Tool for Clinical Research or the UCSD Brief Assessment of
Capacity to Consent. The advantage of these measures is that
they can be tailored to any specific research protocol for which a
potential research participant is being considered.
One factor that should not generally be used to decide
decisional capacity is the presence or absence of a particular
diagnosis. Research indicates that many people with serious
mental illnesses, at least outside the context of the most
acute phases of illness, retain the capacity to understand,
appreciate, reason and to make and express a choice about
participating in research protocols (Appelbaum, 2006; Jeste,
Depp, & Palmer, 2006). Notably in the case of schizophrenia,
the bulk of empirical research suggests that, at least among
outpatients, it is the cognitive deficits that frequently
accompany this disorder that most directly affect decisional
capacity, not the primary psychopathologic symptoms
(Palmer & Savla, 2007). In short, although clinical conditions
are often risk factors for impaired capacity, they are not
synonymous with impaired capacity.
As put forth in the 1979 Belmont Report, the basic research
ethics principle, Respect for Persons, incorporates two ethical
convictions: Individuals should be treated as autonomous
agents, and people with diminished autonomy are entitled to
additional protections. Many of the ethical dilemmas that arise
regarding informed consent for research can be seen as, at least
partially, a tension in balancing these two components. Fully
honoring the spirit of both of these components and ensuring
valid informed consent thus requires that decisional capacity be
considered on an individual basis and within the context of the
specific decision at hand. n
Barton W. Palmer, PhD, is a professor of psychiatry at the
University of California, San Diego, and a member of APA’s
Committee on Human Research.
• American Bar Association Commission on Law and
Aging and American Psychological Association. (2008).
Assessment of older adults with diminished capacity: A
handbook for psychologists. Washington, DC: Authors.
• Appelbaum, P. S., & Grisso, T. (2001).
MacCAT-CR: MacArthur Competence Assessment Tool for Clinical
Research. Sarasota, FL: Professional Resource Press.
• Jeste, D. V., Palmer, B. W., Appelbaum, P. S., Golshan,
S., Glorioso, D., Dunn, L. B., . . . Kraemer, H. C. (2007).
A new brief instrument for assessing decisional capacity
for clinical research. Archives of General Psychiatry, 64,
• National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. (1979).
The Belmont Report: Ethical principles and guidelines for
the protection of human subjects of research. Retrieved
Researchers can improve study participants’ comprehension
of the study at hand by making the consent process more
interactive — and doing so is particularly important when
there may be concerns about a potential participant’s