Institutional Review Board
External IRB Process
You may conduct research at Seattle Children’s that is reviewed by an external IRB. Seattle Children’s IRB has established processes in place with Western IRB (WIRB) and the NCI Pediatric Central IRB (PedCIRB), but you may designate any external IRB as the IRB of record for your study. For more information about submitting a study using an external IRB, refer to External IRB Studies (PDF).
Seattle Children's Research Institute has an agreement in place to allow for review by Western IRB (WIRB) of projects at a cost to study teams and/or sponsors. Below is the process needed for such review. Please contact the IRB office if you have questions about the forms or process.
The WIRB coversheet and consent form template have been updated. The consent form now integrates HIPAA language, so a separate HIPAA form is not required.
- Use Click IRB to submit your Cover Sheet (DOC) with additional attachments, if applicable. Our office will review the request in Click and approve if Seattle Children’s agrees to rely upon WIRB for review. See the Quick Guide on the Click IRB Resources page entitled Submitting External IRB Studies (PDF) for more information.
- Upon approval to use WIRB, make your submission to WIRB using their application forms. Below, you will find a consent template that WIRB has approved for Seattle Children’s use.
WIRB has updated the submission process for all translation requests (WIRB-translated or sponsor-translated). Effective immediately, all translation requests must be accompanied by a Translations Request Submission Form.
New: If the situation arises where you need to collect follow-up information about pregnant partners and/or infants of research subjects as part of your study, please contact the Seattle Children's IRB office for instructions on next steps. This WIRB process was recently updated.
For questions or inquiries, please call WIRB Client Services at 800-562-4789, Monday–Friday from 5 a.m.–5 p.m.
WIRB charges review fees to sponsors and/or research teams. If the sponsor/site is participating in the Single Review Solution program, then the SRS pricing applies.
All documents are PDFs.
- Institutional Fee Schedule 2013
- Institutional Fee Schedule 2014
- Institutional Fee Schedule 2015
- Institutional Fee Schedule 2016
- SRS Pricing
In accordance with the Seattle Children’s OHRP-approved FWA and the Authorization Agreement/Division of Responsibilities between the NCI Central IRB (CIRB) and Seattle Children’s, SCRI will rely on the CIRB Board for human subjects protections requirements for Seattle Children’s clinical trials that are opened via the CIRB independent model.
- (NCI) Pediatric Central Institutional Review (PDF)
- Seattle Children's Research Institute/PedCIRB Intent to Open New Research Study via NCI CIRB Independent Model (DOC)
- PedCIRB Potential Unanticipated Problem or Serious or Continuing Noncompliance Form (DOC)
Other External IRBs
Please request a consultation for using external IRBs other than WIRB or NCI PedCIRB.