Use the Clinical Trial BUA application to initiate IBC review and approval for human studies involving biohazards at a UW location or that are sponsored by UW.
Does my clinical trial require a BUA?
For clinical trials, a BUA from the UW IBC is required for administration of infectious agents or recombinant or synthetic nucleic acids to human research participants if the trial is sponsored by or conducted at the University of Washington. Research cannot be initiated until IBC and all other applicable institutional and regulatory authorization(s) and approvals have been obtained.
Read below for detailed descriptions of these types of clinical studies:
Studies involving deliberate transfer of genes into human research participants (human gene transfer) via either of the following are covered by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Section III-C and require review by the UW IBC:
- Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules; or
- Synthetic nucleic acid molecules or DNA, or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
- Contain more than 100 nucleotides; or
- Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
- Have the potential to replicate in a cell; or
- Can be translated or transcribed.
Administration of infectious agents to human study participants requires BUA approval from the UW IBC.
Infectious agents are biological organisms capable of causing disease in humans, generally Risk Group 2 or higher. More information about the UW IBC’s definition of a biohazard is on the Biological Research Approval webpage.
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When to submit
Check the BUA Application Submission Dates for the monthly IBC meeting schedule and the submission due date for review. Review time is typically four to six weeks but varies depending on complexity and response time.
Research participants cannot be enrolled until IBC and IRB approval and any applicable regulatory authorizations have been obtained
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What to submit
Submit all of the following applicable documents (if available) to initiate IBC review:
- Clinical Trial BUA Application
- Clinical protocol
- Investigator's brochure
- Institutional Review Board (IRB) approval
- IBC approval for other study sites
- FDA required protocol modifications
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How to submit
Email the completed Clinical Trial BUA application and associated documents to ehsbio@uw.edu to submit.
Incomplete applications will be returned to you. A biosafety officer will inform of revisions or additional information needed for review.
Emergency Response and Reporting
UW personnel are required to submit an incident report to Environmental Health & Safety for any work-related event that results in an injury, illness, exposure to hazardous materials, property damage, or fire, regardless of the work location. UW personnel are highly encouraged to submit work-related near-miss events. Visit the Incident Reporting page for more information.
Notify EH&S immediately (after first aid/medical care/emergency services) if the incident involves recombinant or synthetic nucleic acids or genetically modified organisms.
- During EH&S business hours: (8:00 a.m. to 5:00 p.m., Monday to Friday) call (206) 221-7770.
- Outside of EH&S business hours: call the UW Police Department at (206) 685-8973 to reach EH&S on-call staff.