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.
Definitions
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:
Research | Quality Improvement | |
|---|---|---|
| Purpose | To develop or contribute to generalizable knowledge | To implement knowledge, assess a process or program as judged by established/accepted standards |
| Starting Point | Knowledge-seeking is independent of routine care and intended to answer a question or test a hypothesis | Knowledge-seeking is integral to ongoing management system for delivering health care |
| Design | Follows a rigid protocol that remains unchanged throughout the research | Adaptive, iterative design |
| Benefits | Might or might not benefit current subjects; intended to benefit future patients | Directly benefits a process, system or program; may or may not benefit patients |
| Risks | May put subjects at risk | Does not increase risk to patients, with exception of possible patients’ privacy or confidentiality of data |
| Participant Obligation | No obligation of individuals to participate | Responsibility to participate as component of care |
| Endpoint | Answers a research question | Improves a program, process or system |
| Analysis | Analysis Statistically prove or disprove a hypothesis | Compare program, process or system to established standards |
| Adoption of Results | Little urgency to disseminate results quickly | Results rapidly adopted into local care delivery |
| Publication/Presentation | Investigator obliged to share results | QI 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:
- 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
- implementing an application to help improve making clinical decisions, collecting data as the application is implemented and then analyze this data for generalizable knowledge
- if the funding for the activity comes from the outside organizations such as the NIH or those with a commercial interest in the results
Examples of QI projects that do not require IRB approval:
- measuring and reporting provider performance data for clinical, practical, or administrative uses
- assessing whether a campus security training course improves knowledge of faculty, staff, and students
- developing a standardized policy for drug screening and/or testing for obstetrics patients who present for delivery management
- a group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected
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.
- The SQUIRE Website has numerous useful tools and guidelines for those doing Quality Improvement projects.
- Publication Guidelines for Quality Improvement Studies in Health Care: The Evolution of the Squire Project
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.