Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments
Abstract
OBJECTIVE: The need to evaluate decisional capacity among patients in treatment settings as well as subjects in clinical research settings has increasingly gained attention. Decisional capacity is generally conceptualized to include not only an understanding of disclosed information but also an appreciation of its significance, the ability to use the information in reasoning, and the ability to express a clear choice. The authors critically reviewed existing measures of decisional capacity for research and treatment. METHOD: Electronic medical and legal databases were searched for articles published from 1980 to 2004 describing structured assessments of adults' capacity to consent to clinical treatment or research protocols. The authors identified 23 decisional capacity assessment instruments and evaluated each in terms of format, content, administration features, and psychometric properties. RESULTS: Six instruments focused solely on understanding of disclosed information, and 11 tested for understanding, appreciation, reasoning, and expression of a choice. The instruments varied substantially in format, degree of standardization of disclosures, flexibility of item content, and scoring procedures. Reliability and validity also varied widely. All instruments have limitations, ranging from lack of supporting psychometric data to lack of generalizability across contexts. CONCLUSIONS: Of the instruments reviewed, the MacArthur Competence Assessment Tools for Clinical Research and for Treatment have the most empirical support, although other instruments may be equally or better suited to certain situations. Contextual factors are important but understudied. Capacity assessment tools should undergo further empirically based development and refinement as well as testing with a variety of populations.
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There is no gold standard and no hard empirical data for assessing competence to consent.
“The current situation has been referred to as a “hodgepodge of practices” [28]: there is no gold standard and no hard empirical data [14].”
From Why is it hard to make progress in assessing children's decision-making competence? (2015) · cites this paper as [28]
Previous research demonstrated that the MacCAT scales provide the best results.
“Previous research demonstrated that the MacCAT scales provide the best results [28–30].”
From Why is it hard to make progress in assessing children's decision-making competence? (2015) · cites this paper as [28]
The MacCAT tools have ranked the highest and are considered the best choice for measuring capacity to consent to treatment and clinical research in adults.
“Of all these, the MacCAT tools have ranked the highest and are considered the best choice for measuring capacity to consent to treatment and clinical research in adults [28].”
From Why is it hard to make progress in assessing children's decision-making competence? (2015) · cites this paper as [28]
No consensus has been reached on how to assess competence to consent to treatment and clinical research.
“Although the need to evaluate competence to consent to treatment and clinical research has gained increasing attention, no consensus has been reached on how to assess it.”
From Why is it hard to make progress in assessing children's decision-making competence? (2015) · cites this paper as [28]
Decision-making capacity is a task-specific, dynamic construct requiring structured and repeated evaluation.
“decision-making capacity, understood as a task-specific, dynamic construct requiring structured and repeated evaluation”
Decision-making capacity cannot be automatically inferred from the presence of a psychiatric diagnosis; rather, it must be assessed methodically, specifically for the decision at hand (decision-specific), contextualized in time (time-specific), and grounded in observable and documentable clinical elements.
“decision-making capacity cannot be automatically inferred from the presence of a psychiatric diagnosis; rather, it must be assessed methodically, specifically for the decision at hand (decision-specific), contextualized in time (time-specific), and grounded in observable and documentable clinical elements”
In severe depressive disorders, negative cognitive biases, hopelessness, and rigidly pessimistic future outlooks may distort the evaluation of therapeutic alternatives and the perception of reversibility of suffering.
“In severe depressive disorders, for instance, negative cognitive biases, hopelessness, and rigidly pessimistic future outlooks may distort the evaluation of therapeutic alternatives and the perception of reversibility of suffering ( 14 , 17 – 19 ).”
Available evidence indicates that schizophrenia spectrum disorders, mental disorders with psychotic features, and severe mood disorders do not automatically entail incapacity but may selectively impair components of decision-making, particularly appreciation and reasoning.
“Available evidence indicates that these conditions do not automatically entail incapacity but may selectively impair components of decision-making, particularly appreciation and reasoning ( 13 – 15 ).”
Automatic exclusion of patients with severe mental disorders would constitute an unjustified presumption of incapacity, incompatible with the forensic principle of decision-specific and time-specific capacity assessment.
