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External IRB Process

The term external IRB refers to any non-Seattle Children’s IRB that reviews Seattle Children’s research. Seattle Children’s has standing reliance agreements in place with several regional institutions and commercial IRBs. You are not limited to using those external IRBs. Please consult the applicable process below depending on which external IRB will do the review.

The information within this page applies when Seattle Children's is relying on an external IRB. Information about situations where Seattle Children's would serve as the single IRB (sIRB) can be found on the Single IRB (sIRB) Review page.

University of Washington (UW) IRB

Seattle Children’s has a standing reliance/cooperative review agreement with the University of Washington (UW) that allows our institutions to rely on each other’s IRB review for projects.

If UW IRB will do the review:

  1. Submit an external IRB study in Click IRB. Refer to the External IRB Studies Reference Guide on the Click IRB Resources page when making the submission. During the review of the submission, the IRB office will issue a letter to document Seattle Children’s willingness to rely on UW IRB.
  2. Upon approval to use UW IRB, make your submission in UW’s Zipline system using their application forms. Be sure to attach the Seattle Children’s IRB authorization letter.

Fred Hutch Cancer Center (FHCC) IRB

Seattle Children’s has a standing reliance/cooperative review agreement with Fred Hutch Cancer Center (FHCC) that allows our institutions to rely on each other’s IRB review for projects. For research involving FHCC, refer to the SCH-FH Guidance for Relying.

WCG IRB

Seattle Children's 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.

  1. Submit an external IRB study in Click IRB. Refer to the External IRB Studies Reference Guide on the Click IRB Resources page when making the submission. Complete and attach the WCG Cover Sheet with additional attachments, if applicable. During the review of the submission, the IRB office will provide you with written authorization for WCG IRB to do the review.
  2. Upon approval to use WCG IRB, make your submission to WCG IRB using their application forms. You may use the consent template that WCG IRB has approved for Seattle Children's use.

Please note that 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.

For questions or inquiries, please call WCG IRB Client Services at 800-562-4789, Monday-Friday from 5 a.m.-5 p.m.

Advarra IRB

Seattle Children’s has an agreement in place to allow for review by Advarra IRB of projects at a cost to study teams and/or sponsors. Below is the process needed for such review.

  1. Submit an external IRB study in Click IRB. Refer to the External IRB Studies Reference Guide on the Click IRB Resources page when making the submission. Complete and attach the Advarra Cover Sheet with additional attachments, if applicable. During the review of the submission, the IRB office will provide you with written authorization for Advarra IRB to do the review.
  2. Upon approval to use Advarra IRB, make your submission to Advarra IRB using their application forms. You may use the consent template that Advarra IRB has approved for Seattle Children's use.

PedCIRB

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, Seattle Children’s will rely on the CIRB for clinical trials that are opened via the CIRB independent model. Below is the process needed for such review.

  1. Submit an external IRB study in Click IRB. Refer to the External IRB Studies Reference Guide on the Click IRB Resources page when making the submission. Complete and attach the PedCIRB Intent to Open New Research Study Form with additional attachments, if applicable. During the review of the submission, the IRB office will provide you with written authorization for PedCIRB to do the review.
  2. Upon approval to use PedCIRB, make your submission to PedCIRB using their application forms.

For research involving PedCIRB, refer to the (NCI) Pediatric Central Institutional Review.

For potential unanticipated problems or serious or continuing non-compliance, use the PedCIRB Potential Unanticipated Problem or Serious or Continuing Noncompliance Form.

Other External IRBs

Seattle Children’s is willing to rely on other external IRBs – but the review must be authorized by the IRB office in advance. Below is the process needed for such review.

  1. Obtain authorization from the Seattle Children’s IRB office to use the external IRB: The IRB office must authorize the use of an external IRB for each study. To submit a request to use an external IRB, complete and submit a Reliance Request Form to SCH Rely at [email protected]. The IRB office will evaluate your request and provide you with written authorization for the external IRB to do the review.
  2. Submit an external IRB study in Click IRB: Upon authorization to use the external IRB, you will be instructed to submit an external IRB study in Click IRB. Refer to the External IRB Studies Reference Guide on the Click IRB Resources page when making the submission.

    During review of the external IRB study, the IRB office will facilitate the execution of the reliance agreement with the external IRB office directly. Once the reliance agreement is executed, you will be instructed to attach the final reliance documents to the external IRB submission and the IRB office will confirm the reliance in Click IRB.

    For each institution, HRP-815-FORM-Institutional Profile (available in the Click IRB Library) is collected at the time of initial reliance and is updated at the time of a new reliance request if it has been more than one year since the most recent update. The tracking of Institutional Profiles is managed by the IRB office.
  3. Submit to the external IRB using their application forms: Once the reliance has been confirmed in Click IRB, make your submission to the external IRB using their application forms and processes.

Questions?

Please contact SCH Rely at [email protected] if you have any additional questions about the external IRB review process.

Seattle Children’s complies with applicable federal and other civil rights laws and does not discriminate, exclude people or treat them differently based on race, color, religion (creed), sex, gender identity or expression, sexual orientation, national origin (ancestry), age, disability, or any other status protected by applicable federal, state or local law. Financial assistance for medically necessary services is based on family income and hospital resources and is provided to children under age 21 whose primary residence is in Washington, Alaska, Montana or Idaho.