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」**


***このページは2001年2月22日に更新しました***

バイオ研究者・大学院生のための簡単な英語文例集

その12

Animal studies

The Notice requires that "Any finding from tests in laboratory animals that suggests a significant risk for human research participants..." be reported in an expedited fashion. The society is very concerned about the lack of definition of "Any finding". The Society agrees that prospective studies aimed at assessing the safety of gene therapy should be supplied to OBA. Also, data which become available from well designed studies which document a significant safety concern should be reported. Furthermore, data obtained from such studies which suggest risk should be reported in an expedited manner. Our concern relates to studies which are not designed to assess safety. Animal studies are performed for a variety of different reasons. There is precedence where anecdotal reports, performed without appropriate controls, provided animal data which was misleading. Public disclosure of the initial information without the proper context could have resulted in major harm to the field.

As written, the Notice could be interpreted that each unanticipated animal death must be reported in an expedited manner. Furthermore, the level of analysis required to determine the cause of death is not specified. Understanding trends in toxicity that occur in the course of animal work is important and should be reported. Determining the cause of an isolated toxicity during preclinical experiments presents an onerous task to basic researchers which will hinder development. As written, compliance with the reporting of animal studies will be difficult and may be misleading unless further clarification is provided.

 


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