Institutional Biosafety Committee (IBC)

Review and approval of research on campus involving any of the items indicated below, alone or in combination:

• Recombinant DNA materials (including recombinant proteins, vectors, etc)
• Transgenic animals or plants
• Infectious materials
• Biohazardous materials
• Select Agent toxins
• Human materials (cells, fluids, tissues, etc)
• Human Gene Transfer or Live Vaccine clinical trials
• Clinical trials involving institutionally created investigational compounds
• Incident Reporting and Investigations for incidents involving infectious or recombinant DNA materials

All new and renewal IBC applications must be entered in the eSirius system- word files will not be accepted. For amendment instructions, please contact the IBC Coordinator (IBC@cuanschutz.edu) for instructions.

• The new eSirius system can be accessed here. Before attempting to submit an IBC protocol, please review this document​ regarding the process of accessing & starting a new protocol in eSirius

Please review the CU Denver IBC Compliance Note

• If working with Select Agent Toxins, a new letter of support from your department chair/head is required for new or de novo submissions. A Support Letter Template or you may utilize your department's preferred format.

The IBC reviews human clinical trials involving Human Gene Transfer, Live Vaccine, and some institutionally-mandated investigational compounds. The IBC also reviews manufacturing activities on CU-affiliated institutions that pertain to biological substances, such as potential clinical compounds.  Clinical trials and manufacturing protocols ARE NOT processed in eSirius. These trials are processed via email submission packages only. 

The CU Denver | Anschutz IBC requires a clinical trial submission package including all required documents prior to review consideration at the next IBC meeting. Review the Guidance File for IBC reviewed clinical trials prior to submitting an application. The IBC Clinical Trial Application should be completed as part of the application package. The Biosafety Site-Specific SOP is required for the application package as well.

• PI Change for IBC Clinical Trial
• Review of GMP Project IBC Risk Assessment
  

• NIH Guidelines
• April 2024 Update to NIH Guidelines PDF