Quality Improvement (QI) Projects vs. Research

This guidance is intended to help investigators understand the overall differences between research activities and non-research QI activities, and it is not represented as official policy. Additionally, there may be other activities or characteristics not described below that may or may not meet the definition of research involving human subjects. Please refer to the regulatory definitions for “research” and “human subject” as well as other resources provided below. Anyone requiring an official determination about a project should submit the Determination of Human Research Worksheet in iRIS for IRB review.

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Determining if a proposed project is a non-research quality improvement (QI) activity or research involving human subjects is challenging. Federal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”.

By design, many QI projects are systematic in nature. Most QI projects do not meet the definition of research though because they are not designed to be generalizable. Research studies are intended to create new knowledge that can be generalizable to other populations and settings, while QI in health care uses existing knowledge to improve health care outcomes within a local health care institution or setting.

It is important to note that some QI projects may also be research (systematic and generalizable) and therefore require IRB approval. The table below illustrates some of the key differences between research and (non-research) QI.

	RESEARCH	QUALITY IMPROVEMENT
Purpose	Test a formal hypothesis. Develop or contribute to generalizable knowledge.	Assess and/or improve a process, system, or program within a particular institution. Focus on translating existing knowledge from research into clinical practice to improve the quality of health care for individuals and populations.
Starting Point	A prospectively designed, formal, written research hypothesis or research question.	An established set of standards.
Design	Systematic; generally follows a rigid or strict protocol that remains unchanged through the research. May involve randomization.	Typically, an adaptive, iterative design (i.e., PDSA cycle). Generally, does not involve randomization.
Effect on Program or Practice Evaluated	Findings are not intended to directly affect institutional or programmatic practice.	Findings are intended to directly affect institutional practice where the QI project is conducted.
Benefits	May or not benefit directly; intended to benefit future patients.	Directly benefits a process, system, or program; may or may not benefit participants.
Risks	May place participants at risk.	Does not significantly increase risk to patients, except possible risks to privacy or confidentiality of data.
End Point	Answer research question.	Use existing knowledge to improve a process, system, or program.
Analysis	Statistically test a hypothesis.	Measuring outcomes after changes based on current evidence.

*Adapted in part from VCU Research vs. Quality Improvement Comparison and CHOP IRB: Is This Quality Improvement?

DEFINITIONS

Below are key terms that will help you understand what is considered quality improvement and research involving human subjects.

Quality Improvement: an activity that is specifically initiated with a goal of improving the performance of institutional practices in relationship to an established standard.

Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic Investigation: An activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Generalizable Knowledge: Investigations designed to generate new knowledge and expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
- Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study or internal program.

Human Subject: a living individual about whom an investigator conducting research:

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

FAQs about QI Projects and Research

1. Do QI activities fall under the regulations for protecting human subjects in research if their purposes are limited to: a) delivering healthcare, and b) measuring and reporting provider performance data for clinical, practical, or administrative uses?

No. Such QI activities do not meet the regulatory definition of “research”. Therefore, the federal regulations for protecting human subjects in research do not apply and there is no regulatory requirement for such activities to undergo review by the IRB.

Examples of clinical, practical, or administrative uses for performance measurements and reporting could include:

Helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery or infection rates.
Enabling insurance companies to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.

** As stated at the top of this page, any requests for a determination by the HRPP Office will require submission of a Determination Worksheet in iRIS for IRB review.

2. Do QI activities fall under the regulations for protecting human subjects in research if their purposes are limited to: a) implementing a practice to improve the quality of patient care, and b) collecting patient or provider data regarding the implementation of practice for clinical, practical, or administrative purposes?

Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes include:

A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.
A hospital pharmacy implements an evidence-based approach to reduce pharmacy prescription error rates and collects prescription information by medical chart review. Adherence to this approach and medication error rates are evaluated by chart review after implementation to determine whether medication error rates have decreased as expected.
A clinic that has seen an increase in geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit patient changes in order to see if the assessments are performed with appropriate patients, and will implement additional in-service training of clinic staff if the audit finds that assessments are not being administered routinely.

** As stated at the top of this page, any requests for a determination by the HRPP Office will require submission of a Determination Worksheet in iRIS for IRB review.

3. Are there types of QI activities that are considered to be research that is subject to the human subject regulations?

Yes. In certain cases, a QI project may constitute human subjects research that is also considered “non-exempt”. This means that the research does not meet one of the exempt categories defined in the regulations at 45 CFR 46.104.

Examples of QI projects that may also be human subjects research:

Introducing an untested clinical intervention for purposes that not only include improving the quality of care but also include collecting information about patient outcomes for the purposes of establishing scientific evidence to determine how well the intervention achieves the intended results.
Surgical group practice in a non-academic health system use two standard techniques for hernia repair. The practice would like to determine which repair method is best. The proposed study would randomly assign patients to one technique or the other and patients will sign consent form for regular treatment.

While the practice intends to improve patient care, non-research activities do not usually include randomization. Further, the results may yield generalizable knowledge that expands knowledge of a scientific discipline and may be applicable beyond the patients studied.

4. If I plan to publish the results of a QI project, does the intent to publish qualify as research?

No. The intent to publish is an insufficient criterion for determining whether a QI activity involves research. Planning to publish an account of a QI project does not necessarily mean that the project fits the definition of research. People seek to publish descriptions of non-research activities for a variety of reasons, including, for example, if they believe others may be interested in learning about those activities. On the other hand, a QI project may involve research even if there is no intent to publish the results.

*Important note: it is possible that a QI project may involve research even if there is no intent to publish the results. Refer to the definition of “research” and “generalizable knowledge”. Individuals may also request an official determination from the IRB by submitting a Determination of Human Research Worksheet in iRIS.