Single IRB (sIRB)

Institutions may work together cooperatively on a human subjects research project. In these cases, it may be advantageous or required to obtain IRB review from only one IRB for some or all of the engaged institutions. This arrangement is referred to as single IRB (sIRB) review.

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.

Before You Begin

For an sIRB arrangement to be appropriate, at least two institutions must be engaged in non-exempt human subjects research. If only one institution is engaged, the submission should be made to that institution’s IRB.

If Seattle Children’s is engaged, that means IRB review is required for the research activities that Seattle Children’s employees or agents will complete. Generally, Seattle Children’s is considered engaged if its employees or agents for purposes of the research project will obtain any of the following:

  • Data about subjects of the research through intervention or interaction with them;
  • Identifiable private information about the subjects of the research;
  • The informed consent from subjects of the research; and/or
  • A direct federal funding award

There are scenarios in which Seattle Children’s would not be considered engaged even though one or more of the above criteria are met. If Seattle Children’s is not engaged, IRB review is not required for the involvement of its employees or agents in the research.

Engagement determinations can be challenging, and Seattle Children’s investigators should work with the IRB office to make these determinations. More information about engagement can be found in HRP-311-WORKSHEET-Engagement in the Click IRB Library. If you are unsure if Seattle Children’s is engaged, contact SCH Rely at [email protected].

Please note “not engaged” determinations cannot be made for Seattle Children’s involvement in FDA-regulated clinical investigations using the above criteria. You will need to contact your sponsor and/or the applicable FDA review division to determine if IRB review is required for your involvement in these types of research projects.

Investigators at other institutions should consult with their own IRB to determine whether they are engaged.

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.

Seattle Children's will generally only serve as the sIRB for a study if required by NIH or federal regulations. Researchers are encouraged to consult with Seattle Children’s IRB office to confirm any sIRB plans when preparing funding applications. Seattle Children’s cannot guarantee Seattle Children’s IRB review for any multi-institutional research for which it has not been consulted.

If you are unsure who should serve as the sIRB for a given study, contact SCH Rely at [email protected].

Requesting sIRB Review

For Seattle Children’s to serve as the sIRB (meaning one or more institutions will rely on Seattle Children's IRB for review), it must be authorized by the IRB office in advance. This authorization is required for each study. Information about situations where Seattle Children's would rely on an external IRB for review can be found on the External IRB Process page.

To request that Seattle Children's serve as the sIRB, 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 Seattle Children’s to serve as the sIRB.

Please note that prior authorization is not required for studies involving the University of Washington (UW) or Fred Hutch Cancer Center (FHCC).

Research Involving the University of Washington (UW)

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 Seattle Children’s IRB will do the review:

  1. Submit an external IRB application in UW’s Zipline system to request UW HSD’s formal authorization for Seattle Children’s to review the research. UW HSD will evaluate your request and provide you a written authorization letter.
  2. Upon approval to use Seattle Children’s IRB, submit at Seattle Children’s IRB per standard process. Be sure to list UW as a participating site on the first page of the protocol.

Research Involving Fred Hutch Cancer Center (FHCC)

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.

Documenting Reliance

For institutions with which there is no cooperative agreement, Seattle Children’s IRB office will need to execute a study-specific reliance agreement with that institution. After obtaining authorization from the IRB office, the Seattle Children’s study team will be asked to provide a reliance packet to the relying institution to complete.

Seattle Children’s primarily makes use of the following agreements:

  1. SmartIRB reliance agreement. Seattle Children’s will use this agreement when the other institution is a SmartIRB Participating Institution. The IRB office requires that the flexible terms of this agreement be documented prior to IRB review of the site.
  2. Seattle Children’s template reliance agreement. Seattle Children’s will use this agreement with any institution.

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.

IRB Review Process

Seattle Children’s IRB reviews sIRB studies in a sequential manner. It first reviews and approves the overall protocol, any study-related materials to be used across all sites, and any site-specific Seattle Children’s materials. After that, it begins the review of the relying site(s).

After the overall protocol is approved and a reliance agreement is executed, the IRB office will create a site record in Click IRB for that relying site. At that time, the IRB office will provide instructions in Click IRB to the Seattle Children’s study team for how to submit site materials for IRB review.

Seattle Children’s IRB will generally require the following for each relying site:

  • A completed HRP-508B-Protocol-Participating Site Supplement to Protocol (available in the Click IRB Library)
  • A completed HRP-811-FORM-Basic Site Information (available in the Click IRB Library)
  • Site-specific consent/assent forms with required site language inserted (note that Seattle Children’s templates should be used to create these documents)
  • Other site-specific materials (recruitment materials, evaluation instruments, surveys, etc.)

Please note:

  • Investigators from relying sites should not be listed as study team members in Click IRB unless they are also acting as an employee or agent of Seattle Children’s. This includes investigators from the UW.
  • HRP-811-FORM-Basic Site Information is not required for institutions with which Seattle Children’s has a cooperative agreement (UW and FHCC) as requirements affecting IRB review have already been communicated.
  • Relying sites 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 site 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 site to deviate from this requirement.

Once the site materials are complete, the Seattle Children’s study team must submit them to the IRB using the instructions provided in Click IRB.

The relying site study team may be required to make a submission to their own IRB to document the reliance on the Seattle Children's IRB. It is the responsibility of the Seattle Children's study team to work with the site investigators to ensure any site submission requirements are met.

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 the sIRB. Refer to the fee schedule for additional information.

Questions?

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