the review paths
Not human subjects, exempt, expedited, full board: what actually sorts a Herzing file.
Four depths of reading exist, and only the last of them is what most people picture when they say "IRB review". Which one your file receives is settled by a handful of facts about the design — what gets recorded, whether a person could be picked out of it, what exposure would cost them, and who is in the population. It is not settled by your topic, your programme, or how urgently you need to start.
Olivia Tremblay, MSN, RN·Filed 23 August 2026·Updated 23 August 2026
Four landings: not human-subjects research, an exempt category, expedited review, or the convened board. Herzing's Bylaws give the sorting to the IRB Chair, who reads it off your design. You may argue for a level in the application; you cannot assign one.
Who assigns the level, and can you pick it yourself?
One person sorts, and it is not you. Herzing's IRB Bylaws list among the Chair's duties the review of every incoming application to establish whether it is exempt, eligible for expedited handling, or in need of full board review. The Bylaws then go further on the lightest path: investigators may submit protocols they believe qualify for exemption, but the Chair or a designee makes the final determination — and research may not begin until written approval has been granted.
That leaves you a real but limited role. You can present the design so the sorting is obvious, and argue for a level in the language the reviewer already uses. What you cannot do is treat your own reading as the answer and start work on it. A file behaving as though its exemption were self-executing turns a procedural question into a compliance one.
What are the four landings, and what does each ask of the file?
The differences are worth memorising, because they change what the folder must carry and who reads it.
| Level | What puts a file here | Who reads it | What the file still has to carry |
|---|---|---|---|
| Not human-subjects research | The design fails one of the two Common Rule tests — no generalizing aim, or nobody identifiable behind the data | The Chair, from your written account | An exact statement of aim, setting, data and who is touched |
| Exempt | Human-subjects research sitting wholly inside a listed exemption at minimal risk | The Chair or a designee, who makes the final call | The full application, the instrument, and consent information where the category requires it |
| Expedited | Risk at or below the minimal threshold, and a design that appears on the federal list — or a minor change to an approved protocol | The Chair, or an experienced member designated by the Chair | Consent file, data-security answers and site permission, all read closely |
| Full board | Risk above that threshold, a protected population, deception, or one of Herzing's own printed triggers | The convened board, at a stated meeting, on a quorum | Everything above, plus the justification for the population and the risk |
Which exempt categories does a nursing project realistically reach?
Herzing's Statement of Principles reprints the ones its board actually uses, and for practice-based work the field narrows quickly to two.
- Surveys, interviews, educational testing, or watching behaviour in public places. This is the route most questionnaire and interview projects travel — and the route that collapses the moment answers become identifiable and damaging at the same time, which is covered below.
- Existing data, documents or specimens. Open to material that is either already public, or written down in a form leaving nobody identifiable. This is the chart-review route, and it lives or dies on the word recorded: what matters is how the information reaches your dataset, not what the source record contained.
- Research in established educational settings using normal educational practices, public benefit or service projects approved by a government department or agency, and taste and food-quality evaluations round out the list Herzing publishes. They rarely fit a clinical practice project, but they are there.
Note the trap in the second one. A chart pull is not exempt because the charts already existed; it is exempt because of how you record what you take from them. Pull the medical record numbers into your working sheet "just in case" and the category you were relying on quietly closes behind you.
What does expedited mean, and what is it unable to do?
Expedited is not a shortcut through review — it is the same review carried out by fewer people. The federal rule opens it where risk stays at or below the minimal threshold and the design appears on the list of categories the Secretary publishes, or where a change to an approved protocol is a minor one. Herzing's Bylaws put that reading in the hands of the Chair or an experienced member the Chair designates.
Three of the federal categories carry most nursing work: materials — data, documents, records or specimens — gathered purely for non-research reasons such as treatment or diagnosis; recordings made for research purposes; and work on how people behave, singly or in groups, which the notice expressly extends to quality assurance methodologies, program evaluation, focus groups, oral history, interviews and questionnaires. That third one holds a great many practice projects.
