Considerations for legal, ethical, and effective practice in dementia research.

Dementia represents a potentially overwhelming health burden, both for the UK and worldwide. Addressing this fast-growing issue is a key priority for the government, health service and the public. Advances in care including the development of efficacious disease-modifying, and eventually curative, treatments can only be achieved through effective dementia research. Specifically, research directly involving participants with dementia is essential to further understanding. However, working with cognitively impaired participants with and without capacity to consent to research presents unique ethical and legal challenges. For clinicians and scientists on the frontline of dementia research, scenarios frequently arise that pose such challenges. A lack of guidance for a consistent approach in navigating these scenarios limits researchers' ability to proceed with confidence. This represents a threat to the rights and wishes of research participants as well as the field at large, as it may lead to studies being unnecessarily terminated or, worse, poor practice. In this article, we take a multiprofessional approach, informed by carer input, to these issues. We review the relevant ethical and legal literature relating to the conduct of non-interventional research studies in patients with dementia. This includes a thorough recap of the Mental Capacity Act (2005), which provides a legal framework in England and Wales for conducting research with participants who lack capacity to consent. We also discuss the important, but sometimes incomplete, role of research ethics committees in guiding researchers. We then present and discuss a series of case vignettes designed to highlight areas of incomplete coverage by existing governance. These vignettes describe theoretical scenarios informed by our own real-word experiences of encountering ethical issues when conducting dementia research. They include scenarios in which participants demonstrate varying degrees of understanding of the research they are involved in and ability to communicate their wishes and feelings. Building on these vignettes, we then provide a checklist for researchers to work through when presented with similar scenarios. This checklist covers the key ethical, legal and practical considerations that we have argued for. Taken together, this article can act as a guide, previously lacking in the literature, for colleagues in the field to enable much needed ethical, legal and effective research.

No consent for brain death testing.

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court questioned whether the clinicians were even required to seek consent from the parents of a child at all.

Questioning our presumptions about the presumption of capacity.

All contemporary frameworks of mental capacity stipulate that we must begin from the presumption that an adult has capacity. This presumption is crucial, as it manifests respect for autonomy and guards against prejudice and paternalism on the part of the evaluator.Given its ubiquity, we might presume that we all understand the presumption's meaning and application in the same way. Evidence demonstrates that this is not the case and that this has led to harm in vulnerable persons. There is thus strong reason to question our presumptions about the presumption of capacity.We distinguish between two main ways of understanding and applying the presumption of capacity, and advocate for the one that we argue mitigates risk of harm. Our proposed interpretation offers many advantages in that it is consonant with actual practice of capacity evaluations, precludes confused and abusive avoidance of needed evaluations, and preserves the respect for autonomy motivating the presumption in the first place.

Can the courts be viewed as an appropriate vehicle to settle clinical unease?

This paper is an exploration of the state of 'clinical unease' experienced by clinicians in contexts where professional judgement-grounded in clinical knowledge, critical reflection and a sound grasp of the law-indicates that there is more than one ethically defensible way to proceed. The question posed is whether the courts can be viewed as an appropriate vehicle to settle clinical unease by providing a ruling that clarifies the legal and ethical issues arising in the case, even in situations where there is no dispute between the patient (or her proxies) and the healthcare team.The concept of 'clinical unease' is framed with reference to the broader experience of clinical decision-making, and distinguished from other widely discussed phenomena in the healthcare literature like moral distress and conscientious objection. A number of reported cases are briefly examined where the courts were invited to rule in circumstances of apparent 'unease'. The respective responsibilities of clinicians and courts are discussed: in particular, their capability and readiness to respond to matters of ethical concern.Four imagined clinical scenarios are outlined where a clinical team might welcome a court adjudication, under current rules. Consideration is given to the likelihood of such cases being heard, and to whether there may be better remedies than the courts. There are final reflections on what clinicians may actually wish for in seeking court involvement, and on whether a willingness to engage with the experience of clinical unease may lead to greater sensitivity towards the value perspectives of others.

Teenager and the transplant: how the case of William Verden highlights action is needed to optimise equitable access to organs for patients with impaired decision-making.

In February 2022, the Court of Protection was faced with the question of whether a kidney transplant was in the best interests of William Verden. The case highlighted the legal, ethical and clinical complexities of treating potential kidney transplant patients with impaired decision-making. Above all, it exposed the potential risk of discrimination on the basis of disability when treatment decisions in relation to potential kidney recipients with impaired capacity are being made. In this paper, we draw on the Verden case to (1) examine the role of the Court of Protection in cases relating to patients with impaired decision-making capacity who require a transplant, (2) to highlight the lack of empirical data on patients who have faced inequitable access to transplant and (3) highlight the shortcomings of the existing legal and regulatory framework in England and Wales guiding clinical decision making for patients in William's position. We consequently argue that there is a clear need for action to ensure equitable access to transplant for those in William's position. Furthermore, we suggest that there is a responsibility incumbent on policy makers and clinicians alike to develop a meaningful, and meaningfully operational, framework centred on preventing discrimination against potential organ recipients based on their decision-making capacity.

