Frequently Asked Questions (FAQ's)
Frequently asked questions about Biosafety programs.
What is the Institutional Biosafety Committee?
The Institutional Biosafety Committee (IBC) is responsible for approval and oversight of activities involving the use, storage and handling of biohazardous materials, in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Medical Waste Management Act, and CDC’s Biosafety in Microbiological and Biomedical Laboratories (BMBL) document. The IBC is a faculty-led committee and consists of experts in various fields including biosafety, plant and animal containment, infectious diseases and recombinant DNA. The Biosafety Officer (BSO) and other EH&S specialists perform laboratory inspections and other activities in association with the IBC - both reporting to and acting as directed by the Committee. For additional information on Committee functions, please reference the UCR IBC Charter.
What does the IBC review?
The Institutional Biosafety Committee is charged under the NIH Guidelines and UCR Policy with oversight of all research and teaching activities involving:
- Recombinant/synthetic nucleic acid molecules and genetically modified organisms, as covered by the NIH Guidelines
- Potentially infectious 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, regardless of quantity, as covered by the CDC DSAT regulations
- Infectious proteins (prions) and cellular penetrating peptides
- Human and nonhuman primate derived materials (including established cell lines), as covered by the Cal/OSHA Bloodborne Pathogen Standard
- At its discretion or by request by the Institutional Animal Care and Use Committee (IACUC), the IBC may also review protocols involving animals or animal specimens known to be reservoirs/vectors of zoonotic diseases
- Dual Use Research of Concern
Additionally, there are materials not within the IBC purview by regulation that UCR may add to IBC oversight:
- Plant infectious organisms or other infectious organisms with potential environmental impact
- Exotic arthropods
- Exotic microorganisms
- BSL-1 microorganisms
- Biological material requiring an APHIS, CDFA, EPA or other governmental permit
The fundamental consideration for the IBC in reviewing projects using recombinant/synthetic nucleic acids, infectious and other biohazardous materials, is that the activities meet standards of good biological safety practice emphasizing protection of personnel, the general public, and the environment. The IBC is not responsible for the scientific review of the project, except in those cases where the scientific design of the studies contributes to or requires potentially unsafe or risky practices. In those cases, the IBC may require modifications that would reasonably mitigate the risk without impacting the research outcomes. Specifically the IBC reviews the following aspects of the study:
- Appropriate biosafety level for proposed agent(s) and procedures
- Vectors and host systems used in the proposal
- Use of appropriate biosafety practices
- Potential for environmental release
- Suitable facilities, procedures, practices and training of personnel
Are there activities that do not require IBC review?
Yes, Section III-F and Appendix C of the NIH Guidelines detail experiments that are considered “exempt” and do not require IBC review. However, at UCR, all research activities involving biohazardous materials require pre-review through the BUA system and confirmation of III-F status is determined by EH&S. BUAs that have III-F status but include any other items under IBC purview (see Question 2) may not qualify for exemption.
How do I determine which section of the NIH Guidelines apply to my research?
Please contact the UCR Biosafety office to assist you in making such a determination at firstname.lastname@example.org or (x25119). All BUAs must undergo a pre-review by the Biosafety Officer before any work can begin.
What is a BUA and how do I submit for IBC review?
BUA stands for Biological Use Authorization. This is the online application form that is used by researchers to apply for IBC approval. This is sometimes used interchangeably with the term “IBC Protocol.” Researchers may not begin the work executed under the BUA until they have approval from the IBC unless EH&S has determined that the research falls under III-E or III-F of the NIH guidelines. Any changes to an already approved BUA need to be done via an amendment that also requires prior approval from IBC.
Can I begin work immediately after I submit my BUA?
No, all BUAs must undergo a pre-review by the Biosafety Office before any work can begin. If the BUA fits NIH Guidelines III-E or III-F criteria, the Biosafety Officer will notify the PI that their work can proceed pending a satisfactory lab evaluation. In the case of NIH Guidelines III-E experiments, the BUA will still be reviewed by the IBC.
In all other circumstances, no research related to the BUA can be performed until the IBC has formally reviewed the BUA.
