ArticleTrials2019
Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed.
- Comparing in-person and remote consent of people with dementia into a primary care-based cluster randomised controlled trial: lessons from the Dementia PersonAlised Care Team (D-PACT) feasibility study.BMC medical research methodology · 2025Trial
- Proxy decision-making about participation in palliative care research: A scoping review.Palliative medicine · 2026Article
- Enhancing Equality, Equity, Diversity and Inclusion in Rare Disease Research in the United Kingdom.Nursing reports (Pavia, Italy) · 2025Article
- Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review.NIHR open research · 2024Article
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- (Re)Conceptualising 'good' proxy decision-making for research: the implications for proxy consent decision quality.BMC medical ethics · 2022Article
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- 'Do I have the capacity to make capacity judgements?' Researcher reflections from a person-centred dementia support study.Dementia (London, England) · 2022Article
- Development of a decision support intervention for family members of adults who lack capacity to consent to trials.BMC medical informatics and decision making · 2021Article
- Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.Contemporary clinical trials · 2020Article
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundResearch 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.
methodsStudies 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.
resultsConsiderable 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.
conclusionsDespite 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.
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What OpenQuestion holds
Registered trials
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