Quality Improvement Projects

• Data Collection Plan:
  • Baseline data
  • Target
  • Numeric gap
• It may be necessary to further “Breakdown the problem” in order to articulate the project scope
• Identify project team members
• If you are able to articulate your project as QI (not as research), then this process will be very smooth and seamless.

• Every institution’s review board may have slightly different processes and procedures for completing different reviews for different types of approval. Hence, it is important to inquire early so not to be surprised by certain steps, timelines, or requirements.
• When a project aligns strongly to a QI intent (i.e., clear gap is articulated with a limited scope and a proposal for evidence-based interventions), the review and approval process may be completed with a turnaround as quickly as a few days.
• When there are elements of the project design that are not clear or that suggest the “intent to produce new generalizable knowledge” (i.e., the definition of “research”), then you may expect to invest more time and dialogue on a deeper review to clarify the elements of the project’s investigation.

• Research seeks to create new knowledge that can be generalizable to other populations/settings, while QI activities seek to apply existing knowledge (i.e., benchmarks, evidence, guidelines/best practices) to create change that will achieve the best possible clinical outcomes.
  • When an activity involves the inclusion of people to test a new, modified, or previously untested intervention, service, or program for which there is insufficient evidence to determine whether it is safe and/or effective, this is research involving humans and it is subject to IRB review and approval.
  • A comparative effectiveness study examining two evidence-based methods, with people randomized between the two methods to determine which is better, is also regarded as research involving humans.

• The goal of QI is for the combined efforts of everyone to make changes that lead to 1) better patient outcomes (health); 2) better system performance (care); and 3) better professional development (learning). The goal of “research” is to generate new scientific knowledge that can be generalized to other settings and populations. However, some QI projects can also involve human subjects research (HSR); hence all QIPS projects should be submitted for IRB review for a NHS determination
• Conducting “research” without IRB approval can be a violation of federal regulation. Obtaining a non-human subjects research (NHSR) “determination letter” citing that the work does not involve human subjects research (NHSR determination) eliminates the risks.
• Institutional review boards will not, and cannot, grant retroactive approval of an activity that is conducted as a QI project which is later determined to be human research.
• Often, an individual, office, or entity may be able to review applications on behalf of their respective institutional review board (without formal application, presentation, or review) to grant a NHSR “determination letter” for your records.
• Note: A NHSR determination is different than a determination for “IRB exemption,” which does require review by the IRB and may be done by expedited review in many cases.

• Simply having an “intent to publish” is an insufficient criterion for determining whether a QI activity involves research. Even planning to publish an account of a QI project does not necessarily mean that the project fits the definition of research.
• The process of data collection is an insufficient criterion for determining whether a QI activity involves research. Both QI and research may include prospective or retrospective data collection and may collect data on living/deceased individuals.
• An authoritative determination might be required by a journal or conference prior to acceptance of a health care related manuscript for publication or presentation in a public forum.
• Additionally, many institutions require IRB review when there is an intent to submit for publication and/or present in a public forum.
• Hence, it is important to inquire early in the project design phase to avoid being surprised by certain steps, timelines, or requirements.

• Describe the purpose of the improvement effort, program, or evaluation and what internal processes you intend to improve (e.g., increase/decrease, reduce, etc).
• Avoid using the words “research,” “study,” and “principal investigator.” Instead, use “project,” “project leader,” and “project team.” 
• It becomes confusing to a reviewer if the terms quality improvement/program evaluation/research/study are used interchangeably.
• Limit data collection to the fewest data fields, smallest time periods, and number of patients, etc., needed to demonstrate a gap, the impact of the intervention on change, and improvement over time. 
• Avoid use of complex statistical methods aside from what is needed to demonstrate a gap, the impact of the intervention on change, and improvement over time.
• Make sure it is evident that you are not doing research.

• Do not refer to QI projects as “research” in publications or presentations.
• If the project was not submitted to the IRB for determination, the following statement may be included in the manuscript: “This project was undertaken as a Quality Improvement Initiative and as such does not constitute human subjects research.”
• If the project was reviewed by a research compliance office and was determined not to be human subjects research, the following statement can be included in the manuscript: “This Quality Improvement Initiative was reviewed and determined to not meet the criteria for human subjects research by the [institution].”

UMKC/University Health

Children’s Mercy

Saint Luke’s Hospital