42 - Single IRB Stakeholder Feedback: Evaluating the Use of the IRB Reliance Exchange

Background:  In 2018, the NIH Single IRB (sIRB) Policy went into effect, requiring NIH-funded multi-site research to utilize a single IRB of record. sIRB coordination (communications and documentation) continues to be multi-faceted and complex, made more so by the fact that each sIRB chooses or creates their own processes.

Program

Description:  The Institutional Review Board (IRB) Reliance Exchange (IREx) is a freely available, NIH-supported web-based platform supporting sIRBs, lead study teams, and relying sites (HRPPs and study teams) through the complex sIRB process for the life of the study. Over 40 different sIRBs use IREx to support more than 650 studies, making IREx the most widely used platform of its kind (to our knowledge). Since IREx launched in 2017, over 3700 reliance decisions and over 29,000 site approvals over the life of the studies have been documented for over 500 unique sites. The IREx team is consistently evaluating the functions and utility of the platform, modifying it to be most responsive to the varied needs of users. We also evaluate platform satisfaction amongst driving users (sIRB personnel, lead site study teams) and those who are required to use it per sIRB processes (relying site HRPPs).

Program

Assessment:  IREx users were asked to complete satisfaction surveys in Q2 of 2023. Forty-eight sIRB, lead study teams, and relying HRPP users provided feedback. All (100%) sIRB respondents would recommend using IREx to coordinate sIRB studies. A majority of sIRB respondents also said using IREx takes less time for sIRB studies than studies where IREx is not used. 85% of lead study team respondents were satisfied/very satisfied with using IREx for their studies, reported that IREx made their lead study team duties easier, and would recommend other lead study teams use IREx. Nearly 90% of relying site HRPP respondents found using IREx made their steps as a relying site easier. Five different feature suggestions arising from survey results have already been addressed and implemented in IREx, demonstrating the program’s flexibility and commitment to continually improving the user experience.

Limitations: There was a small sample size for this survey, especially for sIRB users. We intentionally did not want to overburden sIRB and lead study team personnel, and only offered the survey after certain actions were completed by users (i.e., after an approval upload). Additionally, we did not survey relying site study teams, as we worried they would be unable to distinguish between their known frustration with the sIRB process and IREx.

Discussion:  IREx users are highly satisfied with their experience and utilization continues to grow annually, both in the number of new sIRBs that use IREx for the first time and number of studies created in the platform each year. The IREx team and frequent users believe utilization can be increased if we allowed lead study teams to initiate IREx use, rather than the sIRB. Additionally, new features to support EFIC studies and to streamline the capture of local considerations will drive users to the platform.