Short answers
The fifteen questions the desk is asked most, each answered in a sentence or two first, with the longer reading beneath. Where a detail depends on this term's forms, the answer says so and points you to Capella's current handbook or IRB portal.
Capella's IRB is the fourth and last gate on a fixed route — CITI training, topic approval, Scientific Merit Review, then the IRB — and nothing is collected before its approval. Most returns are file problems, not research problems: version drift, a consent mismatch, a missing site letter, a wrong claim about the review category. The desk handles the entire IRB process end to end; the study stays yours and the board's decision is always its own. The answers below say the same thing, one question at a time.
Does a Capella DNP quality-improvement project need IRB review?
Yes — at minimum a determination. Most quality-improvement work is read as not-human-subjects research, but Capella's board makes that call, and you file to obtain it.
Claiming the category yourself is the longest bounce on the route: quality improvement filed as research, or the reverse, is re-routed and waits out another review pass. The determination instrument on the home page gives an honest first reading, and the free review gives a considered one.
Where does the IRB sit in Capella's sequence?
Fourth, and last. Capella's route runs CITI training, then topic approval, then Scientific Merit Review, then the IRB — and data collection begins only after the board's approval.
The order is not a formality. The IRB reads your application against the plan Scientific Merit Review stamped, so the board's reference document is written one gate earlier. The route is drawn out on the how-it-works page.
Can I collect any data before IRB approval?
No. Nothing may be collected before the board approves — not a pilot interview, not an early survey — and anything gathered before approval can be invalidated.
Capella's current handbook and IRB portal carry the detail; the principle is the route itself — the approval letter opens data collection, and nothing else does. This includes recruitment: inviting participants is part of the study the board approves.
Do I need CITI training, and which modules?
Yes — current CITI certification in the modules that match your study, as named in Capella's current handbook or IRB portal. An expired certificate quietly invalidates an otherwise clean file.
Check the expiry dates before a word is drafted. It is the one row the board can fail without reading the protocol, and it is the first thing the desk checks in a free review.
What is a site permission letter, and why is it the slow one?
Written permission from the organisation where you will collect data — on its letterhead, signed by someone authorised to give it, naming the data you will touch. Organisations sign slowly, so files stall at the IRB gate waiting for the letter.
Request it upstream, at topic approval or earlier. We draft the letter for the signatory, so the only thing the organisation has to do is sign; that is Margaret Ostrowski's seat on the desk.
What is the difference between exempt, expedited and full-board review?
Risk and population decide it. Minimal-risk studies in defined categories may qualify as exempt or expedited; studies that record identifiers or involve vulnerable populations go to the full board.
The category is claimed in the file and the board confirms or re-routes it. The determination on the home page gives you an honest first reading — and tells you when you don't need us.
What happens when the board returns an application?
Returned, not rejected. You answer the board's points one by one, resubmit the revised documents, and the file waits out another review pass before it moves again.
Most returns are file problems, not research problems — version drift, a consent mismatch, a missing letter — and a revision response answers them document by document. What happens on a return is written out in full, and the articles go deeper on the response itself.
Do you conduct the research, or just the IRB?
We handle the entire IRB process end to end — the determination, every document, the submission and every reply until approval. The study, the data and the findings stay yours, and the board's decision is always its own.
We do not conduct the research, author findings or represent the university. Everything the board touches is ours to carry.
What does it cost?
It is quoted in writing after the free application review — one fixed fee, nothing billed by the hour — across three packages: Determination & Plan, The Complete File, and Full Handover, the premium.
The free review costs nothing and commits you to nothing; the quote follows the file, not a menu. What each package covers is set out on the pricing page.
How long does Capella's IRB review take?
We do not quote a duration, and nobody outside the board can honestly give one: Capella's board sets its own pace, and its current handbook or IRB portal is the only reliable source for what to expect. What the file controls is the number of passes — a complete, version-matched application moves through in one, and a returned one waits out another full review pass before it moves again.
That is why the desk spends its effort on the file rather than on the calendar: the only reliable way to shorten the wait is to give the board no reason to write back.
Why does the IRB read my application against the Scientific Merit Review plan?
Because the stamped plan is the board's reference document: it is the version of your study that was approved as sound, and the IRB checks that what you are asking permission to do is that study. Any drift between the two — sample, sites, instruments, recruitment — is the single most common reason a file comes back.
The practical rule: once the plan is stamped, stop editing it. If the study must change, amend the plan formally first and bring the application into line with the amended version, so the board never reads two versions of one fact.
Does a project using only de-identified or public data need IRB review?
It still needs a determination. Work on data that were never identifiable, or that are public, is often read as not human-subjects research — but the reading is the board's to make, and the file has to show how the data were obtained and that no one on the team can re-identify anyone.
"De-identified" is claimed more often than it is true: a record set with dates and unit names can identify people in a small unit. Name the data precisely and let the determination settle it.
Can I do my project in my own workplace, with my own patients or staff?
Usually yes, and the board will read the consent architecture closely. Your own patients and your own direct reports are people who may feel they cannot say no, so the file has to show how participation is voluntary, how refusal carries no consequence, and who — other than you — holds the identifiable data.
These files pass when consent, access and data handling are designed before submission rather than patched after a return. They are also where a site permission letter signed by the right person matters most. If your own role at the site could read as a conflict, say so in the file and let the board weigh it; Capella's current handbook or IRB portal names any disclosure form in force.
What is an amendment, and what is continuing review?
An amendment is the board's approval of a change to an already-approved study — a new site, an altered instrument, a different recruitment route — filed before the change is made. Continuing review is the board's periodic look at a study that runs past its first approval period, usually a progress report with the current documents.
Both are part of the process, and under Full Handover both are on the desk: the amendment matched to the plan and the file, the continuing-review report prepared before the notice arrives so the study never pauses. Where Capella's current portal sets the exact forms and intervals, it is the source.
What does the free application review include, and what happens after?
A consultant reads where your project stands — before Scientific Merit Review, stamped but not filed, or returned — and writes back at the email you gave with where it sits on the route, what the file needs, and what would come back. It costs nothing and commits you to nothing.
If you want the process carried from there, the package is quoted in writing; nothing is drafted, filed or billed until you say go. Some reviews end with the honest note that you can file the application yourself. The form is the way in; so is the live chat.
A question that isn't here is exactly what the free review is for — put it in the form, or . Longer pieces on the route, returns, consent and site letters are in the articles.