The right to equal recognition before the law, protected by Article 12 of the United Nations (UN) Convention on the Rights of Persons with Disabilities (CRPD), mandates the use of supported ...decision-making practices to enable disabled people, particularly those with intellectual and/or psychosocial disabilities, to enjoy their legal capacity. Finding ways to translate this theoretical mandate into practice poses a number of particularly challenging socio-legal issues, which this research seeks to address. The English Mental Capacity Act 2005 (MCA) sets out a right to support with decision-making (s.1(3)), underpinned by a presumption of capacity (s.1(2)). Qualitative interviews with intellectually disabled people, their supporters, and care and support professionals were undertaken to explore how disabled people make decisions in their everyday lives, the kinds of support they need, and the strategies for supported decision-making used in practice. Analysis of these interviews suggests that a range of supported decision-making techniques have been developed in practice and are effective in supporting everyday preferences and some life choices. Paradoxically, it appears that as decisions become more complex, the support available to disabled people reduces. Specifically, much less support is available for more difficult decisions around finances, healthcare and legal matters. We argue that the reasons for this are due to a web of regulatory, social and policy issues. We conclude that implementing the right to enjoy legal capacity through supported decision-making will require a combination of regulatory reform, social change and policy amendment.
The world of dementia care can be a difficult one for carers to navigate, posing new challenges at every stage from diagnosis to end of life. In her ground-breaking investigation, rooted in original ...empirical data, Rosie Harding explores the regulatory and legal dimensions of caring for a person with dementia. By exploring carers' experiences of dementia care, she critiques the limitations of current approaches to health and social care regulation. This socio-legal work is a new contribution to the study of feminist care ethics, relationality, and vulnerability theory. Duties to Care argues that by understanding the relational contexts that shape everyday experiences of regulatory structures, we will better understand where law is operating to support carers, and where it adds to the difficulties they experience. Ultimately, the challenges that dementia poses will be addressed only if we find solutions that take account of the relationality of life, dementia, and law.
In this article, I reflect on the praxis of doing qualitative interview research involving intellectually disabled people as participants. I explore the ways in which ethical and legal norms work ...together to shape what is possible in research with intellectually disabled participants. I use stories from the field to explore issues of recruitment and sampling, working with ‘gatekeeper’ organizations, accessible information and informed consent, and data sharing and open access. As these reflections demonstrate, undertaking fieldwork involving intellectually disabled participants presents multiple challenges for socio‐legal researchers. They also show that many of the challenges are surmountable, offering concerns, considerations, and solutions that can, and perhaps should, be considered by all socio‐legal researchers who wish to ensure that all of the voices of society are included and reflected in their research.
This article addresses 'statutory wills' executed under the Mental Capacity Act 2005 (MCA) for persons with impaired mental capacity. The article provides an overview of the historical development of ...statutory wüls, before exploring their rising contemporary significance. It considers the shift from the previous 'hypothetical substituted judgment' test to the contemporary 'best interests' orientation of the MCA. The article assesses the problems that the best interests approach raises in this area, and its (in) compatibility with the right to equal recognition before the law under the UN Convention on the Rights of Persons with Disabilities, arguing that the pervasive reach of best interests in contemporary mental capacity law requires reconsideration. The paper concludes by suggesting that a more limited framing of the power to execute statutory wüls is required in order to appropriately balance the rights of individuals with disabüities with practical considerations around the distribution of assets on death.
IntroductionThe use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical ...trials of advanced therapy medicinal products (ATMPs) are not yet well understood. This protocol describes a qualitative study that aims to evaluate the feasibility and acceptability of ePRO data capture using a trial-specific ePRO system (the PROmics system) within an advanced therapy trial involving patients with immune-mediated inflammatory disease (rheumatoid arthritis, lupus, primary sclerosing cholangitis (PSC) and Crohn’s disease).Methods and analysisThis protocol for a remote, qualitative, interview-based feasibility study is embedded within the POLARISE trial, a single-arm, phase II, multisite ATMP basket trial in the UK. 10–15 patients enrolled in the POLARISE trial and 10–15 research team members at the trial sites will be recruited. Participants will take part in semistructured interviews which will be transcribed verbatim and analysed thematically according to the framework method. Data collection and analysis will occur concurrently and iteratively. Researcher triangulation will be used to achieve a consensus-based analysis, enhancing rigour and trustworthiness.Ethics and disseminationThis study was approved by the London—West London and GTAC Research Ethics Committee (Ref: 21/LO/0475). Informed consent will be obtained from all participants prior to data collection. The study findings will be published in peer-review journals and disseminated via conference presentations and other media. Our patient and public involvement and engagement group and ATMP stakeholder networks will be consulted to maximise dissemination and impact.Trial registration numberISRCTN80103507.
