Quality Improvement (QI) Projects vs. Research

No. Such QI activities do not meet the regulatory definition of "research". Therefore, the federal regulations for protecting human subjects in research do not apply and there is no regulatory requirement for such activities to undergo review by the IRB.

Examples of clinical, practical, or administrative uses for performance measurements and reporting could include: 

• Helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery or infection rates.
   
• Enabling insurance companies to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.
   

No. Such activities do not meet the regulatory definition of "research". Therefore, the federal regulations for protecting human subjects in research do not apply and there is no regulatory requirement for such activities to undergo review by the IRB.

Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes include:

• A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.
   
• A hospital pharmacy implements an evidence-based approach to reduce pharmacy prescription error rates and collects prescription information by medical chart review. Adherence to this approach and medication error rates are evaluated by chart review after implementation to determine whether medication error rates have decreased as expected.
   
• A clinic that has seen an increase in geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit patient changes in order to see if the assessments are being performed with appropriate patients, and will implement additional in-service training of clinic staff if the audit finds that assessments are not being administered routinely.
   

Yes. In certain cases, a QI project may constitute human subjects research that is also considered "non-exempt". This means that the research does not meet one of the exempt categories defined in the regulations at 45 CFR 46.104.

Note: At OUHSC, the IRB reviews all research involving human subjects, including research that meets one of the exempt categories defined in the regulations at 45 CFR 46.104.

Examples of QI projects that may also be human subjects research:

• Introducing an untested clinical intervention for for purposes that not only include improving the quality of care but also include collecting information about patient outcomes for the purposes of establishing scientific evidence to determine how well the intervention achieves the intended results.
   
• Surgical group practice in a non-academic health system uses two standard techniques for hernia repair. The practice would like to determine which repair method is best. The proposed study would randomly assign patients to one technique or the other and patients will sign consent form for regular treatment.
  
  While the practice intends to improve patient care, non-research activities do not usually include randomization. Further, the results may yield generalizable knowledge that expands knowledge of a scientific discipline and may be applicable beyond the patients studied.

No. The intent to publish is an insufficient criterion for determining whether a QI activity involves research. Planning to publish an account of a QI 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, including, for example, if they believe others may be interested in learning about those activities. On the other hand, a QI project may involve research even if there is no intent to publish the results.

Important note: it is possible that a QI project may involve research even if there is no intent to publish the results. Refer to the definition of "research" and "generalizable knowledge". Individuals may also request an official determination from the IRB by submitting a Determination of Human Research Worksheet in iRIS.