Regulated Biohazardous Materials (IBC)

News and Announcements  

March 2024: Research involving unfixed animal tissues must be submitted to the IBC for review via CATS Safety protocol submission system. Learn more.

February 2024: Updated guidance for researchers working with potentially infectious poliovirus-relevant materials. Researchers using or storing materials identifided by the CDC as potentially infectious must notify the IBC program.  Learn more.

CATS Safety is now LIVE!  Find training and resources for the system. 

Contact ORP-biosafety@psu.edu to see how to best move into the system. Find training and learn more here.

 

About the Institutional Biosafety Committee

The primary responsibility of the Institutional Biosafety Committee (IBC) is to review research and teaching activities involving the use of materials that have the potential to pose a danger to the health and safety of the researchers and the community as defined by Penn State Policy RP11

There are specific training requirements for all study personnel. Review the required IBC training based on your research activities.

 

Submit to the IBC

Anyone utilizing regulated biohazardous materials in teaching or research at Penn State must submit proposed use to the IBC for review and approval prior to utilizing the materials. In addition to the use of regulated biohazardous materials, Penn State policies address infectious-waste disposal and the handling of human blood, blood products, tissue and/or cell lines samples. Some research practices (even if ancillary to the experimental goal) involving strands and/or segments of DNA or RNA must conform to the NIH Guidelines for Research Involving Recombinant DNA Molecules and IBC before approval before the work is initiated. If a Material Transfer Agreement (MTA) is required for your research, you will be contacted. IBC protocols must be submitted through CATS Safety. Existing protocols in PRAMS are in the process of transitioning into CATS Safety.

 

Update a Submission

All changes to how biohazardous/regulated materials, as defined in Penn State Policy RP11, will be used in the course of your activities must be submitted to the IBC for review and approval prior to the changes being implemented or the new materials being used. In addition, all new laboratory personnel who will work with biohazardous/regulated materials must be approved on the appropriate IBC protocol(s) prior to beginning this work.

Protocols Not In CATS Safety:

To add personnel only to an approved protocol outside the CATS system, complete and submit the IBC’s Addition of personnel to an Approved IBC Protocol Form.  For other changes, complete and submit the IBC’s Modification Request Form. For protocol modifications, researchers have the option to use the opportunity to compile their existing protocols in PRAMS and do a single lab-based protocol submission/review in CATS Safety which includes the modifications. Alternatively, paper modification requests will be processed if researchers prefer to use a phased multiple submission/review approach into CATS Safety based on protocol expiration dates. Using this approach, researchers must submit their existing PRAMS protocols into CATS Safety prior to the expiration of the protocol.

DURC and ESCRO

In addition to IBC review, some protocols may also require approval from the Institutional Review Entity (IRE) and/or the Embryonic Stem Cell Research Oversight (ESCRO) committees. Any IBC application that lists the agents under DURC will be required to submit a DURC application to the IRE. The ESCRO committee does not require a separate application as the information provided in the IBC application is sufficient. If ESCRO review is needed, a copy of the IBC application will be sent to the committee. The Biosafety Analyst will notify the PI if either approval is needed.