Biological Research Approval

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)

Refer to the IBC Project Review Flow Chart and Experiments Covered by the NIH Guidelines. Refer to Clinical Trials for specific information about clinical trial BUAs.

1. 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.
2. Each project is categorized depending on the level of review required by the NIH Guidelines:
   1. 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.
   2. 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.
   3. 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.
3. All IBC members will have the opportunity to review your BUA application.
4. 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.
5. 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.

Visit Clinical Trials for specific information about obtaining a BUA for a clinical trial.

• Biological Use Authorization (BUA) is required for all research involving biohazards.
• The BUA application was updated in Spring 2024. Read about the changes in our news post.
• You may need to obtain approval from the IBC and EH&S before starting your research. Review the Experiments Covered by the NIH Guidelines to determine what level of approval is required for your work.
• Changes to agents or locations require an update to your BUA. Submit a BUA Change application for updates.
• Follow all of the biosafety containment practices and guidance as specified in your BUA letter.
• Ensure the BUA letter available to laboratory personnel.
• Biosafety lab inspections are conducted as part of the BUA approval process.

The Principal Investigator is an individual who is designated and given authority by a university department, school, or administrative unit to direct the research program or project. The PI has scientific and technical direction for the research. The PI has the responsibility and authority to enforce biosafety and biosecurity regulations and policies, including the NIH Guidelines. This includes ensuring that the facilities are appropriate for the research conducted and for ensuring that personnel who will be involved with the project are trained. Any Biological Use Authorization Application with an assigned PI who does not fall within this definition will be considered on a case-by-case basis.

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.

Submit a BUA application or BUA change application that describes the cell lines and how the iPS cells were generated. You’ll also need to obtain approval from UW Embryonic Stem Cell Research Oversight (ESCRO).

Yes, you need a BUA for your research with biological agents, even if performed in a core facility.

In general, BUAs are not issued for teaching labs. BUAs are intended for research involving biohazards.

EH&S Biosafety can consult with teaching labs on practices, facilities, training, and more. Feel free to reach out to us.

Biosafety training

• Administrative Policy Statement 12.3 

• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules 

• CDC’s Biosafety in Biological and Biomedical Laboratories

• UW Biosafety Manual

• WA State Bloodborne Pathogens WAC 296-823