“As a result, the automatic exclusion of patients with severe mental disorders would constitute an unjustified presumption of incapacity, incompatible with the forensic principle of decision-specific and time-specific capacity assessment ( 13 – 15 , 33 ).”
Evaluating decision-making capacity in psychiatric EAS cannot be reduced to a one-time certification, but must be conceived as a structured, repeated clinical-evaluative process embedded in a multidisciplinary framework that balances protection of autonomy with safeguarding of vulnerability.
“evaluating decision-making capacity in psychiatric EAS cannot be reduced to a one-time certification, but must be conceived as a structured, repeated clinical-evaluative process embedded in a multidisciplinary framework that balances the protection of autonomy with the safeguarding of vulnerability”
An individual with a past diagnosis of major depressive disorder, bipolar disorder, or another mental illness, now in full remission or clinically stable, may demonstrate decision-making capacity fully comparable to someone with no psychiatric history.
“An individual with a past diagnosis of major depressive disorder, bipolar disorder, or another mental illness, now in full remission or clinically stable, may demonstrate decision-making capacity fully comparable to someone with no psychiatric history ( 13 – 15 , 55 , 56 ).”
Capacity is not diagnosis-specific, but rather decision-specific and time-specific; it must be assessed in relation to the specific decision at hand and the patient's current clinical condition.
“Capacity is not diagnosis-specific, but rather decision-specific and time-specific; it must be assessed in relation to the specific decision at hand and the patient’s current clinical condition ( 13 – 15 , 33 , 55 , 56 ).”
In the scenario of somatic comorbidity with non-causative psychiatric disorder, psychiatry plays a primarily safeguarding role; the psychiatrist is not tasked with validating the EAS request based on diagnosis, nor with exercising a blanket veto, but with rigorously assessing current decision-making capacity, emotional stability, absence of active psychopathology that might interfere with decision
“In this scenario, psychiatry plays a primarily safeguarding role. The psychiatrist is not tasked with “validating” the EAS request based on diagnosis, nor with exercising a blanket veto, but with rigorously assessing current decision-making capacity, emotional stability, absence of active psychopathology that might interfere with decision-making, and consistency of the request with the patient’s”
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Assessment of Patients' Competence to Consent to Treatment
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Why is it hard to make progress in assessing children's decision-making competence?
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“Of all these, the MacCAT tools have ranked the highest and are considered the best choice for measuring capacity to consent to treatment and clinical research in adults [28].”
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Self-citationAn Ethics Checklist for Digital Health Research in Psychiatry: Viewpoint
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Mental capacity and consent to treatment in psychiatric patients: the state of the research
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The recovery of factors associated with decision-making capacity in individuals with psychosis
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Tripi, D., Giantesani, M., Arena, J. F., & Ferracuti, S. (2026) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2026.1835123
- Authors
- Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., & Saks, E. R.
- Affiliations
- University of California San Diego (US)
- Venue
- American Journal of Psychiatry
- Published
- 2006-08
- Volume
- 163
- Issue
- 8
- Pages
- 1323-1334
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- OpenAlex
- W2123423334
- Cited by
- 464
- References
- 90
- Citations by year
- 2026: 14 · 2025: 10 · 2024: 18 · 2023: 32 · 2022: 17 · 2021: 21 · 2020: 17 · 2019: 21 · 2018: 21 · 2017: 19 · 2016: 17 · 2015: 27 · 2014: 27 · 2013: 39 · 2012: 29
- FWCI
- 26.21
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- Johns Hopkins University
- National Institute of Mental Health (R01MH059101, R01MH067902, MH-67902, MH 66248, MH-66062, MH59101, R01MH064722, MH-19934, K23MH066062, P30MH066248, MH 64722, T32MH019934)
- 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
- decision-making capacity, informed consent, clinical research participants, treatment decision-making, psychometric properties, reliability and validity, information disclosure
- MeSH terms
- Adult, Mental Disorders, Clinical Protocols, Decision Making, Humans, Informed Consent, Middle Aged, Patients, Psychiatric Status Rating Scales, Psychometrics, Reproducibility of Results, Mental Competency, Research Subjects
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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