The Biosafety Office of the University of Utah primary purpose is to provide guidance to Principal Investigators on practices to minimize laboratory hazards while working with biological agents. Our support is designed to help Investigators meet regulatory requirements of the Occupational Safety and Health Administration (OSHA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). The Biosafety Office supports the University of Utah Institutional Biosafety Committee (IBC), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Review Board (IRB) in the oversight of research involving hazardous biological materials.
If your work involves any of the following, some level of review and oversight by the the IBC or the Biosafety Office is necessary:
- Non-exempt recombinant or synthetic nucleic acid molecules research.
- Studies using human or animals pathogens, including materials known to harbor pathogens (for example, blood from HBV-positive patients).
- Generation of de novo transgenic animals. The breeding of transgenic animals to generate additional transgenic offspring does not require IBC approval.
Those transgenic animals that already exist or which have been purchased also do not require IBC approval.
- Work with Acute Biological Toxins
- Human Subjects research involving the introduction of recombinant molecules or biohazards into human subjects: these studies must be approved by the IBC and by the IRB.
- Animal Subjects: All research involving the use of recombinant molecules or human or animal pathogens in whole animals requires both IBC and IACUC approval.
- Materials potentially containing human pathogens (for example, unfixed human specimens, human blood).
- Human cell lines that are not well-characterized or require BSL 2 containment All cell and organ cultures of human origin (except well-established cell lines that have had comprehensive pathogen testing), human embryonic stem cells, and pluripotent cells and their derivatives.
- The administration of human or non-human primate cells (primary cultures and established cell lines) or tumors into whole animals: this requires both IBC and IACUC approval.
PIs with biological materials will need to register their work with the IBC through BioRAFT, a web-based research management platform used by the University to support laboratory safety compliance.