The goal of this research is to inform and influence the debate on the ethics of schizophrenia research with empirical data on the central question of informed consent and decisional capacity. Decisional capacity and quality of informed consent will be ascertained in 100 persons participating in schizophrenia research and compared to 100 normal subjects. Impairments will be related to clinical symptoms and cognitive variables in schizophrenia and cognitive variables in normal controls. An informed consent educational process will be tested in a RCT design to determine if observed impairments in schizophrenia subjects can be remediated. The effect of time (2 weeks) and medication status on decisional capacity and informed consent will be determined. Preliminary data are presented which support the following hypotheses: 1. Baseline decisional capacity is reduced in schizophrenia subjects; 2. Good quality informed consent can be obtained, even in schizophrenia subjects with low decisional capacity; 3. In schizophrenia subjects, symptoms are modestly related and cognitive impairments robustly related to decisional capacity; the relation of cognition to decisional capacity will be described in the normal subjects; 4. Decisional capacity will improve to normal levels following an educational informed consent process which addresses specific cognitive liability in contrast to the effect of skills training; and 5. Adequate informed consent will persevere over a 2 week period which includes a medication withdrawal period, and the effect of time and medication status on decisional capacity will be described. The proposed work will provide a major source of scientific data of relevance to the current debate on ethics of schizophrenia research.
