VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R019

Edward Via College of Osteopathic Medicine

Policy Order No: R019 Effective Date:

February 15, 2026

Signature on File

__________________________ Dixie Tooke-Rawlins, D.O. President ___________________________________________________________________________________ VCOM Policy on Quality Assurance (QA) and Quality Improvement (QI) ___________________________________________________________________________________ 1. PURPOSE..............................................................................................................................................1 2. DEFINITIONS ......................................................................................................................................1 3. POLICY .................................................................................................................................................2 3.1 QA/QI Activities Related to the Academic Program ......................................................................2 4. DETERMINING WHETHER A PROJECT IS QA/QI OR RESEARCH .....................................3 4.1 QI/QA Activities Requiring IRB Review .......................................................................................4 4.2 QI/QA Activities Not Requiring IRB Review ................................................................................4 5. CLARIFICATIONS FOR PUBLISHING OR PRESENTING QA/QI...........................................5 6. DURATION OF POLICY DURATION OF POLICY......................................................................5 1. PURPOSE The purpose of this policy is to assist faculty, students and other personnel on the definition of Research versus Quality Assurance/Quality Improvement (QA/QI). According to federal (OHRP) guidance, IRB review and approval is not required for activities that are limited to QA/QI projects where the project does not meet the definition of research or where there is no research component. As there are several common features between QA/QI and human subject research, QA/QI determinations are not always straightforward. The purpose of this policy is to provide guidance on this topic for IRB regulatory staff and the VCOM research community. The policy also references a QA/QI or Research Assessment Worksheet to aid investigators in determining whether an activity falls within the realm of research involving human subjects. 2. DEFINITIONS Quality Assurance/Quality Improvement: An activity conducted to assess, analyze, critique, and improve current processes in an institutional setting or to ensure it conforms with expected norms - involving data guided, systematic activities designed to bring about prompt improvements. Quality Assurance (QA): Focuses on ensuring that a process, product, or service meets specific standards and is defensive in nature. It involves monitoring for compliance and fixing any deviations or "bugs." It

VCOM Policy on Quality Assurance (QA) and Quality Improvement (QI)

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