Last updated | 5-25-23 11:01 a.m.
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.
The lead or coordinating site is usually the institution that receives the grant or contract directly from a funding agency and then establishes subawards or subcontracts with the other participating sites. The lead PI is the PI in whose name the overall grant application was submitted to the funding agency and who is responsible for overall management and coordination of the study across all participating sites. If there is no clear lead site or PI identified as part of the funding structure, it will be important to discuss with collaborators early on to identify which site will undertake the sIRB review responsibilities.
The lead site has specific responsibilities related to the sIRB, further described below.
1. Identify any costs for sIRB review
Identify and budget for any costs associated with sIRB review. Include any sIRB fees and sIRB-related personnel costs in the grant budget, as well as appropriate budget justification information. You may also contact the Office of Sponsored Research for help on details that need to be included in grant applications regarding sIRB fees.
2. Study set-up and management
The IRO anticipates that studies with more than a handful of sites will require significant additional staffing resources on the study team to manage the complex communications, coordination, and document management associated with the use of a sIRB across sites. When developing your project budget, it may be worth including a position to support coordinating IRB submissions for all sites relying on the sIRB. Primary duties may include:
3. Determine how to request reliance on the sIRB from participating sites
Any letters of support about sIRB review that you obtained for the grant application are not IRB reliance agreements. Each participating site must negotiate and sign a formal written agreement with the sIRB. The reliance agreement will document the arrangement and establish expectations about communication, reporting, and procedures.
Investigators are not authorized to sign reliance agreements. Each agreement must be signed by the sIRB and by an appropriate institutional official for each site. Most institutions that have an IRB office will have an established process by which the site PI can formally request reliance on the sIRB. Sites that do not have an IRB office may have an institutional representative who manages the process.
Each site PI should identify and be prepared to initiate this process for their institution. Institutions differ significantly and may need only limited information, or they may need substantive materials including a copy of the protocol, consent form, funding application, etc. Site PIs may need to wait until they have the required information and documents before reliance can be initiated.
To request Fred Hutch initiate reliance agreements with relying sites, see Requesting a Reliance Agreement.
4. Obtain initial IRB approval
IRB approval must first be obtained for the Fred Hutch investigator and subsequently for each participating site. For multi-site studies, initial IRB review and approval will be a two-step process:
Generally, the Fred Hutch study team is responsible for initiating, managing, and tracking the lead site and the participating sites’ IRB applications. Ideally, the Fred Hutch study team collaborates with the pSite to complete the pSite application.
5. Follow-On Submissions
For all follow-on submissions, the Fred Hutch study team is again responsible for initiating, managing, and tracking the submissions for the lead site and all pSites that are reviewed by Fred Hutch IRB.
The lead file CR and all pSite CR submissions should be turned in together for review by the IRB as a group.
Study-wide modifications must be approved prior to review of the corresponding modification to a psite.
In general, modifications to the protocol and other study-wide documents are approved in the lead file only. After approval in the lead file, the Fred Hutch investigator may distribute the approved study-wide documents to each participating site that is under the purview of the Fred Hutch IRB.
Modifications to the model consent form are also approved in the lead file first; then additional Modifications must be submitted to incorporate the approved model consent language into each separate site-specific consent form. (The site modifications usually qualify for expedited review.)
Adding non-Cancer Consortium sites does not require a modification to the Lead study file (the Multi-Center Supplement should be updated at the time of the Lead file’s next Continuing Review).