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Cited by 255Healthcare Decision-Making and RestraintsEthics in Clinical ResearchEthics and bioethics in healthcare

The DOI matches its Crossref record; 19 of the 20 references it cites were found in a registry or an index.

Assessing the Competence of Persons With Alzheimer’s Disease in Providing Informed Consent for Participation in Research

Kim, Scott Y. H., Caine, Eric D., Currier, Glenn W., Leibovici, Adrian, Ryan, J. Michael·2001·American Journal of Psychiatry
DOI 10.1176/appi.ajp.158.5.712
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Abstract

OBJECTIVE: The capacity of persons with Alzheimer's disease or other neuropsychiatric disorders for giving consent to participate in research has come under increasing scrutiny. While instruments for measuring abilities related to capacity have been developed, how they should be used to categorize subjects as capable or incapable is not clear. A criterion validation study was carried out to help address this question. METHOD: The authors measured the ability of 37 subjects with mild-to-moderate Alzheimer's disease and 15 elderly comparison subjects to provide consent for participation in a hypothetical clinical trial. Using the judgment of three experts as the criterion standard, the authors performed a receiver operator characteristic analysis for the capacity ability measures from the MacArthur Competence Assessment Tool-Clinical Research VERSION: The results were compared with categorizations of capacity status that were based on normative values. RESULTS: While most comparison subjects scored perfectly on all measures of the competence assessment tool, the majority of the group with Alzheimer's disease showed significant decision-making impairment. Thresholds based on normative values resulted in 84% (N=31) of the Alzheimer's disease subjects being rated as incapable on at least one ability; thresholds based on expert judgment resulted in 62% (N=23) failing to meet cutoff scores on at least one ability. CONCLUSIONS: Even relatively mild Alzheimer's disease significantly impairs consent-giving capacity. But differentiating capable from incapable subjects remains an issue despite the aid of standardized tools. More research is needed to understand the relationship between subject factors (performance on ability measures) and categorical judgments about their capacity.

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Crossref · 10.1176/appi.ajp.158.5.712

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1 of the 20 references couldn’t be matched to a known paper.

Research works printed but not linked: 2

  1. American Psychiatric Association: Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. Am J Psychiatry 1998; 155:1649–1650
  2. Charney DS, Innis B, Nestler EJ: New requirements for manuscripts submitted to Biological Psychiatry: informed consent and protection of subjects. Biol Psychiatry 1999; 46:1007–1008

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Metadata

Authors
Kim, S. Y. H., Caine, E. D., Currier, G. W., Leibovici, A., & Ryan, J. M.
Affiliations
University of Rochester Medicine (US)
ORCID
Venue
American Journal of Psychiatry
Publisher
American Psychiatric Association Publishing
Published
2001-05-01
Volume
158
Issue
5
Pages
712-717
ISSN
  • 0002-953X (ISSN-L)
  • 1535-7228
DOI
10.1176/appi.ajp.158.5.712
OpenAlex
W1982530475
Cited by
255
References
20
Citations by year
2026: 4 · 2025: 3 · 2024: 1 · 2023: 4 · 2022: 4 · 2021: 6 · 2020: 6 · 2019: 7 · 2018: 8 · 2017: 11 · 2016: 12 · 2015: 10 · 2014: 8 · 2013: 24 · 2012: 8
FWCI
17.76
Type
journal article
Language
en
Open access
closed
Locations
  • American Journal of Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Funders
National Institute of Mental Health (MH18911, T32MH018911)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Healthcare Decision-Making and Restraints
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
Keywords
Alzheimer's disease, informed consent, research participation, decision-making capacity, neuropsychiatric disorders, expert opinion, decision-making impairment
MeSH terms
Aged, Alzheimer Disease, Clinical Trials as Topic, Female, Forensic Psychiatry, Humans, Informed Consent, Male, Psychiatric Status Rating Scales, Psychometrics, Research Design, ROC Curve, Sensitivity and Specificity, Severity of Illness Index, Geriatric Assessment, Mental Competency, Patient Selection

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