical and legal. Doctors and other healthcare professionals increasingly must try to resolve these and may sometimes have to do so in the face of contrary opinion expressed by patients and/or their surrogates. While clearly qualified in the medical arena, and although (...) there is now more ethics teaching in the medical curriculum, healthcare professionals are seldom qualified to adjudicate on ethical or legal matters, or even, perhaps, to recognise them when they arise. Yet, as Doyal says, “clinical life must go on and moral and legal indeterminacy within medicine cries out for practical resolution.”1 Meanwhile, the expectations of patients and their families—and, indeed, of wider society—are that decisions about patient care, resources and therapeutic regimes should be soundly based on appropriate ethicolegal, as well as scientific, principle.Recognition of these additional burdens on healthcare professionals has generated some interest in the provision of ethics consultation. In the USA this has been undertaken by a variety of tribunals and individuals. Hospital ethics committees and ethics consultants feature in many US hospitals and perform a variety of roles. In Europe, a number of countries have also established clinical ethics committees and they are becoming more common in the UK—primarily in England and Wales for the moment. Whereas, however, “[i]n North America, CECs have … become an integral part of the organisational infrastructure of hospitals ...”,1 in the United Kingdom they remain essentially ad hoc bodies, generated for a variety of reasons and with different goals, structures, membership, methods of working and functions. The initial impetus for the …. (shrink)