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Assessing Capacity to Consent for Research in Cognitively Impaired Older Patients

Overview
Publisher Dove Medical Press
Specialty Geriatrics
Date 2017 Oct 14
PMID 29026293
Citations 23
Authors
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Abstract

Background: The number of clinical trials including older patients, and particularly patients with cognitive impairment, is increasing. While statutory provisions exist to make sure that the capacity to consent is assessed systematically for each patient, many gray areas remain with regard to how this assessment is made or should be made in the routine practice of clinical research.

Objectives: The aim of this review was to draw up an inventory of assessment tools evaluating older patients' capacity to consent specifically applicable to clinical research, which could be used in routine practice.

Methods: Two authors independently searched PubMed, Cochrane, and Google Scholar data-bases between November 2015 and January 2016. The search was actualized in April 2017. We used keywords (MeSH terms and text words) referring to informed consent, capacity to consent, consent for research, research ethics, cognitive impairment, vulnerable older patients, and assessment tools. Existing reviews were also considered.

Results: Among the numerous existing tools for assessing capacity to consent, 14 seemed potentially suited for clinical research and six were evaluated in older patients. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was the most frequently cited.

Conclusion: The MacCAT-CR is currently the most used and the best validated questionnaire. However, it appears difficult to use and time-consuming. A more recent tool, the University of California Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice because of its simplicity, relevance, and applicability in older patients.

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References
1.
Jeste D, Palmer B, Appelbaum P, Golshan S, Glorioso D, Dunn L . A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007; 64(8):966-74. DOI: 10.1001/archpsyc.64.8.966. View

2.
Bean G, Nishisato S, Rector N, Glancy G . The assessment of competence to make a treatment decision: an empirical approach. Can J Psychiatry. 1996; 41(2):85-92. DOI: 10.1177/070674379604100205. View

3.
Kraft S, Cho M, Constantine M, Lee S, Kelley M, Korngiebel D . A comparison of institutional review board professionals' and patients' views on consent for research on medical practices. Clin Trials. 2016; 13(5):555-65. PMC: 5025342. DOI: 10.1177/1740774516648907. View

4.
Black B, Wechsler M, Fogarty L . Decision making for participation in dementia research. Am J Geriatr Psychiatry. 2013; 21(4):355-63. PMC: 3381948. DOI: 10.1016/j.jagp.2012.11.009. View

5.
Kim S, Caine E, Currier G, LEIBOVICI A, Ryan J . Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001; 158(5):712-7. DOI: 10.1176/appi.ajp.158.5.712. View