Setting up the Single IRB Arrangement
Identify the sIRB
If you were not able to identify the single IRB (sIRB) prior to submitting the grant application, you should do this as soon as possible.
Identify any costs for sIRB review
If you have not already identified whether the sIRB will charge fees see this guidance.
If you already obtained an estimate for your grant application budget, consider whether any changes made to the research plan since you submitted your grant application could affect the IRB fees. (For example, the funding agency may have cut part of your proposed research, a participating site may have dropped out, or new participating sites may have been added.) Re-negotiate by consulting with the funding agency and working directly with the sIRB.
Identify and/or hire the IRB liaison
If you will hire an IRB liaison to coordinate sIRB review, see HSD’s discussion of the responsibilities of the Lead Study Team and the suggested position description, which could be a full-time or part-time position depending upon the nature of the study and the number of participating sites.
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 documents the arrangement and establishes 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 many 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.
In some cases, the sIRB can initiate this process on behalf of all sites. You will need to work with the sIRB to understand their processes.
To request UW’s reliance on a non-UW IRB, follow the instructions to Ask for Non-UW IRB Review.
Establishing reliance agreements between the sIRB and each site can be surprisingly slow, so HSD advises PIs to initiate and manage this process centrally (i.e., the coordinating center or a single IRB liaison person) to ensure that it does not languish or become bogged down.
Determine how to obtain sIRB approval
sIRB approval must be obtained for each participating site. This includes the initial application, modifications, continuing review (“Status Reports”), and reports of problems. For most multi-site studies, initial IRB review and approval will be a two-step process:
- Submitting the generic protocol and consent materials for review by the sIRB.
- Submitting site applications with site-specific information such as investigator qualifications, recruitment and consent information, and other local context information (e.g., state laws about the age of majority) for review by the sIRB. Participating site applications are typically approved after the generic protocol and consent materials are approved, however this varies among IRBs.
Study leadership should decide who will initiate, manage, and track the IRB applications for each of these two steps, and who is responsible for providing what information for the applications.
- Generic protocol and consent. Generally the lead or coordinating center prepares and submits this part of the IRB application.
- Participating sites. There is currently no national standardization or consistency regarding who prepares and submits the IRB application for each participating site – it could be the local PI, the lead site, or the coordinating center depending on the sIRB’s policies.
To understand the submission process when the UW IRB is a single IRB see Steps in the Single IRB Review Process.
Plan for communication among sites
Before preparing and submitting the IRB applications, it is important for study teams to plan for how they will communicate the required information about IRB application materials. This plan will be a synthesis of how the sIRB operates and how the study team wishes to coordinate their operations. Examples of issues to consider:
- Is the sIRB’s application system accessible to all sites, or only to the lead study team? If not, who on the lead study team will be responsible for collecting and submitting materials to the IRB, and sending approved materials and IRB communications to the sites?
- Will the lead study team prepare and submit all materials on behalf of sites, will sites prepare and submit all of their materials, or will the responsibility be shared?
- Will sites create their own consent forms, or will they use a template prepared by the lead site?
- Does the study team need to establish a system for keeping track of regulatory documents and disseminating them to sites? Who will set up and manage that system?
- How will sites keep track of and report unanticipated problems, noncompliance and other reportable events? How will reporting be accomplished within the reporting timeframe of the reviewing IRB?
- How will required information be collected for reporting if continuing review is required?
Prepare and submit IRB applications
If you are responsible for any of the IRB application processes: Use the forms, system, and processes required by the sIRB.
To prepare and submit an application to the UW IRB as a single IRB follow the UW Reviewing for Other Institutions pathway in Zipline.