Revised on
08/04/16 02:28pm

Human Gene Transfer (HGT) BUAs

Contact information

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.

 

Other Information

 

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.