CONSENTING TO PSYCHIATRIC AND MEDICAL TREATMENT RESEARCH

该提案响应了NIH的申请请求（RFA）。它 结合自然主义和实验的方法来研究知情 精神病和医学治疗研究中的同意过程。项目 是基于临床研究中心的研究成人 精神分裂症，一个NIMH资助的研究组织，现在进入第20个 年本研究的参与者将从以下志愿者中抽取： 精神分裂症和躁郁症，这两种严重的精神疾病， 症状和认知特征的共同点，和一个对照组， 没有精神疾病的冠状动脉移植患者。所有受试者将 在为几个大型的，正在进行的， 随机临床试验的药物治疗他们的严重，慢性 病利用人们做出重要的医疗保健决定是一种 该项目与以往关于这一主题的大多数研究不同， 让人们参与到假设的决策情境中。的 研究包括一项仔细评估基本认知能力的计划， 能力、思维和情绪障碍以及社会影响 因素随机实验设计将评估 披露强制性知情同意内容的新方法。主要 因变量包括客观和开放式的措施， 获得和理解法定的知情同意，以及措施 描述决策过程的连贯性。后续行动 三个月将决定这些结果随时间的稳定性， 治疗经验本身的功能，以及健康和 症状状态

The proposal responds to a Request for Applications (RFA) from NIH. It combines naturalistic and experimental methods to study the informed consent process in psychiatric and medical treatment research. The project is based at the Clinical Research Center for the Study of Adult Schizophrenia, an NIMH-funded research organization now entering its 20th year. Participants for this study will be drawn from volunteers with schizophrenia and bipolar disorder, two serious mental illnesses that have symptomatic and cognitive features in common, and a comparison group of coronary transplant patients without mental illness. All subjects will be in the process of being recruited for one of several large, ongoing, randomized, clinical trials of medications for their serious, chronic illness. The use of people making important health care decisions is a departure of this project from most previous research on this topic, which has involved people in hypothetical decision-making situations. The research includes a plan for careful assessment of basic cognitive capacities, disturbances of thinking and mood, and social influence factors. A randomized experimental design will evaluate the efficacy of a novel method of disclosure of mandated informed consent content. Major dependent variables include objective and open-ended measures of acquisition and comprehension of mandated informed consent, and measures describing the coherence of the decision making process. Follow-up at three months will determine stability of these outcomes over times as a function of the treatment experience itself, and of changes in health and symptom status.