Collecting all the required information about multiple sites can be time- and resource-intensive, and IRB offices generally aren’t in a good position to handle this task. Under the NIH’s proposed business model for sIRB, a lead site (usually the awardee institution) is responsible for communications between the research sites (i.e. relying institutions) and the reviewing IRB (e.g. collecting the required information from sites and compiling it for the reviewing IRB, making IRB submissions on behalf of sites, and communicating IRB decisions and approved documents back to sites).
Most study teams aren’t prepared to handle this level of coordination and communication, so studies involving reliance represent a major change in responsibilities. Some larger research networks may have resources available to lead sites through these tasks. However, in many cases, lead sites will need to be ready to handle this additional work themselves and may need to consider budgeting for additional staff. The Indiana CTSI may be able to provide resources for local lead sites.
Reliance is unlikely to result in less work, even for those sites which aren’t designated as lead. Most institutions (including IU) require a submission to the local IRB office describing the protocol and requests that a reviewing IRB be allowed to provide review for the site’s participation. These submissions are generally much shorter than a full IRB application, but are required before the reviewing IRB’s review can be accepted. In addition, the reviewing IRB often has additional forms that must be completed by each site and may even need local IRB input.
All sites must be prepared to follow the policies and procedures of the reviewing IRB. There is no standard set of IRB policies and procedures, although many IRBs may have similar requirements. Each site is responsible for understanding the policies and procedures of the reviewing IRB and conducting the research accordingly. Specifically, it is important for sites to understand the reviewing IRB’s expectations for reporting adverse events, deviations, noncompliance, and other problems to the reviewing IRB, as well as expectations for updating personnel and enrollment status, submitting amendments, and tracking subject enrollment and status, among other things. The lead site should provide this information to the sites and help study sites comply with reviewing IRB requirements.
The IRB chosen to provide review – the reviewing IRB – has to fulfill the same responsibilities as any other IRB. In fact, those same responsibilities become harder to carry out since the information that could previously be gathered from one site must now be gathered from multiple sites. The reviewing IRB has to make the same determinations without the benefit of knowing the investigators, how they conduct research, or the resources available to them.
To provide appropriate IRB review for all sites, the reviewing IRB reviews basic information about the protocol (e.g. procedures, risks, benefits, data safety monitoring, template consent language) to determine whether the protocol meets the federally mandated criteria for approval. Then the reviewing IRB considers each site individually and how each site will implement the protocol locally, collecting information about investigator qualifications and local context information, and incorporating site-specific language into template consent and authorization documents.
The reviewing IRB also has to ensure that any institutional requirements applied by the participating sites have been completed (e.g. human subjects training, conflict of interest disclosure, scientific review, radiation safety review). These activities are often tracked on a local level using site-specific electronic systems that aren’t available to the reviewing IRB. Therefore, that information also has to be collected and considered for all sites.
All of these steps facilitate the initial review. Ongoing review, including amendments, renewal, and review of reportable events, requires additional information specific to the submission and the specific sites affected.
All in all, serving as the reviewing IRB can be extremely complicated and requires a huge amount of coordination by IRB staff. Most institutions, including IU, are still in the process of enhancing our electronic IRB systems to help coordinate IRB review of multiple sites. In the meantime, additional site-specific forms are often required.
To utilize reliance for a project, the institutions involved have to enter into a contractual agreement that documents one institution's willingness to rely on the reviewing IRB and outlines each site's responsibilities. These are often called reliance agreements or IRB authorization agreements.
A national model called SMART IRB allows all institutions to sign a single agreement, then utilize that agreement for any research. IU is a participating institution in SMART IRB.