CONSENT CAPACITY OF ADULTS WITH MENTAL RETARDATION

这项研究的既定目标是评估和发展 提高轻度和中度精神障碍成年人能力的程序 迟缓(MR)为治疗研究提供知情同意，并 在获得代孕同意时行使同意或不同意的权利。这个 项目将有两个阶段，第一个阶段旨在检查 对精神药物治疗的基本要素的理解，包括目的 和研究的性质、风险和收益、自愿的性质 参与，以及不受惩罚地退出的权利。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和And概述的四个心理法律标准范围内进行评估 Grisso(1988)。在第一阶段，轻度、中度和“典型”者； 情报将对描述研究的假想插曲作出回应 利用一种新药的随机对照试验来减少攻击性 行为。在第二阶段，作者将使用第一阶段产生的数据 制定和评估三种旨在提高 轻度和中度MR患者：1)图画书格式，2)视频 格式，以及3)支持的决策格式。另一个重要的人也是 在三种形式的演示中，由受试者选择来帮助他们。

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.