Fred Hutch Serves as the sIRB

Fred Hutch Serves as the Lead or 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 whose name is in the overall grant application that 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

When the grant is awarded, study set-up requires formally establishing the sIRB arrangement as well as setting up the personnel and structure for handling the lead site responsibilities.

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:

• Understand and communicate the policies and processes of the reviewing IRB, and be familiar with the research and each site
• Work with the sites and their research compliance or IRB offices to establish reliance agreements with the reviewing IRB
• Coordinate the timing of initial review and modifications across all sites
• Assist the participating sites with completing and submitting materials to the reviewing IRB, which may include preparing and submitting all materials on their behalf
• Facilitate the continuing IRB review for the entire study by collecting information from all sites and submitting it to the reviewing IRB
• Serve as an intermediary between the reviewing IRB and the participating sites
• Obtain local context considerations (e.g., a state’s age of majority) for each site and ensure the information is provided to the reviewing IRB
• Assist the participating sites with responding to IRB requests (pSite staff outside the Cancer Consortium may not obtain access to Hutch IRB due to security considerations)
• Plan IRB and other regulatory approval timelines and troubleshoot challenging situations
• Coordinate the payment of IRB fees by the lead site

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 authorized official at Fred Hutch and each participating 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:

1. Submit an IRB Application with the protocol and template consent materials for review. This is referred to as the “lead file.” This submission should include the Multi-Center Supplement that lists all planned participating sites, including those that will be relying on Fred Hutch IRB review.
   In general, all engaged Cancer Consortium sites can be listed on and covered by the lead file—unless the lead PI does not have oversight of the Cancer Consortium site PI or the conduct of the work at that site. 
2. Submit a Participating Site (pSite) application for each individual site. This submission should include site-specific information such as the site investigator’s qualifications, local recruitment and consent information, and other local context information (e.g., state laws about the age of majority). Participating Site Applications are reviewed only after the protocol and template consent materials are approved in the lead file.
   As part of the reliance agreement process, the IRO will provide the relying site with a Local Context Form to complete. This form should be completed and signed by the relying site’s institution and provided with the pSite application.

Generally, the Fred Hutch study team is responsible for initiating, managing, and tracking the lead site and the participating sites’ IRB applications.  The Fred Hutch study team should collaborate with the pSite to complete the pSite application. 

Important: Research activities may not begin at a pSite until the site has a site-specific approval letter from the sIRB (the reliance agreement alone is not sufficient). 

5. Follow-On Submissions

For all follow-on submissions, the Fred Hutch study team is responsible for initiating, managing, and tracking the submissions for the lead site and all pSites that are reviewed by Fred Hutch IRB. 

Continuing Review
The lead file CR and all pSite CR submissions should be submitted together for review by the IRB as a group.

Modifications
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 Site 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 in real-time (the Multi-Center Supplement should be updated at the time of the Lead file’s next Continuing Review).

Reports
A Reportable New Information Supplement should be submitted for each site involved in the event. See Reportable Events for more information about reporting.