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Fred Hutch Status Alert: Details at status.fredhutch.org

Last updated | 6-27-22 11:01 a.m.


Overview and Definitions

When one IRB relies on the review of another IRB, this arrangement is documented through an IRB reliance agreement in accordance with 45 CFR §46.103 and §46.114. The reliance agreement outlines the responsibilities of each party and delegates review authority to the IRB of record. In order for one IRB to serve as the single IRB (sIRB) where required, reliance agreements must be executed between the sIRB and each individual site relying on the sIRB. 

Fred Hutch has established cooperative or broad agreements with some IRBs and can also enter into a protocol-specific agreement to rely on an external IRB, called a reliance agreement.

The IRB reliance agreement must be signed and executed before IRB review can happen. To prevent the reliance agreement from holding up your IRB review, please plan ahead and contact the IRO as early as you can.

There are several types of reliance agreements that Fred Hutch enters into:

When possible, Fred Hutch generally prefers to utilize the SMART IRB agreement to enable IRB reliance when cooperative agreements or IRB services contracts do not apply.

Cooperative/Broad Agreements

Fred Hutch has cooperative/broad agreements with a number of institutions. Cooperative/broad agreements allow institutions to rely on each other's IRB review for multiple projects without a protocol specific authorization agreement. In most cases this eliminates the need for duplicate review when research is conducted at multiple locations.

The following institutions have cooperative/broad agreements with Fred Hutch:

  • University of Washington
  • Seattle Children's
  • Kaiser Permanente (formerly Group Health Cooperative)
  • Benaroya Research Institute at Virginia Mason
  • Washington State Department of Health
  • NCI CIRB
  • NMDP

Typically, these institutions will accept Fred Hutch IRB review and vice versa. Often, the IRB selected for a study will be based on the primary affiliation of the lead investigator. Learn more about determining primary affiliation here.

Seattle Children's relies on Fred Hutch as the IRB when the lead PI's primary appointment is Fred Hutch. Fred Hutch relies on Seattle Children's as the IRB when the lead PI's primary appointment is Seattle Children's. If you are unsure if Fred Hutch or Seattle Children's would be the appropriate IRB, please contact the IRO to discuss the study before filling out the IRB forms.

If Fred Hutch will be relying on an external IRB under a cooperative agreement, you will still need to complete and submit an External IRB Cover Sheet – New to the Fred Hutch IRO prior to submitting to the external IRB. For more information, see How to Ask for an External IRB Review.

SMART IRB

SMART IRB is a platform that offers an overarching IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. SMART IRB is not an IRB – only a tool for documenting reliance agreements between institutions.

Reliance using SMART IRB may be documented through the SMART IRB online reliance system or outside the reliance system using a letter of acknowledgment.

When possible, Fred Hutch generally prefers to utilize the SMART IRB agreement to enable IRB reliance when cooperative agreements or IRB services contracts do not apply. 

SMART IRB online reliance system:

  • To use the online reliance system, the Fred Hutch study team must first submit a request for reliance through the SMART IRB online reliance system.
  • The IRO will review the request and determine if Fred Hutch will serve as the reviewing IRB for some or all sites, or as the relying IRB.
  • Once reliance has been confirmed in the online reliance system by both Fred Hutch and the reviewing/relying IRB, the IRO will complete the SMART IRB Online Request Implementation Checklist (or reviewing IRB’s SMART IRB reliance documentation) to document the flexible terms to be used during the study.

Documentation outside the SMART IRB online reliance system:

  • For participating sites that will rely on the SMART IRB agreement, but will not utilize the online system, the IRO will prepare and send the SMART IRB Letter of Acknowledgement and Agreement Implementation Checklist to the participating site.
  • The IRO will work with the participating site to confirm all flexible terms to be utilized during the study.
  • The letter of acknowledgment is signed by the participating site’s institutional official and the IRO Director (or designee) to confirm reliance outside the online system. 

IRB Authorization Agreements

An IRB Authorization Agreement is another way that institutions holding a Federalwide Assurance can document reliance on each other. While Fred Hutch prefers to use SMART IRB for reliance, an IRB authorization agreement can be used with institutions that have not signed onto the SMART IRB agreement.

If a site requests the use of an IRB authorization agreement for your research study, please contact the IRO.

IRB Services Contracts (Independent IRBs)

IRB services contracts establish reliance arrangements between the Fred Hutch IRB and independent IRBs. Fred Hutch currently has IRB services contracts with Advarra and WGC and can rely on them for review of industry-sponsored studies.

For more information on relying on Advarra or WGC for IRB review, see Fred Hutch Relies on an Independent IRB.

Individual Investigator Agreements

When a Fred Hutch PI collaborates with an individual investigator at a performance site that does not have an approved FWA (e.g., a clinic or a small community hospital) and that site plans to rely on Fred Hutch IRB, an individual investigator agreement (IIA) is used to document reliance. In this agreement the individual investigator is covered under the Fred Hutch FWA and must agree to follow the Fred Hutch Human Research Protection Program requirements.

If this is the type of collaboration planned for your study, please contact the IRO Director to discuss prior to submitting the participating site application to Fred Hutch IRB.

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Requesting a Reliance Agreement

Whether Fred Hutch serves as the IRB of record or will be relying on an external IRB, a reliance agreement will need to be in place prior to IRB review.

For studies where Fred Hutch will be the IRB of record (such as a multi-site study requiring single IRB review), the reliance agreement for a participating site will need to be completed before the Participating Site Application can be submitted to the Fred Hutch IRB.

For studies where Fred Hutch will be relying on an external IRB, the reliance agreement should be completed before submitting your External IRB Cover Sheet - New to the Fred Hutch IRO.

How to request a reliance agreement

To initiate a new reliance agreement, please complete the Reliance Request Intake Form and submit to IRBreliance@fredhutch.org.

If Fred Hutch will be asked to serve as the sIRB for more than five (5) participating sites:

  • Contact IRBreliance@fredhutch.org to initiate a conversation with the IRO Director about the capacity for Fred Hutch to serve as sIRB for your study. We may recommend another IRB serve as the IRB of record in this context.
  • Complete the Reliance Contacts Template to detail all the sites that will be involved. 

 

Local context review for relying sites

The single IRB needs to know about state laws and local requirements in order to complete their review for the relying site. For example, state laws affect the age at which minors are able to consent to research (i.e., without requiring parental permission).

When Fred Hutch is the reviewing IRB, IRO collects information about local context via the Local Context Review form. IRO provides this to the institutional reliance contact during the reliance process. This form is intended to be completed by the relying institution’s IRB office or research compliance group. The completed form should be submitted with the Participating Site Application.

What do I do once the reliance agreement is in place?

Once a reliance agreement is executed, the next step is to obtain IRB review.  For Fred Hutch IRB review, see Fred Hutch Serves as the sIRB.  

If an external IRB will review, see How to Ask for an External IRB Review.

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Last updated | 6-27-22 11:01 a.m.