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Is my QI Project a Research Study? (Do I need IRB Approval?)

"The challenge for us and regulatory boards is to ask the key questions when we examine our studies to determine whether we go to IRB1” Dr. Christine A. Goeschel.

The above quote from Dr. Goeschel addresses an important issue faced by clinical and research scientists studying healthcare improvement. Research is defined in the Code of Federal Regulations (CFR) as systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge. Oversight of this definition is assigned to the Office for Human Research Protection (OHRP). OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

In a Spring 2012 issue of the ISRN Network News1, Dr. Goeschel states that “it is crucially important to understand this purpose statement of OHRP’s authority but also to understand that for studies that transcend the bounds of this authority, we may need to go beyond OHRP for guidance.” The interpretation of the CFR’s definition is one of the challenges that affect regulatory boards in determining whether what we do, as improvement science researchers, is subject to Institutional Review Board (IRB) review. In the same article Dr. Goeschel continues; “The challenge for us and regulatory boards is to ask the key questions when we examine our studies to determine whether we go to IRB.”

Below is a checklist to help you determine if your QI project is considered research.

IRB Checklist

If you check any of the boxes below, then your study will require IRB Review.

 
  • Does the activity involve research? (45 CFR 46.102(d))
  • Does the research activity involve human subjects? (45 CFR 46.102(f))
  • Does the human subjects research qualify for an exemption? (45 CFR 46.101(b))
  • Is the non-exempt human subjects research conducted or supported by HHS or otherwise covered by applicable FWA approved by OHRP?

Experts in the ISRN have successfully and efficiently navigated the IRB waters for two network studies. The strength from the collaboration comes from an IRB template and support to the site PIs during the process. To date, the ISRN quality improvement studies have obtained IRB approvals across 26 different sites! 

Does your work fall into the research or QI project domain?
Have you had any successes with this distinction in your setting?
What is your opinion on the definition provided by the Code of Federal Regulations?

Please share your experiences in the comments section below.

Dr. Goeschel’s January 2012 ISRN web seminar presentation on this topic entitled “Quality Improvement vs. Research: Regulatory Issues in Improvement Science” adds further detail to this important issue. To view this and other ISRN presentations, visit www.ISRN.net/events.


1Improvement Science Research Network. (2012). IRB Issues in QI Research. Network News, Vol.2 (3), p1. http://isrn.net/sites/improvementscienceresearch.net/files/documents/newsletter/ISRN_NetworkNews_Spring2012.pdf

* Christine A. Goeschel, ScD, MPA, MPS, RN, FAAN, Director of Strategic Development and Research Initiatives at the Johns Hopkins Armstrong Institute for Patient Safety and Quality

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Comments

Great article in July JONA on the use of a user-friendly checklist to determine if your project is a performance improvement vs. research. Linda Roussel

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