Activities conducted by one or more institutions whose primary purposes are limited to:

(a) implementing a practice to improve the quality of patient care, and

(b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes

are considered to be quality improvement rather than research. However, if the project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute human subjects research (HSR) under HHS regulations.

QA/QI generally refers to a range of activities conducted to assess, analyze, critique, and improve current processes of health care delivery in an institutional setting. QA/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 the delivery of clinically-indicated care to patients, nor do they impose more than minimal additional risks or burdens on patients.

• ensuring new evidence-based interventions are incorporated into practice
• improvement of over-all quality of life
• reduction of morbidity and mortality
• ensuring that 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.

Quality Assessment and Improvement consist of systematic, data-guided activities to bring about prompt positive changes in the delivery of health care and involve deliberate actions to improve care. Depending on the activity, QA/QI can look like practical problem solving, an evidence-based management style or the application of a theory-driven science of how to bring about system change. Introducing QA/QI methods often means encouraging people in the clinical care setting to use their daily experience to identify ways to improve care, implement changes on a small scale, collect data on the effects of those changes, and assess the results.

The Office of Human Research Protections (OHRP) defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge and human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, OR (2) Identifiable private information (45 CFR 46.102(d)).  For example, if a project using human subjects is designed to test a novel hypothesis, replicate another researcher’s original study, or withhold any aspect of conventional care shown to be beneficial in prior studies, OHRP’s definition of human subject research would apply.

The FDA does not use the term research, but considers it to be synonymous with clinical investigations, meaning any experiment that involves a test article and one or more persons (21 CFR 56.102(23)(c)). For example, if you are comparing the safety and/or effectiveness of a drug, or comparing a regulated device to another, you are engaged in a clinical investigation and must follow FDA regulations.

Yes. The following characteristics make it more likely that a project involves both QA/QI and human subjects research and would fall under the jurisdiction of the IRB. Consult with the IRB if you are uncertain.

• Randomization of patients into different intervention groups in order to enhance confidence in differences that might be obscured by nonrandom selection (but not to achieve equitable allocation of a scarce resource).
• Testing issues that are beyond current science and experience, such as new treatments.
• The involvement in key project roles of researchers who have no ongoing commitment to improvement of the local care situation.
• Delayed or ineffective feedback of data, especially if feedback is delayed or altered in order to avoid biasing the interpretation of results.
• Funding from an outside research organization with an interest in the use of the results.

No. An example of a QA/QI study that involved medication compliance included the randomization of patients to one of three arms:

• In one arm patients were given a cell phone and a reminder call when it was time to take their medication.
• Patients in a second arm were given a reminder call but no cell phone.
• Patients in a third arm took their medication while being directly observed by staff (direct observation therapy--DOT).

The intent to publish is an ‘insufficient criterion’ for determining whether a quality improvement activity involves research, according to OHRP.

When QA/QI is published or presented, the intent is usually to discuss potentially effective models, strategies, assessment tools or to provide benchmarks, rather than to develop or contribute to ‘generalizable’ knowledge.

Outside external funding may make a difference in distinguishing between QA/QI and research. An NIH research grant to support a project would often be considered research. Internal funding to improve a program may not.

Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes.  Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.  Ideally, the author of the article will obtain the signed authorization of the subject, or the subject’s legally authorized representative if the subject is deceased, to use the subject’s information in the article.  If it is not possible to obtain authorization, the author should be aware that one of the identifiers described by HIPAA as requiring written authorization is, “Any other unique identifying number, characteristic, or code….”  Moreover, HIPAA requires that, at the time of publication, “[t]he covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.” 

• Authors who remove HIPAA identifiers (including unique patient characteristics) from the data prior to submission and publication of the article do not need to obtain a signed privacy authorization. 
• Investigators who wish to publish case report data with HIPAA identifiers will need to obtain from the patient a signed HIPAA compliant authorization.  This authorization does not need to be submitted to the IRB for review. 
• If the author strips off all HIPAA identifiers, but the information associated with the subject of the article includes a “unique characteristic” which would make it identifiable to the subject, or the author has actual knowledge that the information about the subject could be used alone or in combination with other information to identify the subject, the author must contact the HIPAA Privacy Officer to discuss the required steps to take prior to publication.

Submit an application for Determination of Human Subjects Research and/or contact umkcirb@umkc.edu if you are still uncertain how to proceed.