Institutional Review Board Checklist for Trainee Quality Improvement Project Approvals

Setting and Problem

In 2012, the Accreditation Council for Graduate Medical Education (ACGME) introduced a requirement for trainees to participate in quality improvement (QI) and patient safety (PS) work. This requirement increased trainee exposure to QI/PS, and created an opportunity for scholarly work. For traditional scholarly work, trainees must obtain approval from their Institutional Review Board (IRB) prior to conducting a study. In practice, the IRB process acts as a significant barrier for trainees, due to the significant amount of administrative work and advanced planning required during a trainee's other, unrelated rotations. Expansion of IRB submissions due to required QI/PS projects also creates the potential for IRB submission overload, bogging down timely review. Internal surveys at our urban, academic hospital confirmed that delays in IRB review already deter trainees from ambitions to create impactful projects.

Intervention

At our hospital, which is responsible for 450 trainees, we implemented our interpretation of ACGME requirements by requiring all residents to participate in QI/PS projects. We created an institution-wide curriculum and an online QI platform to facilitate QI/PS scholarship. During initial implementation, trainees submitted project applications through the IRB before starting these scholarly activities. Subsequently, we observed IRB feedback that (1) the majority of projects were not human subject research, and (2) the remaining submissions evaluated by the IRB were ultimately approved as exempt.

Noting the opportunity to improve efficiency, we collaborated with our IRB to create a checklist that would appropriately route all institutional QI/PS projects. If the project met checklist criteria (figure), it would be approved as QA/QI Status and would not require separate IRB submission. The IRB included a quality assurance (QA) designation for this checklist in anticipation of other groups choosing to do projects in this area; our projects were predominantly focused on QI and PS. Enforcement of the checklist completion and umbrella protocol compliance was tasked to graduate medical education leaders overseeing the QI/PS effort at our institutions (A.C. and K.M.). This checklist was placed on an online QI platform so trainees can certify that a project qualifies; projects that do not qualify require IRB submission.

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Outcomes to Date

From October 2016 to January 2017, a total of 47 projects have been entered onto the site. Of these projects, all but 3 have met QA/QI Status approval conditions, bypassing traditional IRB submission.

Most QI/PS projects are initiated with the intent to improve systems at the home institution. In the event that any outcomes are deemed worthy of dissemination, and thus presentation or publication, they will fall under the original umbrella protocol and can be published. We also have anecdotal evidence (via focus groups) that residents are more satisfied and eager to complete QI projects without the barrier of IRB approval. We plan to continue to track submissions to the QI platform as well as IRB submissions for QI/PS work.

This checklist for QI projects is easily transferable to other institutions in order to facilitate trainee QI/PS endeavors. Preliminary results suggest that this checklist will assist with initiation of QI projects while adhering to IRB guidelines.