Institutional Biosafety Committee Protocol Submission
Per the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and KUMC Policy, registration with the IBC is required for research activities that include but are not limited to the use of:
- Recombinant or synthetic nucleic acid molecules, including viral vectors
- Use of transgenic animals including the generation of a novel transgenic animal line through the breeding of two different lines of knockout animals
- Use of other transgenic organisms
- Infectious agents (pathogens affecting humans, animals or plants)
- Human-derived materials (e.g. blood, unfixed tissues, primary cells, established cell lines)
- Non-primate mammalian cell lines, tissues and source materials
- Non-human primate source materials (e.g. blood, unfixed tissues, primary cell culture, bodily fluids)
- Biological toxins (e.g. derived from microorganisms or animals that adversely affect humans or animals)
- Biological select agents and toxins regulated by the CDC and/or USDA/APHIS
An IBC Registration Form must be submitted to email@example.com. A pre-IBC review will be conducted to determine if the registration is exempt or not exempt from the NIH Guidelines. Non-exempt experiments (Sections III-A through III-E of the NIH Guidelines) will undergo full committee review. A registration consisting of only exempt experiments does not need to go to full committee review and can be reviewed and approved by the Biological Safety Officer. Categories of exempt experiments are found in Section III-F of the NIH Guidelines.
For projects that include the use of an infectious agent (human pathogen) or viral vector, a Pathogen Registration Formor Viral Vector Registration Form must be completed for each infectious agent or viral vector used. These forms (when applicable) must be submitted along with the IBC Registration Form.
If changes need to be made to an approved IBC registration, an IBC Addendum Form must be submitted to firstname.lastname@example.org. Some modifications (e.g. changes in the host/vector/insert system or addition of new biohazardous materials) will require full committee review while other changes (e.g. addition/removal of lab locations or personnel) can be administratively reviewed and approved by the Biological Safety Officer.
If changes include the addition of an infectious agent or viral vector, the applicable Pathogen or Viral Vector Registration Form(s) must be submitted along with the IBC Addendum Form.
Research involving the use of vertebrate animals requires the submission of an Animal Care & Use Protocol (ACUP) to the Institutional Animal Care & Use Committee (IACUC). Guidance for submitting an ACUP can be found on the KUMC Office of Regulatory Affairs for Biological Sciences / IACUC website. ACUPs are reviewed by the Biological Safety Officer to check for the use of recombinant DNA, infectious agents or other biohazardous materials in animals. Registration with the IBC is required if such materials are being administered to animals or if the research involves the use of genetically modified animals or animal experiments covered under or exempt from the NIH Guidelines.
Human Subjects Research:
Research encompassing the use of human subjects (including research involving identifiable private information and identifiable biospecimens) requires the submission of a study application to the Institutional Review Board (IRB). Guidance on submitting a study application can be found by visiting the IRB website.
Please see KUMC's Procedure on Review of Human Gene Transfer Studies for guidance on NIH compliance requirements and the IBC submission process regarding human gene transfer research.