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ヘルシンキ宣言の2000年改訂は,前進の一歩か,さらなる混乱か?
H P Forster1, E Emanuel, C Grady
1Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Lancet (London, England)
|November 14, 2001
まとめ
世界医学会 (World Medical Association) は,世界医学会 (WMA) を設立しました.
科学分野:
- 医療倫理 医療倫理について
- 臨床研究の倫理について
背景:
- ヘルシンキ宣言は,倫理的な研究慣行をガイドしています.
- 以前の改訂は1975年に行われた.
- 2000年の改訂版は,臨床研究における公的論争に続いて発表された.
研究 の 目的:
- ヘルシンキ宣言の2000年改訂プロセスを分析する.
- 第5版の主要な変更点について検討する.
- 倫理基準の進化を徹底的に検討する.
主な方法:
- 第5次ヘルシンキ宣言の改正プロセスの分析.
- 2000年10月に採択された第5版の検討.
- 歴史的文脈と公共の論争の見直し.
主要な成果:
- 第5回改訂 (2000年) は,1975年以来の最も実質的な変更を表しています.
- 改正プロセスは,欠陥を修正し,倫理基準を進化させることを目的とした.
- 2000年の改訂は,宣言の論争の的になったバージョンをもたらした.
結論:
- 2000年のヘルシンキ宣言の改訂は,プラセボ対照試験を超えて徹底的な調査を要求しています.
- 改訂プロセスの理解は,倫理的研究監督において極めて重要です.
- 医学研究における倫理基準は,継続的な進化と議論の対象となります.
キーワード:
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