Decisional capacity and consent for schizophrenia research.

BACKGROUND

Despite substantial research on overall decision-making capacity (DMC) levels in schizophrenia, factors causing individuals to make errors during decision-making regarding research participation or treatment are relatively unknown.

METHODS

We examined the responses of 84 middle-aged and older patients with schizophrenia or schizoaffective disorder on a structured DMC measure—the MacArthur Competence Assessment Tool for Clinical Research—to determine the frequency and apparent cause of patients’ errors.

RESULTS

Most errors were due to difficulty recalling the disclosed information (seen in 65.5% of patients), particularly the study’s procedures, potential risks/discomforts, and purpose. Errors attributable to concrete thinking, thought disorder or other psychotic symptoms, or perceived coercion were rarer.

CONCLUSIONS

Informed consent procedures might be improved for this population by providing information in a way that facilitates learning and memory, such as iterative disclosure of the information, corrective feedback, and emphasis of key points (e.g., the study’s purpose, procedures, and potential risks).