The December 2012 revision of the Biological Use Authorization (BUA) Application is now available. New Frequently Asked Questions (FAQs) to accompany the BUA Application are also available.
The revised BUA Application captures research involving synthetic nucleic acids as necessitated by the amended NIH Guidelines which go into effect on February 28, 2013.
For information about how the amended NIH Guidelines may impact your research see our informational webpage.
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
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:
- Molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell (i.e., recombinant nucleic acids);
- 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);
- 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
|Section||Experiments Covered||Examples of Experiments Covered
||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-B||Experiments that Require NIH/OBA and IBC Approval Before Initiation
|| Cloning of toxin molecules with LD50 less than 100ng/kg
||Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review Before Research Participant Enrollment
||Human gene transfer
||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.
||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
||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
When EH&S Research and Occupational Safety (ROS) receives your completed Biological Use Authorization Application, the (PDF) review process will begin.
- 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.
- The IBC primary reviewer and/or EH&S Biosafety Officer will be assigned to review and assess your research.
- 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.
- All IBC members will have the opportunity to review your BUA Application.
- Projects are presented to the IBC for review at monthly convened meetings involving experiments covered by Sections III A-D of the NIH Guidelines.
- 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.
- Biological Use Authorization Application: Submit this application to initiate the BUA process for new projects and renewals.
- 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.
- Appendix A: Hazardous Material Information for Animal Husbandry Staff
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.
||EH&S Research and Occupational Safety
|UW Campus Box:
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 Dates||BUA Application Submission Deadlines
|January 16, 2013
||December 19, 2012
|February 20, 2013
||January 23, 2013
|March 20, 2013
||February 20, 2013
|April 17, 2013
||March 20, 2013
|May 22, 2013
||April 17, 2013
|June 19, 2013
||May 22, 2013
|July 17, 2013
||June 19, 2013
|August 21, 2013
||July 24, 2013
|September 18, 2013
||August 21, 2013
|October 16, 2013
||September 18, 2013
|November 20, 2013
||October 23, 2013
|December 18, 2013
||November 20, 2013
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.
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 email@example.com . An EH&S Biosafety Officer will work with you to update your approval.
Contact an EH&S Biosafety Officer at EH&S Research and Occupational Safety: