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All non-exempt work with biological materials must be submitted by the Prinicpal Investigator (PI) for review and approval by the Institutional Biosafety Committee (IBC) prior to the commencement of work.

 
 

 

PIs of work involving the following categories of biological materials will need to register their work with the IBC through BioRAFT.

bioraft

  • Non-exempt recombinant or synthetic nucleic acid molecules.
  • Studies using human or animals pathogens.
  • Work with transgenic animals. The breeding of transgenic rodents to generate additional transgenic offspring typically does not require IBC approval. Those transgenic rodents that already exist or  which have been purchased also typically do not require IBC approval.
  • Work with transgenic plants.
  • Work with Acute Biological Toxins.
  • Animal Subjects: All research involving the use of recombinant molecules or human or animal pathogens in whole animals requires both IBC and IACUC approval.
  • Work with materials from non-human primates.
  • Work with human cell lines that are not well-characterized or require BSL 2 containment. This includes all cell and organ cultures of human origin.

PIs of work involving the following categories of biological materials will need to register their work with the IBC through ERICA.

   ERICA   

  • 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. The IBC module will be prompted during the completion of the IRB application in ERICA.
  • Human Subjects research involving the collection and handling of samples. The IBC module will be prompted during the complation of the IRB application in ERICA.

However, it also possible to register this work independently of an IRB application using a  "Registration On Demand" Feature in ERICA under the IBC tab. These can be linked to multiple IRB applications with the same risk assessment.

 

Questions and Advice

contact biosafety@ehs.utah.edu

 

IBC Review

Most registrations will be reviewed by the IBC at their monthly convened meeting (https://ibc.utah.edu/ibc-registrationreview.php).

The following categories typically require administrative review and approval by the Biosafety Officer and/or IBC Chair:

  • Materials potentially containing human pathogens (for example, unfixed human specimens, human blood).
  • Work with human cell lines that are not well-characterized or require BSL 2 containment.
  • Work with materials from non-human primates.

 

Resources

 

 

 

Last Updated: 3/11/24