This fact sheet provides a summary of the responsibilities of Principal investigators (PIs) working with biological materials. A more detailed description can be found in the University of Utah Biosafety Manual.
PIs of work with hazardous biological materials will need to register their work with the IBC: See “Registering with the IBC” Fact Sheet for details: https://ibc.utah.edu/library/.
In addition, PI’s must:
- Create a laboratory Biosafety Manual, which should include laboratory-specific Standard
Operating Procedures (SOPs) for all experiments involving biological agents, risk
assessments for the agent, descriptions of personal protective equipment, procedures
for using and decontaminating equipment, spill procedures and post-exposure plans,
waste disposal and emergency equipment and practices.
- Laboratories working with human blood, tissues or cells must create a laboratory-specific exposure control plan, as defined in OSHA standard 1910.1030. This can be part of a Biosafety manual or a standalone document.
- Templates for Biosafety Manuals and Exposure Control Plans can be found at https://ibc.utah.edu/biosafety-policies.php
- Ensure all lab personnel are trained and proficient prior to beginning experiments. The IBC may require documentation of training prior to final protocol approval. Details of required and/or recommended training can be found at https://ibc.utah.edu/training.php.
- Avail their lab(s) to audits/inspections.
- Review and respond to IBC review and audit questions and findings.
- Submit amended protocols when there are changes in lab personnel, agents used, the
location of experiments, and any changes that may alter the risk-assessment of the
approved protocol.
- For human gene transfer experiments, changes to the risk assessment and/or to the risk section of the informed consent document will need to be submitted as an amended protocol: all other revisions to the informed consent document should be provided to the IBC after the document has been approved by the University of Utah Institutional Review Board (IRB).
- Conduct an annual review of laboratory-specific SOPs, manuals, and IBC registrations.
- Submit a Continuing Review application to the IBC every 3 years for continuing experiments, or at intervals determined by the IBC.
- Enforce adherence to all health and safety procedures in the approved protocol(s) and SOPs.
Resources
- University of Utah Biosafety Manual (https://ibc.utah.edu/biosafety-policies.php)
- University of Utah Exposure Control Plan (https://ibc.utah.edu/biosafety-policies.php)
- Institutional Biosafety Committee website (https://ibc.utah.edu/)