A career development award is requested to allow the candidate to gain the skills required to become a leader in research ethics, with special expertise in determining competence for informed consent in individuals with decisional impairment. The focus will be on individuals with schizophrenia, because proposals to regulate research with persons with severe mental illness remain controversial. A key reason for this is the paucity of data directly answering the question: how should we translate dimensional, contextual data on decisional impairment into categorical judgments of competency status? To achieve his goal, the candidate will follow a career development plan that consists of: coursework and workshops to further develop his methodological skills, mentorship and consultation with recognized leaders in the field of competency research in both theoretical and empirical scholarly endeavors, and research studies on the competency determination process of individuals with schizophrenia being recruited into actual clinical trials. A model of competency determination process that includes three factors will be systematically examined: subject performance factors, contextual risk-benefit factors, and competency evaluator factors. The core research proposal is an ancillary study to the multi-site Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). It will examine the effect of subject performance factors on competency evaluators? judgments. The effect of degree and type of decisional impairment on competency judgments will be determined using receiver operating characteristics analysis, to determine thresholds for competence, and logistic regression, to characterize how the quality of impairment predicts competency status. In the later years of the Award period and beyond, the effect of the contextual risk-benefit factors and competency evaluator factors on final competency judgments will be examined using an innovative, internet-based format.
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