Quality Assurance (QA) and Quality Improvement (QI)
When Does a QA/QI Activity Become Research?
The terms Quality Assurance and Quality Improvement generally refer 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. They involve the collection and analysis of data to which the investigators have legitimate access through their institutional roles, They do not prevent or hinder the delivery of clinically–indicated care to patients, nor do they impose additional risks or burdens (physical or psychosocial) on patients or hospital staff.
The information below is to help educate investigators about the differences between QA and QI activities and those activities that would be considered research subject to oversight by the IRB. Federal regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Also, research must involve the collection of data or private information about a living individual.
Quality Assurance Research Guideline
The purpose of a QA study is simply to assure known quality. A QA study should present no additional risk to participants. These studies are mechanisms to assure that the Carilion Clinic functions optimally. Such projects are usually for internal auditing purposes only. QA studies might be used to evaluate direct patient care processes (typically involved in creating clinical practice guidelines), evaluate billing practices, accumulate statistical data for monitoring and clinical performance assessment purposes, and assess community-based outreach programs for delivery of health care.
QA studies must not:
- Infringe on a patient’s privacy;
- Breach a patient’s confidentiality; or
- Pose additional risk to patients, healthcare providers or staff
Quality Improvement Research Guidelines
The purpose of a QI study is to determine quality, improve patient services, and/or improve the provision of medical care. A QI study is generally applied within a defined institutional setting, often a single department or division. It is usually intended to motivate change of practice in a specific location. The intent is to evaluate and alter processes constituting the delivery of health care in the near future, with the expectation that the population of patients usually served in that location will benefit. This is different from research, which is traditionally intended to generate universally applicable knowledge. The experimental method in research is chosen to generate, evaluate or confirm an explanatory theory or conclusion and invite critical appraisal of its stated conclusion by peers through publication and debate.
Examples of projects that are human subjects research:
- A project that involves interventions, procedures or tests beyond what is routine for patient care and then collects data or gathers information about the interventions, procedures or tests.
- A project that compares prospective interventions that are deliberately administered or made available (through randomization or other process) to some patients and not to others. This does not include a QI process of a small percent of patients at Carilion first to ensure feasibility before introducing it to the entire patient population.
- A project that utilizes test subjects for new devices, products, drugs or materials.
- A project that collects sensitive data through intervention or interaction with individuals. Examples: internet surveys about alcohol consumption, research involving risky behaviors or attitudes, studies requesting information on HIV status.
- A project involving deception.
- A project utilizing open-ended interviews with minors that contributes to generalizable knowledge.
- A project that uses bodily materials such as cells, blood, urine, tissues, organs, hair or nail clippings; even if one did not collect these materials for the study.
- A project that produces generalizable knowledge about categories or classes of subjects from individually identifiable information.
- A project involving the use of human beings to evaluate environmental alterations. Examples: weatherization options or habitat modifications to their living or working space or test chamber.
- A project involving care practices, interventions or treatments that are not standard.
- A project involving more than minimal risk to subjects.
Examples of projects that are not human subjects research:
- A project that collects only data for internal departmental, school or other Carilion administrative purposes. Example: teaching evaluations, customer service surveys.
- A project involving only service surveys issued or completed by Carilion patients, students or staff for the intent and purpose of improving services and programs of Carilion or for developing new services and programs, as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained and survey participation is voluntary.
- A project involving only information-gathering interviews where questions focus on things, products or policies rather than people or their thoughts regarding themselves. Example: canvassing nurses about a new hand-washing policy.
- A project involving only court-related activities designed specifically for education or teaching purposes, where data is collected from and about human subjects as part of a class exercise or assignment, and not intended for use outside of the classroom.
- A project involving only biography or overall history research involving a living individual that is not generalizable beyond that individual.
- A project involving only an innovative therapy; an intervention designed solely to enhance the well-being of an individual patient or client, with the purpose being to help provide diagnosis.
- A case history when the case is limited to a description of the clinical features and/or outcome of a single patient and does not contribute to generalizable knowledge.
- A project involving only coded private information or biological specimens that were not collected for the currently proposed project and involves only information and specimens that the investigator cannot link back to the individual subjects.
Before medical records are released, Health Information Management or Clinical Integration and Analytics may require a letter from the IRB regarding the status of your study proposal. If this happens, please fill out the form by following the link at the end of this page and submit it to the IRB.
IRB review and approval should be sought if it is expected that the results of the research are to be published or presented at a conference in a way designed to contribute to generalizable knowledge. A journal or national body sponsoring a conference may not accept or publish research results without IRB review.
- IRB QA/QI Determination Application (updated 4/2014)
This information is based on guidelines from the Human Studies Committee at Washington University Medical Center and the Institutional Review Board at LDS Hospital in Utah.