How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both.

Area of Science:

• Healthcare Regulation
• Research Ethics
• Quality Improvement Science

Background:

• Investigating research projects requires differentiating between human subjects research and quality improvement initiatives.
• Similarities between human subjects research and quality improvement projects can cause confusion in classification.
• Regulatory compliance hinges on correctly identifying the nature of the planned activity.

Purpose of the Study:

• To provide definitions, questions, and examples to aid investigators in distinguishing between quality improvement projects and human subjects research.
• To guide investigators on when to seek regulatory guidance for their projects.
• To clarify the distinct aims and regulatory implications of each project type.

Main Methods:

• Comparative analysis of definitions and characteristics of human subjects research and quality improvement projects.
• Presentation of guiding questions and illustrative examples for decision-making.
• Review of regulatory frameworks governing human subjects research.

Main Results:

• Human subjects research and quality improvement projects possess distinct overall aims despite shared rigorous methods.
• Quality improvement projects utilize data-driven approaches to enhance healthcare delivery and quality, often involving experiential learning.
• Research is defined as a systematic investigation aimed at developing or contributing to generalizable knowledge.

Conclusions:

• Human subjects research and quality improvement projects typically have non-intersecting goals, with quality improvement projects generally exempt from US Department of Health and Human Services (HHS) regulations.
• Certain projects may encompass both quality improvement and human subjects research elements.
• Investigators must understand human subjects research criteria to ensure appropriate application of HHS protection regulations when necessary.