When is quality improvement research

Depending on how these data were stripped of individual patient identifiers, the resulting dataset would not meet the definition of human subject as found in the regulations. Thus if the research project includes the analysis of data for which the investigators cannot readily ascertain the identity of the subjects and the investigators did not obtain the data through an interaction or intervention with living individuals for the purposes of the research, this project does not meet the definition of human subjects research and does not require IRB review.

If a project involves introducing an untested clinical intervention then this is considered research. When the purpose goes beyond simple QI and also involves collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, the project will likely meet the definition of human subjects research and will require IRB review.

If even a small component of the QI activity is research, then the project must be reviewed by the IRB. The intent to publish is not a sufficient criterion for determining whether a QI activity involves research requiring IRB review. Planning to publish an account of a QI project does not necessarily mean that the project fits the definition of research. Download the worksheet on this page and if necessary, consult with one or more of the resources listed to determine if IRB review is necessary.

Skip to main content. You are here Help! When is IRB approval needed i. What ethical oversight is appropriate for QI activities that aren't research?

However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving the quality of care, and in these cases the regulations for the protection of subjects in research 45 CFR part 46 may apply. To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order:.

For those quality improvement activities that are subject to these regulations, the regulations provide great flexibility in how the regulated community can comply. Other laws or regulations may apply to quality improvement activities independent of whether the HHS regulations for the protection of human subjects in research apply. Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes include:.

The clinical, practical, or administrative uses for such performance measurements and reporting could include, for example, helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery data or infection rates.

Other practical or administrative uses of such data might be to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.

Private information must be individually identifiable i. Yes, in certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human subjects research under the HHS regulations.

No, the intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. Too often, quality improvement investigators seek to proceed to clinical trials before sufficient exploration, investigation, and understanding of the complex system and its interactions have been achieved. Campbell et al present a trajectory for QI research required to build requisite knowledge [ 3 ]. The design and testing of complex interventions in care delivery proceeds through a series of planned stages.

One begins by developing a concept or theory and then progresses to designing a prototype. Next, an intervention is piloted on a small scale before performing a detailed test and finally disseminating the ideas generated. A variety of study designs may be used as learning proceeds across this trajectory of understanding.

In order to successfully implement change or study improvement initiatives, the researcher should understand the unique nuances of the system in which a change will operate. It is helpful for studies to include measures contextual factors e. Without more defined and detailed descriptions of local contexts, we cannot build on knowledge learned across systems improvement initiatives.

Important lessons can be learned from both high and low performing teams. Furthermore, we must not forget the importance of looking outside of our own disciplines for insights. Fields of engineering, business, psychology, and social sciences offer methodological approaches that are particularly relevant to QI research.

Several barriers exist to large-scale QI research, including needing many participating sites when the unit of analysis is the site; having a limited number of outcomes at a given site, and the challenge of managing improvement interventions across sites.

We recommend building research programs capable of supporting experimentation at all units of analysis to help advance the field of quality improvement research [ 4 ]. Sequential experimentation needs to occur at the patient, practice, and health system levels. Start by thinking of a clinic or ward as such a clinical laboratory. What is the measurement plan to be used during implementation of the project? Will the results of this project directly improve patient-care outcomes or processes?

What is the sustainability plan for the results? Research versus practice in quality improvement? Understanding how we can bridge the gap. Search ADS. Research and quality improvement experience and knowledge: A nursing survey.

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Is it quality improvement or is it research? Quality improvement, clinical research, and quality improvement research—Opportunities for integration. Financial support and sponsorship The author disclosed no funding related to this article. Conflicts of interest The author disclosed no conflicts of interest related to this article.

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