QA/QI vs Research

Why the change in QA/QI vs Research Determinations by the IRB?

Additional guidance has been provided by various federal agencies as it relates to “quality” vs “research” projects. As a result, the Sebastian Ferrero Office of Clinical Quality and Patient Safety has worked to develop a “Quality Improvement Performance Registry (QIPR)” you can access at https://qipr.ctsi.ufl.edu. Besides registering your project, you will be asked six questions, based on your answers the app will either provide you with a “Registration Certificate” or indicate that you may need IRB approval to conduct your project.  Please note that this is not intended to circumvent the need for IRB approval when warranted.

A few things to be aware of:

  • As of March 7, 2017, you no longer need to complete the “CQI vs. Research” request form and send to the IRB-01 Chairman. Instead, you should go to the QIPR addressed above. If you are truly conducting a Quality Project, the publication of a Quality Project no longer needs IRB approval.
    • Please remember, if you submit your project to a journal, and the journal wants you to provide your IRB approval, the only IRB approval that can be issued retrospectively is for projects that would have met “Exempt” review or “Non-human” status. You can contact the IRB Chairman if this occurs. If not, the IRB will not be able to provide you an approval letter.
    • Also, the Privacy Rule (HIPAA) still applies; please make sure you are not including PHI in any publication. Please contact the Privacy Office if you have questions.
  • Random audits will be conducted to confirm that what has been “registered” as a “Quality Project” is indeed a quality project.

 

What is QA/QI?

Please refer to the “Investigator Guideline on Quality vs. Research” for additional information. There is no regulatory definition, but often QA/QI is described as “systematic, data-guided activities designed to bring about immediate (or nearly immediate) improvements in health care delivery”, and the combined efforts of everyone to make changes that will potentially lead to better patient outcomes, better system performance, and better professional development. In medical institutions, QA/QI is a necessary, integral part of hospital operations and is not subject to review as research, as defined under federal regulation. Rather, it is governed by Joint Commission and hospital standards. Human Subject Research (HSR) is governed by federal regulation, under IRB oversight.

 

What are some differences between QA/QI and Research? 

Points to consider Research QA/QI
Purpose To test a hypothesis OR establish clinical practice standards where none are accepted To assess or promptly improve a process, program, or system; OR improve performance as judged by accepted/established standards
Starting Point To answer a question or test a hypothesis To improve performance
Design Typically a fixed protocol with fixed interventions that are not revised as data is collected. Typically interventions are adjusted based on data collected if quality goal is not being attained.
Benefits Designed to contribute to generalizable knowledge and may or may not benefit subjects Designed to promptly benefit a process, program, or system and may or may not benefit patients
Risks / Burdens May place subjects at risk and stated as such By design, does not increase patient’s risk, with exception of possible privacy/confidentiality concerns
Data Collection Systematic data collection Systematic data collection
End Point Answer a research question Promptly improve a program/process/system, typically has a quality goal to measure improvement.
Testing / Analysis Statistically prove or disprove a hypothesis Compare a program/process/system to an established set of standards.