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. 

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.

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

QI/PI Project Guidance -Updated 6/2021 to update the definition of human subject to align with the revised common rule

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/PI Project Application -Updated 10/2020

This application is an abbreviated form that should be submitted to the QI IRB email inbox (PROVOST-IRB-QUALITY@pobox.upenn.edu) when a formal determination by QI IRB is requested by the faculty/staff.

QI/PI Application Review Process

The review process for QI/PI applications is depicted in the flow chart linked here: Download QI Project Submission Flow Chart. To summarize, the following steps are involved:

  • Step 1: Consult the operational leader;
  • If the project is clearly a research activity, then, submit to the IRB for review via HS ERA.
  • If the operational leader determines the project is QI/PI and no formal determination by IRB is needed, proceed with the project.
  • If the operational leader is unsure or a formal determination by IRB is desired, proceed to the steps below. 
  • Step 2: Complete the most recent version of the QI/PI application available on this webpage and the IRB Forms page. 
  • Step 3: Email completed materials to PROVOST-IRB-QUALITY@pobox.upenn.edu
  • Step 4: Initial assessment will be conducted by the QI review team. The QI Review team may contact the submitter for additional information/clarification.
  • Step 5: The QI Review team will send the submitter a formal determination via email. If the project is determined to qualify as human subjects’ research, the submitter will be directed to submit an application to the IRB via HS-ERA.

Information to include in a QI application to the IRB:

  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

1. Does the intent to publish a QI/PI project mean that project is considered research?

No. Per OHRP, “the intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research.” Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may qualify as research even if there is no intent to publish the results.”

2. What statement should I include in a resulting publication?

To avoid confusion, QI/PI projects should not be referred to as research in publications and presentations. 

If a project is established as quality improvement by the IRB: the following statement may be included in the resulting publication: “This project was reviewed and determined to qualify as Quality Improvement by the University of Pennsylvania’s Institutional Review Board.” 

If the project was not submitted to the IRB for a formal determination: the Operational Leader and the project team should be comfortable with including the following statement in the publication: “This project was undertaken as a Quality Improvement Initiative and as such was not formally reviewed by the University of Pennsylvania’s Institutional Review Board.”

3. Whom can I contact if have questions related to submitting QI/PI application for IRB review? 

If you have further questions, after reviewing this guidance document, please contact PROVOST-IRB-QUALITY@pobox.upenn.edu

4. Why is the Operational Leader input important in the QI/PI project review and implementation process?

For projects that involve health care interventions, it is sometimes difficult for the IRB team to assess if an intervention is going to change standard of care. In such cases, it is helpful during the assessment to know that the project is intended as a quality improvement project by the department/team. In addition, the operational leader’s input helps to establish what the current standards of practice are pertaining to a particular service area and confirm whether the proposed project meets an operational need.

5. What happens if my project is truly research and the project was not submitted to IRB?

If the project was not assessed up front as research, the data may not be usable and journals/professional conferences may not accept the work.

6. Why does the IRB require a separate application in HS ERA if my project does not qualify as QI/PI?

The QI/PI review process is not a full ethical review. When a project is determined to qualify as “human subjects’ research” the project needs IRB review and approval.

7. What do I do if my project has evolved from QI/PI to research after implementation?

If the project evolves into research, then the research will need to undergo IRB review. This should occur as soon as it is known. QI/PI and research components should be clearly distinguished.

8. At what point in the process do I submit the QI/PI application to the IRB?

An application should be submitted before the project is implemented.

9. Is consent required for QI/PI projects? 

While there are no regulatory requirements for obtaining consent for activities that do not meet the definition of human subjects' research, the IRB advocates that informing project participants is best practice, especially in the following scenarios: 1) The project team is interacting with QI/PI participants and/or 2) Data is being prospectively collected from QI/PI participants. Additionally, if QI/PI participants are not informed, the data may not be usable and journals/professional conferences may not accept the work. 

Likewise, the IRB expects project teams to respect those who participate and ensure they have the same autonomy as research participants. To ensure autonomy, the IRB expects project teams to minimize undue influence to participate in QI/PI activities, especially in scenarios where employees and students may be involved. Ideally, consent should be obtained from someone who is not in a position of authority over the QI/PI participants.