What are the NIH Guidelines?
The NIH Guidelines detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
All institutions must follow the NIH Guidelines if they receive any funding from the NIH for research involving recombinant or synthetic nucleic acid molecules. Even if only one research project involving recombinant or synthetic nucleic acid molecules at an institution benefits from NIH support, all such projects conducted at or sponsored by that institution must comply with the NIH Guidelines. Also, adherence to the NIH Guidelines may be a condition of support from other federal agencies, or even private funders of research. UC System-Wide policy requires all campuses to adhere to the NIH Guidelines. Finally, regardless of NIH funding, institutions may be subject to local ordinances, federal or state regulations, or agency guidelines that require compliance with the NIH Guidelines.
What are Recombinant and Synthetic Nucleic Acid Molecules?
Recombinant and Synthetic Nucleic Acid Molecules (referred to as r/sNA) are defined by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) as:
- molecules that i) are constructed by joining nucleic acid molecules and ii) that can replicate in a living cell, i.e., recombinant nucleic acids;
- nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
- molecules that result from the replication of those described in a or b above.
I've determined that my work involving recombinant or synthetic nucleic acids is exempt from the NOH Guidelines - do I still need to submit to the IBC?
Yes. At UCR, all research activities involving biohazardous materials, including NIH Guidelines III-F experiments and experiments without recombinant DNA/RNA, require pre-review through the BUA system. Exempt status is determined by EH&S (see question 3 above: “Are there activities that do not require IBC review?”). BUAs for exempt research activities will be pre-reviewed and approved by the Biosafety Officer and/or the IBC Chair without the need of full IBC review.
- Who can be a Principal Investigator (PI) on a Biological Use Authorization (BUA)?
Principal Investigators (PIs) must meet the criteria for PI eligibility as defined in UCR Policy 527-3 or identify a Faculty Sponsor who meets the PI eligibility criteria.
The review time varies based on the type of application. Certain applications may be reviewed via a process called Delegated Review, while other applications may require Full Committee Review.
The Committee meets once per month to review BUAs that require Full Committee Review. Please check the submission and review schedule for dates. In order for a new protocol submission to be placed on the agenda for an IBC meeting, the PI must submit a BUA application at least seven weeks before the scheduled meeting and have adequately addressed any issues raised during the EH&S pre-review. If any major issues including an incomplete lab inspection or key documents are still pending, the BUA will not be reviewed at a convened meeting. Investigators are encouraged to submit renewal BUAs at least two meetings before the expiration date of their existing BUA to allow sufficient time for the pre-review and to address any issues.
Once a BUA is submitted through the online portal, EH&S and ORI are notified of the submission. The Biosafety Officer (BSO) will contact the PI to initiate the pre-review which will include:
- a lab inspection (Biosafety Laboratory Checklist)
- confirmation of biosafety cabinet (BSC) or certification
- review of training records, and
- review of relevant lab specific documents, if any
If during the pre-review, it is determined that modifications are required to the BUA, the BSO will reset the BUA to allow the PI to edit the application. The database system design then requires PI's to resubmit the application. Please note, the lab inspection and submission of relevant documents must be completed prior to review at a convened meeting. The updated BUA will then be reviewed by the IBC during a convened meeting. If the IBC determines that modifications are required in order to approve the BUA, the PI will be notified and the BUA will be reset for editing and resubmission. Once all modifications are reviewed and found to be sufficient, the BUA will be approved. If significant issues or questions are found during any stage of IBC review, the IBC may request that the revised BUA return to full committee review.
For BUAs that are eligible for delegated review, the BUA will not be reviewed at a convened meeting. Rather, it will be reviewed through a delegated process by the BSO and Chair or an IBC member with relevant expertise to the proposed research.
How long is the BUA approval period?
BUA approval is valid for a period of three years. In order to maintain continuity of approval, PIs must submit a renewal BUA for IBC review sufficiently in advance of expiration of the existing BUA, to ensure there is no lapse in approval. Prior to the expiration date, the Office of Research Integrity typically sends reminder messages to the PI, including a link to the online submission Portal along with instructions for submitting a renewal BUA. However, regardless of any reminders sent, federal regulation states it is the PI’s responsibility to submit renewal applications as needed to ensure that the BUA remains active throughout the project’s duration. If there is a gap in approval, PIs will be required to shut down experiments that require IBC approval.
