A systematic review and narrative synthesis of the research provisions under the Mental Capacity Act (2005) in England and Wales: Recruitment of adults with capacity and communication difficulties.

BACKGROUND: The Mental Capacity Act (MCA, 2005) and its accompanying Code of Practice (2007), govern research participation for adults with capacity and communication difficulties in England and Wales. We conducted a systematic review and narrative synthesis to investigate the application of these provisions from 2007 to 2019. METHODS AND FINDINGS: We included studies with mental capacity in their criteria, involving participants aged 16 years and above, with capacity-affecting conditions and conducted in England and Wales after the implementation of the MCA. Clinical trials of medicines were excluded. We searched seven databases: Academic Search Complete, ASSIA, MEDLINE, CINAHL, PsycArticles, PsycINFO and Science Direct. We used narrative synthesis to report our results. Our review follows Preferred Reporting Items for Systematic Reviews and is registered on PROSPERO, CRD42020195652. 28 studies of various research designs met our eligibility criteria: 14 (50.0%) were quantitative, 12 (42.9%) qualitative and 2 (7.1%) mixed methods. Included participants were adults with intellectual disabilities (n = 12), dementia (n = 9), mental health disorders (n = 2), autism (n = 3) and aphasia after stroke (n = 2). We found no studies involving adults with acquired brain injury. Diverse strategies were used in the recruitment of adults with capacity and communication difficulties with seven studies excluding individuals deemed to lack capacity. CONCLUSIONS: We found relatively few studies including adults with capacity and communication difficulties with existing regulations interpreted variably. Limited use of consultees and exclusions on the basis of capacity and communication difficulties indicate that this group continue to be under-represented in research. If health and social interventions are to be effective for this population, they need to be included in primary research. The use of strategic adaptations and accommodations during the recruitment process, may serve to support their inclusion.

[Action before ethical dilemmas in the consultation after divorce. Role of the minor according to age and level of maturity]. / Actuación ante los dilemas éticos en la consulta tras divorcio. Papel del menor según edad y nivel de madurez.

Lately, number of divorces is increasing, nevertheless, a parents' divorce can become a traumatic problem for paediatric patients. Consequently, the aim of this study was to analyze the ethical conflicts that appear in the relationship between physician/parents/son/daughter, and more specifically those that a divorce generates. A descriptive study was developed through a survey composed by 39 items. Previously, an exhaustive bibliographic analysis was carried out. Our results show that only 35% of paediatricians interviewed have been educated in bioethics although this issue is important in daily practice. Other items show that 57,5% would not cancel a pharmacological treatment in order to improve quality of life. Also, they would react against a wrong parents' decision (82,5%). They give low value to the minor`s decision (6,05%), and rarely inform exclusively to adolescents (5%). In contrast, paediatricians sometimes ask to adolescents (20%) in first place and involved them to decide in 90% of cases. Besides, there are differences in the relation with fathers and mothers, 17,5% of mothers are informed exclusively, a fact that never happens with fathers. Ethics has an intrinsic value very important in daily clinical decisions in order to respect the rules and to adapt them to the situation of every paediatric patient. When an important ethical conflict become, as a divorce is, it is essential to know who must be informed and the rights everyone has to make a decision. It is complicated to the paediatricians yet to develop 41/2002 law for Patient's autonomy.

Re H (A Child) (Parental Responsibility: Vaccination): The Merits of Adopting A Softer Approach To Vaccination of A Child in Care?

In Re H (A Child) (Parental Responsibility: Vaccination), the Court of Appeal decided that vaccination did not represent 'grave' or 'serious' medical treatment and determined that, in the case of a child under the care of a Local Authority, court authorization for consent to and arrangement of vaccination is no longer required. This is due to the strong medical evidence in support of vaccination. Thus, with due reference to 33(3)(b) Children Act 1989 and while considering proportionality and, particularly, the proportionate response to interference with the parents' right to respect for private and family life under Article 8 of the European Convention on Human Rights, the court held that vaccination is in line with the best interests of the child. This commentary supports this judgment but identifies a slight prospective anomaly in the approach adopted to children in care and those who are not in care. The resolution of this dichotomy lies in broadening the scope of King LJ's approach in this case.

