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 WCG IRB and the NCI Pediatric Central IRB (PedCIRB) and Advarra, 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 WCG IRB 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 WCG IRB 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 WCG IRB for review. See the External IRB Studies Reference Guide on the Click IRB Resources page for more information.
- Upon approval to use WCG IRB, make your submission to WCG IRB using their application forms. Below, you will find a consent template that WCG IRB has approved for Seattle Children’s use.
WCG IRB has updated the submission process for all translation requests (WCG IRB-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 WCG IRB process was recently updated.
For questions or inquiries, please call WCG IRB Client Services at 800-562-4789, Monday–Friday from 5 a.m.–5 p.m.
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 WCG IRB or NCI PedCIRB.