When do I need to amend an approved BUA?
PIs must submit all changes to their BUA for review and approval by the IBC. Any change that would have resulted in a different statement or an addition to the existing BUA must receive approval via the amendment process prior to initiation of the new/altered activity. The approved BUA must accurately reflect the materials, operations, locations, and personnel active in the lab at any time. Unless specified otherwise, the proposed changes must not be implemented until the PI receives a written approval notice from the IBC. The types of changes that require an amendment to the BUA are:
- Change in facility or use of facility
- New sources of nucleic acids (including DNA and RNA)
- Change in recipient organisms/hosts
- New materials (infectious agents, Select Toxins, viral vectors, etc.)
- Change in procedures involving biohazardous materials
- Addition of animal experiments involving biohazardous agents
Depending on the type of amendment request, a lab inspection with the campus Biosafety Officer (BSO) may be required.
Do I need to register my select biological agent or toxin? What do I need to do if I am working with a Select Toxin even at exempt quantities?
Possession, use and transfer of biological agents or toxins that are included in the Federal Select Agents and Toxins list require registration with the National Select Agents Registry Program (NSAR) and UCR IBC. The NSAR allows possession of nine select agents and toxins at exempt quantities without registration with NSAR; however, UCR IBC review and approval are still required. Please refer to the EH&S biosafety guidelines and the Federal Select Agent Program website for more information.
Additional review may be required if the use of a select agent or toxin also meets Dual Use Research of Concern (DURC) potential.
It is recommended that researchers contact EH&S should they want to work with a select agent.
Is IBC approval required for the use of immortal/established human cell lines?
Yes, UCR policy requires that all human cell lines and non-human primate cell lines, including immortal/established lines, require IBC review. Research involving the use of human-derived substances (e.g., blood or blood components, tissues, cells, secretions) is subject to the OSHA "Bloodborne Pathogens" (BBP) Standard and requires additional training for all employees on the BUA as well as any employee who can reasonably anticipate exposure to human blood or other potentially infections materials. This training is required both at the time of initial work assignment and at least every twelve months thereafter. Information about BBP training can be obtained at: EH&S Training
How do I check if my personnel have completed the required trainings to be listed as an approved user of biohazardous materials?
PIs can check the Laboratory Hazard Assessment Tool (LHAT) to check research personnel training. LHAT can also be used to modify/update a lab’s personnel roster.
What is OBA?
As part of the NIH Office of Science Policy (OSP), the NIH Office of Biotechnology Activities (OBA) promotes science, safety and ethics in the development of public policies in three areas: Biomedical Technology Assessment, Biosafety, and Biosecurity. By monitoring research and through consultation, coordination, and analysis, the office develops policies related to:
- The conduct of clinical trials using recombinant and synthetic nucleic acids,
- Biosafety for NIH supported research,
- Biosecurity, including oversight of dual use research, and
- Registration of new stem cells lines for NIH-funded research.
What is RAC?
The Recombinant DNA Advisory Committee (RAC) is a federal advisory committee that provides recommendations to the NIH Director related to basic and clinical research involving recombinant or synthetic nucleic acid molecules. RAC proceedings and reports are posted to the OBA website to enhance their accessibility to the scientific and lay public.
Where can I get my training records?
Individual training records can be reviewed by accessing your transcripts via ucrlearning.ucr.edu.
What training am I required to complete and where can I access it?
Any individual working in a laboratory are required to complete training as specified by EH&S. Laboratories working with biological materials will need to complete the minimum required training which include, but not limited to, Biosafety, Laboratory Safety Orientation Fundamentals, and Hazardous Materials and Waste Management. Additionally, laboratories working with bloodborne pathogens or any human-derived materials, including human cell lines and tissues, will need to complete Bloodborne Pathogens training. All training can be complete via the UC Learning Center: ucrlearning.ucr.edu.