Module Components

• Learning Activities

Topics

• Definition of QI
• Differentiating between Research and Quality Improvement
• QI and Ethics
• Dissimination of QI

NRSG 790 - Methods for Research and Evidence-Based Practice

Module 14: Outcomes Management and Quality Improvement

QI and Ethics

Does the IRB review all QI activities?

The IRB system was designed to provide oversight for human subjects. The system is costly and can take weeks to months to obtain approval. By its very nature, QI is an iterative, adaptive process that often requires rapid action. To force all QI activities into the IRB system would impose such a heavy overhead that many worthwhile projects wouldn't be feasible.

When is IRB approval needed for QI activities?

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
  • https://irb.research.chop.edu/quality-improvement-vs-research

Decisional Tool

Whether a project is research or quality improvement can affect whether or not Institutional Review Board (IRB) approval is required. Examine the IRB decision tool from the University of Wisconsin-Madison:

• https://kb.wisc.edu/images/group78/33386/ResearchDecisionTree6-18-13.pdf