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. You can learn more about what qualifies as human subject research at the IRB FAQ webpage. However, even if a QA/QI project is NOT research, it may still require IRB review. This may be the case if, for example:

 

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

Submit Your QA/QI Application via IRBManager