Now the limit that catches workplace projects. The expedited route is closed wherever naming the subjects, or their answers, would realistically put them within reach of civil or criminal liability, or dent their finances, their employability, their insurability or their good name, or mark them out — unless safeguards hold all of that down to the minimal threshold. Read it against a questionnaire asking colleagues on your own unit why a protocol gets skipped, with role and shift recorded beside each answer. The topic is ordinary; the exposure is not.
One reassurance sits inside the same rule. Someone reading an expedited file can wield every authority the board holds except one — the power to refuse. A refusal has to come out of the non-expedited procedure. The worst an expedited read can do is push the file upward.
What pushes a Herzing file to the convened board?
Herzing publishes its own triggers, and one of them is easy to trip without noticing.
- It qualifies for neither exemption nor expedited handling. The default is the full board, not the lightest available reading.
- More than minimal risk — procedures that are personally intrusive, stressful or potentially traumatic, or risks that are physical, psychological, social, financial or legal.
- A protected population sitting at the heart of it — children, people who are incarcerated, or people with cognitive impairments, each carrying additional safeguards.
- Intentional deception, where participants are misled or given false information.
- Sensitive topics capable of causing harm or distress to the people taking part.
- Participants drawn from Herzing itself. The Research Protocol Application asks outright whether participants will be Herzing's own enrolled people, its faculty or its other staff — and prints the consequence beside the box: a yes there means the study requires full IRB review.
That last one deserves a moment. A project that recruits inside the university — surveying cohorts, interviewing faculty, studying a course intervention — has chosen the convened board by choosing its population, before any question of risk arises. If your design has drifted toward a Herzing-internal sample for convenience, that is the moment to notice.
Does the level change what the folder must contain?
Barely. It changes the depth of the reading and who does it. At every level the board still has to satisfy the same set of approval criteria: selection of participants that is equitable; risk held down and weighed against whatever benefit is anticipated; consent properly sought and either documented or lawfully waived; monitoring of the data where that is warranted; and real provision for privacy and confidentiality — with extra safeguards wherever a vulnerable population is involved.
Continuing oversight is the one place where the levels genuinely part, and where Herzing's own rule is the stricter one. Federally, a board may dispense with continuing review for work that would qualify for expedited handling, unless it decides otherwise. Herzing's Bylaws take no such step back: all approved research stays under continuing oversight and is re-evaluated at least annually. Where a university rule is tighter than the federal floor, the university rule governs — so treat annual re-evaluation as your baseline, and confirm it against Herzing's current IRB handbook or portal.
The determination that opens all of this — whether the project is research at all — is read on its own in why you file for a determination rather than claim QI. The order the whole file travels in is set out in the nine moves a Herzing file makes, and short answers to the questions that arrive with most folders sit on the FAQ page.
What to do next
Take four facts off your design and write them down: what you will record, whether any of it points back at a person, what it would cost that person if it escaped, and who exactly is in the population. Those four decide your level. Your subject matter does not.
Then let someone read them who reads them weekly. Our free application review comes back with the level your design points toward and the reasoning behind it, the pocket worth opening first, and an honest note wherever two levels are genuinely arguable. No charge, no obligation, and where a folder is already fit to send we say exactly that. How it works sets out what follows for anyone who would sooner put the whole file on someone else's desk.
Sources
- Herzing University IRB, Statement of Principles (PDF, September 2025) — exemption, expedited and full board criteria, and the approval criteria. IRB_Statement_of_Principles.pdf
- Herzing University, Institutional Review Board Bylaws (PDF, September 2025) — Chair duties, action on research proposals, continuing review. IRB_Bylaws.pdf
- Herzing University IRB, Application for Research Protocol Approval (PDF, October 2025) — the participant section and its full-review note. IRB_Research_Protocol_Application_1025.pdf
- Herzing University, Institutional Review Board (IRB). herzing.edu/institutional-review-board-irb
- OHRP, the 1998 notice setting out which kinds of research an expedited procedure may cover. hhs.gov — expedited review categories
- 45 CFR 46.104, 46.109, 46.110 and 46.111 — exemptions, review, expedited procedures and approval criteria. ecfr.gov — title 45, part 46
Category numbering and named routes shift with handbook editions and portal rebuilds; verify each against Herzing's current IRB handbook or portal. The facts that sort a design do not shift.
the other tabs in this file