| 札幌医科大学医学部 分子医学研究部門 |
＊＊「バイオ研究者・大学院生のための便利メモ」＊＊
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バイオ研究者・大学院生のための簡単な英語文例集 その９ アメリカ遺伝子治療学会の見解（１） The Notices proposes certain changes to the NIH Guidelines which are well reasoned and will enhance the development of gene therapy. Most notably, the goals of public disclosure and rapid identification of trends in adverse events reporting improves patient protection from research risk and is an objective the Society remains firmly dedicated to. The Society is in full support of the following important modifications: 以下の３点に関しては全面的にサポートするとしています。まずは大筋に関して大賛成であるというわけです。Public access to information about serious adverse events. The Society agrees with OBA that adverse events, in general and collectively, should be made public and not kept confidential. We also believe that reporting can and should be performed without the release of trade secrets. Protection of individually identifiable patient information as it relates to serious adverse event reporting. The Society is in full agreement that identifiable patient information should be deleted from OBA submissions to protect patient privacy. A new mechanism for the review and assessment of data on serious adverse events and other relevant safety information . The general goal of the NIH Gene Transfer
Safety Assessment Board, to identify
trends
in vector toxicity, is an important
one. アメリカ遺伝子治療学会の見解つづき
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