Human Subjects Review of a Multi-Site Quality Improvement Study Conducted through a National Research Network

Purpose: The need to conduct relevant quality improvement research is increasing across the country, however, confusion still exists on whether a project is considered quality improvement or research. This project reports the IRB review process for each of the 14 sites engaged in the STAR-2 study (paper 2).

Methodology: This study enrolled 14 hospitals engaging nurses within 3 medical-surgical units in each hospital to collect data on operational failures, in real time, using a index sized “Pocket Card” for 10 shifts over 20 days.  To assure scientific rigor and protocol fidelity was maintained each site was provided with a Protocol Implementation Kit (PIK) with standardized materials and IRB templates. Using the IRB application and correspondences as data, we identified the type of review conducted (exempt, expedited or full board) and noted any changes that were made in the final approved documents relative to the standardize protocol and consent form. The primary author reviewed the IRB application materials and correspondences. Where materials were unclear, the site PI and/or local IRB, if needed, was contacted for clarification. 

Results: Thirteen of the 14 sites engaged in this project conducted independent reviews of the project with one site deferring to the UTHSCSA IRB. Average review time ranged 4-6 weeks. Twelve IRB approved the study through expedited review, category 7 while 2 IRBs reviewed the project at their full board meeting due to engaging a vulnerable population (hospital employees). Lastly, 11 of the 14 sites required documented consent. IRBs did not request any changes or modifications to the study protocol.

Conclusions: QI research continues to be a challenge for IRBs, regardless of their institutional affiliation. IRB approvals, facilitated by the ISRN Coordinating Center, resulted in no resubmission and quick turnaround time with no major issues during the review process.