札幌医科大学医学部

分子医学研究部門

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**「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19 アメリカ遺伝子治療学会の見解 つづき

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The Society also wishes to comment in general terms regarding the increased regulatory role OBA is proposing. ASGT is committed to the ethical conduct of clinical trials with an appropriate emphasis on patient safety. Adherence to these general principles assures that the field will maintain a necessary level of credibility as it develops and advances. The Society strongly supports an oversight structure which assures that trials will not proceed until all elements of the risk-benefit ratio are addressed and approved. Nevertheless, we are very concerned that investigators in this field are faced with two distinct systems of oversight. While some aspect of the proposed Notice attempt to improve harmonization, other proposed changes only solidify the distinct features of the oversight organizations. By default, investigators are forced to contend with two varying sets of requirement and it is not clear that this additional burden proves any added value to enhancing patient safety in human clinical trials.


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