The UC Davis Institutional Biosafety Committee (IBC) reviews all Human Gene Transfer (HGT) protocols.

Before the IBC reviews an HGT protocol, that protocol is pre-reviewed to ensure that all information needed by the IBC are provided.

HGT protocols also involve review of:

• Risk assessment and mitigation
• Proper training
• Responses to the NIH Guidelines Appendix M,
• RAC correspondence
• FDA IND review correspondence
• Investigator's brochure
• IRB-approved Informed Consent form
• Site-specific recombinant DNA SOP

Other Information

• Frequently Asked Questions about the NIH Review Process for HGT Trials
• Frequently Asked Questions about the Vaccine Exemption in the NIH Guidelines

Questions or Concerns

If you have any questions or concerns regarding the IBC review process for Human Gene Transfer studies, please contact the UC Davis Biosafety Office:

biosafety@ucdavis.edu
(530) 752-1493 phone
(530) 752-4527 fax