28 - Implementing a Quality Improvement Review Board for Oversight of Non-Human Subjects Research Projects

Background:  Quality Improvement (QI) projects are fundamentally distinct from Human Subjects Research (HuSR); however, the differences between them are subtle and highly nuanced. Determining whether a project meets the definition of QI or qualifies as HuSR, thus requiring Institutional Review Board (IRB) review, can be confusing and frustrating.

Program

Description:  The Quality Improvement Review Board (QIRB) was established specifically for QI project oversight. QIRB review helps project leaders understand the difference between QI and HuSR and establish the correct path toward either QIRB or IRB review. This ensures that HuSR is not mistakenly conducted under the label of a QI project, and strengthens the scholarly rigor of QI projects.
The first step for establishing the new board was the creation of an interdisciplinary team of faculty members from the Schools of Nursing, Medicine, Biomedical Sciences, and Pharmacy together with Office of Research executive administration and representatives from the Compliance Office and a member of the IRB. This team was tasks with putting together a plan to present to the President's Executive Council. Ongoing costs associated with the QIRB include salary and benefits of one full time employee.
Project review evaluates the intent, design, risks, and benefits inherent to the project to determine whether it is QI or HuSR. QI projects must have a specific prospective improvement goal, and an evidence-based intervention offered to all participants. QI projects should also have a cyclical design with data analysis to measure change over time. There should be no risks to participants outside those inherent to receiving care. Characteristics of HuSR, including control groups or other techniques intended to produce generalizable results will trigger an evaluation by the HRPP.
Possible review outcomes include approval as QI, referral to the IRB, or “other” (i.e., the project does not meet the definition of either HuSR or QI). The QIRB Director maintains records of all project submissions and outcomes.

Program

Assessment:  The availability of a separate QI review process has enhanced support for QI initiatives and promoted scholarly activity for faculty, residents, and students, while relieving a burden on busy IRB staff. Upon follow-up, 75% of QI project leaders reported that their project was successful and resulted in publication or presentation of the results.
Since 2017, 78% of submissions were ultimately approved as QI, while 5% were referred to the IRB as HuSR. The remaining 17% were deemed to be neither QI or HuSR. The average review turnaround time is 2.7 days.
Educational outreach has continued, with the QIRB Director offering regular (5-10 per year) educational presentations to faculty, residents, and students.
The number of projects submitted to the QIRB, which were ultimately determined to be HuSR, is evidence that in the absence of a QIRB, project leaders may have conducted those projects without IRB review.

Limitations: The creation of a new review board dedicated to QI project oversight required a significant financial commitment from the institution.
Success of the program has been measured informally by feedback from program users, during routine project follow up conducted by the Administrator.

Discussion:  The QIRB is a success. It has lifted a frustrating burden from IRB administrative staff, who were previously tasked with processing projects that did not fall under the purview of the IRB. Review and approval of QI projects also helps to promote scholarly activity for project leaders, and reduced the risk of HuSR conducted outside of appropriate IRB review.
Future directions for the QIRB include ongoing QI education for faculty, residents, and students, publication of a QIRB Policy Manual, and implementation of internal quality control measures within a newly drafted Quality Improvement Program.