Concern about the capacity of individuals with schizophrenia to consent to clinical research studies has largely focused on impairment due to psychotic symptoms associated with the disorder. Less attention has been given to the cognitive errors that prospective participants make when undergoing a formal assessment of decisional capacity.

In a study reported in IRB: Ethics & Human Research, a team of psychiatrists and clinical psychologists found that errors due to cognitive difficulties were common. For example, 65.5 percent of individuals undergoing the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) made errors resulting from difficulty recalling study information and 22.6 percent overemphasized the potential for personal gain from study participation.

Individuals’ “responses were also notable for the errors they did not make,” the researchers noted. “Ethical concerns have been raised surrounding the notion that psychotic symptoms per se (e.g., delusional thinking) might impede the capacity for decision-making. However, in the present analyses, no evidence supports detrimental effects of psychosis on decisional capacity for research participation among this outpatient sample.”

Additionally, 90.5 percent of participants understood that the study was voluntary after hearing the study information only once. When the information was repeated, all but one participant understood the voluntary nature. “Despite concerns regarding the potential for coercion, the fact that the vast majority of participants in the present study recognized the voluntary nature of participation suggests that perceived coercion is uncommon,” the researchers commented.

Based on their findings, the researchers identified ways to increase the likelihood that individuals with schizophrenia will make informed decisions about participating in research. Though 55 of the 84 participants made errors in recalling study information, repetition of relevant information led to perfect or nearly perfect recall in 36.4 percent of them; 47.3 percent had improvements in recall, though they continued to miss important details. The researchers concluded that “given difficulties some individuals have with recalling information conveyed during the consent process, key study information should be highlighted and repeated to them.”

As this study was limited to stable outpatients with mild to moderate psychiatric symptoms, the results cannot be extrapolated to inpatient or acutely ill populations.

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The authors of the study are Allison R. Kaup, MS, of San Diego State University/University of California, San Diego; Laura B. Dunn, MD, of University of California, San Francisco; Elyn R. Saks, JD, of the University of Southern California and the University of California, San Diego; Dilip V. Jeste, MD, of the University of California, San Diego; and Barton W. Palmer, PhD, of the University of California, San Diego.

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