VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R019

alignment with institutional standards, making additional independent QA/QI research by those other than faculty or academic leadership unnecessary.

4. DETERMINING WHETHER A PROJECT IS QA/QI OR RESEARCH As QA/QI activities are considered operational, they do not require the same level of review as research because their primary purpose is internal improvement rather than generalizable scientific knowledge. VCOM policy; therefore, is that QA/QI is not research that must be approved by the IRB. However, to determine whether a project constitutes research or QA/QI can be challenging and under certain circumstances, a QA/QI project may also constitute human subjects research. The IRB does not have the authority to retrospectively review a protocol or provide retroactive approval. It is therefore important to determine whether an activity meets the criteria for human subjects research or a QA/QI initiative BEFORE the activity is initiated. To determine whether QA/QI requires IRB review, complete the Quality Assurance (QA)/Quality Improvement (QI) or Research Assessment Worksheet and submit it to the IRB Coordinator for review. QA/QI activities are typically observational and unobtrusive and can involve the collection and analysis of data to which investigators have legitimate access through their institutional roles. Depending on the activity, QA/QI can look like practical problem solving, an evidence-based management style or the application of a theory-driven science of how to bring about system change. Introducing QA/QI methods often means encouraging people to use their daily experience to identify ways to improve care, implement changes on a small scale, collect data on the effects of those changes, and assess the results. Both QI/QA activities and research activities use scientific methodology equally, so it is difficult to define research activities that require IRB review by the methods they employ. Other attributes, such as publication of findings, methodological design, selection of subjects, and hypothesis testing and generating, also do not necessarily differentiate QA/QI activities from research. QA/QI projects involving VCOM curriculum, student performance outcomes, and/or any other academic related topics are not generally approved for publication as the study was conducted for internal use. Outside external funding may make a difference in distinguishing between QA/QI and research. A NIH research grant to support a project would often be considered research. Internal funding to improve a program may not. The intent to publish is an ‘insufficient criterion’ for determining whether a QA/QI activity involves research, according to OHRP. When QA/QI is published or presented, the intent is usually to discuss potentially effective models, strategies, assessment tools or to provide benchmarks, rather than to develop or contribute to ‘generalizable’ knowledge. To aid in determining whether a project is QA/QI or research some guidance has been provided below. Additionally, to determine whether a QA/QI project requires IRB review, complete the VCOM IRB Quality Assurance/Quality Improvement or Research Assessment Worksheet and submit to IRB Administration via the IRBNet portal. This worksheet also includes criteria that typically represent QA/AI versus research.

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

Page 3 of 5