The UNL Biosafety Guidelines apply to clinical/diagnostic, research, and teaching activities involving any of the following items individually or in combination with each other:
Recombinant or Synthetic Nucleic Acid molecules (see definitions in Section 1.2 of the UNL Biosafety Guidelines
Exception: Experiments conducted in academic teaching lab courses for demonstrative purposes and not considered "research projects" are not subject to IBC Review.
- Human, animal, and plant pathogens (bacteria, virus, yeast, fungus, prions, & parasitic agents) including growth, manipulation and/or other handling and use in vitro or in vivo.
- Toxins of biological origin, when the originating organism is grown for the purpose of obtaining toxin. Toxins obtained in pure form commerically are not covered, except for Select Agent toxins. Any amount of a Select Toxin requires submission of an IBC protocol.
- Human blood and other potentially infectious materials, as defined by the United States Occupational Safety and Health Administration (OSHA) and the UNL Exposure Control Plan.
- Human and non-human primate cells and organ/tissue cultures
- Select Agents and Toxins, as defined by the United States Departments of Agriculture Or Health and Human Services, including Dual Use Research of Concern, involving agents and research categories as defined in the UNL Biosafety Guidelines.
- Genetically-modified animals and plants including growth, breeding, manipulation or other use of the organism. Field trials of transgenic plants authorized by the United States Department of Agriculture - Animal and Plant Health Inspection Service (USDA-APHIS) are not subject to review by the IBC.
- Field Collection or Sampling of Wild Animals, when there is risk of exposure to zoonotic diseases. See section 4.7 of the UNL Biosafety Guidelines for detailed parameters regarding these types of studies.
Activities not subject to IBC Review
Clinical/diagnostic, research, and teaching activities that:
- Are properly conducted at biosafety containment level 1 (BSL-1); and
- do not involve human, animal, or plant pathogens capable of causing disease in healthy organisms; and/or
- involve only the in vitro use of nucleic acids (i.e., PCR, naked siRNA, sequencing) and do not involve the cloning and propagation of recombinant or synthetic nucleic acid molecules in cells or organisms; and
- the nucleic acid molecules are not able to produce infectious forms of a biological select agent or encode for the functional form of a select agent toxin. (See EHS SOP "Select Agents" for details.)
Important: Contact the BSO if you are unsure if you are in need of an IBC protocol.
The Institutional Biosafety Committee (IBC) is responsible for:
- Investigating potential violations of the NIH Guidelines in coordination with the BSO and ORR.
- Reviewing protocols and amendments, including an independent assessment of the containment levels required by the NIH Guidelines for the proposed research; and consideration of information provided in the protocol or by the BSO regarding facilities, procedures, practices, and training and expertise of personnel involved in the protocol.
- Setting final containment levels for certain experiments as described in the NIH Guidelines, specifically Section III-D-2-a (Experiments in which DNA from RG 2-3 or Restricted Agents are Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems); Section III-D-4-b (Experiments Involving Whole Animals); and III-D-5 (Experiments Involving Whole Plants).
- Adopting standard emergency procedures covering accidental spills and personnel contamination resulting from activities subject to the NIH Guidelines and the UNL Biosafety Guidelines. This includes reviewing and approving alternate procedures proposed by the individual PIs, as applicable.
- The IBC Chair is responsible for ensuring the IBC members are appropriately trained regarding laboratory safety and implementation of the NIH Guidelines.
- The UNL IBC also functions as the Institutional Review Entity (IRE) for review of IBC protocols that fall under the DURC policy oversight
- If a research project is subject to the DURC policy, and such is confirmed by the IRE, then a risk mitigation plan will be developed and implemented. The risk mitigation plan will be collaboratively developed by the PI, BSO, and Research Compliance staff and presented to the IBC for review and approval.
Principal Investigators (PI) are responsible for:
Adhering to and training all personnel in all applicable rules, regulations and standard practices, including but not limited to NIH and CDC (BMBL) guidelines.
Maintaining IBC protocol forms by submitting Amendment, Minor Modification and Annual Update Forms as needed and terminating protocols that are no longer active. (See the IBC Protocol Development page for more information)
Adhering fully to UNL policies and procedures for work activities subject to the UNL Biosafety Guidelines.
Adhering fully to other UNL policies related to the responsible conduct of research (http://research.unl.edu\orr\rcr.shtml).
Restricting activities to those that are approved by the IBC and abstaining from initiating or modifying research/experiments, as applicable under these Guidelines.
Making available to all laboratory personnel a copy of the biosafety manual; training and supervising laboratory workers in good microbial techniques and other practices and procedures related to safety, security, personal protective equipment (use, limitations, and maintenance), accidents, and emergency preparation/response. See the EHS SOP, Biosafety Training, for further training guidance/requirements. NIH encourages PIs to retain training records.
Routinely supervising the performance of laboratory workers to assure a safe workplace and correct work errors and conditions that are a risk to the worker or the environment.
Maintaining a current and accurate inventory of all pathogenic agents in his/her possession at UNL and submitting inventory documentation as described in the EHS SOP Pathogen Inventories to the UNL Biosafety Officer at least annually.
Immediately reporting violations of the NIH Guidelines, injuries and illnesses attributable to occurrences in the laboratory, personnel contamination, spills, and loss of containment to the Biosafety Officer or Chair of the IBC. See EHS SOP Incident Reporting – National Institutes of Health (NIH) Guidance for more information.
Complying with applicable shipping regulations, permit requirements, and Material Transfer Agreements.
Ensuring that facilities and equipment are maintained to support the required biosafety containment level and enforcing laboratory access limitations to maintain adequate security.
Informing laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
Other stakeholder roles and responsibilities are described in the UNL Biosafety Guidelines.
Laboratory Workers are responsible for:
- Completing relevant training as provided by EHS and the PI.
- Being familiar with hazards posed by all agents used in the laboratory regardless of whether he/she directly works with them.
- Keeping a current and accurate inventory of the pathogenic agents used and notifying the PI of any inventory changes.
- Knowing and adhering to all emergency procedures established by the PI.
- Reporting all occupational accidents, illnesses, and injuries to the PI and in accordance with UNL policy, as described in the EHS SOP, On-the-Job and Student Injuries.
- Following all laboratory practices established by the PI.
- A list of current IBC members can be accessed here: Committee Members