Quality Improvement/Quality Assurance (QI/QA)
Description
OHRP has provided guidance specific to quality improvement activities to help delineate between quality improvement activities and human subject research activities.
- DHHS regulations do not apply to QI activities whose 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."
DHHS OHRP Quality Improvement Guidance
These interpretations may be extrapolated to QI activities conducted in non-healthcare settings such as education, academia, or community.
If a project is originally initiated as a local QI project but the findings are of interest and the project investigator chooses to expand the findings into a human subjects research study, IRB review is required at that time.1
OPRS is currently working on providing additional guidance for the UIUC campus and its researchers. Until the UIUC-specific guidance and policies are provided, please review the attached guidance for background information and contact OPRS with any questions.
UIUC: Research vs. QI vs. Program Evaluation
University of Wisconsin-Madison Guidance
Oregon State University Guidance
1Bankert, E.A., Gordon, B.G., Hurley, E.A., Shriver, S.P. (2021). Institutional review board: Management and function (3rd ed.). Jones and Bartlett Publishers.