Relevant IRB Policies and Procedures
This page provides guidance for submitting and managing multi-site studies when the Fred Hutch IRB serves as the reviewing IRB (also known as the IRB of record). For studies being submitted for review by another IRB, see How to Ask for an External IRB Review instead.
Overview
A multi-site study involves two or more institutions engaged in human subjects research, with each institution completing all or some of the research activities outlined in a specific protocol. It may also be referred to as a multi-center study. Sites on the study are referred to as participating sites or pSites.
When a multi-site study is initially approved, the IRB first approves the overall study protocol and the involvement of Fred Hutch (called the “lead” IRB file). At the same time reliance agreements must be negotiated with each site our IRB will be reviewing for. Only after the study is approved and reliance agreements are in place, the IRB then reviews site-specific information for each relying institution and approves each site individually. The approved pSites then are part of the lead file.
Other Cancer Consortium sites (University of Washington and Seattle Children’s Hospital) on a multi-site study generally do not require a separate participating site application to our IRB and are covered by the lead file. The exception is if the Fred Hutch PI does not have oversight of the work to be done at UW or Seattle Children’s.
IMPORTANT:
Fred Hutch considers Exempt and Not Human Research determinations to be institutional determinations, so we do not issue those determinations for any work outside of Fred Hutch. Each institution involved should follow their own institution’s policies for those determinations.
Single IRB (sIRB)
Some multi-site studies must be reviewed by a single IRB. Fred Hutch may serve as the single IRB (sIRB) when Fred Hutch is engaged in human subjects research per OHRP guidance. When Fred Hutch serves as the sIRB, the Fred Hutch study team engaged in the research will either be the Lead site (Fred Hutch PI is the lead PI on the protocol) or the coordinating site.
Investigators hoping to have Fred Hutch serve as the single IRB must first contact IRBreliance@fredhutch.org to confirm our IRB has the capacity to conduct the review of multiple sites. This is especially important for studies with 5 or more participating sites.
Additional information about single IRB:
Submission Instructions for Multi-Site Studies
Here are the steps involved for Fred Hutch to review a multi-site study and pSites on the study.
- Plan ahead: Contact IRBreliance@fredhutch.org to confirm Fred Hutch has the capacity to serve as the IRB of record for other sites. This is required for studies with more than five pSites.
- Submit the protocol for IRB review:
- Complete the appropriate IRB Application (Contact or No Contact to cover all activities on the protocol, regardless of whether Fred Hutch is conducting Contact activities).
- Also complete the Multi-Center Supplement and any other forms as prompted by the IRB Application form.
- Prepare and submit the study in Hutch IRB.
- Request reliance agreements for pSites:
- For each participating site that is outside the Cancer Consortium, complete the Reliance Request Intake Form and submit to IRBreliance@fredhutch.org to initiate the reliance agreement process.
- Additional details about this process are here.
- Submit pSites for IRB review:
- After reliance is executed for a pSite, work with each pSite outside the Cancer Consortium to prepare a Participating Site Supplement and the required attachments. Submit in Hutch IRB on behalf of each site.
- The Fred Hutch IRB will assess the qualifications of the site and the site investigator using the information provided in the participating site application, and by obtaining local context review as needed (in general, from all sites outside Washington, and from non-Cancer Consortium sites in Washington depending on familiarity to the Fred Hutch IRB).
- Await specific IRB approval for the site before initiating research at the site.
IMPORTANT:
Research activities may not begin at a pSite under the Fred Hutch IRB’s purview until the site has received a site-specific approval letter from our IRB (the reliance agreement alone is not sufficient).
At the time of modifications or continuing reviews, specific instructions apply for the pSites as well. See those pages for additional details. Contact IRO@fredhutch.org with questions about multi-site follow-on submissions.
Note that pSite staff outside the Cancer Consortium cannot be given access to Hutch IRB due to security considerations.