What is QI and does it need to be reviewed by the PLU HPRB?
QI does not meet the definition of “human subjects research,” according to federal guidelines.
Instead, QI generally refers to a range of activities used to assess, analyze, critique, and improve current processes of health care delivery in an institutional setting. QI activities are typically observational and unobtrusive and can involve the collection and analysis of data to which investigators have legitimate access through their institutional roles. These activities do not prevent or hinder delivery of clinically-indicated care to patients, nor do they impose more than minimal additional risks to patients.
Because QI is not considered “research,” it is not subject to review by the PLU HPRB. Instead, if you believe your project to be QI, you should work with the administration at the health care agency or hospital where the project will take place (e.g., their Institutional Review Board or Research Office).
If you are not sure, please go to our online HPRB system, Mentor, and take our pre-proposal diagnostic survey. This will walk you through a series of questions that will help you determine if your project qualifies as QI and if it needs to be reviewed by the PLU HPRB.
- ensuring new evidence-based interventions are incorporated into practice
- improvement of over-all quality of life
- reduction of morbidity and mortality
- ensuring patients receive evidence-based interventions for their particular illness
- improvement in patient and family comprehension
- reduction in in-patient admissions and length of stay
- reduction of ER visits
- reduction in costs of service
- evaluating procedures no greater than minimal risk to patients, usual care practices, and interventions offered to all patients.
No, QI does not meet the definition of “human subjects research,” according to federal regulations.
Federal regulations define “research” as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)]. For example, if an investigator designs a project to test a novel hypothesis, replicate a previous study, or withhold any aspect of conventional care shown to be beneficial in prior studies, the federal definition of human subjects research (HSR) would apply. HSR is governed by federal regulation and does require submission to and oversight by the HPRB.
QI projects are not “research” but they often include “research-like” activities such as conducting surveys, reviewing identifiable data, drawing conclusions about problems, and suggesting methods for improvement. The key, however, is determining whether QI projects are designed to be generalizable beyond the scope of the specific institution where they take place. Most often, they are not.
Instead, QI projects focus on improving a specific institutional practice in comparison with an established standard or goal. The investigators are not using their participants as a representative sample. The results of the project are not intended to apply to anyone beyond the scope of the project, and conclusions are drawn only in relation to the particular practices at a specific institution, even when the findings are disseminated outside that institution. When QI is published or presented, the intent is usually to discuss potentially effective models, strategies, or assessment tools, or to provide benchmarks, not to develop or contribute to generalizable knowledge.
|Points to Consider||Research||Quality Improvement|
|Purpose||To test a hypothesis or establish clinical practice standards where none are accepted||To assess or promptly improve a process, program, or system; OR improve performance as judged by accepted/established standards|
|Starting Point||To answer a question or test a hypothesis||To improve performance|
|Benefits||Designed to contribute to generalizable knowledge and may or may not benefit subjects||Designed to promptly benefit a process, program, or system and may or may not benefit patients|
|Risks/Burdens||May place subjects at risk and stated as such||By design, does not increase risk to patient, with exception of possible privacy/confidentiality concerns|
|Data Collection||Systematic data collection||Systematic data collection|
|End Point||Answer a research question||Promptly improve a program, process, or system|
|Testing/Analysis||Statistically test a hypothesis||Compare a program, process, or system to an established set of standards|
Yes, it is possible. Some parts of a project may qualify as QI while other parts meet the definition of human subjects research (which are subject to HPRB review). It is also possible for a project to begin as QI and then lead to a research study. At the point where the project would involve human subjects research, the investigator would need to obtain IRB/HPRB approval.
Thus, it is important to consult with the institution where the research will take place (i.e., their IRB or research office) and/or the PLU HPRB.
If you are uncertain of whether a project constitutes QI, please go to our online HPRB system, Mentor, and take our pre-proposal diagnostic survey. This will walk you through a series of questions that will help you determine if your project qualifies as QI and if it needs to be reviewed by the PLU HPRB.
QI projects should be submitted to the health care agency or hospital where the project will take place.
In medical institutions, QI is a necessary and integral part of operations and, as such, QI projects are governed by standards within the agency/hospital and by the Joint Commission. You should contact the hospital/agency administration—and their Institutional Review Board (IRB) or Research Office—about how to proceed. Their IRB will make a determination whether the project is research, exempt research, or QI not requiring review.
Although the PLU HPRB has reviewed QI projects in the past, it will no longer routinely do so. However, if there is no IRB at the institution where the project is being conducted, you should submit to the HPRB at PLU.
Verify that your project is QI by taking the diagnostic pre-proposal survey through our online HPRB system, Mentor.
PHI is individually identifiable health care information or clinical specimens from an organization considered a “covered entity” by federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
PHI includes: name, date of birth, admission and discharge dates, phone number, street address/zip code/county, email address, Social Security Number, birth certificate number, photographs, fingerprints, drivers license number, medical records number, treatment dates and lists of services rendered.
More information on Protected Health Information can be found here.
HIPAA makes an exception for QI activities, including outcomes evaluation and development of clinical guidelines or protocols. These activities fall under the category of “health care operations” for which no HIPAA Authorization or Waiver of Authorization needs to be sought. The hospital or health care agency’s Privacy Office can authorize the use of PHI for QI projects.
If you intend to present your findings, please be sure to describe your project as QI rather than research. Investigators can disseminate their findings publicly, even though QI findings are not intended to be generalizable to settings beyond the one where they are carried out. That is, the results would not apply directly to other institutions. There is still value in presenting QI projects, as the methods used and questions asked might well generalize to other hospitals or health care agencies.
If you intend to publish your findings, you may find that the journal requires verification that the project has been submitted to an IRB (Institutional Review Board; we call it HPRB at PLU because we only review human participants research, rather than animal research). You will be able to get this document from the IRB at the QI site (e.g., hospital or other health care agency). If they determine your project to be QI, they will send you a document verifying that and indicating that because the project is QI and not “human subjects research” it does not require oversight from the IRB.
If the project site does not have its own IRB, you should submit to the PLU HPRB, and if we determine your project to be QI, we will send you verification that you can submit to the journal.