Institutional Biosafety Committee (IBC)
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- Dual Use Research of Concern (DURC) Policy
About the IBC
The Institutional Biosafety Committee (IBC) functions as the UCR review body responsible for approval and oversight of activities involving the use, storage and handling of biohazardous materials (defined below), in accordance with the NIH's Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Medical Waste Management Act, and the CDC's Biosafety in Microbiological and Biomedical Laboratories (BMBL) document. The IBC may choose to implement additional guidelines based on risk assessments.
Do I have to submit a BUA application?
A Biological Use Authorization (BUA) is required for every laboratory that uses or stores biohazardous materials. The term “biohazardous materials” includes:
- Recombinant/synthetic nucleic acid molecules and genetically-modified organisms, as covered by the NIH Guidelines
- Potentially infectious organisms (typically Risk Group 2 or greater organisms) such as viruses, bacteria, fungi, or prions that can cause disease in humans or cause significant environmental or agricultural impact
- Select agents and select toxins, as covered by the CDC's Division of Select Agents and Toxins (DSAT) regulations
- Human and nonhuman primate materials (including established cell lines), as covered by the Cal/OSHA Bloodborne Pathogen Standard
- At its discretion or upon IACUC request, the IBC may also review protocols involving animals or animal specimens known to be reservoirs/vectors of zoonotic diseases
- Dual Use Research of Concern (DURC)
- Materials not within the IBC purview by regulation, that UCR may add to IBC oversight:
- Plant infectious agents or other infectious agents with potential environmental impact, exotic arthropods, exotic microorganisms, BSL-1 microorganisms, biological material requiring an APHIS, CDFA, EPA or other governmental permit
*Biological Agent Risk Group does not necessarily correspond to Biosafety Level (BSL)
How Do I submit?
The ORI uses an online BUA submission portal for applications and amendments. Using the online submission portal, a researcher can submit a BUA to the ORI for review. Please note, the system only allows faculty members to submit.
What are the levels of review?
ALL research activity, regardless of review level, is subject to pre-review and approval by EH&S. The pre-review includes a laboratory evaluation, check of relevant training completion, and review of the BUA application and any supplemental documents (e.g., lab-specific standard operating procedures).
Additional compliance reviews that may be required:
Institutional Animal Care and Use Committee (IACUC): The use of vertebrate animals (e.g., testing viable recombinant or synthetically modified microorganisms on whole animals) must be approved by the IACUC (via an AUP).
Institutional Review Board (IRB): IRB review of human protections may be required for some activities, such as the collection of blood or primary tissues.
Stem Cell Research Oversight (SCRO): SCRO review of the use or storage of human pluripotent stem cells is required.
Material Transfer Agreement (MTA): Some biohazardous materials (e.g., plasmids, vectors, viruses, human cell lines) cannot be obtained without a Material Transfer Agreement (MTA). The Research and Economic Development Office is required to review these contracts in accordance with UC mandated restrictions. It is recommended that you contact firstname.lastname@example.org as soon as you have determined you will be obtaining materials from an external source.
The IBC normally meets on the fourth Thursday of each month. For a BUA application to be placed on the agenda for a meeting, the PI should submit the BUA at least seven weeks before the scheduled meeting and adequately address any issues raised during the pre-review by Environmental Health & Safety (EH&S). If any major issues are unresolved or key documents are still pending, the BUA review may be postponed for a future meeting. PIs are encouraged to submit renewal applications at least two meetings before the BUA expiration date to allow sufficient time for pre-review and to address any issues.
BUAs are approved for a three-year period. The IBC generally contacts the investigators for renewals. However, it is the responsibility of the investigator to ensure that an active approved BUA is maintained. This responsibility includes the submission of amendments when changes to the research are required.
Schedule of IBC Meetings & Submission Deadlines for Full Committee Review
Whom can I contact?
Contact Information (making an appointment, if necessary)
Office of Research Integrity
216 University Office Building
Environmental Health & Safety (EH&S - for laboratory and SOP guidance)
UCR Biological Safety Officer
Where can I find additional information?
Researchers and committee members can find more information in the IBC section of the ORI Resources Page.