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:

Click here for the NIH OBA list of experiments that are exempt from IBC oversight.

 

BUA Submittal

Email or share the unsigned BUA form in MS Word or Google Doc Format to the biosafety officer at Bishop@UCSB.edu

Please wait to send signature pages electronically or by campus mail until the BUA has been finalized and you have received the letter of approval.

Email: Bishop@UCSB.edu
Campus mail code: 5132
Campus phone: (805) 893-8894

 

Biological Use
Authorization Form

 

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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.  BUA Lab Space Review Checklist
  • IBC meets on the second Tuesday of the month during the academic year, 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.

 

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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 and new information within the originally approved BUA, and update the training roster and biosafety cabinet certification dates.

 

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Roster Changes

 

Provide the biosafety officer with the name, title (graduate student researcher, undergraduate, etc.), and date of BBP training within 12 months by email. 

 

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Registering Work with Human 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 or approval 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

 

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Describing 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

  • 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.

  • 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 animals work, the site of inoculation, method of administration, and how or whether the vector is expected to be shed

 

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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.

 

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