Institutional Biosafety Committee

The CU Denver | Anschutz Institutional Biosafety Committee (IBC) provides review and approval for a wide range of laboratory research activities on campus. IBC protocol applications are reviewed and overseen for compliance with the National Institute of Health (NIH) Guidelines, Federal Select Agents Regulations, as well as state and institutional requirements for laboratory research on campus.

The convenes monthly to review biosafety/IBC protocol applications.

For researchers using human samples, the Biosafety Office has provided updated guidance for researchers with regards to COVID-19 safety.

Please direct all questions regarding IBC requirements, the review process, and Cayuse website troubleshooting to the IBC Office ([email protected]).

The IBC provides oversight on the CU Denver | Anschutz campus involving any of the bulleted items indicated below, alone or in combination:

Recombinant DNA (rDNA) materials including plasmid/viral vectors, large recombinant proteins, small interfering RNA (siRNA), or other modified nucleic acids
Transgenic animal/plant materials
Biohazardous materials in conjunction with live animals
Field studies (applicable to collection of samples outside of a clinical setting)
Radioactive materials
Human biological materials (i.e., cells, fluids, tissues, etc.)
Nonhuman primate biological materials (i.e., cells, fluids, tissues, etc.)
Potentially infectious agents/microorganisms including laboratory strains of Escherichia coli (E. coli)
Select agents/toxins including tetrodotoxin and Staphylococcal enterotoxin B (SEB)
Nanoparticles (applicable if there is a recombinant/NIH-covered aspect)
Clinical trials involving human gene transfer (HGT) or live vaccines
Clinical trials involving institutionally-created investigational products (IPs)/compounds
Incident reporting and investigations for incidents involving infectious or recombinant DNA materials

For further information, please review the following document:
Institutional Biosafety Committee Policy and Procedures

All new, de novo/renewal, and amendment applications for IBC protocols must be submitted via the Cayuse protocol website. For assistance with adding new personnel that do not populate in the personnel drop-down menu, please contact the IBC Coordinator ([email protected]).

Cayuse can be accessed through the link here. Before attempting to submit a new IBC protocol, please review the following document regarding Accessing and Starting an IBC Protocol within Cayuse.

Please review the CU Denver IBC Compliance Note.

If working with Select agents/toxins, a new letter of support from the department chair/head is required for all new and de novo/renewal application submissions. Please utilize either the Support Letter Template or the department's version in their preferred format.

The CU Denver | Anschutz IBC reviews human clinical trials involving human gene transfer (HGT), live vaccine, and some institutionally-mandated investigational products/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 protocol applications are not processed in the Cayuse protocol website. The submission package for these applications are managed via email to the IBC Office ([email protected]) only.

Submitted clinical trial application packages will need to include all required documentation in order for the pre-review process to begin and consideration at a convened, full committee meeting. Please review the Guidance File for a list of required documents prior to submitting an application to the IBC Office. Completed versions of the IBC Clinical Trial Application and Biosafety Site-Specific SOP are both required for the application package. Exclusion of these two documents may cause potential delays in review and approval of the application.

Please see the following templates for principal investigator (PI) changes and risk assessment submissions:

Tools & Resources

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Regulatory Compliance

Institutional Biosafety Committee (IBC)

Office of the Vice Chancellor for Research

Institutional Biosafety Committee (IBC)

Responsibilities of the IBC

Biosafety Authorization Forms

Human Clinical Trial & Manufacturing Protocol Applications

Template Language for Cayuse IBC Protocol Applications

NIH Reference Links

Additional Links

IBC Meeting Minutes

Office of the Vice Chancellor for Research