The latest revisions of the Biological Use Authorization (BUA) Applications are now available. Previous versions
of all forms will not be accepted after September 1, 2017. Submit complete and accurate applications to firstname.lastname@example.org
by the BUA application deadline or clinical trial application deadline to be
reviewed at the Institutional Biosafety Committee (IBC) meeting.
To learn more about promoting biosafety, see the Biosafety Stewardship webpage.
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 Office of Science Policy 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 Office of Science Policy 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.
Principal Investigators may request changes to their current approval (e.g., new agent, location, or animal procedure). In certain situations, EH&S ROS will be able to make the change administratively.
Some changes will require review and approval from the IBC. 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.
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 Room N130A of William H. Foege Bioengineering unless otherwise announced.
A complete and accurate BUA Application or Request for Change to the BUA must be received by 5:00 PM four weeks 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.
|BUA Application Submission Deadlines||IBC Meeting Dates
|December 21, 2016
||January 18, 2017
|January 18, 2017
||February 15, 2017
|February 15, 2017
||March 15, 2017
|March 22, 2017
||April 19, 2017
|April 19, 2017
||May 17, 2017
|May 24, 2017
||June 21, 2017
|June 21, 2017
||July 19, 2017
|July 19, 2017
||August 16, 2017
|August 23, 2017
||September 20, 2017
|September 20, 2017
||October 18, 2017
|October 18, 2017
||November 15, 2017
||November 15, 2017
||December 13, 2017
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.
Contact an EH&S Biosafety Officer at EH&S Research and Occupational Safety at firstname.lastname@example.org