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Compliance with the UNL Biosafety Guidelines

Principal Investigators are expected to understand their responsibilities under the NIH Guidelines and other national standards or regulations as summarized below:

• They must adhere to all sections of the UNL Biosafety Guidelines relevant to their project(s) and ensure that all personnel involved in the project(s) is aware of their responsibilities in the conduct of this research.
• They must adhere to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories manual, the Select Agent Rules (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) and other authoritative and/or regulatory sources as appropriate.
• They must amend their protocol and seek IBC approval prior to implementing major changes to the approved protocol; further, they must complete the annual update form in a timely fashion and provide notification of minor changes that do not require submission of a formal amendment to the protocol.
• They are responsible for the safe conduct of the experiments to be conducted in their lab and must ensure that all associated personnel complete required training relative to this work, as described in the UNL Biosafety Guidelines and Section IV of the NIH Guidelines.
• Non-compliance and Existing Protocols
  • The committee has authority to withdraw or suspend protocol approval in response to violations of the NIH Guidelines or UNL biosafety policies and procedures, including but not limited to:
    • failure to obtain IBC approval prior to initiating work;
    • failure to maintain an existing approved protocol or;
    • failure to complete required training or;
    • failure to adhere to safety and containment design and principles.
  • Non-compliance incidents are reported to the IBC during monthly meetings for review. Corrective actions issued by the IBC may include:
    • Retraining of PI and lab staff on the NIH Guidelines and roles/responsibilities;
    • Strict oversight of PI and laboratory experiments by the IBC, enforced and reported by the Biosafety Officer;
    • Suspension of experiments;
    • Suspension of funding
    • Other corrective actions as required by NIH-OSP following review of the incident report.
  • In general, the PI is expected to implement corrective actions in a timely manner (upon notice of deficiency).
  • The AVCR may also administer additional consequences, up to and including suspension of access to research funds. Refer to the supplemental IBC policy on remediation of non-compliance with UNL Biosafety Guidelines for additional detail.
• Reinstatement of Suspended Protocols
  • A suspended protocol can be reinstated when the following occurs:
    1. The violation has been addressed/corrected to the satisfaction of the IBC and AVCR and;
    2. The PI has submitted an explanation, in writing, to the IBC of his/her reasons for non-compliance with the UNL Biosafety Guidelines and actions taken to prevent reoccurrence.
  • The IBC will discuss reinstatement at the next meeting following completion of the items above and a decision will be made about reinstating full approval of the protocol. The PI will receive a letter notifying him/her as to the IBC's decision.
• Unapproved Work Activities
  • If it is discovered that a PI is conducting work activities for which he/she is not approved, the IBC or BSO on behalf of the committee will notify the PI and require immediate submittal of a biosafety protocol for review by the IBC and suspension of work activities if the activities are subject to review by the committee prior to initiation. The AVCR may also administer additional consequences, up to and including suspension of access to research funds.  Refer to the supplemental IBC policy on remediation of non-compliance with UNL Biosafety Guidelines for additional detail.
    • Any manipulation of r/s NA (including transgenic organisms) without submission and approval of an IBC protocol could be considered non-compliant with the NIH Guidelines and may be directly reportable to the NIH Office of Science Policy (OSP).
    • In the event of a non-compliance incident, a protocol amendment must be filed immediately, delineating all experiments and materials not previously disclosed.
    • It is important to remember that non-compliance with the NIH Guidelines may jeopardize future federal funding of both the PI and the institution as a whole.
• Supplemental Policies
  • Non-compliance policy (#01.2013)
  • Preliminary approval of protocol amendments (#03-2016)
• Training (EHS Web-Based Training)
  • Training in the principles and practices of general biosafety is essential to maintaining a safe work environment and it is the responsibility of each PI to ensure that his/her lab personnel are properly trained.  All employees of UNL are required to take the following EHS courses:
    • Core - Injury and Illness Prevention Plan
    • Core - Emergency Preparedness Training
    • Chemical Safety Training (if assigned tasks with potential for chemical exposure)
  • Biosafety training is required of all PIs and laboratory personnel working on IBC approved research protocols. This training must be completed prior to working on experiments/protocols that require IBC approval.  Additionally, laboratory workers must receive annual refresher training on biosafety. Biosafety training requirements are further detailed in the EHS SOP,Biosafety Training, but below is a list of training material that applies to most IBC protocols.
    • Biosafety Research Compliance (required for all UNL employees working with biological materials subject to UNL's Biosafety Guidelines. Training covers the oversight of biological research at UNL, risk assessment, protocol development, and the NIH Guidelines)
      • Biosafety 100: Research Compliance - web-based - (UNL EHS)
    • Biosafety Procedures and Practices (as applicable to approved protocol)
      • All biosafety levels - web-based - Biosafety 101 (UNL EHS)
      • BSL-2/ABSL-2 - web-based - Biosafety 101 and Biosafety 201 (UNL EHS)
      • BSL-3 -Biosafety 101 and Biosafety 201 (UNL EHS) and additional training provided by BSL-3 facility director or alternative as prescribed by BSO.
    • Bloodborne Pathogens Training - PIs and their staff working with bloodborne pathogens or other potentially infectious materials (OPIM) including human cell lines are required to take training annually in addition to other required training.
      • Bloodborne Pathogens for Laboratory Workers - web-based - (UNL EHS)
    • Additional training may be necessary as applicable to the research approved. Examples include autoclave operation training, radiation safety training, export control awareness, animal handling, etc.
    • Biosafety Refresher Training - Several options exist to complete refresher training. Preferably, this should be relevant to the research conducted in the lab.
      • Complete the Biosafety Refresher Training - web-based - (UNL EHS)
        • This online module covers common safety issues observed in labs as well as special topics. EHS will update the annual refresher training every October, therefore the content will change each year.
      • Request EHS staff members to conduct instructor-led training at a location of your choice in a biosafety topic that is particularly relevant to your laboratory.
      • Hold a meeting with laboratory workers:
        • Review relevant lab-specific or EHS Safe Operating Procedures; and/or
        • Discuss a relevant near miss incident or laboratory acquired infection and lessons learned (this could be an incident that occurred anywhere);
        • Watch a safety video as a lab.
          • A curated YouTube playlist of biosafety-related videos is available at this address: https://go.unl.edu/zp39