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.
The UC Davis IBC uses WCG Biosafety, a division of WIRB-Copernicus Group (https://www.wirb.com/Pages/IBCServices.aspx), for the pre-review of HGT protocols. WCG Biosafety consultants review HGT protocols on a regular basis and thus their expertise and experience ensure that the HGT protocol is complete and has all necessary components. Use of WCG Biosafety consultants also ensures that HGT protocols are reviewed in a timely manner.
Industry-Sponsored HGT Studies
WCG Biosafety will bill study sponsors directly for these services so there will be no cost to UC Davis researchers. The fee for providing initial review of each HGT submission is $3,500. The fee for each amendment review (not including minor amendments such as updating personnel) is $1,000. Download and complete the "WCG HGT primary review form" in the "Resources" section of this webpage (the PDF has a "submit" button at the bottom of the form).
PI-Initiated HGT Studies
UC Davis PI-initiated HGT studies are also pre-reviewed by WCG Biosafety. However, the pre-review is done at no cost to the UC Davis PI.
- NIH Oversight of Human Gene Transfer Research
- 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.