Determining whether a project is evidence-based practice (EBP), quality improvement (QI), or research can be challenging—even for experts! Some projects that appear to be EBP or QI may contain elements of research. Conversely, some projects that we refer to colloquially as research are actually EBP or QI. Finding the correct determination is important for ensuring that projects are reviewed by the appropriate bodies since research projects require Institutional Review Board (IRB) review while EBP and QI projects do not. This guide is designed to clarify the definitions of EBP, QI, and research, and to provide insight into which projects meet the definition of research.
As a reminder, all MSHS nurse-led EBP, QI, and research projects must be reviewed by the Nursing Project Approval Council (NPAC) before they begin. NPAC will determine whether projects meet the definition of research and require IRB review. For more information about NPAC, please see our guide titled The Nursing Project Approval Council (NPAC): Who, What, Where, When, Why, and How to Submit Your Project.
Part I. Definitions and Characteristics of EBP, QI, and Research Projects
- Asks the question, “Does our current policy, practice, or standard operating procedure reflect the best available evidence?”
- Goal is to find existing research that demonstrates which policy, practice, or procedure is the best known way to produce a specific outcome in a specific population.
- May use the PICO (Population, Intervention, Comparison, Outcome) framework to search the literature.
- If the best practice differs from the organization’s current practice, the organization adopts the best practice and evaluates whether outcomes improve after the change.
- Asks the question, “Are we optimally performing our current policy, practice, or procedure when we deliver care?”
- Goal is to improve patient outcomes by methodically identifying areas where performance falls short of the standards set by the organization.
- QI projects use evidence from the literature to implement interventions aimed at improving performance to meet the standard (e.g., staff education, workflow redesign, revised informatics, or communications), and then evaluates whether the intervention improved performance. While patient outcomes may be used as a proxy for or indicator of performance, the goal is to improve the performance of a specific task or process in accordance with institutional policies or standards.
- Research is any systematic investigation designed to contribute to generalizable knowledge. Methods vary depending on the aims of the study.
- Goals may be to describe a phenomenon, develop or test a new method or hypothesis, or evaluate the implementation of a new method.
- Asks a variety of questions such as “Is one policy, practice, or procedure superior to another for achieving an outcome?” or “What are factors and processes that lead to an outcome?”
Part II. Guidance for Differentiating EBP and QI from Research
In partnership with the IRB, the NPAC developed standardized criteria for distinguishing EBP and QI projects from research projects that require IRB review. The criteria and rationale, which are based on federal guidelines and institutional policy, are described below.
The intent of EBP and QI projects is to improve the process of care delivery or implement a new practice standard within the organization. While the proceedings of these projects may be published, the intent of EBP and QI projects is not primarily for publication or dissemination of findings.
The intent of a research project is to generate new knowledge and disseminate findings to the scientific community. While a research study may also have direct benefits to patients in the organization, the primary purpose is advancing knowledge to benefit patients generally.
EBP and QI projects involve the implementation or optimization of care that is already the standard or has already been tested in other environments to demonstrate safety and efficacy.
Projects that implement and evaluate new, modified or adapted practices that have not been tested previously are considered research.
3. Participants and setting
EBP and QI projects are undertaken by staff who normally interact with the population included in the project or are responsible for overseeing quality in the practice area.
Projects that target populations outside the practice or oversight areas of the study team are research.
4. Data collection and storage
EBP, QI, and research projects must take steps to protect data confidentiality. Regardless of the type of project, teams must (1) access only the minimum amount of data required to meet the objective; (2) establish and follow a plan for how the data will be stored and who can access it; (3) and destroy the data after the project and dissemination of findings is complete.
Projects that collect data through intervention (e.g., drawing labs) or interaction (e.g., conducting surveys or focus groups) with the population are research.
EBP and QI projects must have the potential for direct benefit to the population included in the project.
Research projects may or may not have a potential for direct benefit to the population included in the project.
EBP and QI projects must not introduce risks greater than those associated with the organization’s current policy, practice, or procedure.
Research projects may or may not introduce risks greater than those associated with the organization’s current policy, practice, or procedure. The IRB is responsible for evaluating the level of risk associated with research, ensuring that appropriate measures are in place to reduce risks, and determining whether the level of risk is acceptable in relation to the potential benefits.
In situations where one policy, practice, or procedure is known or suspected, based on evidence, to be superior to another, it is not ethical to assign some people to receive the superior and others to receive the inferior. Since EBP and QI projects implement and optimize policies, practices, or procedures that have already been shown to be superior for achieving an outcome, EBP and QI projects generally will not include randomization or other means of assignment to a control group. EBP and QI projects typically employ a pre-post design to compare outcomes before and after the best policy, practice, or procedure is implemented or optimized.
If there is genuine uncertainty about which policy, practice, or procedure is best, a research project is needed to generate this knowledge. Since the best policy, practice, or procedure is not yet known, it is ethical to assign some individuals to receive one and some to receive another through randomization or other means of assignment to a control group.