ArticleContemporary clinical trials2020
Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.
Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Toward global reproductive justice: a universal framework for evaluating equity and autonomy in in-vitro fertilization policies.Reproductive health · 2025Pooled it
- Pooled it
- 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
- Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation.Trials · 2023Trial
- Barriers and facilitators to recruiting older adult care home residents into clinical trials of medicines and vaccines: a scoping review.Age and ageing · 2026Article
- Exploring the Perspectives of Patients and Healthcare Providers on Rheumatology Clinical Trials: A Single-Center Cross-Sectional Study in Hungary.Journal of clinical medicine · 2026Article
- Equitable inclusion of people with disabilities in clinical trials: a scoping review.BMJ open · 2026Article
- Article
- Ethics of Sensor-Based Surveillance of People with Dementia in Clinical Practice.Sensors (Basel, Switzerland) · 2025Article
- Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change.Frontiers in pharmacology · 2025Article
- Equity in Clinical Care and Research Involving Persons with Disorders of Consciousness.Neurocritical care · 2024Review
- Challenges to conducting research on oral health with older adults living in long-term care facilities.BMC oral health · 2024Article
- Improving thePalliative medicine · 2024Article
- Challenges and Solutions in Recruiting Older Vulnerable Adults in Research.International journal of public health · 2024Article
- Assessing Facilitator Fidelity to Principles of Public Deliberation: Tutorial.JMIR formative research · 2023Article
- Article
- 'Language has been granted too much power'.Health expectations : an international journal of public participation in health care and health policy · 2022Article
- Article
- Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.BMJ open · 2022Article
- (Re)Conceptualising 'good' proxy decision-making for research: the implications for proxy consent decision quality.BMC medical ethics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
Informed consent is an essential requirement prior to clinical trial participation, however some 'vulnerable' groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity. Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population. This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.