Posted On

The Institutional Biosafety Committee (IBC) has updated the IBC guidance document, IBC Requirements for Human Gene Transfer (HGT) Studies. Changes to the document largely reflect updates summarized in the April 2019 Amendment of the NIH Guidelines in the oversight of HGT studies.

The IBC will also be implementing yearly CRs for HGT studies, effective April 2022. This change is intended to align the review process with the IRB process whilst ensuring efficient IBC oversight of all HGT studies and resolving any uncertainty on when amendments are required.  

This change will not have an initial impact on any HGT studies due to expire in the next 12 months, however, when next reviewed by the IBC they will be approved with an annual expiry. All other HGT BUAs will be updated and placed on the annual CR schedule.  

Please do not hesitate to contact us at (310) 794-0262 or if you have any questions.