55 - Aligning Practice with Policy: A simple QI process to help both analysts and investigators with submissions

Background: USC Human Research Protection Program noted that our turnaround times for exempt studies were averaging 38 days, which is over the national average of 9 days. At USC, exempt studies make up the majority of submissions. In Q1 of 2023, 58% of IRB submissions (n= 242) were determined to be exempt.

Methods: We conducted a QA/QI investigation to understand what factors were contributing to our long review times for exempt studies. 242 exempt studies were examined for comments and requests from analysts, and questions from investigators. Two main themes emerged: 1) iStar (System) challenges, and 2) Common questions being asked by analysts to investigators. Based on informal interviews with IRB analysts, an updated Social Behavioral protocol was created. A ‘soft launch’ of the protocol was shared with the research community and daily improvements were made to the protocol. Approximately 200 study teams that used the new template were surveyed regarding their experience. The Human Protection Council, which brings together members of the USC research community to provide advice and support regarding the human protection efforts at USC, also provided written feedback regarding the protocol.

Results: We saw a decrease in average turnaround time from 38 to 11 days. The new protocol template directly asks for information that staff need to complete their reviews, so applications do not need to be sent back for revisions or requests for more information as often. Further, staff have less extraneous information to sift through, which lessens analyst mental load and allows for quicker categorization of applications into an exempt category. By involving staff in the QA/QI process, and drawing on the unique experiences (degrees, employment, etc.) and areas of expertise of our staff, we note an increase in staff engagement. Staff report experiencing increased satisfaction, camaraderie, and confidence in their reviews, and the lead analysts note increased productivity on their teams. Importantly, the research community have also responded to these changes with generally positive feedback. One researcher reported: “Working with the new template was a breath of fresh air.”

Limitations: This QI project was limited to the Social Behavioral side of our IRB. The QI team is currently working with our Biomedical analysts to make improvements to their workflow and review documents. Additionally, this project focused primarily on exempt studies, as these make up the largest proportion of our workflow. We are currently working with the QI team to re-examine our expedited and full board study review processes.

Discussion: QA / QI initiatives led by external personnel or imposed on an institution in a top-down manner can be experienced as alienating, and therefore may not be widely embraced. We built our QI initiative to center the opinions of the personnel whose workflow we were re-examining, as these individuals were best positioned to speak to deficiencies and also most likely to benefit from any improvements to their processes. In working from the ground up, the changes we have made have been enthusiastically adopted, and we believe they will be long lasting because they were meaningfully co-created by us for us.