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.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Mentored Patient-Oriented Research Career Development Award (K23)
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Study Section
Special Emphasis Panel (ZMH1-CRB-X (01))
Program Officer
Mayo, Donna J
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Support Year
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University of Michigan Ann Arbor
Schools of Medicine
Ann Arbor
United States
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Frank, Samuel A; Wilson, Renee; Holloway, Robert G et al. (2008) Ethics of sham surgery: perspective of patients. Mov Disord 23:63-8
Kim, Scott Y H; Appelbaum, Paul S; Swan, Jeffrey et al. (2007) Determining when impairment constitutes incapacity for informed consent in schizophrenia research. Br J Psychiatry 191:38-43
Srebnik, Debra S; Kim, Scott Y (2006) Competency for creation, use, and revocation of psychiatric advance directives. J Am Acad Psychiatry Law 34:501-10
Kim, S Y H; Holloway, R G; Frank, S et al. (2006) Volunteering for early phase gene transfer research in Parkinson disease. Neurology 66:1010-5
Muroff, Jordana R; Hoerauf, Sarah L; Kim, Scott Y H (2006) Is psychiatric research stigmatized? An experimental survey of the public. Schizophr Bull 32:129-36
Kim, Scott Y H; Caine, Eric D; Swan, Jeffrey G et al. (2006) Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics 47:325-9
Karlawish, J H T; Casarett, D J; James, B D et al. (2005) The ability of persons with Alzheimer disease (AD) to make a decision about taking an AD treatment. Neurology 64:1514-9
Kim, Scott Y H; Kim, Hyungjin Myra; McCallum, Colleen et al. (2005) What do people at risk for Alzheimer disease think about surrogate consent for research? Neurology 65:1395-401
Kim, Scott Y H; Frank, Samuel; Holloway, Robert et al. (2005) Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers. Arch Neurol 62:1357-60
Kim, Scott Y H (2004) Evidence-based ethics for neurology and psychiatry research. NeuroRx 1:372-7

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