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QI/QA or Human Subjects Research

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Does Your Research Project Require Approval of a Human Subjects Protocol?

If you have a question about the category in which your project falls, the first step would be to go to the Research and Economic Development (RED) website and fill out and submit a Determination of Activity Form, which can be found on the Research and Economic Development forms page. The act of filling out the form may clarify where your research falls; if not, submit the form and RED will review and let you know the next necessary steps.


Definitions of Terms

An activity conducted to assess, analyze, critique, and improve current processes in an institutional setting, involving data-guided, systematic activities designed to bring about prompt improvements (e.g., a survey that is intended only to improve patient experience at one clinic where they are members).

Per the Office of Human Research Protocols (OHRP), research is any systematic investigation designed to develop or contribute to generalizable knowledge (e.g., if you plan to publish or present your results, suggest they are adopted by other locations, or provide them to government officials for use in policy decisions).

Per the Food and Drug Administration (FDA), these are clinical investigations involving human subjects and must submit an IRB application. For the UCR IRB, research involving human subjects is any research involving living individuals or their personal health information (PHI), intervention (including manipulation of a person or a person’s environment), interaction (e.g., surveys, interviews, tests, or observations, etc.), and/or obtaining identifiable private information about living individuals.

There is a lot of grey area between QA/QI and human subjects research. The case studies here will help you think about the differences, but when in doubt, you should submit a proposal to the IRB for comment or review, since Human Subjects research cannot be legally started until a protocol has been reviewed and approved by the IRB.

About Human Subjects Research

If your research includes interaction with anything related to a living individual or their Personal Health Information (PHI) and is a systematic investigation designed for generalizable knowledge (e.g., publication, presentation, expansion to an institution other than the research location, approaches to lawmakers), then it is considered to be Human Subjects Research and requires an application form to be submitted to RED. Because federal regulations and forms change on a regular basis, it is best to always go to the website for the most current IRB application form.

For additional information regarding what RED confirms is in place before an application is sent to the IRB for review, see the criteria provided to the IRB members when they are considering review