31 - IRB Efficiency Project

Background: Surveys of our research community identified several areas of dissatisfaction with the IRB/HRPP processes including lack of faculty engagement in policy decisions, increasing self-imposed administrative burden and long times to IRB approval.

Program

Description: Assessments identified several key opportunities for improvement to increase IRB efficiency and consistency of review. These included 1) adopting standard procedures and review tools validated for recommended practice within the research ethics community to reduce and simplify the high volume of overlapping documents, 2) substantially altering the IRB intake and pre-review process, 3) implementing structural changes to the IRB committees to maximize flexibility, 4) securing central campus funding to eliminate most IRB fees and unifying two IRB offices into a single office to align related business process and accountability, 5) launching a new, combined website to house the research templates, review tools, investigator manuals and unified guidance documents. Over the two-year project period, a faculty advisory group and seven different project groups focused on unique aspects of the project. Project success was measured by changes in turn-around time, efficiency of review, and success of AAHRPP reaccreditation.

Program

Assessment: Our program received full AAHRPP reaccreditation in 2022. The step one documentation for reaccreditation (our 3rd), took less time to prepare there were no observations requiring response. Two primary assessments of efficiency were the mean number of rounds of review between IRB and study teams and mean time to approval, as both were identified as areas of concern in faculty surveys. Pre-project, more than 50% of studies to the full board had at least 3 rounds of pre-review and only 15% had a single round of review. Post-project, less than 10% experienced three rounds of pre-review and 50-60% had a single round of review. For studies reviewed by our Health Science IRB, median time from submission to IRB response decreased from ~22 days to 10 days, time to full board review decreased from ~68 to 36 days and time from submission to approval decreased from ~75 days to 45 days. These efficiencies have continued through most recent analysis in October 2023. Similar shifts to a single round of total review and shortened median time to approval were also seen for expedited studies and exempt determinations.

Limitations: While study teams are enthusiastic about the decrease in turn-around time, we had not conducted a follow-up survey to rate overall satisfaction since early 2022. At that time, many respondents hadn’t visited the new website, submitted using the new applications or experienced a review with the new process. We conducted a survey at the end of 2023 and data is presented from the survey.

Discussion: Major challenges to IRB offices are consistency of review and training of staff. Adoption of revised procedures and industry-standard review tools allowed us to reference a set of documents that clearly identified all the regulatory requirements, and importantly did not lend itself to inconsistencies as there is one source of truth for all processes.