Frequently Asked Questions

• Do I submit my Quality Improvement (QI) project through myResearch IRB and the Qualtrics (Quality Improvement Survery) 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.

• 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.

• 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.

• 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

• 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.

• 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.