Getting Started: Planning your Improvement Project
Like many scientific fields, theoretical frameworks exist to guide the development of projects in quality improvement, clinical innovation, and implementation research. A popular framework for improvement projects, the Model for Improvement, can be used to quickly study small changes through cycles of Plan-Do-Study-Act (PDSA). Using these frameworks to plan your project prior to data collection can drastically increase the rigor of your improvement project, saving you time and unnecessary hurdles. Before your project begins, think about what measures you will use, how those measures will be defined, how you will collect your data, and how your data will be presented. Below, are resources to help guide you in planning your improvement project.
Institution of Medicine’s Six Aims for Improvement
Project PDSA Worksheet: a tool for planning each PDSA cycle of your project
Measurement Planning Worksheet: a tool for defining your measures prior to data collection
Introduction to Control Charts
- Does your project include Human Subjects Research?
- Yes: The Institutional Review Board (IRB) governs human subject research.
- No: If you plan to share data or results outside of UCM, you must complete the Determination of Quality Improvement Application.
- Send your application to your Quality Chief or QI Contact
- Neither process allocates resources for acquiring or extracting data.
- The intent to publish the results of a project does not determine whether it is research nor whether it needs IRB review.
- Are you collecting data?
- Be sure to review all institutional policies on appropriate handling of data
- If you need to request data, submit your request to Analytics Core
- Please note, your request is one of many in each analytic team’s queue, there may be competing resources and a request does not guarantee data will be provided.
- Share your results internally. Submit your work to the annual Quality & Safety Symposium.
Human Subjects Research vs Quality Improvement
Human subjects research protections are governed by the Institutional Review Board (IRB) and other applicable policies. Quality improvement is not human subjects research. Having a process to ensure clear distinctions between the two is important for patients, for investigators, and for the institution. Current guidance from the Department of Health and Human Services can be found here. The intent to publish the results of a project does not determine whether it is research nor whether it needs IRB review.
Sharing of quality improvement data and results outside of the University of Chicago (e.g. presentation at meetings, poster presentations, abstracts, and publications) requires formal approval via the Determination of Quality Improvement Application.
Have questions? Contact Heather Limper
Institutional Review Board
All projects determined to involve human subjects research must be submitted to the Institutional Review Board (IRB). All faculty and staff interested in participating in research of any kind must complete CITI Training, which is offered online. Be sure to “affiliate” yourself with the University of Chicago on the CITI website to ensure verification of completion is sent to UCM. Additionally, it is highly recommended you print the “Certificate of Completion” presented at the end of the training for your records. If your study will involve certain participants, you may need additional approval prior to submitting to the IRB:
Nursing Research Committee (NRC): If your research involves nursing staff (other than nurses hired to do research or hired as Clinical Research Associates) or nursing care as either investigators or subjects, you must obtain approval from the NRC prior to submitting your proposal to the IRB. For more information on the NRC submission process or to find out if your protocol requires NRC review, please contact Dr. Janice Phillips, Nurse Researcher, at 2-6084.
Clinical Trials Review Committee (CTRC): If your research involves cancer patients or their data, you must obtain approval from the CTRC prior to submitting your proposal to the IRB. For more information on the CTRC submission process or to find out if your protocol requires CTRC review, please contact Amber Burnett in the Cancer Research Center at 4-0357 or firstname.lastname@example.org
Institutional Biosafety Committee (IBC): If your research involves biohazards, such as infectious agents, genetically altered organisms and agents, or recombinant DNA, you must obtain approval from the IBC prior to submitting your proposal to the IRB (assuming human subjects are also involved).
The MacLean Center Ethics Consultation Service: Research Ethics consultations are a collaboration between clinical investigators and clinical research ethicists. Together, they review the design and implementation of a research project that poses novel issues in human subject protections. Any investigator can call for a Research Ethics Consultation (REC) at any stage of the research protocol design. Also, the Institutional Review Board (IRB) can request that an investigator obtain an REC for particularly complex ethical issues.
For a list of institutional oversight committees, Click Here.
Useful resources at University of Chicago Medicine:
The BSD/UCM IRB website: IRB submission and meeting dates
AURA: This system allows you to electronically submit your proposal to the IRB
Office of Clinical Research: Find researcher training and education as well as resources for conducting clinical research
The Center for Research Informatics: This group provides computational resources and expertise in biomedical informatics for researchers within BSD
Analytics Core: This group oversees data requests made throughout UCM. All data requests should be submitted via this mechanism.