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Regulated Biohazardous Materials (IBC)
Anyone utilizing regulated biohazardous materials in teaching or research must submit proposed use to the Institutional Biosafety Committee (IBC) for review and approval prior to utilizing the materials.
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IBC News and Announcements
- Attention: an Executive Order released on 5/5/25 has paused planned May 2025 policy changes to Dual Use Research of Concern (DURC). We are awaiting new federal guidance. In the interim, the IRE will review research involving DURC on a case-by-case basis. If you have questions, please contact the IRE Program Office at orp-biosafety@psu.edu or the ICDUR at sqs7186@psu.edu.
- Attention: an Executive Order released on 5/5/25 has paused implementation of the Framework for Nucleic Acid Synthesis Screening, which would require federally funded researchers who work with synthetic nucleic acids and benchtop nucleic acid synthesis equipment to procure these materials from suppliers that adhere to the Framework for Nucleic Acid Synthesis Screening. Visit the Framework for Nucleic Acid Synthesis webpage to learn more.
- February 2025: University Policy RP11: Use of Regulated and Biohazardous Materials in Research and Instruction has been updated to clarify when Institutional Biosafety Committee (IBC) review is required and to better align the University Park and College of Medicine IBCs. Biological biospecimens (e.g., saliva, blood, urine, feces, rumen contents, raw milk, or unfixed tissues) collected from animals, including invertebrates, requiring handling conditions above Biosafety Level 1 are considered a regulated material and must be submitted to the IBC for review. Learn more.
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 Materials Transfer Agreement (MTA) is required for your research, you will be contacted. IBC protocols must be submitted through 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.
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 an IRE protocol application. 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.
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The Office for Research Protections (ORP) ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.