発展途上国における情報に基づいた同意の際の理解
Daniel W Fitzgerald1, Cécile Marotte, Rose Irene Verdier
1Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port au Prince, Haiti.
Lancet (London, England)
|November 5, 2002
まとめ
開発途上国における情報に基づいた同意の確保は極めて重要です. カウンセラーとの複数のセッションを通じて情報を提供することで,単一の医師の会議と比較して,同意書に対する参加者の理解が著しく改善されました.
科学分野:
- グローバル・ヘルス グローバル・ヘルス
- 臨床研究の倫理について
- インフォームド・コンセントとは
背景:
- 発展途上国における同意書に対する参加者の理解を確実にするための実用的なガイドラインは限られている.
- 情報に基づく同意は,特に脆弱な集団における臨床研究の重要な倫理的要素です.
研究 の 目的:
- 資源の限られた環境で,同意書に対する研究参加者の理解を向上させるための方法を評価する.
- 理解率に関するさまざまな情報提供方法の有効性を評価する.
主な方法:
- ハイチでのHIV-1感染に関する研究では,参加者に同意書の内容について口頭試験 (80%の合格点数) を受けることを要求しました.
- 初期グループ (n=15) は1回の医師の診察で情報を受け,次グループ (n=30) は3回のカウンセラーの診察で情報を受けました.
主要な成果:
- 医者の1回の診察の後,理解テストに合格したのは,参加者の20% (3/15) しかありませんでした.
- カウンセラーが3回のセッションで情報を提供したとき,80% (24/30) の大幅に高い合格率を達成しました.
結論:
- 情報提供の方法は,開発途上国における研究参加者の理解に大きく影響を与えます.
- 正式な理解の評価を実施し,複数セッションのカウンセリングを利用することは,これらの環境における知的な同意のための標準的な慣行であるべきです.
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