CONSENT CAPACITY OF ADULTS WITH MENTAL RETARDATION

本研究的目标是评估和开发 程序，以提高能力的成年人与轻度和中度精神 为治疗性研究提供知情同意，以及 在获得代理同意时行使同意或不同意的权利。的 该项目将分两个阶段进行，第一阶段旨在审查 了解精神科治疗的基本要素，包括目的 和研究的性质，风险和收益，自愿性质， 参与，并有权退出而不受惩罚。该项目还将 检查对同意要素的理解（例如，目标，角色 科学家、安慰剂条件的性质等）。同意能力也将是 在Appelbaum概述的四个心理法律标准中进行评估， Grisso（1988年）。在第一阶段，轻度、中度和“典型”的人; 情报部门将对一个描述研究假设性小插曲作出反应 利用一种新药的随机对照试验， 行为在第二阶段，作者将使用第一阶段产生的数据， 开发和评估旨在提高同意能力的三种格式 轻度和中度MR患者：1）图画书格式，2）视频 格式;（3）支持的决策格式。另一个重要的是， 由受试者选择，以帮助他们在三种格式的演示文稿。

The stated objectives of this research are to assess and develop procedures to enhance the capacity of adults with mild and moderate mental retardation (MR) to provide informed consent for therapeutic research, and to exert their rights to assent or dissent when surrogate consent is obtained. The project will have two phases, with the first designed to examine the understanding of basic elements of psychotropic treatment including the purpose and nature of the research, risks and benefits, voluntary nature of the participation, and right to withdraw without penalty. The project will also examine comprehension of the consent elements (e.g., goals, role of a scientist, nature of placebo conditions, etc). Consent capacity will also be evaluated within the four psycho-legal standards outlined by Appelbaum and Grisso (1988). In phase 1, persons with mild, moderate and "typical;" intelligence will be respond to a hypothetical vignette describing research utilizing a randomized control trial of a new medication to reduce aggressive behavior. In phase 2, the authors will use data generated from phase 1 to develop and evaluate three formats designed to improve the consent capacity of individuals with mild and moderate MR: 1) a picture book format, 2) a video format, and 3) a supported decision-making format. A significant other is also chosen by the subjects to aid in them during the three format presentations.