Competence to Consent in Schizophrenia Research

描述：要求职业发展奖，以允许候选人 获得成为研究道德领导者所需的技能，特别是 确定个人知情同意能力的专业知识 决策障碍重点将放在精神分裂症患者身上， 因为规范对严重精神疾病患者的研究的提议 仍然存在争议。一个关键的原因是缺乏直接的数据 回答这个问题：我们应该如何翻译维度，上下文数据， 能力状态的绝对判断是否存在决策障碍？到 为了实现自己的目标，候选人将遵循职业发展计划， 包括：课程和讲习班，以进一步发展他的方法 技能，指导和咨询领域的公认领导人 在理论和实证学术努力的能力研究，以及 关于个人能力确定过程的研究， 精神分裂症被招募到临床试验中。的典范 能力确定过程包括三个因素， 系统检查：受试者性能因素、环境风险-获益 因素和能力评估因素。核心研究提案是一项 多中心临床抗精神病药物干预试验的辅助研究 有效性（CATIE）。它将检验受试者表现的影响 能力评估者的因素？判断。程度和类型的影响 能力判断的决策障碍将使用接收器来确定， 运行特性分析，以确定能力阈值，以及 逻辑回归，以描述损伤的质量如何预测 能力状况。在奖期的最后几年及以后， 情境风险-获益因素和能力评价者因素的影响 对最终能力的判断将使用一个创新的， 基于互联网的格式。

DESCRIPTION: 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.