Overview of Quality Improvement
The conduct of quality improvement falls under the jurisdiction of Stony Brook Medicine’s Division of Medical and Regulatory Affairs and/or a hospital-recognized departmental quality improvement committee (collectively referred to from this point on as ‘Hospital QI’). The Chief Quality Officer provides leadership and oversight on matters related to quality improvement projects.
Quality Improvement promotes accountability for the quality of health care delivery and service. This is accomplished through a systematic approach of assessing, defining interventions, implementing, and evaluating effectiveness of interventions with the goal of continuous improvement of clinical care and service. Quality Improvement is supported by a structure that establishes accountability to Stony Brook University and allows for information flow to and from Stony Brook University and personnel.
In order for you to be certified to conduct a quality improvement project, you must satisfy a training requirement (along with obtaining approval for the Quality Improvement activity).
The Institute for Healthcare Improvement (IHI) collaborated with Dr. Mike Evans, Associate Professor of Family Medicine and Public Health at the University of Toronto, to create a dynamic, animated whiteboard video that introduces the concepts of quality improvement in health care.
Complete the training requirement by viewing this video below. When completing the
Qualtrics survey you will be asked to confirm that you completed this module.
Effective July 30, 2025
Review the Policies and Procedures document to learn what needs to be included in your Quality Improvement application (data security, etc) and how the applications are reviewed. This will help ensure that your project will be conducted both ethically and as smoothly as possible.
The Institute for Healthcare Improvement site has a variety of training opportunities as well as a toolkit that can assist you with your Quality Improvement project.
| Accordion Item Title | Accordion Item Content |
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Do I submit my Quality Improvement (QI) project through myResearch IRB and the Qualtrics (Quality Improvement Survey) for review and approval? |
No. Quality Improvement (QI) projects do not need IRB review and oversight. Once you have submitted your QI project using the Quality Improvement (QI) Survey for review, the oversight for that QI project is throught the Chief Quality Officer. |
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Who can complete and submit the Qualtrics Quality Improvement Survey for a QI project? |
Any faculty, staff, resident, or student involved with the project may submit. |
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If I plan to carry out a quality improvement project and publish the results, does the intent to publish make my quality improvement project fit the regulatory definition of research? |
No, the intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. The regulatory definition under 45 CFR 46.102(d) is “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. |
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Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subject regulations? |
Yes, in certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a 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 nonexempt human subjects research under the HHS regulations. |
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Does a quality improvement project that involves research need to be reviewed by an IRB? |
Yes, in some cases. IRB review is needed if the research involves human subjects, is not exempt, and is conducted or supported by HHS or otherwise covered by an applicable Federalwide Assurance |
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What if I need to access Protected Health Information (PHI)? |
The Health Insurance Portability and Accountability Act (HIPAA) makes an exception for QA/QI activities, including outcomes evaluation and development of clinical guidelines or protocols. These activities fall under the category of “health care operations” for which no HIPAA Authorization or Waiver of Authorization needs to be sought. |
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What if I am getting funding for my project? |
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. |