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NIH Guidelines
Recombinant DNA Advisory Committee -- RAC
Documents of Interest
- Biosafety Considerations for Research with Lentiviral Vectors
- Conclusions and Recommendations of the RAC Gene Transfer Safety Symposium: Current Perspectives on Gene Transfer for X-SCID (March 14, 2007)
- Letter to Principal Investigators Conveying RAC Recommendations Regarding Adverse Events in a Gene Transfer Trial Studying X-linked SCID (March 20, 2003)
- Assessment of Adenoviral Vector Safety and Toxicity: Report of the National Institutes of Health Recombinant DNA Advisory Committee
- Report from the ACD Working Group - Enhancing the Protection of Human Subjects in Gene Transfer Research at the National Institutes of Health, July 12, 2000.
- Statement by Dr. Amy Patterson to the Subcommittee on Public Health, U.S. Senate (PDF) (February 2, 2000)
- Letter from OBA--Requirements for Reporting Serious Adverse Events: Request for Institutional Review, (November 22, 1999) (PDF)
- FDA Letter to IND Sponsors/Principal Investigators of Gene Transfer Clinical Trials Regarding Protocol Submission and Adverse Event Requirements (November 5, 1999). (PDF)
- RAC Statement Regarding In Utero Gene Transfer Research (March 11, 1999).
- Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene (Orkin/Motulsky Report), (December 7, 1995)
- Ad Hoc Review Committee - Executive Summary of Findings and Recommendations (Verma Report), (September 8, 1995)
- Gene Therapy for Human Patients - Information for the General Public (April 1990)
Data Management Reports [DMR]
- December 2007, DMR
- September 2007, DMR
- June 2007, DMR
- March 2007, DMR
- December 2006, DMR
- September 2006, DMR
- June 2006, DMR
- March 2006, DMR
- December 2005, DMR
- September 2005, DMR
- June 2005, DMR
- March 2005, DMR
- December 2004, DMR
- September 2004, DMR
- June 2004, DMR
- March 2004, DMR
- December 2002, DMR
- September 2002, DMR
- June 2002, DMR
- March 2002, DMR
- December 2001, DMR
- September 2001, DMR
- June 2001, DMR
- March 2001, DMR
- December 2000, DMR
- September 2000, DMR
- June 2000, DMR
- March 2000, DMR
- December 1999, DMR
- September 1999, DMR
- June 1999, DMR
- March 1999, DMR
- September 1998, DMR
- June 1998, DMR
- March 1998, DMR
- December 1997, DMR
- September 1997, DMR
- June 1997, DMR
- March 1997, DMR
Amendments and Updates
- September 2002, Amendments, Updates and Responses to Appendix M-I-C-1
- June 2002, Amendments, Updates and Responses to Appendix M-I-C-1
- March 2002, Amendments, Updates and Responses to Appendix M-I-C-1
- December 2001, Amendments, Updates and Responses to Appendix M-I-C-1
- September 2001, Amendments, Updates and Responses to Appendix M-I-C-1
- June 2001, Amendments, Updates and Responses To Appendix M-I-C-1
- March 2001, Amendments and Updates
- December 2000, Amendments and Updates
- September 2000, Amendments and Updates
- June 2000, Amendments and Updates
- March 2000, Amendments and Updates
- December 1999, Amendments and Updates
- September 1999, Amendments and Updates
- June 1999, Amendments and Updates
- March 1999, Amendments and Updates
- September 1998, Amendments and Updates
- June 1998, Amendments and Updates
- March 1998, Amendments and Updates
- December 1997, Amendments and Updates
- September 1997, Amendments and Updates
- June 1997, Amendments and Updates
- March 1997, Amendments and Updates
- December 1996, Amendments and Updates
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