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遺伝学を含む集団ベースの研究のための情報に基づいた同意
L M Beskow1, W Burke, J F Merz
1Office of Genetics and Disease Prevention, Centers for Disease Control and Prevention, 4770 Buford Hwy NE, MS K-28, Atlanta, GA 30341-3724, USA. laura_beskow@unc.edu
JAMA
|November 17, 2001
まとめ
遺伝子研究のためのガイドラインを策定することは極めて重要です. このアプローチは,参加者が集団研究における遺伝的多様性によるリスクと利益を理解することを保証します.
科学分野:
- 遺伝学 遺伝学とは
- バイオエシック バイオエシック
- 公衆衛生は公衆衛生である.
背景:
- 集団ベースの遺伝子研究は,家族ベースの研究とは異なる特定の倫理的指針を必要とします.
- 遺伝子変種と遺伝子環境相互作用を理解することは,疾患リスク予測の鍵です.
- 低浸透性の遺伝子変異は,遺伝子研究においてユニークな考慮事項を提示します.
研究 の 目的:
- 人口ベースの遺伝子研究のための情報に基づいた同意のアプローチを開発する.
- 遺伝子変異データを研究に統合するためのガイドラインの必要性を解決する.
- 遺伝学研究の参加者に情報に基づいた意思決定を容易にする.
主な方法:
- 疾病管理予防センターで多学科グループを招集した.
- 専門家の意見,連邦法令,既存の倫理報告書と文献を活用した.
- インフォームド・コンセント文書と補足用ブローチャーのための提案された言語を開発しました.
主要な成果:
- 結果の解釈と健康上のアウトカムとの関連性を強調するインフォームド・コンセント・フレームワークを作成しました.
- 同意プロセスは,実行可能な,証拠に基づいた介入を生み出す可能性を評価することを提案しました.
- 参加者の理解を助けるため,同意書とパンフレットのための生成された言語.
結論:
- 提案された情報に基づいた同意アプローチは,遺伝子研究における参加者の理解を向上させることを目的としています.
- 集団遺伝学における情報に基づいた同意に関するベストプラクティスの議論を奨励する.
- 遺伝子研究倫理に関する研究スポンサー,IRB,研究者の検討を図る.
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