Legal and Ethical Considerations for Requiring Consent for Apnea Testing in Brain Death Determination.

The past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria (DNC). The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for requiring consent before apnea testing and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: (1) a justice-based objection to allocate scarce resources fairly and (2) a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors.

Legal Liability Associated With rtPA Administration and Surrogate Decision Makers.

Stroke is one of the most common conditions neurologists treat in emergency situations. This article examines the issues of surrogate decision makers and the physician's potential legal liability in the context of the administration or nonadministration of recombinant tissue plasminogen activator (rtPA) in a common emergency department scenario.

Deprivation of Liberty in Care. An ECHR and CRPD Approach and its Consequences for Belgium.

This contribution examines deprivation of liberty in Belgian healthcare within the frameworks of the ECHR and CRPD. We develop and apply an ECHR-based framework to demonstrate that it is not the admissions to care facilities based on Belgium's involuntary commitment law that give rise to the unjustified deprivation of liberty, but those based on representation regimes. This can be remedied by broadening Belgium's involuntary commitment law. However, doing so would go against a CRPD-based framework, which is incompatible with the ECHR; the former opposes disability-based laws. Building on the right to legal capacity and to liberty, the scope of the CRPD's approach is uncovered. It is suggested that to reconcile the two frameworks, Belgium's involuntary commitment law should be abolished, and representation regimes should be changed to avoid (rather than to justify) deprivation of liberty. Although its desirability is open for discussion, this could solve a problem that occurs worldwide.

Ethics of organ procurement from the unrepresented patient population.

The shortage of organs for transplantation by its nature prompts ethical dilemmas. For example, although there is an imperative to save human life and reduce suffering by maximising the supply of vital organs, there is an equally important obligation to ensure that the process by which we increase the supply respects the rights of all stakeholders. In a relatively unexamined practice in the USA, organs are procured from unrepresented decedents without their express consent. Unrepresented decedents have no known healthcare wishes or advance care planning document; they also lack a surrogate. The Revised Uniform Anatomical Gift Act (RUAGA) of 2006 sends a mixed message about the procurement of organs from this patient population and there are hospitals that authorise donation. In addition, in adopting the RUAGA, some states included provisions that clearly allow organ procurement from unrepresented decedents. An important unanswered question is whether this practice meets the canons of ethical permissibility. The current Brief Report presents two principled approaches to the topic as a way of highlighting some of the complexities involved. Concluding remarks offer suggestions for future research and discussion.

Five Things Clinicians Should Know When Caring for Unrepresented Patients.

Increasingly, clinicians confront patients who are incapacitated and have no available surrogate. Such unrepresented patients cannot consent to proposed health care, and nobody else is available who is authorized to consent on their behalf. Despite the challenge of decision making for unrepresented patients, few laws or professional organization policy statements offer a solution. This article helps fill this void by describing the top 5 things clinicians should know when they are caring for unrepresented patients: (1) realize that these patients are highly vulnerable; (2) confirm that the patient is incapacitated; (3) confirm that the patient is unrepresented; (4) appreciate variability among state law decision-making processes for unrepresented patients; (5) use guardianship only as a last resort.

Who Makes Decisions for Incapacitated Patients Who Have No Surrogate or Advance Directive?

Unrepresented patients are those who have no surrogate or advance directive to guide medical decision making for them when they become incapacitated. While there is no perfect solution to the problem of making medical decisions for such vulnerable patients, 3 different approaches are noted in the literature: a physician approach, an ethics committee approach, and a guardianship approach. Recent policies and laws have required an approach that is "tiered" with respect to both who is involved and the gravity of the medical treatment questions at issue. In a general sense, some variant of a tiered approach is likely the best possible solution for jurisdictions and health institutions-both those already with and those without a tiered approach-to the challenging puzzle of treating unrepresented patients.

