You do not claim QI at Herzing. You file for a determination.

Does a Herzing capstone or practice project need IRB review at all?

It needs a filing. Herzing's own Getting Started letter states that all proposed research projects undertaken under the university's name must be submitted to the IRB for review and approval, and that doing so is a requirement of university policy rather than a courtesy. There is no self-certification route, no threshold below which you quietly proceed, and no category you can assign yourself on the strength of a course title.

What varies is which application you file and what the board concludes from it. Both forms open by explaining their own purpose in nearly identical language: the IRB reviews the request to determine whether it is human-subjects research meeting the definitions in the Common Rule, and therefore whether it requires the board's review and oversight. The determination is the product. Your job is to give the board enough to make it — the improvement form is explicit that supplying complete information about the planned processes is the investigator's own responsibility.

What two questions does the determination actually turn on?

Herzing's Statement of Principles walks the same path a federal reviewer walks, and it is shorter than people expect. First: is the project research? The regulation's test is a systematic investigation — development, testing and evaluation all count as forms of one — carried out with the aim of contributing to knowledge that generalizes. Second: does it involve human subjects? That means a living person from or about whom an investigator, doing research, either obtains information by intervening or interacting and then analyses it, or obtains, generates and studies identifiable private information.

Both yes, and the project may need IRB approval to proceed. Either one no, and the regulations do not reach it — though the filing that establishes that fact still happens. Herzing adds a third gate that nursing projects trip more often than expected: if the activity uses a drug outside the normal course of medical practice, uses a medical device outside the normal course of medical practice, or produces data that will go to or be held for the FDA, the project needs IRB approval regardless of how the first two questions came out.

OHRP sets these out as an ordered test, and the order matters because a "no" ends the enquiry:

1. Does the activity involve research, as the regulation defines it?
2. Does that research activity involve human subjects?
3. Does the human-subjects research qualify for an exemption?
4. Is the non-exempt research conducted or supported by HHS, or otherwise covered by an applicable assurance?

Notice that "is it quality improvement?" appears nowhere on that list. QI is not a fourth category with its own door; it is a description of a purpose, and purposes are what question one examines.

How does Herzing itself separate research, evidence-based practice and QI?

Unusually, it publishes the comparison rather than leaving it to a course. The Statement of Principles sets out three activities side by side, and the row that decides most files is the third one.

Which row do arguments actually break on?

Generalizability, nearly every time. Herzing lists it as a defining feature of improvement work that it is not intended to travel beyond the site — while noting that findings are often shared for others to consider, which is a different thing entirely. A project measured against its own unit's baseline, aimed at that unit's own process, remains improvement work even when a poster about it goes to a conference.

The methods row is the second break point. Improvement work runs iterative, data-driven cycles — Herzing's improvement application asks you to name the framework you will use and offers KTA, PDSA, ADKAR, Lean, Six Sigma and DMAIC as examples. Research runs systematic scientific inquiry against measurable or manipulable variables. If your design has arms, a comparison group, or an allocation rule, the framework field is not going to rescue it.

Does intending to publish make it research?

No, and the desk sees this misread more often than any other. OHRP treats a plan to publish as an insufficient basis, on its own, for calling an improvement activity research — people write up non-research work for all sorts of ordinary reasons. The inverse is the half nobody quotes: an improvement project can involve research even where nothing will ever be published.

What does move a project across the line is the purpose the data serves. OHRP's own example is precise: introducing an untested clinical intervention for purposes that include not only improving care but also collecting information about patient outcomes in order to establish scientific evidence of how well the intervention works — that may constitute non-exempt human-subjects research. Untested plus evidence-building is the combination. Implementing a practice already demonstrated to work, and auditing whether your site adhered to it, is not.

Which application carries which determination?

Herzing's routing is by programme, and each form is shaped around the determination it expects.

• DNE and DNP practice projects file the Improvement or Innovation Project Application. It asks for an aim statement — pointing you at the Institute for Healthcare Improvement's aim-statement worksheet — a project overview covering purpose, strategy, measures and desired outcomes, the improvement framework, and a data-security plan. It carries three signature lines: yours, your project faculty's, and your program chair's.
• Everything else files the Research Protocol Application. It asks for the research question in P.I.C.O.T. form, a project abstract naming purpose, variables and the intended use or publication of the knowledge gained, a methodology section, a participant section, risks and benefits. Where the principal investigator is not yet faculty, a faculty sponsor signs too — and that signature accepts responsibility as co-principal investigator, which is a real undertaking rather than a countersignature.

There is a diagnostic hiding in that contrast, and it is better than any checklist. The form you can answer honestly is the form your design belongs on. If the P.I.C.O.T. line writes itself and the improvement-framework box feels like a stretch, you are describing research. If the aim statement is natural and the "variables" field makes you uneasy, you are describing improvement work. A design that fights its own form is a design about to be re-categorised by someone else.

Why does the category get settled before anything else is built?

Because a category corrected during review does not send back a document — it sends back the design, and every pocket built on the old assumption goes with it. Consent language, the instrument, the data-security answers and the recruitment route all inherit their shape from the category. Rebuilding them is not editing; it is starting the folder again.

It also determines the depth of the reading. Once the board has decided the project is human-subjects research, a second question opens immediately: exempt, expedited, or the convened board? That one is read on its own in the four landings a Herzing file can reach, and the documents each landing expects are laid out in the checklist the board reads as one file. How it works gives the tab-by-tab account of how we make that call alongside you.

What to do next

Write down your design in three lines — what you will introduce, what you will record about whom, and who is meant to act on the result — and read those lines against the table above rather than against your project's title. If they point one way and the title points the other, trust the lines.

Then send them to us. The free application review comes back with the honest call set down in writing, the review path your design points toward, and the first pocket worth opening. It costs nothing, it commits you to nothing, and plenty of people take the reading and file everything else themselves. The project, the data and the conclusions remain yours throughout; the determination remains the board's.

Sources

• Herzing University IRB, Statement of Principles (PDF, September 2025) — Common Rule definitions, and the research / EBP / QI comparison. IRB_Statement_of_Principles.pdf
• Herzing University IRB, Getting Started: Read this First (PDF, October 2025). IRB_Getting_Started_1025.pdf
• Herzing University IRB, Application for Improvement or Innovation Project Approval (PDF, November 2025). Healthcare_Improvement_InnovationProject_Application.pdf
• Herzing University IRB, Application for Research Protocol Approval (PDF, October 2025). IRB_Research_Protocol_Application_1025.pdf
• Herzing University, Institutional Review Board (IRB). herzing.edu/institutional-review-board-irb
• Office for Human Research Protections, the FAQ set on quality improvement activities. hhs.gov — OHRP guidance on QI activities
• 45 CFR 46.102 — the definitions section of the Common Rule. ecfr.gov — title 45, part 46

Form names and programme routings change with handbook editions; verify both against Herzing's current IRB handbook or portal. The two Common Rule questions underneath them do not change.