Broad concepts and messy realities: optimising the application of mental capacity criteria.

Most jurisdictions require that a mental capacity assessment be conducted using a functional model whose definition includes several abilities. In England and Wales and in increasing number of countries, the law requires a person be able to understand, to retain, to use or weigh relevant information and to communicate one's decision. But interpreting and applying broad and vague criteria, such as the ability 'to use or weigh' to a diverse range of presentations is challenging. By examining actual court judgements of capacity, we previously developed a descriptive typology of justifications (rationales) used in the application of the Mental Capacity Act (MCA) criteria. We here critically optimise this typology by showing how clear definitions-and thus boundaries-between the criteria can be achieved if the 'understanding' criterion is used narrowly and the multiple rationales that fall under the ability to 'use or weigh' are specifically enumerated in practice. Such a typology-aided practice, in theory, could make functional capacity assessments more transparent, accountable, reliable and valid. It may also help to create targeted supports for decision making by the vulnerable. We also discuss how the typology could evolve legally and scientifically, and how it lays the groundwork for clinical research on the abilities enumerated by the MCA.

Compulsory treatment of physical illness under MHA 1983.

Taken together, Sections 145 and 63 of the Mental Health Act 1983 (MHA) provide for treatment without consent of physical illness ancillary to the mental disorder with which a patient presents. On a daily basis, clinicians make both the decision that the Act's authority can be applied to their patient's case, and that it should be applied. But in the unusual circumstances where there is uncertainty as to the applicability of the MHA to the ancillary treatment of physical illness, the assistance of a court may be sought. In so doing, the law (and thence the courts) may justify compulsion but never prescribes it; the clinician is presented with authority that he or she could use but is left to decide whether it should be employed. This paper explores how the clinical question is set before the court, and whether the distinction between symptom, manifestation and consequence is sufficiently understood. This has important consequences in the context of self-neglect and its close cousin self-harm: the question whether the relevant ailment was attributable to or exacerbated by neglect or self- inflicted harm will determine whether compulsion under the MHA is applicable; and furthermore, whether or not compulsion is clinically acceptable.

Should age matter in COVID-19 triage? A deliberative study.

The COVID-19 pandemic put a large burden on many healthcare systems, causing fears about resource scarcity and triage. Several COVID-19 guidelines included age as an explicit factor and practices of both triage and 'anticipatory triage' likely limited access to hospital care for elderly patients, especially those in care homes. To ensure the legitimacy of triage guidelines, which affect the public, it is important to engage the public's moral intuitions. Our study aimed to explore general public views in the UK on the role of age, and related factors like frailty and quality of life, in triage during the COVID-19 pandemic. We held online deliberative workshops with members of the general public (n=22). Participants were guided through a deliberative process to maximise eliciting informed and considered preferences. Participants generally accepted the need for triage but strongly rejected 'fair innings' and 'life projects' principles as justifications for age-based allocation. They were also wary of the 'maximise life-years' principle, preferring to maximise the number of lives rather than life years saved. Although they did not arrive at a unified recommendation of one principle, a concern for three core principles and values eventually emerged: equality, efficiency and vulnerability. While these remain difficult to fully respect at once, they captured a considered, multifaceted consensus: utilitarian considerations of efficiency should be tempered with a concern for equality and vulnerability. This 'triad' of ethical principles may be a useful structure to guide ethical deliberation as societies negotiate the conflicting ethical demands of triage.

Isolating residents including wandering residents in care and group homes: Medical ethics and English law in the context of Covid-19.

This article investigates the lawfulness of isolating residents of care and group homes during the COVID-19 pandemic. Many residents are mobile, and their freedom to move is a central ethical tenet and human right. It is not however an absolute right and trade-offs between autonomy, liberty and health need to be made since COVID-19 is highly infectious and poses serious risks of critical illness and death. People living in care and group homes may be particularly vulnerable because recommended hygiene practices are difficult for them and many residents are elderly, and/or have co-morbidities. In some circumstances, the trade-offs can be made easily with the agreement of the resident and for short periods of time. However challenging cases arise, in particular for residents and occupants with dementia who 'wander', meaning they have a strong need to walk, sometimes due to agitation, as may also be the case for some people with developmental disability (e.g. autism), or as a consequence of mental illness. This article addresses three central questions: (1) in what circumstances is it lawful to isolate residents of social care homes to prevent transmission of COVID-19, in particular where the resident has a strong compulsion to walk and will not, or cannot, remain still and isolated? (2) what types of strategies are lawful to curtail walking and achieve isolation and social distancing? (3) is law reform required to ensure any action to restrict freedoms is lawful and not excessive? These questions emerged during the first wave of the COVID-19 pandemic and are still relevant. Although focussed on COVID-19, the results are also relevant to other future outbreaks of infectious diseases in care and group homes. Likewise, while we concentrate on the law in England and Wales, the analysis and implications have international significance.

