Competence to Consent in Schizophrenia Research

描述：要求获得职业发展奖，以允许应聘者 获得成为研究伦理领袖所需的技能，具有特殊的 在确定个人知情同意能力方面的专业知识 决策障碍。重点将放在精神分裂症患者身上， 因为建议规范对严重精神疾病患者的研究 仍然存在争议。造成这种情况的一个关键原因是直接缺乏数据 回答问题：我们应该如何将维度、上下文数据 将决策损害转化为对能力状态的分类判断？至 达到目标后，应聘者将遵循职业发展计划 包括：课程和研讨会，以进一步发展他的方法论 技能、指导和与该领域公认领导者的咨询 在理论和实证学术努力方面的能力研究，以及 个体胜任特征确定过程的研究 精神分裂症被招募到实际的临床试验中。一种模型 能力确定过程将包括三个因素 系统检查：受试者绩效因素、背景风险-收益 因素和能力评估者因素。核心研究建议是一项 多点抗精神病药物干预临床试验的辅助研究 有效性(Catie)。它将检查主体表演的效果 影响胜任力评估者的因素？判断力。程度和类型的影响 将使用接收器确定对能力判断的决策损害 运营特征分析，以确定能力门槛，以及 Logistic回归，以表征损伤质量如何预测 能力状态。在获奖期的最后几年及以后， 情境风险-收益因素和胜任力评估者因素的影响 关于最终的能力判断，将使用创新的 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.