新生児重症治療におけるオプトアウトの同意に関する親と医師の経験:試験内の混合方法の研究
Tracy Mitchell1, Izabela Andrzejewska2, Cheryl Battersby3
1Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.
Archives of disease in childhood. Fetal and neonatal edition
|September 1, 2025
まとめ
口頭でのオプトアウトの同意は 低リスクの新生児試験では受け入れられますが タイミングは重要です neoGASTRIC試験は,親とスタッフが
科学分野:
- 新生児の研究倫理
- 臨床試験の採用戦略
- 情報に基づく同意のプロセス
背景:
- 新生児試験の効率と代表性を高めるために,口頭によるオプトアウトの同意が利用されます.
- 多中心の新生児試験におけるオプトアウトの同意の運用性および受容性に関する理解は限られている.
- neoGASTRIC試験では,早産の乳児の胃内部の測定を定期的に行うか,定期的に行わないかを調べました.
研究 の 目的:
- neoGASTRIC試験における親とスタッフの意見と口頭による同意の経験を探求する.
- マルチセンターの新生児環境におけるオプトアウトの同意の受け入れ性と運用性を評価する.
- 新生児の研究におけるオプトアウト同意手続きの有効性に影響を与える要因を特定する.
主な方法:
- 質疑書,インタビュー,フォーカスグループを含む混合手法によるプロセスの評価が行われました.
- この研究には,英国の4つの新生児病院で253人の参加者 (167人のスタッフと86人の親) が参加しました.
- データの収集は,参加者の口頭での同意のプロセスに対する経験と認識に焦点を当てた.
主要な成果:
- neoGASTRICの介入は低リスクで非侵襲的だと見なされ,親もスタッフも一般的にオプトアウトの同意を支持しました.
- 研究情報バナー/ポスターに対する認識は低い (21%).
- オプトアウトの同意の実行における変動は観察され,一部の親は出産中にまたは出産直後のアプローチで圧倒されたと感じた.一部のスタッフは変更されたオプトインアプローチを使用した.
結論:
- 適切なタイミングでの口頭によるオプトアウトの同意は,認められた臨床慣行を比較する低リスクの新生児試験では受け入れられ,比例する.
- neoGASTRIC試験の結果は,同様の新生児の研究環境における同意手続を洗練するための貴重な洞察を提供します.
- この研究は,オプトアウトの同意モデルにおける親権の考慮と情報提供のタイミングの重要性を強調しています.
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