Distinguishing between quality improvement (QI/quality assurance initiatives (QA) and human subjects’ research requiring IRB review is often challenging, especially when there is an overlap between these goals. According to the Office of Human Research Protections (OHRP), QI and QA initiatives may or may not be considered research. Beginning in February 2014, the IRB, in collaboration with faculty of the Perelman School of Medicine, launched a new pilot initiative to facilitate the process of determining which projects are QI/QA and which projects are considered research prior to the implementation of such projects.
The purpose of the IRB’s QI/QA application process is to provide a mechanism through which the IRB may help provide a determination of whether the proposed initiative qualifies as QI/QA or as research requiring further IRB review in circumstances where this determination is unknown.
As noted in the guidance document and process flow chart, submission to the IRB is not required for quality improvement/assurance activities however the process may be used when a formal determination by the IRB is desired.
If you plan to conduct a QI/QA project, reviewed the guidance document, and require a QI/QA determination from the IRB, please email your completed submission form to the following dedicated QI/QA email address: email@example.com Prompt feedback will be provided.
Download QI Project Guidance -This guidance document seeks to provide an overview of the QI/QA application review process, identify common factors considered in determining if a project qualifies as human subjects’ research, and list additional resources related to QI/QA projects.
Download QI Project Submission Flow Chart -This flowchart depicts the QI/QA project review process once a faculty/staff has decided to pursue and implement a QI/QA project
Download QI Project Application -This application is an abbreviated form that should be submitted to the QI IRB email inbox (firstname.lastname@example.org) when a formal determination by QI IRB is requested by the faculty/staff.