• Submit a PI Information form to be entered into the EH&S database or to report information changes.

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• Follow instructions on the BUA Application welcome screen to apply for a new BUA.
• Choose the appropriate type of BUA. Two types of BUA applications are offered:
  • Research BUA – for standard research
  • Clinical trial BUA – for human gene transfer (gene therapy)
    • Clinical trial applications have special requirements:
      • See the list of requirements (Word) (PDF).
      • Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for detailed formatting and submission instructions.
      • Send the required material to EH&S Biosafety:
        E-mail: ehsbio@ucsd.edu (preferred method)
        Mail Code: 0091
        Fax: (858) 534-1510

  Submission deadline: To ensure your BUA application is reviewed at the IBC's monthly meeting, submit your complete application no later than the 20th of the month.

  Note: BUAs are subject to review, updating, and renewal 1 year after initial approval. Environment, Health & Safety (EH&S) initiates the renewal process by sending the PI a renewal notice.

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IBC approval is required before beginning work involving any of the following examples (this list is not inclusive):

• New infectious agents
• New vector systems
• Enhanced infectivity
• Expression of toxins or oncogenes
• Work with human or primate cell lines
• Partial genomes increased to more than two-thirds of whole genome
• Changes in constructs or systems that result in significantly higher titres
• Changing work with non-human systems into work in human systems
• New or altered procedures that pose increased risk of aerosol or other type of exposure to biohazards
• Any recombinant DNA in vitro, in vivo, and in clinical trials

To amend your BUA:

• Follow instructions on the BUA Application welcome screen to amend an active BUA.
• Clinical trial BUAs (gene therapy) have special requirements.
  • Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for consultation and formatting instructions.

  Submission deadline: To ensure your BUA application is reviewed at the IBC's monthly meeting, submit your complete application no later than the 20th of the month.

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To get a BUA verification letter:

• Print a BUA Verification Letter for Funding Agencies request form (Word) (PDF).
• Complete the form and have both the applicant and responsible PI sign it.
• Send the form to EH&S Biosafety:
  • Mail Code: 0091 (preferred method)
  • Fax: (858) 534-1510
• A verification letter signed by the UCSD Biosafety Officer will be sent to you according to instructions you provide on the request form.

  Important: EH&S needs at least 3 days to process the form.

  Note: You must have a current BUA (approval granted within the last 11 months) to obtain a BUA verification letter.

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• Request BUA deactivation by notifying EH&S Biosafety in writing, referencing the BUA number:
  • E-mail: EH&S Biosafety
  • Mail Code: 0091
  • Fax: (858) 534-1510
• Deactivations of clinical trial BUAs (gene therapy) have special requirements.
  • Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for consultation.
• See How to Close or Relocate a UCSD Laboratory if the lab is being closed.

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