43 - Single IRB Budget and Feasibility Considerations for Large Federal Grants

Background: : In compliance with NIH policy, the CAUSE network underwent a transition from an independent IRB, to an academic IRB currently used by the CAUSE network. Important considerations included cost, academic IRB experience with asthma research and external site documentation and communication needs.

Program

Description: : The CAUSE network was awarded $70 million to continue a multi-study, multi-center initiative to study asthma in urban communities, and became an early test of the University IRB’s recent transformation effort with Huron Consulting. This resulted in the University's increased capacity to serve as the IRB of record for the CAUSE network. Other considerations included budgeting for and retaining an IRB facilitator who would assist with the development of SOPs for all external sites. Processes for education material development and instructions for all regulatory oversight by the University and NIAID were drafted by leadership and implemented by the IRB facilitator. In addition to cost, expertise, and logistics, turnaround times were also considered. Data was collected and analyzed to determine outcomes. An IRB liaison was retained in this transition with some operational adjustments to fill in the gaps in communication between the academic IRB and site personnel.

Program

Assessment: : Overall, the implementation resulted in positive outcomes. The cost associated with IRB operations was greatly reduced with no measurable impact on IRB submission turnaround times. All sites signed on to SMART IRB and site HRPP personnel were quick to update site surveys.

There was a learning curve for all parties involved in understanding the mechanisms of an academic IRB and adjusting to the new processes and workflows. Having a reliable IRB facilitator, a cost that was already factored in the previous program, helped alleviate some of these issues. SOP’s were developed to address topics where knowledge deficits were expected and these were adapted, or new documents were developed, as necessary. Additionally, some sites had access to regulatory staff to support HRPP requirements and sIRB submissions, however, this access was at times inconsistent due to different staffing landscapes. For this reason, the IRB facilitator’s ability to ensure effective communication between network entities and the sIRB was vital in meeting the changing needs of a large network performing multiple studies simultaneously.

Limitations:: Independent IRBs have existing systems in place to communicate with sites and are able to grant access to, communicate directly with, and transmit documents to them. The use of IRB Reliance Exchange helped mitigate this issue since it addressed these limitations, however, personnel unfamiliar with the platform struggled with navigating this system. Additionally, documentation provided by the new IRB may lack pertinent information needed by external sites, DAIT, and monitors conducting site visits.

Discussion: : Taking these limitations into consideration, our network has found that implementing a sIRB, while challenging, has been a positive and cost-effective component of our large network. CAUSE continues to implement processes to streamline and communicate with all external sites while maintaining open lines of communication with the University's IRB office. With our current framework in place, we feel confident in assisting other multi-site networks or outside academic institutions with setting up a framework to operate a sIRB successfully.