Health Center Institutional Review BoardP O Box 100173

FWA00005790Gainesville FL 32610-0173

Telephone: 352-273-9600

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When is CQI Research?

This memo attempts to clarify the relationship between Continuous Quality Improvement (CQI) projects and research projects. It also gives guidelines as to when CQI projects should be submitted to IRB for approval.

Why is this important?

A report in the New England Journal of Medicine discussed a CQI study of catheter infections by Johns Hopkins which their IRB ruled was exempt from federal regulations. After publication of the results, the Office of Human Research Protection reviewed the results and claimed that this was research and should have been reviewed by the local IRB. This generated much discussion. See the link below.

Locally and nationally, there is confusion about when CQI projects should be submitted to the IRB and if they are submitted, what regulations need to be followed.

What is CQI?

CQIis the process whereby quality of care can be monitored and improved. CQI uses scientific methodology to improve performance. Performance can be measured in terms of clinical outcomes, patient satisfaction, error rates, productivity and other metrics. All hospitals and ambulatory clinics utilize CQI projects to improve patient care. Results are used locallyto improve care.

What is research?

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

How can you tell if CQI is research and thus when the project must be submitted to IRB?

  1. When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information gained from the evaluation will be used to solely provide feedback to improve that program, the activity is not human subjects research. The evaluation is a management tool for monitoring and improving the program. Information learned has immediate benefit for the program and/or clients receiving the program or services.
  2. When the activity involving human participants 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 research. The systematic comparison of standard or non-standard interventions involving human participants also is research.
  3. CQI projects are research when there is a testable hypothesis, there is rigorous scientific methodology used and there is the intention to contribute to generalizable knowledge (publications or presentation in a public area or outside of the institution). These projects must be submitted to the IRB. They can often be reviewed by an administrative (Expedited Review) process.

If a CQI research project is submitted to the IRB, then all human subjects regulations apply. Any revisions in the protocol must be reviewed and approved by the IRB prior to implementation. Adverse reactions need to be reported promptly to the IRB.

Generally, projects that involve the collection of data by residents or students for the purpose of publication are considered research.

On occasion, someone will initiate a CQI project which results in interesting findings that the individual would then like to publish or present outside of the institution. At that time, the project must be submitted to the IRB for review. The type of review will be based on the details of the specific project, but would rarely be a Full Board protocol.

Obviously, there are many gray areas where investigators may be uncertain if a project is considered research. If there is uncertainty, please email the IRB at and we will gladly provide you opinions about whether the project needs to be submitted to the IRB. Additionally, the Shands Core Policy entitled Research Protocol Review Requirements (CP1.85) should be consulted for research and CQI conducted by Shands employees or within a Shands facility.

Further examples to assist you in determining if a project is just CQI and not Research:

Example #1 -

A project is undertaken where 2 FDA approved drugs (eg. phenytoin vs. fosphenytoin) are compared to see if there is any difference in treating seizures. Data will be collected in the emergency department; no change in who receives either drug will be involved. The goal of this project is to report findings to a hospital committee to determine which drug will be on the hospital’s formulary. This is a CQI project, not research.

  • If the same project was undertaken, and the goal of the project was to publish the results in a professional journal or present the results at a professional meeting. This would then be research, whether or not it is also a CQI project.
  • If this same project was undertaken, presented to the hospital committee, then determined that the results were such that the involved individuals want to present or publish the results since others might benefit, then the data should be de-identified, and project submitted to the IRB as an “Exempt” research project.

Example #2 -

To provide better care, management decides to look at how many patients come through the Emergency Room each day and how long patients wait for care on a given day. With this information, additional staff might be needed to serve that population.

  • This evaluation monitors an existing process (flow of patients through the ER)
  • There is no alteration in the clinical care provided to these ER patients.
  • Information about the number of patients seen in the ER is routinely available to designated managerial staff that is responsible for providing efficient care in the ER.
  • There is no intent to publish or present the results.

This would be a QA project not requiring review.

Example #3 -

Same project as above with the exception that the management group from the onset intends to analyze the results for presentation to a national managerial conference in the fall.

  • This evaluation monitors an existing process (flow of patients through the ER)
  • There is no intervention in the clinical care provided to hospital patients.
  • Information about the number of patients seen in the ER is routinely available to designated managerial staff that is responsible for providing efficient care in the ER.

This QA project would need to be brought to the IRB for review since it is known in advance of conducting the project that the findings will be shared in a public area or outside of the institution.

Example #4 -

Data gathered for classroom training in research methods for which the only foreseeable purpose is teaching and there is no intent to publish or present the results outside of that classroom.

Example #5 –

Data gathered for administrative purposes alone within the context of the normal efforts of a department or an institution to find out what is happening or how to assure quality services or operations. There is no intent to publish or present the results.

These types of data gathering in Examples #4 and #5 are not research because there is no foreseeable dissemination of the data. Any record of the data (or interpretations and analyses of the data) remains private, used only for purposes that are appropriate to the classroom or institutional facility in the normal conduct of its work.

IRB version 12/15/2011An Equal Opportunity InstitutionPage 1 of 4