Quality Assurance/Quality Improvement
Quality Assurance/Quality Improvement
Quality assurance/Quality improvement are projects conducted to assess or improve internal processes, programs, or services, often by implementing research-based interventions or procedures. These projects are distinct from research in a few key ways. QA/QI hope to directly benefit their participants using the results of the project or, sometimes, while the project is ongoing. Additionally, QA/QI intend to help the participating institution or organization in determining and following best practices for that individual institution/organization. Unlike research, they do not intend to contribute to general scientific knowledge.
Does My QA/QI Project Require IRB Review?
The IRB must review all activities which qualify as human subjects research. However, even if a QA/QI project is NOT research, it may still require IRB review. This may be the case if, for example:
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You are testing certain drugs or devices.
If a project is testing or using certain drugs or devices, the project may fall under FDA regulations and require IRB review.
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The activity is externally funded and the stipulations indicate or insinuate human subjects research.
If a sponsor indicates that the project is research, then it should be treated as research and undergo IRB review.
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When risks are greater than minimal risk.
The IRB is mandated to protect human subjects. Activities that represent greater than minimal risks to humans will generally require a full board review.
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If you anticipate that IRB approval will be required to publish your results.
The IRB is not able to retroactively review projects. If a journal requires IRB review, the IRB must review it before the project begins
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A group providing you access to their facility or population requires IRB review.
In order to satisfy the requirement, the project will require IRB review before it begins.
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You are working with FERPA or HIPAA data.
FERPA protected data require permission from the Registrar, while HIPAA protected data require review from the privacy board.