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Documents of Interest
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Archived Documents |
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Documents of Interest |
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Protocol List![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) |
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Workshops, Safety Symposia, and Safety and Policy Conferences |
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Biosafety Considerations for Research with Lentiviral Vectors |
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Conclusions and Recommendations![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) of the RAC Gene Transfer Safety Symposium: Current Perspectives on Gene Transfer for X-SCID
(March 15, 2005) |
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Letter to Principal Investigators Conveying RAC Recommendations Regarding Adverse Events in a Gene Transfer Trial Studying X-linked SCID![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(March 20, 2003) |
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Assessment of Adenoviral Vector Safety and Toxicity: Report of the National Institutes of Health Recombinant DNA Advisory Committee![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) |
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Report from the ACD Working Group![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) - Enhancing the Protection of Human Subjects in Gene Transfer Research at the National Institutes of Health
(July 12, 2000) |
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Statement by Dr. Amy Patterson to the Subcommittee on Public Health, U.S. Senate![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(February 2, 2000) |
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Letter from OBA--Requirements for Reporting Serious Adverse Events: Request for Institutional Review![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(November 22, 1999) |
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FDA Letter to IND Sponsors/Principal Investigators of Gene Transfer Clinical Trials Regarding Protocol Submission and Adverse Event Requirements![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(November 5, 1999) |
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RAC Statement Regarding In Utero Gene Transfer Research![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(March 11, 1999) |
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Environmental Assessment and Finding of No Significant Impact![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(approved by the NIH Director on October 22, 1997) |
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Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene Therapy (Orkin/Motulsky Report)![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(December 7, 1995) |
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Ad Hoc Review Committee - Executive Summary of Findings and Recommendations (Verma Report)![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/CLEAR.gif) ![](https://webarchive.library.unt.edu/eot2008/20090131000710im_/http://oba.od.nih.gov/images/pdficon_small.gif)
(September 8, 1995) |
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