25 - A Novel Program to Support Researchers in Making Informed Incident Reporting Determinations

Background: Research events that deviate from expectations present challenges to researchers and the Human Research Protection Program (HRPP). Without clear guidance, researchers were not equipped or empowered to evaluate events independently to determine whether they required reporting. This led to over-reporting and increased burden on research teams and the IRB Office.
Program

Description: In 2021, IRB Office staff implemented a Human Research Incident Surveillance Program (HRISP) to provide training and guidance to stakeholders (researchers and HRPP staff) for research events. Through analyzing data from Investigator-submitted Reportable New Information (RNI) in the electronic IRB submission system (eIRB+), we identified that many RNIs did not meet the criteria to report to the IRB. In response, we developed an Incident Assessment Tool (IAT) to assist researchers in determining when to report an event to the IRB versus documenting the event in the research record. We released the IAT in June 2022.
We provided outreach to stakeholders through surveys, education, institution-wide communications, IRB staff workgroups, and advisory committees.
We streamlined the IAT in response to feedback to be a comprehensive, single-point resource.

Program

Assessment: We designed the IAT in response to data indicating researchers were over-reporting events to the IRB.
Our institution’s HRPP portfolio has 8,629 active human research projects, and approximately 15,000 submissions per year. RNIs represent about 3% of total annual submission volume.

We implemented the IAT, targeted education, and compliance support. Our efforts increased engagement and collaboration with researchers, affiliates, and other external HRPP partners and empowered IRB Office staff and members in their review of RNIs.

In collaboration with the research community, we reduced the number of RNI submissions that did not meet IRB Reporting criteria from 53% of all RNIs submitted in Fiscal Year 2021 to 49% in FY2022, and 48% in FY2023.
The number of RNIs submitted has decreased steadily, from 426 RNIs in FY2021, to 357 RNIs in FY2022, to 277 RNIs in FY2023, although our overall human research portfolio has been expanding steadily each year. This represents a steady decrease from the previous FY of 11% in total RNIs submitted in FY2021, 16% in FY2022, and 22% in FY2023.
Limitations: With Data Analytics we developed Tableau dashboards with tailored metrics to quantify the impact of our efforts and enable us to provide timely and targeted communication and education. These dashboards are currently under development and only include data from eIRB+, which does not track events determined not to require reporting to the IRB.
We filtered FY2020-FY2023 data removing COVID-related RNIs which would increase those RNIs submitted that did not meet reporting criteria.

Discussion: The HRISP allows IRBs to decrease submission volume, confident that researchers are equipped to make informed reporting determinations independently. Using IRB data presents opportunities to determine whether tools and education impact submission volume. Integrating the IAT into eIRB+ would facilitate documentation/tracking of determinations for the HRPP. Tracking events in real-time and increasing specificity of event categories would enable focused support.
Communication with HRPP offices improves collaboration and trust within the HRPP. Granting these teams access to dashboards and increasing the quality of data recorded allows them to act independently to support researchers proactively, and identify trends for targeted institution-level education.