Clinical Trials

Any research involving the administration of infectious agents or recombinant or synthetic nucleic acids to human research participants requires review and approval by the UW Institutional Biosafety Committee (IBC) if it is sponsored by or conducted at the University of Washington. 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.

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.

Clinical Trial BUA application process

All of the following applicable documents must be submitted to initiate IBC review:

Clinical Trial BUA Application (standard BUA application submission not required)
Clinical protocol
Investigator's brochure (if available)
Institutional Review Board (IRB) approval (if available)
IBC approval from the clinical trial site (if available)
FDA required modifications to the protocol (if applicable)

Regardless of exemption from NIH Guidelines Section III-C, all clinical research involving recombinant or synthetic nucleic acids must be reviewed by the UW IBC. The IBC review process begins once all documents of the Principal Investigator's application packet are submitted.

Submit the application at least four weeks prior to the meeting in which your application needs to be reviewed. Review of the application typically takes four weeks, but during times of high volume, clinical trial reviews could take up to six weeks. See BUA Application Submission Deadlines for the meeting schedule and associated deadlines. If you have any questions about the approval timeline for your submission, contact the IBC coordinator at ehsbio@uw.edu.

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 Clinical Trials

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.