This paper explores the legal position of the off-label prescription of antipsychotic medications to people with dementia who experience behavioural and psychological symptoms of dementia (BPSD). ...Dementia is a challenging illness, and BPSD can be very difficult for carers to manage, with evidence that this contributes to carer strain and can result in the early institutionalisation of people with dementia. As a result, the prescription of antipsychotic and other neuroleptic medications to treat BPSD has become commonplace, in spite of these drugs being untested and unlicensed for use to treat older people with dementia. In recent years, it has become apparent through clinical trials that antipsychotic drugs increase the risk of cerebrovascular accident (stroke) and death in people with dementia. In addition, these types of medication also have other risk factors for people with dementia, including over-sedation and worsening of cognitive function. Drawing on recent questionnaire ('n'=185), focus group ('n'=15), and interview ('n'=11) data with carers of people with dementia, this paper explores the law relating to off-label prescription, and the applicability of medical negligence law to cases where adverse events follow the use of antipsychotic medication. It is argued that the practice of off-label prescribing requires regulatory intervention in order to protect vulnerable patients.
Abstract
The issue of when and how disabled people can be lawfully deprived of their liberty is a major contemporary challenge for mental capacity law. People who lack capacity to consent to ...treatment that deprives them of their liberty must have access to safeguards to protect their rights under Article 5 ECHR. The current Deprivation of Liberty Safeguards are widely considered to be unfit for purpose, and a replacement scheme, the ‘Liberty Protection Safeguards’ (LPS) were proposed by the Law Commission of England and Wales in 2017. These safeguards were legislated for in 2018/19 in the Mental Capacity (Amendment) Act and are expected to be implemented in 2022. At the time the reforms were being debated in Parliament, multiple stakeholders expressed serious reservations about the proposals, some going so far as to claim that they are not ‘good law’. In this paper, I evaluate to what extent the LPS is (or has the potential to be) ‘good law’, drawing on two contrasting conceptual frameworks to guide that analysis: Bingham’s (2007) sub-principles of the rule of law; and the capabilities approach developed by Sen and Nussbaum (among others). I argue that despite the technical problems with the legislation that caused such concern during its passage through parliament, if the implementation process is grounded in a strong social justice conceptual frame, the LPS has the potential to be a positive legal reform.
This article uses original data from research at the Court of Protection to explore capacity to consent to sex in practice. It argues that the approach under the Mental Capacity Act 2005 fails to ...place appropriate focus on consent as central to understanding sexual capacity. The capabilities approach to justice is then used to demonstrate the limitations of the existing legal approach to capacity to consent to sex, and to argue that the protective focus of the legal test would be better centred on the social risks resulting from non‐consensual sex and exploitation. Finally, the article argues that, rather than focusing on a medicalized approach to understanding sexual intimacy, an analysis based on capabilities theory provides conceptual tools to support arguments for additional resources to help disabled people to realize their rights to sexual intimacy.
Background
Electronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The ...aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies.
Methods
An ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions. ORBCEL-C™ is an enriched Mesenchymal Stromal Cells product isolated from human umbilical cord tissue using CD362+ cell selection. Usability testing sessions were conducted using cognitive interviews and the ‘Think Aloud’ method with patient advisory group members and Research Nurses to assess the usability of the system.
Results
Nine patient partners and seven research nurses took part in one usability testing session. Measures of fatigue and health-related quality of life, the PRO-CTCAE™ and FACT-GP5 global tolerability question were included in the ePRO system. Alert notifications to the clinical team were triggered by PRO-CTCAE™ and FACT-GP5 scores. Patient participants liked the simplicity and responsiveness of the patient-facing app. Two patients were unable to complete the testing session, due to technical issues. Research Nurses suggested minor modifications to improve functionality and the layout of the clinician dashboard and the training materials.
Conclusion
By testing the effectiveness, efficiency, and satisfaction of our novel ePRO system (PROmics
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), we learnt that most people with an inflammatory condition found it easy to report their symptoms using an app on their own device. Their experiences using the PROmics
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ePRO system within a trial environment will be further explored in our upcoming feasibility testing. Research nurses were also positive and found the clinical dashboard easy-to-use. Using ePROs in early phase trials is important in order to provide evidence of therapeutic responses and tolerability, increase the evidence based, and inform methodology development.
Trial registration
: ISRCTN, ISRCTN80103507. Registered 01 April 2022,
https://www.isrctn.com/ISRCTN80103507
Plain English summary
More and more patients tell clinicians how they feel by completing questionnaires electronically. Therefore, it is important to assess how easy it is for patients to do this. In this study, we describe how we developed an electronic platform for patients to report their symptoms and how we tested the usability of this platform with patient partners and research nurses. Once the electronic platform was developed, quality of life and symptoms questionnaires were programmed onto it. Alerts were sent to the clinical team if specific scores were obtained on the symptoms questionnaires. Although two patient partners were not able to finish the testing session because of technical issues, the ones who completed the session liked its simplicity and responsiveness. The research nurses also liked the system and only suggested minor modifications. Following this testing, we refined the electronic platform to test it further in a larger study which investigates the safety and use of a drug. We hope that thanks to this electronic platform, we will obtain useful information on the safety and efficacy of treatment.
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