Human Gene Transfer (HGT)
Human Gene Transfer and Clinical Trials Training & Educational Resources
The Institutional Biosafety Committee (IBC) is tasked by the NIH Guidelines with assessing the training and expertise of UMN personnel involved in recombinant or synthetic nucleic acid molecule research in clinical trials. The IBC extends this assessment to UMN personnel performing research in clinical trials with other potentially hazardous biological agents (biologically-derived toxins and infectious agents). Most human clinical research subject to IBC oversight falls in the Human Gene Transfer (HGT) category of investigation products (IP).
IBC Specific Online Training Courses
UMN staff directly working with an IP under IBC purview should complete the relevant trainings listed below. Online training courses are not required for administrative staff associated with an application (e.g. Clinical Trials Office) that are not handling the IP. If this is the case, please report this in the text box for "training that is not indicated above.”
Client-owned pet clinical trials have training requirements set by the standard IBC required training.
Implementation of NIH Recombinant and Synthetic Nucleic Acids Guidelines
Course Number: UHS124
UMN personnel on IBC applications that handle an IP in a clinical trial where the IP falls into the research category of Human Gene Transfer (r/sNAs in the IP or used in the development of the IP) must complete this course once. A PI overseeing (not handling) HGT clinical research must also take this training once. The IBC administration is currently working to develop a clinician specific NIH Guidelines training for human clinical trials.
Biological Safety in the Lab
Course Number: UHS122
UMN personnel on IBC applications must complete this course once if they are handling an IP subject to IBC oversight. The PI does not require this training if they will not directly handle the IP. While an IP may not be developed in a UMN lab (e.g. industry sponsored trial), this course contains basic information on biosafety.
Bloodborne Pathogens Annual OSHA Requirement
Course Number: UHS110
UMN personnel on IBC applications must complete this course every year if they are handling IPs based on infectious agents, and/or an IP that involves human or non-human primate cells. This training is required once for a PI not handling an IP as described.
Training Records in eProtocol
After you complete a training module, the courses should appear in the Personnel Information section of your IBC application in eProtocol. To view the training courses for each staff member, click on their name, and then click twice on the double arrows to the far right of "Training Details.”
Completed training for IBC requirements will be recorded and should auto-populate in the eProtocol application. If personnel have taken the training but it isn't listed, then please include each unlisted training module's name and date of completion in the box for "training that is not indicated above" for all personnel (click on their name to locate the text box associated with each individual). Please note that the IBC does not track individuals and the activities they perform. The PI should use the text box to include clarifications on whether staff are not performing work listed in their application so that the IBC Admin does not send requests for training records that are not applicable.
Information for how to access training records.
Contact Information for Questions Related to Training
For questions regarding training, contact the IBC administration at (612) 626-2161 or firstname.lastname@example.org.