多中心の遺伝的流行病学研究の地方機関レビューにおける問題的な変動
Rita McWilliams1, Julie Hoover-Fong, Ada Hamosh
1Bloomberg School of Public Health, Johns Hopkins Medical Institutions, Baltimore, Md, USA.
JAMA
|July 17, 2003
まとめ
マルチセンターの遺伝的疫学研究は,機関審査委員会 (IRB) の承認の有意な変動に直面し,非効率性と不均等な保護につながります. 公共衛生研究のプロセスを簡素化するために,集中的なレビューが必要である.
科学分野:
- 遺伝学 遺伝学とは
- エピデミオロジー エピデミオロジー
- バイオエシック バイオエシック
背景:
- ヒューマンゲノムプロジェクトは,疾患の疫学とDNAの多様性を相関させる大規模な研究を可能にします.
- マルチセンターの遺伝的疫学研究は,適切な統計力を得るために極めて重要です.
- このような研究は,複数の研究機関間の協力を必要とします.
研究 の 目的:
- マルチセンター研究レビューの行政負担を定量化するために.
- マルチセンター遺伝的流行病学の研究のための機関審査委員会 (IRB) の承認プロセスにおける変動性を評価する.
- 人体被験者の保護と研究効率の不一致を特定する.
主な方法:
- マルチセンター研究の出版傾向を追跡するためにPubMed検索を実施しました.
- IRBの審査プロセスに関する7問のアンケート調査を,参加したシスティックフィブロシスケアセンターに実施しました.
- IRBの会議頻度,提出期限,同意書要求,レビューの種類,要求された変更に関するデータを収集します.
主要な成果:
- 出版された多センター遺伝子疫学研究は,1985年から2002年の間に8〜9倍に増加しました.
- 単一の遺伝的疫学研究のIRBレビューは, 77%が完全なレビューを受けることにより,有意な変動を示しました.
- IRBは同意要件 (1-4フォーム) と懸念の不一致を示し,52%が遺伝的側面に焦点を当てた.
結論:
- マルチセンター遺伝的疫学研究のローカルIRBのレビューは,非常に変数的で非効率的です.
- IRBのプロセスにおける統一性の欠如は,被験者の保護を脅かし,管理上の負担を生み出します.
- 集中審査メカニズムは,非効率に対処し,研究監督の一貫性を高めるために提案されています.
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