Peter Iafrate, PharmD Distinguishing Between Quality Improvement and Research
Differentiating between Quality Improvement (QI) and research can be challenging, as both disciplines often use similar systematic methods to collect and analyze data. However, understanding the distinction is crucial for determining the appropriate oversight, methodology, and ethical considerations for a project. Misclassifying a project can lead to confusion about its goals, scope, and regulatory requirements.
The fundamental difference lies in their intent. Research is designed to test a hypothesis and generate new, generalizable knowledge, often using a fixed protocol that may or may not directly benefit the participants. In contrast, Quality Improvement aims to rapidly assess and improve a specific local process, program, or system by comparing its performance to established standards. QI projects are typically iterative, with interventions adjusted based on incoming data to achieve a specific quality goal and promptly benefit the system or patients involved.
Resources
The resources below provide clear guidance on distinguishing between Quality Improvement and research activities.
QA/QI vs. Research Comparison Table
This table provides a side-by-side comparison of Quality Assurance/Quality Improvement (QA/QI) and research across several key points. Use it as a quick reference to understand the fundamental differences between these two methodologies.
Download the QA/QI vs. Research Comparison Table
Features of the Comparison Table:
- Compares purpose, starting point, and design.
- Outlines differences in benefits and risks/burdens.
- Distinguishes between endpoints and analytical approaches.
Quality vs. Research from the UF IRB
The University of Florida Institutional Review Boards issued this policy brief to address frequently asked questions about the complex distinctions between QA/QI and research. Use it to understand the gray areas and determine if your project requires IRB consultation.
Download the Quality vs. Research Policy Brief
The Policy Brief Covers:
- Characteristics of projects that may be both QA/QI and research.
- The role of randomization in determining if a project is research.
- Whether the intent to publish makes a project research.
- How to handle journal requests for IRB approval for a QI project.