研究倫理委員会と臨床試験結果の公表
1University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA. Howard.Mann@hsc.utah.edu
Lancet (London, England)
|September 21, 2002
まとめ
研究倫理委員会 (REC) は,現在,臨床試験結果の普及に関する明確な指針を欠いている. この論文では,RECは,研究成果への公衆のアクセスを確保する上で重要な役割を果たすべきであると主張し,RECがこれをどのように達成できるかを提案しています.
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
- 研究の整合性 研究の整合性
背景:
- ヒトを対象とした生物医学研究は,研究倫理委員会 (REC) の倫理的監督を必要とします.
- 現行の国際法および国内法では,研究成果の普及におけるRECの役割が明示的に定義されていない.
- このギャップは,臨床試験結果の透明性とアクセシビリティに影響を及ぼします.
研究 の 目的:
- 研究倫理委員会 (REC) は,臨床試験結果の公開の確保に積極的に関与すべきであると主張する.
- 研究成果の広範な共有を促進するために,RECの具体的な行動と責任を提案する.
主な方法:
- ヒトの研究倫理を規定する国際規範および国内規制の文献レビュー.
- 研究成果の公開の倫理的必要性に関する議論的分析.
- 結果の普及におけるRECの責任に対する提案開発.
主要な成果:
- 人体研究に関する既存の倫理的枠組みでは,研究成果の普及にRECの関与を明示的に義務付けていません.
- RECが,臨床試験結果の公的共有を促進する上で積極的な役割を果たす明確な必要性がある.
- RECがこの役割を果たすために,具体的で実行可能なステップを定義することができます.
結論:
- 研究倫理委員会 (REC) は,臨床試験結果の公的普及を保証する上で,決定的な,まだ現在未定義の役割を担っています.
- 提案された責任の実施により,研究の透明性と説明責任が強化されます.
- 結果の普及におけるRECの役割を強化することは,生物医学科学と公衆の信頼を前進させ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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