Fifteen questions, answered in the first sentences.

Yes, in some form — assume it does. A capstone, MSN or DNP project that collects information from or about people goes to the IRB for a determination, and even a project that expects to be called quality improvement needs the board to make that call rather than the project. What varies is the path the board assigns, not whether the folder is read; Herzing's current IRB handbook or portal states how your program files it and what must come first.

The paths are not human-subjects research, exempt, expedited and full board, and they are read below under the review paths. The one thing that is never optional is the determination itself: a project that skips the board and later turns out to have needed it cannot use its data.

No. Recruitment, consent and data collection for the project begin only after the board's written determination or approval is in hand — not when the folder is filed, and not because the project expects to be exempt or QI. Data gathered before the determination generally cannot be used in the project and can put the whole file at risk.

What can happen before filing is everything that does not touch participants or their data: drafting the instruments, writing the consent, requesting the site permission letter, completing CITI training for everyone named on the application. That is most of the folder, and it is why the slow documents get requested first.

The human-subjects research course that matches the work — Social-Behavioral-Educational for surveys, interviews and most practice-change projects, Biomedical where the design is clinical — current on the day you file, for every person named on the application, with the completion certificates themselves placed in the folder. Herzing's current IRB handbook or portal names the exact course and any added modules; read that list before you register.

This pocket returns folders in two ways, both found in the first minutes of a pass: a certificate that has lapsed, and a certificate for modules that do not match the work the plan describes. The completion numbers alone are not the document; the certificates are. Pocket five on the homepage shows the two records side by side.

Exempt review is the lightest reading the board gives: it applies to minimal-risk work that falls into categories defined in the federal Common Rule — anonymous surveys and interviews of adults, review of existing records that are de-identified, normal educational practice in educational settings, and a few others. Exempt does not mean exempt from the board: the folder is still filed and the board still makes the determination. The application can propose exemption; only the board can grant it.

How Herzing's board applies the categories, and which form an exempt request uses, is in Herzing's current IRB handbook or portal. Nothing about the path changes what the folder must contain — the consent or information sheet, the instruments, the site letter and the data-security answers are read either way.

Expedited review is for minimal-risk work that falls outside the exempt categories — most surveys and interviews that collect identifiable information, and most chart reviews that touch identifiers — read by one or a few designated reviewers rather than the convened board. "Expedited" describes who reads the folder, not how fast; the board's calendar is its own and no one outside it can predict a pass.

Expedited review still ends in written findings, and it is the path where the consent pocket is read most closely, because participants are identifiable. Pocket two shows the three readings a consent form has to survive.

When the risk is more than minimal, or when the people taking part are in a group the rules protect — children, prisoners, people unable to consent for themselves, and others the board treats as vulnerable — or when the design does not fit a lighter path. The convened board reads the folder at a scheduled meeting, which is why a full-board project has the most to gain from filing complete: a missing document can cost a whole meeting cycle.

Most Herzing MSN and DNP practice-change projects do not go to the full board, but the board decides that from the folder, and the application should propose the honest path rather than the fast one.

The design decides, and the board confirms. Work that improves one unit's own process, measured against that unit's own baseline and shared as operational learning, reads as quality improvement. Work that randomises, tests a hypothesis meant to travel beyond the site, or is designed for publication as research findings reads as research — whatever the cover page calls it. The application claims a category and argues it; the board makes the determination.

Claiming QI because it moves faster is the one shortcut that can restart the whole file, because a category corrected in review does not return a document — it returns the design. It is the first thing we settle in the determination and plan, and the eighth question in the folder pass.

Completeness first, quality second, and the first decides whether the second happens. A coordinator or reviewer confirms that every required document is present, current and version-matched before anyone reads the design; a folder missing a document is returned as incomplete after a full pass, having learned nothing else about itself. Only a complete folder gets its project read.

That is the whole argument of the tabbed folder on the homepage: seven pockets in the order a reviewer opens them, and the only lever you hold is how many passes you ask of the board's calendar.

Three things make it real: it sits on the site's own letterhead, it is signed by a person actually authorised to grant access to the people or records involved, and it names the data or activities it permits — this chart pull, this survey, this staff interview. A warm letter that blesses "the project" in general permits nothing in particular, and reviewers read it that way. It is slow because someone outside your project has to write it, on their own calendar; request it before you polish anything else.

For an MSN or DNP practicum project the practicum site's letter is the one that stalls folders most. We draft it for the signatory's hand so that it says what a reviewer needs it to say and comes back signed without questions — pocket three shows the letter itself.

Three readings: version — the consent in the folder is the one the application cites, with no superseded draft left behind; elements — every required element present, none assumed, from what happens in plain words to who to contact; and level — the language sits at the reading level of the people signing, not the person filing. It is returned most because all three readings are easy to fail quietly, and because the recruitment materials ride the same rules and the same version.

Clinicians can sign clinical language; the people they care for cannot, and a consent written for the board rather than the participant is the commonest version of this finding.

It means the board has written findings it needs addressed before it can decide, and the file is waiting on you; nothing about the project is approved until the revised folder is read again. A return for an incomplete folder — a missing document, a lapsed certificate — and a return with questions about the design are different events: only the second means the project itself got read. Read the letter for which one it is before doing anything.

Either way the next pass is the board's to schedule, and the only part you control is whether the revised folder asks for one more pass or two. Brianna's and Angela's notes describe both kinds of return.

Point by point, in the board's own vocabulary, with each revised document re-filed at a new version that the response names, and nothing changed that the board did not ask about. Quote each finding, state what was changed and where, and attach the document that shows it. A response that argues, that changes unrelated text, or that leaves the old version in the folder asks for another pass.

In Full Handover the response is ours to write and you read it before it goes; the project stays yours, and so does the final word on every answer.

An amendment is the board's approval of a change to an already-approved project — a second site, a new team member, a reworded survey item, a different recruitment channel, a longer timeline. You need one before the change happens, not after, because anything done under the old approval that the old approval did not cover is not covered at all. Herzing's current IRB handbook or portal names the form and the route.

The discipline cuts the same way as the instruments pocket: a question reworded after approval is a question the approval no longer covers. Small changes are usually quick to amend; unamended changes are the expensive kind.

Continuing review is the board's periodic re-reading of an approved project that is still running — typically a progress report stating who has enrolled, what has changed, whether anything unexpected happened, and a request to continue. Whether and when your project needs it depends on the path it was approved under and the board's own rules; exempt and many expedited projects may not, and Herzing's current IRB handbook or portal says which. Missing a continuing-review date can lapse the approval.

When a project closes, the board usually wants to hear that too, in a closure report. We prepare both inside Full Handover.

We handle the entire IRB process, end to end — the determination and plan, every document in every pocket, the site letter drafted for signature, the submission and every reply to the board until approval — and we do not conduct the research: the study, the data and the findings are yours throughout. We are independent of Herzing University and its IRB, and the board's decision is always its own. The free application review is where it starts, and it is also where we tell you if you do not need us.

How it works reads the four tabs in full; the pricing page has the three packages and how a quote is written; the team page has the three people who keep the folder.