Quality / Performance Improvement FAQs

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.”

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.”

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

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.

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.

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.

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

An application should be submitted before the project is implemented.

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.