How To Determine QI vs. Research

Determination of Quality Improvement versus Research
Questions frequently arise about whether or not certain projects qualify as human subjects research or if
they are considered quality improvement.
Quality Improvement (QI) has been defined as systematic, data-guided activities, designed to bring
about immediate improvements in health care delivery in particular settings. Initiators of QI projects
identify promising improvements, implement small scale changes, monitor results, and decide about
additional changes and wider implementation. Quality improvement is a core function of good clinical
care.
Research is defined by the federal government as a systematic investigation, including research

development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Research yields valid results through rigid implementation of a fixed protocol. The focus of research is
on long-term gains in knowledge.
Note there are many similarities between research and QI:

• Both involve a systematic investigation that is carefully designed to achieve reliable and valid
results.
• Both involve analysis of data.
• Both may involve the implementation of a new intervention.
• Both may result in a presentation or publication.
However, there are key differences between quality improvement and research projects.
• QI projects are often flexible and incremental in design, employing strategies such as a plan-do-
study-act cycle.
• QI uses data analysis to find out whether or not the workforce is following best practices and
professional guidelines.
• QI implements a new practice or process to improve (for example) workflow, patient safety, staff
expertise, cost effectiveness, etc.
• QI interventions often have been proven to be successful elsewhere and are widely accepted in the
profession/discipline. QI projects evaluate the best strategies to implement these interventions
locally.
• QI projects can help us characterize our population in order to better serve their needs or improve
their care.
• QI projects aim to directly benefit existing patients by implementing immediate local improvements.
• QI projects do not increase risk to patients beyond the risks that are involved in care they are already
receiving.
• QI tools are applicable primarily to the unique characteristics of our local setting.
• The results of QI projects typically are evaluated by an internal committee or executives who decide
whether or not to permanently adopt the new practice.
Informed consent
Informed consent is not required for quality improvement projects since they pose only minimal risk.
Because quality improvement is an integral aspect of normal health care operations, consent to be
included in QI projects is part of the patient’s consent to receive treatment.
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Presentations and Publications
The federal agency overseeing research has stated that the act of presenting or publishing a quality
improvement project does not change its classification to be research.
Projects that are both Quality Improvement and Research

Some projects contain elements of QI but their focus is developing new, generalizable knowledge.
Additionally, activities that start as a QI initiative may evolve to have a research purpose. Examples of
projects that could be both QI and research are:
• Implementation of a new intervention to improve patient care and analysis of data to establish
scientific evidence of the intervention’s effectiveness
• Implementation of a novel approach that has not been extensively studied
• Development of new quality assessment or measurement tools
• Use of patient data in order to develop new clinical treatment guidelines
Projects that are both QI and research must be approved by the KUMC IRB before they are initiated.
Obtaining a Determination
Determinations about QI versus research are made on a case-by-case basis. Faculty members and other
researchers are encouraged to seek a formal determination about their project to ensure that compliance
requirements are met. A formal determination also may be helpful when submitting the manuscript. The
KUMC REDCap link to submit the request for a QI determination is posted at:
http://www.kumc.edu/compliance/human-research-protection-program/institutional-review-board/forms.html
Please review the instructions as well as the pdf version of the REDCap form to understand the
information required when submitting your request. Determinations are typically made within 2- 3
business days.
Additional Resources:
Lynn, Joann, et.al. The Ethics of Using Quality Improvement Methods in Health Care. Annals of
Internal Medicine. 2007; 146 (9): 666-673.
The federal Office for Human Research Protections provides Frequently Asked Questions on this topic
at http://answers.hhs.gov/ohrp/categories/1569
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How To Determine QI vs. Research

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Determination of Quality Improvement versus Research

Research is defined by the federal government as a systematic investigation, including research

Note there are many similarities between research and QI:

Page 1 of 2 October 2019

Projects that are both Quality Improvement and Research

Page 2 of 2 October 2019

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