22 - Concierge Services for Investigators: Centralized IRB Resource

Background: : Despite efforts of IRBs across the globe to streamline regulatory and institutional requirements, researchers continue to struggle with navigating various prerequisites for IRB approval of their projects. Differences in study types, collaborations, and review arrangements add complexity. This knowledge gap leads to poor-quality submissions ultimately prolonging the IRB process.

Program

Description: : The IRB Concierge Services was introduced with the aim of assisting researchers with their IRB submissions and providing support until the process is complete. The service covers new studies, amendments, progress reports etc. It is provided by the Clinical Research Support Core who liaise closely with the IRB office thereby operating as a central hub of information for researchers.

To assess the impact of the service, data for submissions using the Concierge Service were compared to the regular submissions between the period January 2023 – December 2024. Data extracted included: date of requesting Concierge Service, IRB submission and decision date, number of rounds with researchers until decision, and response time of researchers.

Key metrics included the comparison of mean number of days to a final decision, number of rounds with the researchers for changes, and the researcher’s time to respond to IRB comments per submission between the 2 groups.

Program

Assessment: : 489 submissions were recorded in this period, 75 used the Concierge Service and 414 did not. Most Concierge Submissions (77.3%) occurred in 2024 and 22.7% in 2023. The majority of submissions using the Concierge Service were new projects (34.7%) followed by closures (20%), continuing review (17.3%), response submissions (16%), and amendments (12%).

New project submissions using the Concierge Service had a shorter mean time-to-decision: 30.9 vs. 47.3 days. Response time to IRB conditions was shorter with the Concierge Service (10.4 vs. 25.7 days) for new project submissions. There was no difference in the frequency of submissions returned for comments between the two groups.

A sub-group analysis assessing the impact of engaging the Concierge Service before versus after IRB submission was conducted. Most submissions using Concierge services requested assistance before IRB submission, 86.7% versus 13.3%. Time for researchers to respond to the IRB conditions was significantly reduced for new projects that utilized Concierge Service before the IRB submission, averaging 8.2 versus 22.3 days. This was also seen for other submissions, 3.9 days versus 10.7 days.

Limitations:: As a newly established Concierge Service, the number of submissions were limited. Additionally, the lack of a proper data capture system in early years impacted our analysis. Although the IRB office noted significant improvement in the quality of the content and rigor of the submissions that used the concierge services, this could not be statistically demonstrated due to the limitations in the metrics used for analysis. Furthermore, ancillary reviews may have affected the IRB time-to-decision.

Discussion: : The IRB Concierge Service is a valuable centralized resource for our academic research institution. This is especially crucial for our faculty members who conduct research without the assistance of research staff or teams to navigate the regulatory approval process.

Often, researchers rely on the IRB staff for support which is time-consuming and can sometimes affect the independence of the review process. The centralized Concierge Service alleviates this burden and helps prevent mission creep. It also ensures retention of knowledge of institutional and regulatory requirements in a community where there is a rapid turnover of research staff.