Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders.

OBJECTIVES: We aimed to: (A) describe researcher decision-making when including or excluding adults with conditions that have the potential to affect capacity and/or communication in research and (B) explore the underlying values and reasoning of stakeholders in research which falls under the provisions of the Mental Capacity Act, 2005. DESIGN: The mixed-methods design included semistructured interviews with adults with conditions that have the potential to affect capacity and/or communication, supporters, researchers, research ethics committee members and an online survey with researchers. Triangulation was used to integrate the data and examine the complementarity of the findings. SETTING: England and Wales. PARTICIPANTS: There were 61 participants who took part in semistructured interviews, of which 39 were adults with conditions with potential to affect capacity and/or communication, 6 were in support roles for adults with conditions with potential to affect capacity and/or communication (including family members and professionals in advocacy organisations), 8 were members of research ethics committees flagged under the Mental Capacity Act to review research where there could be issues of mental capacity and 8 were researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication. The online survey had 128 participants, researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication. RESULTS: All stakeholders were supportive of the genuine inclusion of adults with conditions that have the potential to affect capacity and/or communication in research, and exclusion was seen as a form of discrimination. Many researchers were daunted by meeting the threshold within the legislation for including participants who may lack capacity. CONCLUSION: Further training, expertise and resources are required to promote the successful inclusion in research of adults with conditions that have the potential to affect capacity and/or communication.

How are adults with capacity-affecting conditions and associated communication difficulties included in ethically sound research? A documentary-based survey of ethical review and recruitment processes under the research provisions of the Mental Capacity Act (2005) for England and Wales.

OBJECTIVES: This study aimed to determine the characteristics of ethical review and recruitment processes, concerning the inclusion of adults with capacity-affecting conditions and associated communication difficulties in ethically sound research, under the provisions of the Mental Capacity Act (MCA, 2005) for England and Wales. DESIGN: A documentary-based survey was conducted focusing on adults with capacity-affecting conditions and associated communication difficulties. The survey investigated: (1) retrospective studies during the implementation period of the MCA (2007-2017); (2) prospective applications to MCA-approved Research Ethics Committees (RECs) during a 12-month period (2018-19); (3) presentational and linguistic content of participant information sheets used with this population. SETTING: Studies conducted and approved in England and Wales. SAMPLE: Studies focused on adults with the following capacity-affecting conditions: acquired brain injury; aphasia after stroke; autism; dementia; intellectual disabilities; mental health conditions. The sample comprised: (1) 1605 studies; (2) 83 studies; (3) 25 participant information sheets. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the inclusion/exclusion of adults with capacity-affecting conditions from studies. The secondary outcome was the provisions deployed to support their inclusion. RESULTS: The retrospective survey showed an incremental rise in research applications post-MCA implementation from 2 (2012) to 402 (2017). The prospective survey revealed exclusions of people on the bases of: 'lack of capacity' (n=21; 25%); 'communication difficulties' (n=5; 6%); 'lack of consultee' (n=11; 13%); and 'limited English' (n=17; 20%). REC recommendations focused mainly on participant-facing documentation. The participant information sheets were characterised by inconsistent use of images, typography and layout, volume of words and sentences; some simplified language content, but variable readability scores. CONCLUSIONS: People with capacity-affecting conditions and associated communication difficulties continue to be excluded from research, with recruitment efforts largely concentrated around participant-facing documentation. There is a need for a more nuanced approach if such individuals are to be included in ethically sound research.

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.

Inclusion under the Mental Capacity Act (2005): A review of research policy guidance and governance structures in England and Wales.

