Participation in dementia research: rates and correlates of capacity to give informed consent: Table 1
Abstract
BACKGROUND: Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research. AIMS: To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research. METHODS: As part of a pragmatic randomised controlled trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity. RESULTS: Most participants (76%) with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity. CONCLUSION: Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements.
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The research literature shows consistently that persons even in early stages of dementia are, based on a functional model of capacity, very often or usually incompetent to consent to treatment, to research, or to write an advance treatment directive.
“the research literature that shows consistently that persons even in early stages of dementia are, based on a functional model of capacity, very often or usually incompetent to consent to treatment,(30) to research, (31) or to write an advance treatment directive.(32)”
From Euthanasia and Assisted Suicide of Persons With Dementia in the Netherlands (2020) · cites this paper as [31]
Cites
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Euthanasia and Assisted Suicide of Persons With Dementia in the Netherlands
Mangino, D. R., Nicolini, M. E., De Vries, R. G., & Kim, S. Y. H. (2020) · The American Journal of Geriatric Psychiatry · doi:10.1016/j.jagp.2019.08.015 · Cited by 53 · see citing works
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- Authors
- Warner, J., McCarney, R., Griffin, M., Hill, K., & Fisher, P.
- Affiliations
- Imperial College London (GB)
- University College London (GB)
- Royal London Hospital for Integrated Medicine (GB)
- Corresponding author
- Warner, J
- Venue
- Journal of Medical Ethics
- Publisher
- BMJ
- Published
- 2008-03
- Volume
- 34
- Issue
- 3
- Pages
- 167-170
- ISSN
- 0306-6800 (ISSN-L)
- 1473-4257
- OpenAlex
- W2111335898
- Cited by
- 75
- References
- 13
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 5 · 2020: 8 · 2019: 5 · 2018: 4 · 2017: 4 · 2016: 6 · 2015: 4 · 2014: 5 · 2013: 5 · 2012: 4
- FWCI
- 6.60
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Medical Ethics (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Psychology › Clinical Psychology › Healthcare Decision-Making and Restraints
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- dementia research, informed consent, capacity assessment, Mental Capacity Act 2005, Ginkgo biloba, Mini-Mental State Examination, cognitive function, participant recruitment, research ethics, legal capacity
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Dementia, Double-Blind Method, Female, United Kingdom, Humans, Informed Consent, Male, Phytotherapy, Middle Aged, Plant Extracts, Dementia, Vascular, Randomized Controlled Trials as Topic, Patient Selection, Ginkgo biloba, Research Subjects
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