Principal investigators must first obtain a Biological Use Authorization (BUA) from the Institutional Biosafety Committee (IBC) in order to conduct research with the following materials and/or strategies:
- Microorganisms that are pathogenic to humans, e.g. bacteria, fungi, prions, Rickettsia, viruses
- Human or nonhuman primate cell lines or tissues
- Recombinant DNA techniques requiring IBC approval as described by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Cloning genes that encode molecules toxic to vertebrates
- Animal experiments covered by the NIH Guidelines
- Select agents and toxins
BUA Approval Process
The principal investigator is responsible for completing the BUA form and making a preliminary risk assessment based on the biohazards and the manipulations to be performed. The biosafety officer reviews the application and may make suggestions in anticipation of the IBC’s concerns. The IBC then reviews the application for safety controls. The IBC meets on the second Wednesday of the month during the academic year. The biosafety officer then notifies the principal investigator and lead contact of the committee’s recommendations and/or approval. Upon approval, the biosafety officer emails a letter of approval with the BUA title, tracking number, expiration date, biosafety level of containment, applicable section(s) of the NIH Guidelines, training required, and any occupational health recommendations or requirements. BUAs are effective for 3 years from the date of the letter of approval.
Changes to Approved BUA Applications
Changes to the project as specified in the BUA (e.g. personnel, expression vectors, facilities, etc.) shall also be registered with the IBC. Changes should be made using the BUA amendment form listed under the link to the main application.
Please note that additional oversight may be necessary from one or more of the following agencies or committees:
Animal and Plant Health Inspection Service/Centers for Disease Control (APHIS/CDC)
Principal investigators (PIs) must register the use of select agents and/or toxins with APHIS/CDC if they are to possess amounts exceeding the current permissible quantities. If there is no permissible toxin amount listed, then you should infer that registration for the possession of any amount is required. In practice, APHIS/CDC registration is obtained prior to submitting a BUA application.
Institutional Use and Animal Care Committee (IACUC)
PIs must also register live animal studies with IACUC. IACUC ensures that all activities involving live vertebrate species meets the ethical and legal requirements for the humane care and use of animals as set forth by the Public Health Service Policy, the Animal Welfare Act, federal, state, local, and UCSB laws, policies and guidelines. Protocols involving animals should be registered first or concomitantly with the IBC.
Embryonic Stem Cell Research Committee (ESCRO)
ESCRO oversees human embryonic stem cell research and other stem cell research covered by the NIH and the California Institute for Regenerative Medicine policies in order to ensure that UCSB research meets scientific and ethical standards. PIs must register the use of human, nonhuman primate, and murine stem cells with ESCRO. The ESCRO Coordinator is the point of contact for submittals.
Human Subjects Committee (HSC)
HSC oversees protocols involving human subjects, including cells and tissues derived from human subjects. The HSC Coordinator is available to the investigator for advice and assistance in planning the use of human subjects within federal, state, and University regulations.