知的障害のある研究対象. 永続的な政策問題は,政策の問題である
1School of Law, case Western Reserve University, Cleveland, OH 44106, USA.
JAMA
|July 3, 1996
まとめ
精神障害のある成人は,倫理的な研究基準を必要とします. 能力評価と代理人の同意は極めて重要であり,研究には異議を唱える者がめったに含まれません.
科学分野:
- バイオエシック バイオエシック
- 臨床研究の倫理について
- 神経科学の研究研究 神経科学の研究研究
背景:
- 精神障害のある成人は,様々な状態の研究対象として頻繁に利用されています.
- 米国の規制政策は,この研究分野における倫理的課題に適切に対処していない.
- 研究者および機関審査委員会 (IRB) は,精神障害のある成人を含む研究について,特定の基準を定めなければならない.
研究 の 目的:
- 精神障害のある成人を対象とする研究における倫理的手順の概要を述べる.
- 被験者の自律性を高め,意思決定能力を正確に評価する.
- 研究者,IRB,および政策立案者に対し,脆弱な集団を保護するためのガイドを提供すること.
主な方法:
- 現在の米国の規制政策と倫理指針のレビュー.
- 意思決定能力のない成人の研究における倫理問題に関する分析.
- 能力評価,情報開示,代理人による意思決定に関する勧告.
主要な成果:
- 現在の政策は,倫理的な複雑さに対処するのに不十分です.
- 強化された能力評価と明確な情報の開示が不可欠です.
- 代理の意思決定者は,倫理的な責任に関する明確な指導を必要とします.
- 研究に異議を唱える決断力のない成人を研究に含めることは稀であるべきである.
結論:
- 研究者,IRB,アドボカシーグループ,連邦政府の役人との連携は不可欠です.
- 直接的な利益のない研究におけるリスク・利益評価とリスク制限に関するコンセンサスが必要である.
- 研究計画とレビューにおいて被験者集団を代表することが推奨されます.
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