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21 アメリカ遺伝子治療学会の見解 つづき

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The reporting requirement proposed by OBA are onerous. Since only NIH-funded institutions are required to comply with these regulations, the proposal may place burdens selectively on academic investigators. It might also serve to decrease or inhibit the use of such institutions as clinical trial sites. While the Society believes the complicated reporting system proposed by OBA is important for public disclosure, it questions whether this significant burden in warranted should the FDA make the information public (as proposed in their recent notice). Public disclosure was a major factor in establishing the requirement for OBA reporting, but the need for such reporting is greatly diminished if the FDA performs this function. The goals of OBA and the NIH Gene Transfer Safety Assessment Board could proceed as the information is public. FDA-based data collection also increases the information available to OBA, as the FDA will presumably be reporting gene therapy information from both NIH-funded and industrial sources. If the FDA is going to adopt a major role in the matter of public discussion of gene transfer, then it is appropriate for the NIH to reconsider its position with regard to oversight.



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