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 cause disease in humans, animals or plants
- Human or non-human primate primary cells or tissues
- Human or non-human primate feces
- 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
- Biological Select Agents and Toxins
BUA Approval Process
The IBC meets on the second Wednesday of the month during the academic year, and during the summer as necessary. Agenda items are sent out one week before the IBC meets.
Submit BUA forms to the biosafety officer by the begining of each month for consideration at the next meeting.
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 to ensure that the materials and procedures are described with enough detail for the IBC to prescribe or confirm containment measures.
The biosafety officer follows up with the principal investigator (PI) by email with a summary of questions and recommendations from the IBC. Upon finalization of the BUA, the biosafety officer emails the PI with the final version of the BUA and a letter of approval.
Letters of approval contain the BUA title, tracking number, expiration date, biosafety level(s) of containment, applicable section(s) of the NIH Guidelines, training requirements, and any occupational health recommendations or requirements. Letters of approval are forwarded to the IACUC Coordinator for BUAs associated with an IACUC protocol.
BUAs are effective for 3 years from the date of the letter of approval.
Registering Work with Human Cell Lines
Human cell lines that are derived from apparently healthy donors and screened for a panel of the most common bloodborne pathogens are considered well characterized. Well characterized human cell lines are accompanied by a Certificate of Analysis from the vendor indicating that the cells have been screened and found to be negative for, at a minimum, hepatitis B virus, hepatitis C virus, and the human immunodeficiency virus. The Certificate of Analysis documents reduced concerns for the presence of bloodborne pathogens by ruling out the main pathogens that have been encountered in hospital settings. The panel of bloodborne pathogens is specific to the vendor and varies slightly.
Principal investigators register their work with well characterized human cell lines with the IBC via the biosafety officer using the standard BUA form. Use of such cell lines does not require IBC review or approval before work begins.
The California Department of Public Health does not designate well characterized human cell lines as medical waste.
• See California Health and Safety Code Sections 117600 – 118360, specifically, 117700 (a) and (b), for biological materials excluded as medical waste.
The Occupational Safety and Health Administration exempts well characterized cell lines from the Bloodborne Pathogens Standard.
• OSHA Standard Interpretation issued 1994: https://www.osha.gov/laws-regs/standardinterpretations/1994-06-21
For established tumor cell lines, human or NHP origin does not intrinsically make them medical waste unless there is information about contamination with pathogens or integration of non-defective pathogenic viral sequences.
Changes to Approved BUA Applications
Changes to the project, e.g., additional research personnel, biological materials, or facilities must 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, and update the training roster and biosafety cabinet certification dates.
Please note that you may also need approval from Institutional Committees that oversee the ethics of research with human subjects, animals subjects, and/or stem cells. These Committees are administered by Research Integrity within the Office of Research.