Quality Improvement Projects (CQI) vs. Research

Some data collection and analysis activities in the health care setting are not intended to generate scientific knowledge, but rather are used as a management tool to improve the provision of services to a specific health care population.  These activities are not intended to have any application beyond the specific organization in which they are conducted.  These activities may be referred to as program evaluation or quality improvement.  But, like public health, because populations are the targets of study and because the methods used in program evaluation or quality improvement are the same or similar to  those used in research, it is often difficult to determine whether or not the activity is research that falls under the oversight of the IRB (see IRB-01 position paper at When is CQI Research? )

 Generally, when the purpose of an activity is to assess the success of an established program or quality initiative in achieving its objectives, and the information gained from the evaluation will be used to provide feedback to improve that program, the activity is not human subject’s research.  The evaluation is a management tool for monitoring and improving the program or process.  Information learned has immediate benefit for the program and/or clients receiving the program or services. 

 When the quality improvement involving human participants or their protected health information (PHI) is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is human subject’s research.  The systematic comparison of standard or non-standard interventions involving human participants also is research.

 It is often difficult to distinguish QA/QI activities and human subjects research activities, especially when data analysis post implementation of a QA/QI activity will occur.  It is possible that the same project may have both QA/QI and research components.

 

Quality vs Research Determination:

 The UF IRB-01 has worked in collaboration with the Sebastian Ferrero Office of Clinical Quality and Patient Safety at UF Health Shands to establish a process the allows for a determination to be made on your project, before it is initiated.  Prior to implementation of a quality or research project you should note and follow the instructions below.

  • Complete the CQI vs Research Determination Form and email to Dr. Iafrate at iafrate@ufl.edu
  • If it is determined to be a Quality Project only, you will receive a letter from Dr. Iafrate stating this
  • The Sebastian Ferrero Office of Clinical Quality and Patient Safety at UF Health Shands will be copied on this determination, and will review the request to insure appropriate applicability within the organization.