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
Principal investigators are responsible for completing the BUA form and assessing the risks associated with the biological materials and experimental procedures.
The biosafety officer reviews applications before sending them out to the IBC. Agenda items are sent out the preceding Wednesday. The IBC meets on the second Wednesday of the month during the academic year.
The biosafety officer emails the principal investigator and lead contact with questions or recommendations from the IBC. Upon finalization of the BUA, 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 requirements, 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, e.g., additional research personnel, biological materials, or facilities shall also be registered with the IBC. Changes or additions that increase the risk of the project are reviewed and approved by the IBC at the regular monthly meeting. Use MS Word Track Changes within the originally approved BUA to note amendments.
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, and UCSB policies and guidelines. Protocols involving animals should be registered first or concomitantly with the IBC.
Stem Cell Research Committee (SCRO)
SCRO oversees human stem cell research 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 SCRO. The SCRO 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.