Quality / Performance Improvement (QI/PI) Guidance

There is often confusion as to whether a Quality / Performance Improvement project may meet the criteria for human subjects’ research. Most QI/PI efforts do not require IRB review. However, in some cases these activities are designed to accomplish a research purpose as well.

 

If you plan to conduct a QI/PI project, review guidance below, and follow the QI/PI application review process detailed below, as needed.

Quality / Performance Improvement Guidance

This guidance document defines QI/ PI activities, identifies general attributes of QI/PI projects that may be research needing IRB approval, and details additional considerations one should consider when conducting QI/PI projects.

QI Guidance

QI/PI Application Review Process

The QI/PI review process is designed to identify activities that may qualify as research needing IRB review, or confirm such activities are quality improvement not subject to further review. The following steps are involved:

  1. Consult the operational leader.

    1. If the project is clearly a research activity, then, submit to the IRB for human subjects research review via eIRB.

    2. If the operational leader determines the project is QI/PI and no formal determination by IRB is needed, proceed with the project. You do not need to submit materials through eIRB.

    3. If the operational leader is unsure or a formal determination by IRB is desired, proceed to the steps below.

  2. Complete the Quality Improvement (QI) application in eIRB.

    Please note that formal QI determinations will no longer be issued via email. All QI submissions should come through eIRB. In eIRB, “Create Initial Protocol,” then answer the first few questions. When the application opens, selected “Quality Improvement” under the “Review Type Determination” panel when asked for your “Application Type.” This will open the QI-specific application for completion. You should not attach a separate QI form. Please answer the questions in eIRB.

  3. Assessment will be conducted by an IRB staff member through eIRB.

    The reviewer may contact the submitter for additional information/clarification via eIRB.

  4. The submitter will receive a formal determination through eIRB.

    1. If the project is determined to qualify as human subjects’ research, the submitter will be directed to submit a human subjects research application to the IRB via eIRB.

Information to include in the eIRB QI application:

  1. Background:

    • A summary of the operational issue that is being addressed by the project and background about the existing standards of care, education, practice, etc.

  2. Purpose/Goal:

    • How the project will be used to assess or improve the area of focus.

  3. Design:

    • Whether the project involves group assignments or is structured to make comparisons.

  4. Procedures:

    • Procedural and data collection methods, including any manipulations of the environment, interactions with individuals, or protocols that override clinical decision making.

  5. Population /Sites:

    • Whether the project involves the local institution only or involves individuals from additional sites.

  6. Risk:

    • Possibility of exposure of individuals to any additional risk beyond standards of care/practice.

  7. Utility of project results:

    • How will the results be used?

Frequently Asked Questions (FAQs) about QI/ PI Activities

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