智障研究对象. 智障研究对象. 持久的政策问题是持久的政策问题
1School of Law, case Western Reserve University, Cleveland, OH 44106, USA.
JAMA
|July 3, 1996
概括
精神障碍的成年人需要道德研究标准. 能力评估和代理同意至关重要,反对者很少被纳入研究.
科学领域:
- 生物伦理学生物伦理学
- 临床研究伦理学
- 神经科学研究 神经科学研究
背景情况:
- 精神残疾的成年人经常是各种疾病的研究对象.
- 美国的监管政策不足以应对这一研究领域的伦理挑战.
- 调查人员和机构审查委员会 (IRB) 必须为涉及精神残疾成年人的研究制定具体标准.
研究的目的:
- 概述涉及精神残疾成年人的研究的伦理程序.
- 增强学科的自主权并准确评估决策能力.
- 引导研究人员,IRB和决策者保护弱势群体.
主要方法:
- 审查当前的美国监管政策和道德准则.
- 分析研究中的伦理问题与不能做出决定的成年人.
- 关于能力评估,信息披露和代理决策的建议.
主要成果:
- 目前的政策不足以解决道德复杂性的问题.
- 加强能力评估和明确信息披露至关重要.
- 代理决策者需要关于道德责任的明确指导.
- 不能做出决定,反对研究的成年人应该很少被纳入研究.
结论:
- 研究人员,IRB,倡导团体和联邦官员之间的合作是必不可少的.
- 需要就风险/益处评估和没有直接益处的研究的风险限制达成共识.
- 建议在研究规划和审查中代表受试者群体.
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