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)
- Completed Appendix M from the NIH Guidelines
- Any correspondence with the RAC (e.g., RAC response letter, RAC reviewers' comments, PI response to RAC reviewers)
- Clinical protocol
- Investigator's brochure
- PI's curriculum vitae (CV)
- Proposed consent forms
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 email@example.com.
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.