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Enhancing Comprehension of Consent for Research in Older Patients With Psychosis: A Randomized Study of a Novel Consent Procedure

OBJECTIVE: The ability of individuals with schizophrenia to provide informed consent for research has become the focus of public debate. The authors examined whether a novel consent procedure improved the comprehension of consent for older patients with psychosis. METHOD: Fifty outpatients with schizophrenia or other psychotic disorders and 19 normal comparison subjects aged 40–80 were randomly assigned to groups given either a routine or an enhanced consent procedure. The latter utilized a computerized presentation that included sequential bullet points and summaries of key information. A posttest measured comprehension of consent-relevant information. RESULTS: A significantly greater proportion of patients who received the enhanced consent procedure scored 100% on first and second trials of the posttest, compared to those receiving the routine procedure (trial 1: 42.3% versus 8.3%; trial 2: 80.8% versus 45.8%, respectively). CONCLUSIONS: The enhanced consent method improved comprehension of information relevant for consent in older patients with psychosis.

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