Best interests, dementia and the Mental Capacity Act (2005)

The Mental Capacity Act (2005) is an impressive piece of legislation that deserves serious ethical attention, but much of the commentary on the Act has focussed on its legal and practical implications rather than the underlying ethical concepts. This paper examines the approach that the Act takes to best interests. The Act does not provide an account of the underlying concept of best interests. Instead it lists factors that must be considered in determining best interests, and the Code of Practice to the Act states that this list is incomplete. This paper argues that this general approach is correct, contrary to some accounts of best interests. The checklist includes items that are unhelpful. Furthermore, neither the Act nor its Code of Practice provides sufficient guidance to carers faced with difficult decisions concerning best interests. This paper suggests ways in which the checklist can be developed and discusses cases that could be used in an updated Code of Practice

Consent processes in cluster-randomised trials in residential facilities for older adults : a systematic review of reporting practices and proposed guidelines

Objective: To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials. Design: Systematic review of cluster-randomised trials reports, published up to the end of 2010. Data sources: National Library of Medicine (Medline) via PubMed, hand-searches of BMJ, Journal of the American Medical Association, BMC Health Services Research, Age and Ageing and Journal of the American Geriatrics Society, reference search in Web of Knowledge and consultation with experts. Eligibility for selecting studies: Published cluster-randomised trials where the unit of randomisation is a part or the whole of a residential facility for older people, without language or year of publication restrictions. Results: We included 73 trials. Authors reported ethical approval in 59, obtaining individual consent in 51, and using proxies for this consent in 37, but the process to assess residents’ capacity to consent was clearly reported in only eight. We rated only six trials high for the quality of consent processes. We considered that individual informed consent could have been waived legitimately in 14 of 22 trials not reporting obtaining consent. The proportions reporting ethical approval and quality of consent processes were higher in recent trials. Conclusions: Recently published international recommendations regarding ethical conduct in cluster-randomised trials are much needed. In relation to consent processes when cognitively impaired individuals are included in these trials, we provide a six-point checklist and recommend the minimum information to be reported. Those who lack capacity in trials with complex designs should be afforded the same care in relation to consent as competent adults in trials with simpler designs

Moral expertise in the clinic : lessons learned from medicine and science

Philosophers and others have questioned whether or not expertise in morality is possible. This debate is not only theoretical, but also affects the perceived legitimacy of clinical ethicists. One argument against moral expertise is that in a pluralistic society with competing moral theories no one can claim expertise regarding what another ought morally to do. There are simply too many reasonable moral values and intuitions that affect theory choice and its application; expertise is epistemically uniform. In this article, we discuss how similar concerns have recently threatened to undermine expertise in medicine and science. In contrast, we argue that the application of values is needed to exercise medical, scientific, and moral expertise. As long as these values are made explicit, worries about a pretense to authority in the context of a liberal democracy are ill-conceived. In conclusion, we argue for an expertise that is epistemically diverse

Patient engagement or information overload: patient and physician views on sharing the medical record in the acute setting.

BACKGROUND: Patient and professional views about the impact of providing full real-time access to the medical record in the in-hospital setting are unknown. METHODS: Likert-scale and free-text validated questionnaire survey of physicians and patients from acute medical units in two hospitals. The questionnaire explored recent experiences; views on the formation of trust, and views on sharing either the entire medical record or a summary. RESULTS: Two-hundred and forty-eight patient questionnaires (62% response rate) and 32 physician questionnaires (21% response rate) were returned. Twenty-seven per cent of patients did not recall being told their diagnosis. Doctors and patients differed on what practices that they believed built trust.Eighty-one per cent of patients supported the idea of having access to the full medical record (for empowerment; the right to information about oneself; as an aide-memoire for discussion). Doctors feared it might provoke anxiety and change the nature of what was written. A written lay summary record was preferred by doctors and patients. CONCLUSIONS: The current system of providing information verbally to patients is inadequate. Patients want more information and are less concerned than physicians about potential negative effects of real-time access to their records. Patient access to medical records (in both full and summary forms) should be evaluated

