Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders.

Background: Optimizing the abilities of individuals with psychiatric disorders to provide meaningful informed consent for research has become a heightened concern for psychiatric researchers.

Objective: We examined a post-consent test of comprehension given to older patients with psychotic disorders to identify problem areas in the understanding of informed consent for research.

Methods: One hundred and two middle-aged and older outpatients with schizophrenia or related psychotic disorders and twenty normal comparison subjects were administered a 20-item questionnaire to assess their comprehension of consent for a low-risk research protocol after receiving either a routine (paper-based) or an enhanced (computerized, structured slide show incorporating greater review) consent procedure. Data on individual questions were analyzed.

Results: Patients had more difficulty than normal comparison subjects on open-ended questions, including those asking about study procedures, time involved, and potential risks and benefits. Among patients, the enhanced procedure was associated with better performance on questions about potential risks and time required than the routine procedure.

Conclusions: Problem areas in the understanding of informed consent, such as study procedures and potential risks and benefits, should be the focus of attempts to improve the consent process for patient participants with severe mental illness. Research also should be done to clarify how best to assess understanding of consent, since the wording of questions likely affects the responses.