Quality Assurance/Quality Improvement

QA/QI

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:

  • If a project is testing or using certain drugs or devices, the project may fall under FDA regulations and require IRB review.

  • If a sponsor indicates that the project is research, then it should be treated as research and undergo IRB review.

  • The IRB is mandated to project human subjects. Activities that represent greater than minimal risks to humans will generally require a full board review.

  • The IRB is not able to retroactively review projects. If a journal requires IRB review, the IRB must review it before the project begins

  • In order to satisfy the requirement, the project will require IRB review before it begins.

  • FERPA protected data require permission from the Registrar, while HIPAA protected data require review from the privacy board.

Submit Your QA/QI Application via IRBManager