An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Shepherd, Victoria

doi:10.1186/s13063-020-04406-y

Cited by 66 publications

(56 citation statements)

References 49 publications

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“…However, a recent review (Shepherd et al, 2019) of UK clinical trials relating to conditions typically affecting mental capacity found that less than 20% included participants who lacked capacity. Shepherd (2020) has also found that many studies report the exclusion of people lacking capacity in a ‘limitations’ section, but rarely attempt to justify this exclusion. In the studies that did provide some explanation of exclusion, Shepherd found that complex legislation and ethical review processes were among the major motivations.…”

Section: Excluding Dementiamentioning

confidence: 99%

Unethical governance: capacity legislation and the exclusion of people diagnosed with dementias from research

Fletcher

2020

Research Ethics

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This paper considers the potential for the Mental Capacity Act (MCA) of England and Wales to incentivise the exclusion of people with dementia from research. The MCA is intended to standardise and safeguard the inclusion of people with cognitive impairments in research. This entails various procedural requirements, which in pressurised research contexts can lead researchers to exclude people with dementia as a means of simplifying bureaucratic constraints. I consider the risks of an ‘unethical ethics’, wherein procedural ethics indirectly causes the exclusion of people with dementia from research, undermining historic successes toward increased inclusivity. I suggest several solutions, including enhanced sensitivity to impairments and shifting the burden of proof from justifying inclusion to justifying exclusion. The paper responds to the ‘ethics creep’ tradition in procedural ethics, and critical appraisals of capacity legislation in dementia research. This approach recognises that institutional research ethics is itself a major ethical concern and can unwittingly beget unethical practices. Dementia researchers must be alert to such unethical ethics.

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Section: Excluding Dementiamentioning

confidence: 99%

Unethical governance: capacity legislation and the exclusion of people diagnosed with dementias from research

Fletcher

2020

Research Ethics

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“…Family members can be reluctant to support research activities in care homes if their relative has dementia or if they perceive the research to invade privacy (Lam et al , 2018). In addition, some care home providers may act as “gate keepers”, with the intention of protecting their residents, as there is a general lack of understanding that residents who lack capacity should have equal access to research participation (Shepherd, 2020).…”

Section: Current Evidence Basementioning

confidence: 99%

Building relational research capacity in care homes in the COVID-19 era: applying recognition theory to the research agenda

Toms

Green

Orrell

et al. 2020

QAOA

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Purpose Research can be an influential driver in raising care home standards and the well-being and human rights of residents. This paper aims to present a case for how a relational research capacity building programme could advance this agenda. Design/methodology/approach This study uses Axel Honneth’s Recognition Theory as a lens through which to explore organisational and institutional factors (such as research capacity and investment) that can either enable or limit “recognition” in the context of research in care homes. This paper draws on recent evidence from the COVID-19 pandemic in the UK and worldwide, to argue that such a relational capacity building agenda is even more pressing in the current context, and that it resonates with evidence from existing relational capacity building initiatives. Findings A lack of relevant research arguably contributed to the crisis experienced by the care home sector early in the pandemic, and there are only tentative signs that residents, care home providers and staff are now informing the COVID-19 research agenda. Evidence from pre COVID-19 and insights from Honneth’s Recognition Theory suggest that relational approaches to building research capacity within the care home sector can better generate evidence to inform practice. Originality/value This is a novel application of recognition theory to research in the care home sector. Drawing on theory, as well as evidence, has enabled the authors to provide a rationale as to why relationship-based research capacity building in care homes warrants further investment.

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“…This can be challenging for family members acting as consultee or legal representative, who often experience an emotional and decisional burden as a result [ 10 ]. Concerns about the burden of making proxy decisions, together with broader ethical concerns about who should act as proxy and the ethical basis for their decision, contribute to the methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent in trials [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

Shepherd

Wood

Robling

et al. 2021

Trials

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Background Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation. Methods We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020. Results A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting. Conclusions The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies’ experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement. Trial registration The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

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An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Cited by 66 publications

References 49 publications

Unethical governance: capacity legislation and the exclusion of people diagnosed with dementias from research

Unethical governance: capacity legislation and the exclusion of people diagnosed with dementias from research

Building relational research capacity in care homes in the COVID-19 era: applying recognition theory to the research agenda

Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

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