Academic Medical Centers and other Research Institutions are in the process of implementing the NIH’s Single IRB (sIRB) policy (link below). Mixed reactions to the sIRB policy continue to be prevalent as some institutions are anxious about fundamentally changing their approach to IRB review; some are struggling to understand the costing of these new approaches, and others are eager to implement, as they will conduct more research without significant growth in their clinical research infrastructure. Regardless of where your institution stands on this topic, it is clear that implementation strategies are necessary for the mandated changes under this policy. This article summarizes five core strategies for implementation of the sIRB policy for NIH funded research institutions.
1) Implementation Strategy – Conduct a Portfolio Review
Institutions must determine how many NIH funded multi-site studies are currently reviewed where they are already the IRB of record or the lead site for the study. This includes renewal, revision or resubmission in 2018-2019. Additionally, IRB offices and grant offices must communicate with one another to understand how many new multi-site grant applications will be submitted in the upcoming year. Institutions must also determine the number of times that investigators foresee participating in trials as a performance site and whether or not there is an institutional strategy to grow its research portfolio significantly over the next five years. Once the institution knows these volumes, then decisions about whether or not to serve as a sIRB versus outsourcing this function to other institutions or commercial IRBs can be made. If these volumes are small then it is most likely that smaller changes will be necessary to implement the sIRB policy.
2) Implementation Strategy – Determine Who will serve as the sIRB
Generally, the IRB from the Institution of the Lead Principal Investigator on the Sponsored Project will serve as the sIRB or the IRB of record. The lead Institution’s IRB will have the first right of refusal or the choice to use a commercial/independent IRB. Use of commercial/independent IRBs as sIRBs is allowed under the Policy. The sIRB is required to coordinate IRB review processes on behalf of all sites participating in the study. Therefore, the sIRB must have the proper resources to process increased volumes of information. Pre-determination of the sIRB may occur with the study sponsor or in the terms of the grant and can be established by prior arrangement with participating sites. Occasionally, pre-selection of the sIRB is based on expertise in the study area (e.g., type of procedures to be performed, subject populations, or study discipline).
3) Implementation Strategy – Determine Associated Cost(s)
Overall, the NIH has provided costing guidance for the new policy for up to 12 different scenarios and costing FAQs (links below). The scenarios include if your institution is the prime awardee and serving as the sIRB (then IRB activities for your institution = indirect costs; and IRB activities for all participating sites = direct costs). If your institution is the prime awardee, but another participating site is the sIRB (then IRB activities for your institution = direct cost; IRB activities for participating site serving as sIRB = indirect cost; and IRB review activities for all sites = direct cost). If your institution is the prime awardee and a commercial IRB is serving as the sIRB (then IRB review activities for your institution and IRB review activities for all participating sites = direct cost). Institutions can develop their own fee structures for sIRB costs, but they have to follow the requirements for a specialized service facility. Additionally, institutions may choose to remove all IRB costs from indirect cost pool thereby charging all IRB costs, including sIRB costs as a direct cost.
4) Implementation Strategy – Identify Business Processes that Need Creating\Updating
Institutions must identify and document processes and agreements between the sIRB and participating sites that need to either be updated or created to ensure continuity of information. These processes might include turnaround time commitments; authorization agreements (must clearly define the responsibilities of the sIRB and participating sites), communication processes and documentation requirements including access for all participating sites. Resource considerations fall under this strategy as well and include: additional staffing (full or part-time depending on portfolio review); creation of specialized job descriptions; determine if ancillary reviews are required for multi-site studies and how this will impact protocol approval timing; what information is required to track for reporting and monitoring purposes and how will that be made available; what responsibilities are retained by the participating site (e.g., conflict of interest management, radiation safety, etc.); and how sites will manage different requirements for different sIRBs.
5) Implementation Strategy – Evaluate Technology Options
IRB technology options for the sIRB include employing a manual process, which would save on budget in the short-term by avoiding a technology investment, but the institution must also evaluate the overall expense of human resources and the risk of human error now across multiple sites. Other institutions may modify an existing electronic IRB (eIRB) system, which also may take a significant amount of effort and time. This too may add complexity if the institution allows for the participating sites to access the eIRB system remotely. A third option is moving to a new eIRB system with additional functionality. This option poses short-term challenges and additional expenses, but may provide infrastructure needed to ensure long-term success and cost savings. The final option related to technology options is to outsource oversight to a commercial IRB. Institutions running industry-sponsored studies using commercial IRBs may choose to use the same IRB for NIH-funded multi-site studies as well. This increases their return on investment and further centralizes resources.
Additional information regarding sIRB and costing:
Note: This material is part of a presentation for the April 2018 Midwest/Southern Section meeting of SRA by the authors. A modified version of this article appeared in the Clinical Translational Science Collaborative Newsletter at Case Western Reserve University on April 5, 2018.
Associate Professor of Management, Departments of Design and Innovation and Organizational Behavior, Weatherhead School of Management
Case Western Reserve University
Huron Consulting Group