A formal review process is required to ensure clear distinction between human subjects research and quality improvement initiatives to ensure the protection of our patients, investigators, and the institution.
Human subjects research is governed by the Institutional Review Board (IRB) and other applicable policies.
Quality improvement projects do NOT incorporate human subjects research.
Regardless of whether an activity is quality improvement or human subjects research, teams must follow Institutional Security Policies and HIPAA regulations for protecting information, including ensuring that appropriate legal and business associates agreements are in place prior to sharing any individual or identifiable information outside of the institution (e.g. presentations at meetings, poster presentations, abstracts, and publications).
- Complete all aspects of QI Determination application
- Obtain Departmental Quality Chief’s signature by reaching out to them directly (contact information listed below)
- Submit QI Determination application, signed by Quality Chief, to the Center for Healthcare Delivery Science and Innovation
Neither this process nor the IRB provides or guarantees resources for acquiring or extracting data.
Publication of a project has no bearing on whether it is human subjects research or quality improvement. You may wish to publish something if you believe others would be interested in learning about your activities without it being human subjects research. Conversely, some improvement projects are in fact better classified as human subjects research even when there is no intention of disseminating or publishing the findings. This process must be completed for all quality improvement work to be shared outside of the institution.
If the project is deemed a quality improvement project, it must be described in any dissemination of information (publications, posters, presentations, etc.) as a quality improvement project/initiative and not as research or a study.
Quality improvement occurs on a continuous basis throughout the institution. Most quality improvement efforts are very local and will not be shared outside of the institution (e.g. Managing for Daily Improvement huddles). Quality improvement initiatives that are NOT shared outside of the institution are outside the scope of this policy.
Projects that will be shared outside the institution will go through the QI Determination process and then will be sent to the Privacy Office before an ACReS request is granted.
No individual shall make the determination for themselves as to whether their project is quality improvement or human subjects research.
- The QI Determination Application should be completed in enough detail to clearly understand the project and signed by the project leader.
- The Quality Chief (or equivalent) over the area to which the project leader belongs (i.e. Medicine, Nursing) must approve and sign the application, if they agree the project is quality improvement. The submitter contacts the Quality Chief directly, and they are listed below (“Quality Chief Contact Info”).
- The Application is submitted to the Center for Healthcare Delivery Science & Innovation.
- The Application is reviewed by the Chief Quality & Innovation Officer or a Chief Quality Determination Reviewer.
- The project leader will receive an email from the Chief Reviewer with an official determination (either A. meets the definition of QI or B. is more appropriate for IRB).
Human Subjects Research
Human subjects research is governed by the IRB and other applicable policies.
Human subjects research is defined in CFR §46.102 as:
- Research: a systematic investigation … designed to develop or contribute to generalizable knowledge
- Human subject: living individual about whom an investigator conducting research obtains
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.
Quality improvement work is governed by organizational structures and committees, culminating in the University of Chicago Medicine Quality Committee. The senior institutional officials responsible for quality improvement and patient safety are the Chief Quality & Innovation Officer (CQO) and the Vice President of Risk Management and Patient Safety.
Quality improvement is sometimes defined in the following ways:
- “Quality improvement (QI) consists of systematic and continuous actions that lead to measurable improvement in health care services and the health status of targeted patient groups.”
- Quality improvement is “the combined and unceasing efforts of everyone—healthcare professionals, patients and their families, researchers, payers, planners and educators—to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development”
- The pursuit of the triple aim: “Improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations, and reducing per capita costs of health care.”
As examples, the following projects are examples of quality improvement:
- A team changes the approach of scheduling in clinic and uses Lean principles to reduce waiting. To assess impact, they measure throughput, potentially preventable hospital admissions, and patient satisfaction with care, all of which are collected as part of routine operations.
- A guideline for managing pneumonia is published by a national specialty society. A multidisciplinary team adapts this guideline to UCM and implements it using PDSA tools. To assess improvement, the team uses data from the electronic health record on compliance with the guideline, patient outcomes and costs of care.
 U.S Department of Health and Human Services, Health Resources and Services Administration. Quality improvement. 2011. Accessed 29 October 2015 at http://www.hrsa.gov/quality/toolbox/508pdfs/qualityimprovement.pdf.
 Batalden P, Davidoff F. What is ‘‘quality improvement’’ and how can it transform healthcare? Qual Saf Health Care 2007;16:2–3
3Berwick D, Nolan TW, Whittington J. The Triple Aim: care, health, and cost. Health Affairs, 27, no.3 (2008):759-769.
 Berwick D, Nolan TW, Whittington J. The Triple Aim: care, health, and cost. Health Affairs, 27, no.3 (2008):759-769
For more information regarding the background of quality improvement determination, read the following resources:
|Quality Chief or QI Contact||Department|
|Avery Tung, MD||Anesthesia & Critical Care|
|Debra Stulberg, MD||Family Medicine|
|Andy Davis, MD||Medicine|
|Shasha Wu, MD||Neurology|
|Judy Doty, MSN, RN||Nursing|
|Judy Doty, MSN, RN||Nursing Trainees|
|Tessa Balach, MD||Orthopedics|
|Roxane Holt, MD||Obstetrics|
|Kathryn Colby, MD, PhD||Ophthalmology and Visual Science|
|Shari Snow, MD||Gynecology|
|Tatjana Antic, MD||Pathology|
|Allison Bartlett, MD||Pediatrics|
|Randall Knoebel, PharmD, BCOP||Pharmacy|
|Royce Lee, MD||Psychiatry|
|Stanley Liauw, MD||Radiation Oncology|
|Jonathan Chung, MD||Radiology|
|Vivek Prachand, MD||Surgery|
|Marla Robinson, MSc, OTR/L, BCPR||Therapy Services|
To request data, please use the ACReS platform. The ACReS system is the primary method to intake new data requests from throughout UCM/BSD, supporting wayfinding among the 20 different data teams.
Please request data after receiving an official QI Determination letter.
The University of Chicago Medical Center’s Policy and Procedural Manual on Internal Data Sharing: