Biological Use Authorization

A complete and accurate Biological Use Authorization (BUA) Application or Request for Change to Biological Use Authorization must be received by the application deadline to be reviewed at the Institutional Biosafety Committee (IBC) meeting. Frequently Asked Questions (FAQs) are available to assist you in completing the application. Information about the 2013 amended NIH Guidelines is located on the informational webpage.


When is Biological Use Authorization Required?

If your study involves biohazards, your work must be reviewed and approved by the Institutional Biosafety Committee (IBC) and/or Environmental Health and Safety (EH&S) Research and Occupational Safety (ROS). The National Institutes of Health (NIH) mandate that our institution establish an IBC for the review and approval of all research involving recombinant DNA. Institutional Biosafety Committee review and approval for research involving all biohazards is required by the UW Administrative Policy 12.3.

The purpose of the biosafety review is to ensure that biohazardous materials are handled safely from start to finish. EH&S ROS will review both your laboratory operation procedures and Principal Investigator and staff training that is related to work with biohazards including all recombinant DNA or synthetic DNA/RNA. Submitting the BUA Application will register your research with the IBC and EH&S ROS and initiate the Biological Use Authorization process. The IBC's working definition of a biohazardous agent includes the following:

  • Pathogenic agents (bacteria, rickettsia, fungi, viruses, protozoa, parasites, prions, and select agents)
  • Recombinant or synthetically derived nucleic acid, including those that are chemically or otherwise modified analogs of nucleotides (e.g., morpholinos), or both. The NIH defines synthetically derived nucleic acid molecules as follows:
    1. Molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell (i.e., recombinant nucleic acids);
    2. Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids);
    3. Molecules that result from the replication of those described in (a) or (b) above
  • Recombinant DNA molecules, organisms, vectors (e.g., plasmids, viral vectors), and viruses containing recombinant DNA molecules
  • Human and non-human primate blood, tissue, body fluid, and cell culture (primary or continuous)
  • Plants, animals or derived waste which contain or may contain pathogenic hazards (including xenotransplantation tissue)

The BUA Application addresses the NIH OBA directive that the Principal Investigator must self identify the section of The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules that applies to their research. There are different levels of oversight required for research with recombinant or synthetic DNA/RNA depending on the agents and procedures in a specific research project. Thus, it is critical that the Principal Investigator makes the initial assessment of the NIH oversight required for approval. Much of the research with recombinant or synthetic DNA/RNA that occurs at the University of Washington, such as use of viral vectors, falls under Section III-D. Projects that fall under this section of the guidelines may not begin until the Principal Investigator obtains approval from the Institutional Biosafety Committee (IBC). The table below summarizes the section and experiments covered under the NIH Guidelines.


Experiments Covered by the NIH Guidelines for Recombinant or Synthetic DNA
SectionExperiments CoveredExamples of Experiments Covered
Section III-A Experiments that Require Institutional Biosafety Committee Approval (IBC), RAC Review, and NIH Director Approval Before Initiation Deliberate transfer of drug resistance to a microorganism that is not known to acquire it naturally, if such acquisition could compromise the ability to control disease agents in humans, animals or agriculture
Section III-BExperiments that Require NIH/OBA and IBC Approval Before Initiation Cloning of toxin molecules with LD50 less than 100ng/kg
Section III-C Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review Before Research Participant Enrollment Human gene transfer
Section III-D Experiments that Require IBC Approval Before Initiation Recombinant and synthetic nucleic acids in pathogenic microorganisms, viral vectors for gene transfer in Risk Group 2 microorganisms.
Section III-E Experiments that Require IBC Notice Simultaneous with Initiation Recombinant and synthetic nucleic acids in Risk Group 1 microorganisms or formulated into synthetic or natural vehicles, experiments involving whole plants at BSL1-P
Section III-F Exempt Experiments Recombinant and synthetic DNA/RNA that is not in organisms or viruses, DNA/RNA in microorganisms that are under Exempt Experiments Under Section III-F


What is the Biological Use Authorization Process?

When EH&S Research and Occupational Safety (ROS) receives your completed Biological Use Authorization Application, the (PDF) review process will begin.

  1. The IBC Chair and EH&S Biosafety Officer will screen the BUA Application for completeness and accuracy. It is critical that the BUA application is entirely complete per the FAQs for IBC members to review your research. Incomplete applications may be returned to you. This could potentially delay IBC review and approval until the following month when the full committee meets again.
  2. The IBC primary reviewer and/or EH&S Biosafety Officer will be assigned to review and assess your research.
  3. The EH&S Biosafety Officer will work with you to obtain approval. A Biosafety Officer will inspect your laboratory to confirm to the IBC that your laboratory and practices are in compliance with the biocontainment requirements for your research. Deficiencies must be corrected prior to Biological Use Authorization.
  4. All IBC members will have the opportunity to review your BUA Application.
  5. Projects are presented to the IBC for review at monthly convened meetings involving experiments covered by Sections III A-D of the NIH Guidelines.
  6. Once your research has been approved, you will receive a notification of Biological Use Authorization from the IBC. This must be reviewed with your staff and made available to staff in the lab.

Which Applications to Submit?

  1. Biological Use Authorization Application: Submit this application to initiate the BUA process for new projects and renewals.
  2. Request for Change to BUA: Submit this application to request changes to your current BUA. Changes can include adding a new biohazardous agent, changing a location, or adding a new gene delivery method.
  3. Appendix A: Hazardous Material Information for Animal Husbandry Staff

How and When to Submit the BUA Application?


Electronic submissions of the BUA Application are preferred. If the Principal Investigator does not have an electronic signature, then the signature page can be submitted separately via campus mail.

Attention: EH&S Research and Occupational Safety
E-mail: ehsbio@uw.edu
UW Campus Box: 357165
Fax: 206.221.3068

IBC monthly meetings are held on the third Wednesday of each month. Meetings are open to the public and take place from 10:00 AM to 12:00 PM in Magnuson Health Sciences Building, Room T-269. A complete and accurate BUA Application or Request for Change to the BUA must be received by 5:00 PM twenty eight days prior to the meeting to be considered at that month's meeting. See meeting schedule and submission deadlines below.

For research involving recombinant or synthetic DNA/RNA in human research subjects, allow eight weeks for completion of the IBC review which begins once all documents of the clinical investigator's application packet are submitted.

IBC Meeting DatesBUA Application Submission Deadlines
December 18, 2013 November 20, 2013
January 22, 2014 December 25, 2013
February 19, 2014 January 22, 2014
March 19, 2014 February 19, 2014
April 16, 2014 March 19, 2014
May 21, 2014 April 23, 2014
June 18, 2014 May 21, 2014
July 16, 2014 June 18, 2014
August 20, 2014 July 23, 2014
September 17, 2014 August 20, 2014
October 15, 2014 September 17, 2014
November 19, 2014 October 22, 2014
December 17, 2014 November 19, 2014


When Does Biological Use Authorization Expire?

When projects with biological agents are approved, they will receive an expiration date. Approvals will generally be given for a three year period or concurrent with Institutional Animal Care and Use Committee (IACUC) protocol expiration. Any research performed on a project with biological agents after the expiration date will be out of compliance with the NIH Guidelines. This is a reportable incident to the NIH Office of Biotechnology Activities, which oversees the NIH Guidelines.

To renew your approval you must re-submit a BUA Application in sufficient time to obtain IBC approval before your expiration date. You will receive email notification, approximately two months prior, of your impending expiration to remind you of your need to resubmit if you plan to continue your research.


How to Request a Change to Currently Approved Research?

Principal Investigators may request changes to their current approval (e.g., new agent, location, or animal procedure). In certain situations, the EH&S ROS will be able to make the change administratively. In others, review and approval from the IBC will be required. To request a change submit a Request for Change to BUA to ehsbio@uw.edu . An EH&S Biosafety Officer will work with you to update your approval.


Questions?

Contact an EH&S Biosafety Officer at EH&S Research and Occupational Safety:
206.221.7770
ehsbio@uw.edu