Decisional capacity for informed consent in schizophrenia research

Background: The adequacy of subjects' informed consent to research is the f ocus of an important public and professional debate. The potential impairme nt of decisional capacity in persons with schizophrenia is central to the d iscussions. This study ascertains the decisional capacity for informed cons ent in schizophrenic research subjects, to determine if reduced capacity re lates to specific aspects of psychopathologic features and to test the hypo thesis that reduced capacity can be remediated with an educational informed consent process. Methods: Decisional capacity was assessed for 30 research subjects with sch izophrenia and 24 nonill (normal) comparison subjects. Measures of psyche p athologic features and cognition were obtained for the subjects with schizo phrenia. Subjects who performed poorly on the decisional capacity measure r eceived an educational intervention designed to improve their ability to pr ovide informed consent and were then retested. Results: The patient group did not perform as well as the controls on initi al decisional capacity assessment. Poor performance was modestly related to the extent of symptoms but robustly related to cognitive impairments. Foll owing the educational intervention, the performance of subjects with schizo phrenia was equal to that of the nonill comparison group. Conclusions: Many persons with schizophrenia may be challenged by the cogni tive demands of an informed consent process for research participation. In many cases, their reduced capacity can be compensated by a more intensive e ducational intervention as part of the informed consent process.