Ethical difficulties in clinical practice : experiences of European doctors

Background: Ethics support services are growing in Europe to help doctors in dealing with ethical difficulties. Currently, insufficient attention has been focused on the experiences of doctors who have faced ethical difficulties in these countries to provide an evidence base for the development of these services. Methods: A survey instrument was adapted to explore the types of ethical dilemma faced by European doctors, how they ranked the difficulty of these dilemmas, their satisfaction with the resolution of a recent ethically difficult case and the types of help they would consider useful. The questionnaire was translated and given to general internists in Norway, Switzerland, Italy and the UK. Results: Survey respondents (n = 656, response rate 43%) ranged in age from 28 to 82 years, and averaged 25 years in practice. Only a minority (17.6%) reported having access to ethics consultation in individual cases. The ethical difficulties most often reported as being encountered were uncertain or impaired decisionmaking capacity (94.8%), disagreement among caregivers (81.2%) and limitation of treatment at the end of life (79.3%). The frequency of most ethical difficulties varied among countries, as did the type of issue considered most difficult. The types of help most often identified as potentially useful were professional reassurance about the decision being correct (47.5%), someone capable of providing specific advice (41.1%), help in weighing outcomes (36%) and clarification of the issues (35.9%). Few of the types of help expected to be useful varied among countries. Conclusion: Cultural differences may indeed influence how doctors perceive ethical difficulties. The type of help needed, however, did not vary markedly. The general structure of ethics support services would not have to be radically altered to suit cultural variations among the surveyed countries

Research ethics oversight in Norway : structure, function, and challenges

Background While the development and evaluation of clinical ethics services in Norway has been recognized internationally, the country’s research ethics infrastructure at times may have been less well developed. In 2016, media interest in the controversial nature of some health services research and pilot studies highlighted gaps in the system with certain types of research having no clear mechanisms through which they may be given due independent consideration. It is not clear that new legislation, implemented in 2017, will address this problem. Summary We explore relevant law, committee scope, and the function of the system. We show that 1) Norwegian law provides for ethics assessment for all forms of health research; 2) regional RECs in Norway might not have always enforced this provision, considering some interventional health services research to be outside their remit; and 3) Norwegian law does not explicity provide for local/university RECs, meaning that, in practice, there may be no readily accessible mechanisms for the assessment of research that is excluded by regional RECs. This may include health services research, pilot studies, and undergraduate research. New 2017 legislation has no effect on this specifically but focuses on institutions regulating researcher activity. This may place researchers in the difficult situation of on one hand, needing to hold to recognized ethical standards, while on the other, not readily having access to independent committee scrutiny to facilitate consistent operation with these standards. Conclusion To support researchers in Norway and to protect the public, it may be necessary either to widen the regional RECs’ remit or to make legislative alterations that permit and do not discourage the existence of local RECs

Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol

Background Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during pre-hospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Pre-hospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC) trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control) or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. Conclusion The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942)

Ethics and patient and public involvement with children and young people

Patient and public involvement (PPI) is important both in research and in quality improvement activities related to healthcare services . While PPI activities do not require formal ethical approval, they can raise a number of ethical concerns, through the introduction of complex technical medical concepts, challenging language or sensitive subject areas. There is very little published literature to guide ethical practice in this area. We have been conducting PPI with children and young people throughout a research study in paediatric palliative care. PPI started during the application process and continued to guide and shape the research as it progressed. Ethical issues can arise at any time in PPI work. Although many can be predicted and planned for, the nature of PPI means that researchers can be presented with ideas and concepts they had not previously considered, requiring reflexivity and a reactive approach. This paper describes how we considered and addressed the potential ethical issues of PPI within our research. The approach that emerged provides a framework that can be adapted to a range of contexts and will be of immediate relevance to researchers and clinicians who are conducting PPI to inform their work

Development of Clinical Ethics Services in the UK: A National Survey

Background In 2001 a report on the provision of clinical ethics support in UK healthcare institutions identified 20 clinical ethics committees. Since then there has been no systematic evaluation or documentation of their work at a national level. Recent national surveys of clinical ethics services in other countries have identified wide variation in practice and scope of activities. Objective To describe the current provision of ethics support in the UK and its development since 2001. Method A postal/electronic questionnaire survey administered to the chairs of all 82 clinical ethics services registered with the UK Clinical Ethics Network in July 2010. Results Response rate was 62% with the majority of responding services situated in acute trusts. All services included a clinical ethics committee with one service also having a clinical ethicist. Lay members were present in 72% of responding committees. Individual case consultation has increased since 2001 with 29% of chairs spending more than 50% of their time on this. Access to and involvement in the process of case consultation is less for patients and families than for clinical staff. There is wide variation in committee processes and levels of institutional support. Over half of the responding committees undertook some form of evaluation. Conclusion Clinical ethics services in the UK are increasing as is their involvement in case consultation. However, the significant variation in committee processes suggests that further qualitative research is needed to understand how these committees function and the role they play in their institution