Family members, ambulance clinicians and attempting CPR in the community: the ethical and legal imperative to reach collaborative consensus at speed.

Here we present the personal perspectives of two authors on the important and unfortunately frequent scenario of ambulance clinicians facing a deceased individual and family members who do not wish them to attempt cardiopulmonary resuscitation. We examine the professional guidance and the protection provided to clinicians, which is not matched by guidance to protect family members. We look at the legal framework in which these scenarios are taking place, and the ethical issues which are presented. We consider the interaction between ethics, clinical practice and the law, and offer suggested changes to policy and guidance which we believe will protect ambulance clinicians, relatives and the patient.

A new kind of paternalism in surrogate decision-making? The case of Barnsley Hospitals NHS Foundation Trust v MSP.

The modern legal and ethical movement against traditional welfare paternalism in medical decision-making extends to how decisions are made for patients lacking decisional capacity, prioritising surrogates' judgment about what patients would have decided over even their best interests. In England and Wales, the Mental Capacity Act 2005 follows this trend of prioritising the patient's prior wishes, values and beliefs but the dominant interpretation in life-sustaining treatment cases does so by in effect calling those values the 'best interests' of the patient and focusing nearly exclusively on the 'subjective' viewpoint of the patient. In this article, we examine the recent Court of Protection judgment in Barnsley Hospitals NHS Foundation Trust v MSP [2020] EWCOP 26, which adhered closely to this approach, to suggest that it could have unexpected negative consequences. These include insufficient information gathering about and attention to patients' objective medical interests, inadequacy of the evidentiary standard used for the substituted decision-making and, in some cases, even prioritising a surrogate's current substituted judgment over the potential for an actual judgment by the patient.

Withdrawing life-sustaining treatment: a stock-take of the legal and ethical position.

This article, prompted by an extended essay published in the Journal of Medical Ethics by Charles Foster, and the current controversy surrounding the case of Vincent Lambert, analyses the legal and ethical arguments in relation to the withdrawal of life-sustaining treatment from patients with prolonged disorders of consciousness. The article analyses the legal framework through the prism of domestic law, case-law of the European Court of Human Rights and the Convention on the Rights of Persons with Disabilities, and examines the challenge to the ethical consensus made by Foster. It concludes that the right approach remains a version of the approach that has prevailed for the last 25 years since the decision in Airedale NHS Trust v Bland[1993] AC 789, refined to reflect that that there is now, and rightly, a much more limited place for judgments made about the 'burden' of treatment or the quality of life enjoyed by the person made on the basis of assumptions about that person as a category as opposed to investigation of that person as an individual human being.

Law and Rhetoric: Critical Possibilities.

What contribution can rhetoric make to socio-legal studies? Though now a byword for deception and spin, rhetoric was long identified with the very substance of law and politics. Latterly radical scholars have foregrounded an understanding of law as rhetoric in their polemics against legal formalism, but it needs to be complemented by a critical perspective which goes beyond simple revivalism, taking account of rhetoric's own blind spots, inquiring into the means by which some speakers and listeners are privileged and others excluded or silenced. The critical potential of legal rhetoric is tested here through a review of the developing law on mental capacity and the best interests of people with disabilities in England and Wales. Much of what is at stake there is properly grasped in terms of a politics of speech: who is addressed, who can speak, who must speak, and how are they represented in judicial and media discourse.

Litigation Friends or Foes? Representation of 'P' before the Court of Protection.

This article argues that, properly analysed, the common law and the European Convention on Human Rights (ECHR) march hand in hand with the provisions of the Mental Capacity Act 2005 (MCA 2005) so as to impose a set of requirements on litigation friends acting for the subject of applications of proceedings before the Court of Protection ('P') which are very different to those currently understood by practitioners and the judiciary. The authors examine critically current practice and procedures and provide a set of proposals for reforms.

TOEING THE LINE (OR DOING A DELICATE DANCE?): THE COURTS AND THE CLINICIANS.

This comment responds to the comment by Jonathan Youngs in St George's Healthcare NHS Trust v P(1) entitled 'Can the courts force the doctor's hand?' Vol. 24, No. 1, pp. 99-111, doi: 10.1093/medlaw/fwv042. It clarifies an important factual error in that comment as to the nature of the order made by the court, and it provides further observations upon the respective role of courts and clinicians in cases involving medical treatment decisions.