医学研究の出版物における倫理問題に関する報告

Franklin G Miller¹, Donald L Rosenstein

¹Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. fmiller@nih.gov

Lancet (London, England)

|November 5, 2002

まとめ

臨床研究者は,研究設計や患者保護における倫理的考慮を説明することがしばしば失敗します. 私たちは,臨床研究における公衆の信頼と説明責任を改善するために,倫理問題に関する包括的な報告を提唱します.

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
研究方法論研究方法論

背景:

臨床研究における倫理的考察は,患者の安全と公衆の信頼にとって極めて重要です.
研究者は,倫理的に複雑な研究設計と患者保護措置に関する詳細をしばしば省略します.
倫理的に挑戦的な研究構成要素に関する情報に基づいた同意プロセスは,しばしば不十分に記述されています.

研究の目的:

臨床研究における倫理的根拠と保護に関する報告のギャップを強調する.
臨床試験における倫理問題に関する広範な報告のための方針を推奨する.
臨床研究の実施に対する公衆の説明責任と信頼を高める.

主な方法:

倫理問題に関する臨床研究における報告慣行の分析.
総合的な倫理報告のための勧告の策定.
強化された報告方針に対する潜在的な異議を解決する.

主要な成果:

論争の的研究設計の倫理的正当性に関する詳細な報告の一貫した欠如.
敏感な研究における患者保護のための特定の手順の不十分な文書化.
倫理的に複雑な要素について,情報に基づいた同意の取得方法に関する不一致な記述.

結論:

臨床研究における公衆の説明責任を促進するために,倫理問題に関する広範な報告が必要である.
詳細な倫理的報告に関する方針の実施は,研究の誠実さを強化します.
倫理的な複雑さを透明に扱うことは,研究参加者の福祉に対する公衆の信頼を維持するために不可欠です.

キーワード:

生物医学および行動研究

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