Sr. IRB Education Analyst National University, United States
Institutional Review Board Wraparound Educational Services – Chad Becker, National University
The problem addressed through the wraparound educational services program offered by the IRB includes concerns about the length of time in the human subjects research application approval process for student PIs: specifically, the extent that revisions are required for eligibility criteria, recruitment process/materials, and consent process/materials within the IRB application.
IRB’s wraparound educational services program includes, 1) resource-rich website pages that provide support throughout PI engagement with IRB processes including guidance, templates, links to services, and more (based upon best practices drawn from across the spectrum of human subjects protection in research); 2) group writing sessions that are regularly occurring and self-schedulable prior to which PIs submit supplemental application components (eligibility criteria, recruitment material, or consent/assent material) for group leader review. After brief content presentations, feedback is provided verbally and in written form (6-8 PIs/group). We also hold a group session devoted to the application; 3) office hours that are regularly occurring and self-schedulable during which PIs can meet 1:1 with IRB staff at any point in the process and discuss topics ranging from introductory to advanced; and 4) publications consisting of newsletters, live webinars (that are also recorded for asynchronous use), infographics/flyers, and short process/content videos (the latter hosted on the NU IRB’s YouTube channel).
IRB staff observed ongoing improvement to application quality and process/material quality due to feedback loops pertaining to both ‘problems with applications driving changes to educational curriculum’ and ‘themes emerging out of services driving changes to the application’. Robust communication with schools, departments, and programs is part of a culture of intentionality regarding program improvement. With a variety of program types requiring research leading to IRB review, we utilize our wraparound services to adapt to existing and innovative program-specific research requirements. Reports from the application and scheduling systems indicate that during the 1,617 initial application submissions (not counting the average 1.5 additional resubmissions per application due to revisions) between 11/01/22 and 11/01/23, NU’s IRB provided 2,137 service instances (PIs in group sessions – 1,836; OH – 301). New issues arising during implementation of the program are the overwhelming response to service offerings as well as ongoing quality improvement efforts within the OHRPP as well as across the institution (new research institute formed at the university in 2023 to increase the quality and reach of research).
The IRB wraparound educational services are voluntary, so many of the PIs that would benefit from the productivity and efficiency of the services do not take advantage of the offerings. In November 2023, we began tracking the application-related statistical differences between the PIs that use our services and those that do not use our services. We look forward to continuing our inquiry in this regard. Also, we have asked our application hosting software partner to develop more detailed metrics so that our QA/QI efforts help us fully understand the time that PIs spend in our process and which aspects cause delay.
Suggestions for future use of the program include continued expansion of offerings (more sessions, OH, and published educational materials) and regular program improvement efforts. The program is translatable to other IRBs with, 1) an educational orientation and staff for the educational components; 2) a scheduling system for PIs; 3) curricula related to all components of human subjects research (website materials and group writing session presentation materials); 4) templates for all supplemental documents; and 5) live webinars, flyers, short process/content videos, and newsletters. The relevance of the program is exhibited by PIs moving through the IRB process, from initial submission through revisions to determination in 17 calendar days, over 2.5 submission attempts, on average: including time with researcher for any needed revising. Reporting mechanisms also indicate an average initial submission protocol review timeline of 4 business days (our policy is 5-7) which is well below the industry standard of 8 business days, as reported in AAHRPP’s 2022 data for academic institutions. The success of the wraparound services also appeared evident from preliminary QA/QI, post-services survey data and resulted in the creation of an additional educational specialist position rounding out a team of 6 full-time staff (2 directors, 2 analysts, and 2 educators). The NU IRB team utilizes the associate director (.5 for reviews) and two analysts (f/t) to complete all reviews, which compares favorably with the average of 9.8 staff utilized, on average, for IRBs reviewing comparable numbers of applications (AAHRPP 2022 data).
