Human Gene Transfer (HGT) BUAs
The UC Davis Institutional Biosafety Committee (IBC) reviews all HGT protocols. However, before IBC review, each protocol is pre-reviewed to ensure that all information needed by the IBC are provided. In addition to the review of risk assessment and mitigation, as well as proper training, HGT protocols also involve review of other materials such as the responses to the NIH Guidelines Appendix M, RAC correspondence, FDA IND review correspondence, investigator's brochure, IRB-approved Informed Consent form, and site-specific recombinant DNA SOP.
- 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.