Who Are "Unrepresented" Patients and What Count as "Important" Medical Decisions for Them?

Unrepresented patients are hospital patients who lack decision-making capacity but have no advance directive and no one to serve as a legally authorized surrogate. An important first step in efforts to change the law and develop organizational policies that help respond to these patients' needs is determining which patients should be considered unrepresented and which aspects of hospital care should receive attention. This article proposes working definitions of unrepresented patient and important medical decisions based on the work of one statewide initiative, the Unrepresented Patients Project for Illinois.

Should Long-Term Life-Sustaining Care Be Started in Emergency Settings?

Decision making on behalf of an incapacitated patient is challenging, particularly in the context of venoarterial extracorporeal membrane oxygenation (VA-ECMO), a medically complex, high-risk, and costly intervention that provides cardiopulmonary support. In the absence of a surrogate and an advance directive, the clinical team must make decisions for such patients. Because states vary in terms of which decisions clinicians can make, particularly at the end of life, the legal landscape is complicated. This commentary on a case of withdrawal of VA-ECMO in an unrepresented patient discusses Extracorporeal Life Support Organization guidelines for decision making, emphasizing the importance of proportionality in a benefits-to-burdens analysis.

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales.

BACKGROUND: Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capacity. The role of the 'proxy' (or 'surrogate') is to advise researchers about the person's wishes and feelings or to provide consent on the person's behalf for a clinical trial of a medicine. Information about the study is usually provided to the proxy; however, little information is available to proxies about their role, or the appropriate legal and ethical basis for their decision, to help inform their decision-making. The aim of this study was to analyse the written information that is provided to consultees and legal representatives. METHODS: Studies including adults lacking capacity to consent which utilised consultees or legal representatives were identified using the UK Clinical Trials Gateway database. A representative sample (n = 30) were randomly selected. Information sheets and other study documents provided to proxies were obtained, and relevant content was extracted. Content analysis was conducted through four stages: decontextualisation of the unit of analysis, recontextualisation, categorisation, and compilation. The data were summarised narratively according to each theme and category. RESULTS: Considerable variation was found in the written information sheets provided to proxies. Most directed proxies to consider the wishes and feelings of the person who lacked capacity and to consult with others during the decision-making process. However, a small number of studies extended the scope of the proxy's role to consider the person's suitability or eligibility for the study. Particular discrepancies were found in information provided to those acting as consultees or legal representatives in a professional, as opposed to a personal, capacity. Incorrect uses of terminology were frequently found, and a small number of studies inaccurately interpreted the law. CONCLUSIONS: Despite undergoing ethical review, study documents lacked essential information, incorrectly used terminology, and conflated professionals' clinical and representation roles. Future recommendations include ensuring proxies are provided with adequate and accurate information which complies with the legal frameworks. Further research is needed to explore the information and decision-making needs of those acting as consultees and legal representatives.

Determination of Death by Neurologic Criteria in the United States: The Case for Revising the Uniform Determination of Death Act.

Although death by neurologic criteria (brain death) is legally recognized throughout the United States, state laws and clinical practice vary concerning three key issues: (1) the medical standards used to determine death by neurologic criteria, (2) management of family objections before determination of death by neurologic criteria, and (3) management of religious objections to declaration of death by neurologic criteria. The American Academy of Neurology and other medical stakeholder organizations involved in the determination of death by neurologic criteria have undertaken concerted action to address variation in clinical practice in order to ensure the integrity of brain death determination. To complement this effort, state policymakers must revise legislation on the use of neurologic criteria to declare death. We review the legal history and current laws regarding neurologic criteria to declare death and offer proposed revisions to the Uniform Determination of Death Act (UDDA) and the rationale for these recommendations.

Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research.

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.