Principal investigators first obtain a Biological Use Authorization (BUA) from the Institutional Biosafety Committee (IBC) 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
- Experiments involving gene drive modified organisms (NIH Office of Science Policy April 2024 guidance)
- 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, e.g., cloning genes that encode for toxins such as tetanus toxin, alpha-bungarotoxin
- Animal experiments covered by the NIH Guidelines
- Biological Select Agents and Toxins
Click here for the NIH OBA list of experiments that are exempt from IBC oversight.
Submit a BUA
Email or share the unsigned BUA form in MS Word or Google Doc Format to the biosafety officer at Bishop@UCSB.edu
The biosafety officer will collect signatures through DocuSign after IBC approval and after the BUA is finalized.
Email: Bishop@UCSB.edu
Campus mail code: 5132
Campus phone: (805) 893-8894
Biological Use
Authorization Form
Approval Process
- Complete the BUA form and assess the risks associated with the biological materials and experimental procedures.
- Biosafety officer (BSO) reviews the BUA
- BSO meets with the PI or their designee to review the safety equipment, signage, transport containers, disinfection and waste management practices.
- For the 2023-2024 academic year, the IBC meets on the fourth Tuesday of the month, and during the summer as necessary. BUAs on the agenda are sent out the preceding Tuesday.
- BSO emails the PI with any follow up, or the letter of approval along with the final version of the BUA
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 when the BUA is associated with an IACUC protocol.
- BSO collects signatures acknowledging training on the BUA
- BUAs are approved for 3 years
- BUA close-out or renewal after 3 years; PIs not renewing their BUAs arrange for the treatment and removal of all regulated medical waste prior to BUA expiration.
Amending the BUA
Changes that increase the risks of the project are reviewed and approved by the IBC at the regular monthly meeting.
Highlight changes within the BUA, and update the group roster, dates of completion for required training, and biosafety cabinet certification dates.
Group Additions and Changes
Provide the biosafety officer with the name, title (graduate student researcher, undergraduate, etc.), and the dates of completion for required training. Cal/OSHA requires that training be completed annually for those covered by the Bloodborne Pathogens or Aerosol Transmissible Diseases Standards.
Human and Non-Human Primate Cells
Work with primary human and non-human primate blood, body fluids and tissues requires a BUA, and related waste is handled as medical waste. Describe what is known about these materials, including
- Cell or tissue types
- Source, i.e., hospital or clinic, tissue bank, collaborator, or commercial vendor
- Whether the materials are known to be infectious for a certain disease indication
- Whether the materials have been screened for common bloodborne pathogens, and which pathogens are included in the panel. Results, when available, are typically provided for a specific lot on the Certificate of Analysis, showing either a "negative" or "positive" specification or result for the assay.
- Whether the materials will be procured with an IRB-approved Human Subjects Research protocol
Register 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 before work begins.
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. 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. The California Department of Public Health does not designate well characterized human cell lines as medical waste, and OSHA exempts well characterized cell lines from the Bloodborne Pathogens Standard. Example cell line registration
While cell line vendors and repositories may downgrade containment to biosafety level 1 to simplify shipping, these vendors and repositories are not regulatory agencies or part of Health and Human Services.
BMBL (CDC, NIH) and the OSHA and Cal/OSHA Bloodborne Pathogens Standards maintain that work with human and non-human primate cells is done with biosafety level 2 containment practices.
Infectious Agents
Describe the infectious agents that you will work with, and how you will obtain them (commercial vendor, e.g., BEI, or collaborators). If known, specify the strains. A Pathogen Safety Data Sheet may be available on the characteristics of the agents.
Assess the risks and potential modes of transmission of the agents based on the experimental procedures. Specify the volumes that you will culture and store. Include a summary of lab acquired infections.
Lab Acquired Infection Database
Laboratory-Associated Infections, by K. Byers and A. Harding (2016)
Lead investigators should develop written, stepwise Standard Operating Procedures to supplement the agent summaries, safety precautions and risk assessment in the BUA.
Viral Vectors
Information to include for viral vector characterization and risk assessment:
1. Vector System
- Vector type, e.g., lentiviral, adenoviral, pseudorabies, adeno-associated, etc.
- Host cell range i.e., vector tropism or which cell types may the vector infect
- Replicating or non-replicating; design features rendering the viral vector replication incompetent
- Number of packaging plasmids
- Promotor type and whether it is inducible
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Any design features rendering the viral vector safer to the researcher
2. Transgene or Insert Information
- Name and function of the transgene or insert. Specify whether the insert is oncogenic, immunoregulatory, metabolic, a fluorescent reporter, etc. Special care should be given to the design and handling of virus vectors containing genes that make growth-regulating products, products released into the circulation, and products that may have a general effect on the host/researcher immune system.
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Source organism of the gene or insert, e.g., human, rodent, etc.
3. Experimental Procedures
- Source or site of generation, e.g., laboratory, core facility, or commercial provider
- Is there a dilution or concentration step, or is the supernatant from the packaging cell line used?
- The vector titer and total amount of vector
- The volumes of viral particles that will be handled; containment practices may be modified for larger volumes
- For work in vivo, the site of inoculation, method of administration, and how or whether the vector is expected to be shed
4. Training
- Aerosol transmissible diseases training is required for work with broadly pseudotyped viral vectors that present an inhalation hazard post-exposure, e.g., VSV-G glycoprotein pseudotyped lentiviral vectors
- Bloodborne pathogens training is required for work with viral vectors, as well as for work with human and nonhuman primate cells and tissues.
Additional Oversight
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.