Single IRB (sIRB)
Overview
Single IRB (sIRB) review occurs when two or more engaged institutions coordinate to complete research activities and rely on a single institution's IRB for review. The reviewing IRB is called the sIRB; institutions relying on the sIRB are called participating sites (pSITEs). If the sIRB is an IRB from an institution other than Seattle Children's, this sIRB is also known as the External IRB.
The information within this page applies when Seattle Children's is serving as the sIRB (meaning one or more institutions will rely on Seattle Children's IRB for review). Information about situations where Seattle Children's would rely on an external sIRB for review can be found on the External IRB Process page.
sIRB Requirements
Effective January 21, 2020, the federal regulations require sIRB review for collaborative, non-exempt human subjects research. This requirement applies to most federally funded or supported research. The National Institutes of Health (NIH) also have requirements related to sIRB review. Refer to the NIH website for additional information.
Choosing the sIRB
The federal agency/organization funding or supporting the research will at times propose which institution will serve as the sIRB. For studies that are not funded or supported by a federal agency, generally the institution that is most engaged in the research serves as the sIRB. Engagement is a term that is covered in HRP-311-WORKSHEET - Engagement Determination in the Click IRB Library. If you are unsure who should serve as the SIRB for a given study, follow the Consultation Process to schedule a phone consult with staff from the IRB.
Requesting sIRB Review
Seattle Children's will generally only serve as the sIRB for a study if required by federal regulations. There are exceptions when a study involves institutions with which Seattle Children's has a cooperative agreement. These institutions include University of Washington (UW) and Fred Hutchison Cancer Research Center (FHCRC).
To request that Seattle Children's serve as the sIRB for a study, you must request a consult with a member of the IRB Office by following the Consultation Process. If the pSITE is UW, a consultation is not required. During the consult, the IRB Office staff member will discuss the documents required to initiate the sIRB arrangement.
sIRB Review Fees
Conducting sIRB review requires additional resources from IRB staff and members. To help cover the costs associated with the additional effort, fees are charged when Seattle Children's serves as a sIRB. Refer to the fee schedule for additional information.
Seattle Children’s Policies, Forms, Templates and Fees
When Seattle Children's serves as the sIRB, the relying pSITES are subject to Seattle Children's IRB policies unless otherwise indicated in HRP-811 - FORM - Basic Site Information. It is the responsibility of the Seattle Children's study team to ensure that pSITE investigators are aware of the policies and have access to forms and templates that they may need to complete.
Use of Seattle Children's templates is required unless otherwise indicated in HRP-811 - FORM - Basic Site Information or there is a compelling reason for the pSITE to deviate from this requirement.
Communicating With the pSITE IRB
The pSITE study team may be required to make a submission to their IRB to document the reliance upon the Seattle Children's IRB. It is the responsibility of the Seattle Children's study team to work with the pSITE investigators to ensure any pSITE submission requirements are met.