OBJECTIVE: To investigate how people with communication and understanding difficulties, associated with conditions such as dementia, autism and intellectual disability, are represented in research guidance supplementary to the Mental Capacity Act (MCA: 2005) in England and Wales. METHODS: A documentary survey was conducted. The sample comprised the MCA Code of Practice (CoP: 2007) and 14 multi-authored advisory documents that were publicly available on the Health Research Authority website. Textual review of key words was conducted followed by summative content analysis. RESULTS: Representation of people with communication and understanding difficulties was confined to procedural information and position statements that focused mainly on risk management and protection. Whilst a need to engage potential participants was recognized, guidance provided was imprecise. CONCLUSIONS: Tensions exist between the protection versus empowerment of people with communication and understanding difficulties in research. The development of structured, evidence-based guidance is indicated. PATIENT OR PUBLIC CONTRIBUTION: People with communication and understanding difficulties and carers participated in a working group to explore, discuss and interpret the findings.

Healthcare Professional Standards in Pandemic Conditions: The Duty to Obtain Consent to Treatment.

In the United Kingdom, the question of how much information is required to be given to patients about the benefits and risks of proposed treatment remains extant. Issues about whether healthcare resources can accommodate extended shared decision-making processes are yet to be resolved. COVID-19 has now stepped into this arena of uncertainty, adding more complexity. U.K. public health responses to the pandemic raise important questions about professional standards regarding how the obtaining and recording of consent might change or be maintained in such emergency conditions, particularly in settings where equipment, medicines, and appropriately trained or specialized staff are in short supply. Such conditions have important implications for the professional capacity and knowledge available to discuss the risks and benefits of and alternatives to proposed treatment with patients. The government's drive to expedite the recruitment to wards of medical students nearing the end of their studies, as well as inviting retired practitioners back into practice, raises questions about the ability of such healthcare providers to engage fully in shared decision-making.This article explores whether the legal duty on healthcare practitioners to disclose the material risks of a proposed medical treatment to a patient should be upheld during pandemic conditions or whether the pre-eminence of patient autonomy should be partly sacrificed in such exceptional circumstances. We argue that measures to protect public health and to respect autonomous decision-making are not mutually exclusive and that there are good reasons to maintain professional standards in obtaining consent to treatment even during acute pressures on public health systems.

"If the Problem Persists, Come Back To See Me ."-An Empirical Study of Clinical Negligence Cases Against General Practitioners.

The law of negligence, as it applies to General Practitioners (GPs), is underexplored in the literature. There has been no substantial research undertaken that has penetrated deeper into claims that have actually reached court in order to analyse judicial reasoning pertaining to both breach of duty and causation. Given the increased pressures that GPs now face, these are important questions to consider. It is against this backdrop that this article seeks to present the findings of an empirical investigation into a number of reported clinical negligence claims brought against GPs. This analysis provides an original contribution to the developing academic discussion surrounding the changing nature of the doctor-patient relationship, and how it has come to be viewed in the eyes of the law. It also assesses the extent to which judges have become more receptive to protecting patient rights through the law of negligence, engaging in the expanding discourse concerning judicial deference to medical decision-making. It is argued that judges should sometimes show a greater propensity to question expert medical testimony in support of GPs, because some of the issues GPs typically face are less complex than in other clinical negligence cases involving technical areas of medicine, and that causation does not appear to be such a key factor in defeating patient claims. The work also provides useful guidance for GPs and their advisers in respect of where liability is most likely to be founded and how behaviour can be modified accordingly to reduce the chances of being sued.

Live or Let Die?: Fine Margins Between Life and Death in a Brain-Dead Pregnancy.

In PP v Health Service Executive, the Irish High Court was recently asked to decide on the lawfulness of maintaining somatic treatment that was being provided to a brain-dead woman who was 15-weeks pregnant. In delivering judgment, Kearns P held that the treatment should not be maintained and that the artificial support being provided to the woman could lawfully be withdrawn. The legal basis for this ruling, however, is not free from criticism. The focus of this discussion is to consider how an English court would deal with a case similar to this should the need ever arise. There are crucial differences between English and Irish law which could impact upon the reasoning and, quite possibly, the outcome. Given that it is not beyond the realms of possibility that a similar case could occur in England at some point in the future, it is important that a number of legal questions are explored and their implications illuminated.

The value of life in English law: revered but not sacred?

