Determining if an activity is Research or Quality Improvement (QI) can be challenging. Federal regulations require human subject research to be approved by the IRB, while strictly QI activities do not require IRB oversight. However, some QI activities may also include research and therefore require IRB approval. Both research and quality improvement are systematic investigations that may involve human participants, but they differ in important ways.
Research is defined as: “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." (Code of Federal Regulations, 45 CFR 46.102(d)).
Quality improvement (QI) in health care, unlike research, focuses on translating existing knowledge from research into clinical practice to improve the quality of health care for individuals and populations. There is no regulatory definition for QI, however 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" Source: The Institute of Medicine.
The key difference between these two concepts is that 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.
When an activity involving the inclusion of people is intended to evaluate an existing practice and attempt to improve it based upon existing knowledge, and if the data from the evaluation is not intended to be applied to populations other than the population under study, then the IRB would not classify this activity as research, and the activity would not be subject to the DHHS human research regulations.
Examples of QI activities that are likely NOT research include:
- Implementing a practice to improve the quality of patient care
- Collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes
- Measuring and reporting provider performance data for clinical, practical, or administrative uses
- A group of affiliated hospitals implements an application to reduce prescription amount errors, and collects patient prescription information from medical charts to assess whether the application helped reduce error rates as expected.
Intent to Publish
The intent to publish is an insufficient criterion for determining whether a QI activity involves research. Even 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 what worked at another institution. Dissemination of QI efforts will require timely publication and sharing of information to create awareness of lessons learned, as well as what QI projects work well within each other’s institutions.
When is IRB approval needed for QI activities?
A QI activity may also constitute human subject research if it meets the definition of research.
IRB approval may be required when the activity involves some of the following characteristics:
- seeks to develop new knowledge or validate new treatments rather than to assess the implementation of existing knowledge;
- when the methodology employs a standard research design, such as randomization;
- when the protocol is fixed with a rigid goal, methodology, population, time period, etc.;
- when the funding for the activity comes from the outside organizations such as the NIH or those with a commercial interest in the results;
- when there will be a delay in the implementation of results;
- when the risks from the intervention to participants are greater than minimal.
Code of Federal Regulations. Department of Health and Human Services. Effective 14 July 2009, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
OHRP Quality Improvement Activities Frequently Asked Questions. U.S. Department of Health and Human Services, http://www.hhs.gov.
“Quality Improvement Activities in Health Care Versus Research.” Duke University Health System Human Research Protection Program, 3 March 2016, https://irb.duhs.duke.edu/sites/irb.duhs.duke.edu/files/QI_policy_and_checklist_4-30-2013jw.pdf.
“Quality Improvement vs Research.” Children’s Hospital of Philadelphia Research Institute, https://irb.research.chop.edu/quality-improvement-vs-research.
“Quality Improvement vs. Research – Do I Need IRB Approval?” Virginia Commonwealth University Office of Research and Innovation, https://research.vcu.edu/human_research/research_qi_guidance.pdf.
See how QI and research differ in this side-by-side comparison chart.
Work through this checklist to see if your proposed activity is a QI project or human subjects research.
A comprehensive, easy-to-print guide.