Biological Research Approval
The Biological Use Authorization (BUA) process grants approval for work with biohazards. If your research involves biohazards, it must be reviewed and approved by the Institutional Biosafety Committee (IBC) and Environmental Health and Safety (EH&S) to ensure safe handling of biohazardous material.
Biological Use Authorization (BUA)
Biological Use Authorization (BUA) is the process for reviewing and approving research involving biohazards including recombinant or synthetic DNA/RNA. If your research involves biohazards, it must be reviewed by an EH&S biosafety officer and the Institutional Biosafety Committee (IBC) to ensure that biohazards are handled safely from start to finish. The National Institutes of Health (NIH) mandates that our institution establish an IBC for review and approval of all research involving recombinant DNA. IBC review and approval for research with biohazards is required by the UW Administrative Policy 12.3.
The IBC’s definition of a biohazard includes:
- 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 fluids and cell cultures (primary or continuous)
- Plants, animals or derived waste which contain or may contain pathogenic hazards (including xenotransplantation tissue)
BUA application process
Refer to the IBC Project Review Flow Chart and Experiments Covered by the NIH Guidelines.
EH&S screens the BUA application for completeness and accuracy. Incomplete applications may be returned to you, which could potentially delay IBC review and approval until the following month’s meeting.
Each project is categorized depending on the level of review required by the NIH Guidelines:
Work that falls under Sections III-E and III-F of the NIH Guidelines, or that does not fall under the NIH Guidelines, will be reviewed and presented to the IBC by an EH&S biosafety officer.
Work that falls under Sections III-D of the NIH Guidelines will be assigned to an IBC primary reviewer, who will present an individual review of the project at an IBC meeting.
Work that falls under other sections of the NIH Guidelines, or certain special projects such as BSL-3 research, will be assigned to an IBC subcommittee for review. These projects may require additional time for review.
All IBC members will have the opportunity to review your BUA application.
An EH&S biosafety officer will work with you to obtain approval. The biosafety officer will inspect your lab to confirm to the IBC that your laboratory and practices are in compliance with the requirements for your research. You will be required to correct any deficiencies prior to obtaining approval.
If your project is approved by the IBC, you will receive a Biological Use Authorization (BUA). This approval letter must be reviewed with your staff and made available in the lab.
For new projects or renewals:
To make changes to an existing BUA:
Use the Frequently Asked Questions (FAQs) as needed to help you fill out the application.
Electronic submissions to firstname.lastname@example.org are preferred. You can also submit via campus mail to:
Attn: EH&S Research and Occupational Safety
Review of the application typically takes four weeks. Submit the BUA application four weeks prior to the meeting in which your application needs to be reviewed. See BUA Application Submission Deadlines for the meeting schedule and associated deadlines.
Review of clinical trial BUA applications may require more time. Submit the Clinical Trial BUA application at least four weeks prior the meeting in which your project needs to be reviewed. During times of high volume, reviews for clinical trials may take up to six weeks. See BUA Application Submission Deadlines. If you have any questions about the approval timeline for your submission, contact the IBC coordinator at email@example.com.
If your research involves the use of biohazards in animals, submit your BUA application concurrently with the Institutional Animal Care and Use Committee (IACUC) protocol.
Please note your BUA expiration date. You will receive an email reminder to renew the BUA. Be sure to allow enough time for IBC review of your BUA renewal.
More about Biological Research Approval
Biological Use Authorization is required for all research involving biohazards, including recombinant or synthetic DNA/RNA.
Submission of the BUA application initiates the review process.
You may need to obtain approval from the IBC and EH&S before starting your research. Be sure to review the experiments covered by the NIH Guidelines to determine what level of approval is required for your work.
Biological Use Authorization (BUA) expires after three years or concurrently with the IACUC approval. You can apply for a renewal at that time. You will receive an email notification when your expiration approaches.
Changes to agents or locations require an update to your BUA. Submit a Change to BUA application to obtain approval for changes.
Use of biohazards in animals requires IACUC approval. BUA approval for biohazards in animals requires review of the accompanying IACUC protocol by an EH&S biosafety officer.
Be sure any research with biohazards is approved by the IBC. Submit a BUA application for any work involving biohazards, including recombinant or synthetic DNA/RNA.
Follow all of the biosafety containment practices and procedures and additional guidance as specified in your BUA letter.
Make the BUA letter available to laboratory staff.
Ask EH&S for help if you’re not sure how to proceed safely.
Frequently asked questions
Yes, research with recombinant DNA requires approval by the UW IBC, even for commercially available kits and vectors. You need to submit a BUA application or Change to BUA for work with recombinant DNA.
Yes, IBC approval is required for all research with biohazards, regardless of the funding source. The NIH mandate for IBC approval applies to all research at an institution that receives any NIH funding.
Fill out the form as best possible and submit. Once received, a biosafety officer will work with you as you set up your laboratory. The application can be updated when laboratory locations are finalized.
Yes. All new IACUC protocols require an associated BUA. IACUC amendments also require a Change to BUA if it has additional biohazards used in animals.
Yes, you need a BUA for your research with biological agents, even if performed in a core facility.