Terms such as sanctity and inviolability have failed to provide a legally coherent or ethically sound principle upon which to determine the scope of the intrinsic value of life against extrinsic, quality-of-life considerations in a medical context. In their recent work, Margaret Brazier and Suzanne Ost introduce a new term, reverence for life, which they suggest may be more appropriate when attempting to navigate the murky waters of the meaning of life and the value that should be attached to it. They suggest that reverence should be utilised as an alternative that better reflects the nuances and the realities of the dilemma. This paper explores the existing difficulties before considering how the principle of reverence might provide a principled compromise over when the presumption in favour of preserving life should be rebutted.

Revisiting advance decision making under the Mental Capacity Act 2005: a tale of mixed messages.

Whilst most of the existing literature relating to advance decisions has focused on philosophical questions, this article reflects on the significant legal developments that have occurred since the introduction of the Mental Capacity Act 2005. The article provides a critique of the controversial issues which have emerged within contemporary case law. The focus of the discussion centres on capacity, the interpretation of the safeguards, and the bias towards preservation of life.

Moving on from bland: the evolution of the law and minimally conscious patients.

The decision in Bland centred on the withdrawal of artificial nutrition and hydration from a patient in a persistent vegetative state (PVS). Since then, a new medical condition has emerged, known as a minimally conscious state (MCS). In W v M, the Court of Protection was asked to authorise the withdrawal of artificial nutrition and hydration from a patient in a MCS. Baker J refused to grant the declaration. More recently, however, the courts were also asked to rule on the lawfulness of withholding treatment in a similar, albeit factually different, case. In the Court of Appeal decision in Aintree University Hospitals NHS Foundation Trust v David James and Others, Sir Alan Ward, with the agreement of Arden LJ and Laws LJ, granted a declaration that it would be lawful to withhold treatment. The Supreme Court then upheld this ruling, Lady Hale stating that the Court of Appeal reached the right result but for the wrong reasons. This article seeks to critically appraise the evolution of the law in regard to withdrawing treatment from MCS patients. The piece begins by explaining the differences between the two conditions of PVS and MCS and defines the law from the starting point of Bland. From here, the discussion progresses to focus on the challenges that the law has had to face in trying to keep pace with the advancing nature of medical understanding of conditions of the brain and explains how it has responded to these. The narrative then critiques the legal mechanism of best interests as it has been employed in the case law concerning MCS patients to date by analysing the various judicial perspectives on the concept. After addressing both the narrow and wide viewpoints, a conclusion is ventured as to how the balancing of best interests should be approached in respect of future MCS cases.

Parents and medical professionals: conflict, cooperation, and best interests.

Abstract This paper seeks to engage with the ideas expressed by Professor Brazier in her commentary on the Charlotte Wyatt case and to develop contemporary analysis around parental rights, notions of best interests, and shared decision-making between parents and professionals. The article begins by setting the scene in relation to parental/professional conflict and frames the discussion in the context of medical decision-making. Parental rights are then explored before the analysis progresses to how the concept of best interests has recently developed. Finally, the article investigates the benefits of compromise, cooperation, and shared decision-making as the most effective method for resolving disputes concerning children.

Excessive risk disclosure: the effects of the law on medical practice.

This article examines the debate surrounding the challenging concept of informed consent. It argues whilst the English courts have effectively excluded the use of the tort of battery as an appropriate mechanism for protecting a patient's right to self-determination, they have left the law in a state of flux due to the uncertainties associated with categorising similar claims within negligence where the onus is on risk disclosure. This confusion may stem firstly from the fact that medical practitioners are unsure exactly which risks to disclose, and secondly, from the way in which both doctors and patients perceive the consent process. The paper suggests this disorder may be having a detrimental effect on medical practice as medical practitioners are taking it upon themselves to disclose excessive information, which patient's may not want or need. A suggestion is also made that in these situations, in order that the law truly respects self-determination, consideration must be given to the patient's desire to waive their right to informed consent.