Apply for and Manage a Biohazard Use Authorization (BUA) for Laboratory Research or Clinical Trials Using Biohazardous Materials

IBC review

Comprehensive review by the IBC is made of all the biohazardous work proposed in any given laboratory.

The combination of all work proposed by a laboratory group—regardless of the source of funding (or even lack of funding)—is subject to a comprehensive "umbrella" review. Therefore, for the purposes of the BUA review, a principal investigator* shall be the ultimate, single point of accountability and responsibility for a given laboratory.

*Principal Investigator is defined as a person who is assigned laboratory space or is conducting a human gene transfer clinical trial.

Related research authorizations

Other research authorizations for work with regulated materials or human or animal subjects at UCSD may be required.

• See Research Safety Authorizations for Principal Investigators.

BUA application

The Biohazard Use Authorization (BUA) application provides a standardized and secure web-based program for managing research, clinical and teaching activities involving biohazardous materials.

Use the BUA application to apply for a new BUA (see "How to Apply for a BUA" below for instructions), and to amend or renew an active authorization.

Approval must be sought and obtained from EH&S and the IBC prior to the initiation of work involving any of the following (this list is not inclusive):

• New infectious agents
• New viruses, new vector systems
• Enhanced replication or infectivity of viruses of microorganisms
• Biological toxins
• Work with human or primate cell lines
• Nucleic acids
• Changes in constructs or systems 
• increased risk of aerosol or another type of exposure to biohazards
• Any recombinant DNA in vitro, in vivo, and in clinical trials

Submission dates

BUA applications are reviewed at the IBC's monthly meeting. 

• See IBC Meeting and Submittal Dates (PDF) for due dates. For any questions regarding the IBC and scheduled meetings, please email ehsbio@ucsd.edu. 

How to apply for a BUA

Step 1: First-time applicants

Two things must happen before you can access the BIO application to apply for a BUA:

1. You must be entered in the Environment, Health & Safety (EH&S) database to enable certain research safety authorizations and access EH&S online applications.
   • Use the PI Information form to be entered into the EH&S database or to report information changes.
2. You must have a UCSD Business Systems (sometimes referred to as Single Sign-On) username and password to access the BIO application.
   • See How to Get Access to UC San Diego Business Systems for simple instructions. Contact your departmental security administrator (DSA) if you need assistance.

Step 2: Apply for a BUA

1. Go to My Research Safety Web portal.
2. Click the Authorizations tab and select to open the application.
3. Follow instructions on the welcome screen to apply for a new BUA.

Choose the appropriate type of BUA. Two types of BUA applications are offered:

• Type 1: Research BUA – for standard research

• Type 2: Clinical Trial BUA – for human gene transfer (gene therapy).  
  
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Renewal

BUAs must be renewed every 1, 3, or 5 years, depending on the risk. EH&S initiates the renewal process by sending the PI a renewal notice.

* The My Research Safety Web portal is operated and maintained by EH&S.

When to amend your BUA

The PI must notify EH&S and obtain IBC approval via the BUA amendment process before changing any variable which may carry increased biohazard risk. Notification and subsequent IBC approval are also required of the PI before any given COMBINATION of such variables may be changed.

As a working principle, PIs must decide if a new agent or protocol poses any new or increased hazards from those indicated in the currently approved proposal. If there are new or increased hazards (or if there is any doubt or question), approval must be sought prior to implementing the change.

The PI must submit an amendment for

• Addition/Deletion of Locations
• Addition/Deletion of Biological Materials
• Changes in constructs
• Changes in SOP
• Changes in participant enrollment for Clinical trial BUA
• Updates in Serious Adverse Event (SAE) for clinical trial BUA

Amendments require IBC approval before the new work can commence.

Use the BUA (Biohazard Use Authorization) application to amend your BUA.

How to amend your BUA:

1. Go to My Research Safety.
2. Click the Authorizations tab and select to open the application.
3. Select your BUA from the My BUAs tab and press the Renew or Amend function button at the bottom of the screen to proceed.

The BUA application allows a PI or lab manager to do the following without creating or submitting an amendment

• Add or remove authorized personnel
• Add or remove PI contacts and assign editing privileges
• Assign required biosafety training based on personnel lab assignments.

Lab personnel can enroll for required training using UC Learning. See required biosafety training for UC San Diego laboratories.

To be sent to funding agencies requesting proof of approval to use recombinant DNA and assurance that the applicant is compliant with regulations applicable to use of biohazardous materials.

How to get a BUA verification letter:

• Complete a BUA Verification Letter for Funding Agencies request form.
• A verification letter signed by the UCSD Biosafety Officer will be sent to you according to instructions you provide on the request form.

Important: If the request is urgent please include "URGENT" in the subject line of your email. 

Deactivate a BUA when the responsible PI retires, leaves or no longer possesses UC San Diego regulated biological materials. 

A BUA can be deactivated only if all activity has stopped, all biological materials have been removed and disposed of, and all work surfaces and equipment have been decontaminated.

How to deactivate a BUA:

Request BUA deactivation by notifying EH&S Biosafety in writing:

• Reference the BUA Number and PI's name.
• Include a short description of how biohazardous agents and materials were removed from the lab.

Notify EH&S Biosafety by:

• E-mail: EH&S Biosafety
• Mail Code: 0090

Clinical trial BUAs

Clinical trial BUA’s can be deactivated once the project meets all of the following criteria:

• It has been one month since the last dosing of a participant.
• All investigational new drugs have been destroyed or returned to sponsor.
• Study is closed to enrollment.

Related links:

• See How to Close or Relocate a UC San Diego Laboratory if the lab is being closed.

This tutorial provides an introduction step-by-step instruction for how to create and manage Hazard Control Plans (HCP) and BUAs: 

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