Quality Improvement

Quality Improvement versus Research

Quality improvement (QI) projects can be similar to the type of human subjects research that the IRB needs to review.  QI projects often include activities such as conducting surveys, reviewing identifiable data, drawing conclusions about problems, and suggesting methods for improvement. Federal regulations require human subjects research to be reviewed and approved by the IRB, while activities that are solely QI do not require IRB oversight. However, some QI activities may also fall under human subjects research and therefore need IRB approval.


Quality Improvement project (QI): There is no regulatory definition for QI. It is often described as a systematic pattern of actions that is constantly optimizing productivity, communication, and value within an organization in order to achieve the aim of measuring the attributes, properties, and characteristics of a product/service in the context of the expectations and needs of customers and users of that product.

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

Systematic Investigation: An activity that is planned in advance and that uses data collection and analysis to answer a question. Although research must include systematic investigation, many non-research activities also include systematic investigation. Systematic investigation does not, in and of itself, mean the project is “human subjects research”.

The following table* summarizes characteristics of QI and research: 

Quality Improvement
PurposeTo develop or contribute to generalizable knowledgeTo implement knowledge, assess a process or program as judged by established/accepted standards
Starting PointKnowledge-seeking is independent of routine care and intended to answer a question or test a hypothesisKnowledge-seeking is integral to ongoing management system for delivering health care
DesignFollows a rigid protocol that remains unchanged throughout the researchAdaptive, iterative design
BenefitsMight or might not benefit current subjects; intended to benefit future patientsDirectly benefits a process, system or program; may or may not benefit patients
RisksMay put subjects at riskDoes not increase risk to patients, with exception of possible patients’ privacy or confidentiality of data
Participant ObligationNo obligation of individuals to participateResponsibility to participate as component of care
EndpointAnswers a research questionImproves a program, process or system

Statistically prove or disprove a hypothesis
Compare program, process or system to established standards
Adoption of ResultsLittle urgency to disseminate results quicklyResults rapidly adopted into local care delivery
Publication/PresentationInvestigator obliged to share resultsQI practitioners encouraged to share systematic reporting of insights

*The table is based on information adapted from The Ethics of Using QI Methods to Improve Health Care Quality and Safety

Examples of QI projects that require IRB approval:

Examples of QI projects that do not require IRB approval:

Publications for QI projects

Publication is only one of many criteria for determining whether a QI project is also human subject research, by itself, intent to publish is not sufficient to require IRB review and approval.

Standards for reporting QI initiatives have been developed and published by the SQUIRE Development Group. Individuals intending to publish the results of a QI project should consult this Guideline.

If you are not certain whether your quality improvement project is human subject research, please complete and submit the IRB application with the protocol attached in the Georgetown-MedStar IRB system. DO NOT assume that your quality improvement project is not human subjects research.