IRB Notes: quality improvement or research?

Quality improvement or research? How to make sure you’re in the clear

In the era of quality improvement, questions about how to make QI into scholarship come up frequently.

FAQs about Quality Improvement Projects and how they relate to research:

Is all QI research?  No.

Projects that are intended only for process improvement, and used in a local setting are quality improvement and do not require IRB approval.  An example of QI that is not research:  Chart review of all patients who have blood pressure readings above goal, with the intent to develop a process for scheduling these patients for a follow-up appointment in order to discuss their blood pressure control.  Measurement of the percentage of the clinic population before and after the intervention can inform the clinic about whether the intervention was effective.  Note that the goal of this project is improvement of quality metric (percent of patients at goal) or clinic processes and the information is used only within the context of the local health system (the clinic).

If we want to publish our QI project, is that research?  YES.

Any time you systematically collect information with intent to inform those outside your local environment, the project becomes research.  The federal definition of research is:  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)).

What if I started a QI project and then the results were really interesting and now I want to publish? I didn’t have IRB approval when I started.  What should I do?

First – stop working on the project.  Your goal has changed from a local improvement project to a generalizable systematic evaluation (in other words – it’s now research).  You need IRB approval before continuing with the project.

Second – submit a Request for Determination.  The IRB will determine whether your project qualifies as human subjects research, and if so what level of review/oversight is required.  Once this is completed, you can proceed with the project or if you’re sure its research, go ahead and just submit as a new research study.

Further information from the Dept Health & Human Services, Office for Human Research Protections:  http://answers.hhs.gov/ohrp/categories/1569.

Please contact Ames Elliot if you have any questions.

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