CITI training. Topic approval. Scientific merit. Then the IRB.
At Capella the order is fixed — nothing collects a single interview until the gate ahead of it clears,
and a returned application waits out a full review pass before it moves again.
We are independent consultants who handle the entire Capella IRB process —
the determination, every document, the submission, and every reply to the board — end to end, every week.
Independent of Capella University. We run the whole IRB process for you;
the research itself stays yours, and the board's decision is always its own.
What a returned file looks like
One application, five rows, three returns — and every one of them was visible before it was filed.
This is the file we see most, drawn from the ones we carry every week.
The most common return. The application quotes one sample size; the SMR-stamped plan quotes another. The board reads both, stops at the difference, and sends the whole file back.
Version drift. A consent form stamped to an earlier protocol — every required element present, and still the wrong document. Returns are rarely about content. They are about which version.
Returned
IRB application — first submission
CITI certificatesAttached
Research plan alignmentSample size differs
Consent versionDoesn't match protocol
Site permission letterMissing
Data security planComplete
The slow one. A site permission letter takes an organisation weeks to sign. "Missing" here does not mean a rewrite — it means the file waits at the fourth gate until the letter arrives. Request it upstream.
What files get right. CITI attached, data security named: the easy rows. No file has ever been returned for its easy rows — and no file has ever passed on them.
None of these are research problems. They are file problems — foreseeable, and preventable before submission. That is the whole case for reading the file before the board does.
6,400+Capella IRB application files prepared
Since 2006preparing Capella files — and reading them every week
4.9 / 5average rating from the professionals we've served
The route is fixed. Walk it in order.
Capella's sequence runs one way: human-subjects training, topic approval, the research plan through
Scientific Merit Review, then the IRB. Site permission is the tributary almost everyone starts too late —
it joins the route at the IRB gate, but the letters take longest to obtain. Select a gate to see what clears it.
Gate 4 of 4
The IRB application
The board reads your application against the research plan Scientific Merit Review already approved.
Any drift between the two — sample, sites, instruments, recruitment — is the single most common reason a file
comes back. The application must also carry consent documents, recruitment materials, site permission letters
and your CITI certificates, version-matched to the protocol.
Holds the route until: the file and the approved plan say exactly the same thing.
Collecting data before approval isn't a shortcut — it's a compliance violation that can
disqualify everything gathered. The route only ever moves forward one way.
Which review path is your project on?
The costliest early mistake is misreading what your project is. A quality-improvement project framed as
research — or the reverse — sets you on the wrong path for months. Five questions, an honest reading.
A reading, not a ruling — the review category is always Capella's IRB's call.
This instrument will tell you when you don't need us.
Why applications come back
The board rarely rejects — it returns. Each return waits out another review pass. These are the five
returns we see most across the Capella files we prepare, and what each one throws you back to.
The file contradicts the approved plan
Sample size, sites or instruments drifted after Scientific Merit Review signed off.
The fix: reconcile every number and instrument name against the stamped plan — or amend the plan first.
Throws you back to Gate 3.
Consent doesn't match the protocol
Wrong version attached, missing required elements, or written past the reading level of the people signing it.
The fix: one consent version, stamped to the protocol, every required element present.
Revise and resubmit.
Site permission is missing or unusable
No letter, the wrong signatory, or a letter that never names the data you'll actually touch.
The fix: letterhead, an authorised signatory, and the data named. Organisations sign slowly — start upstream.
Stalled at Gate 4 until it arrives.
The review category is claimed wrong
QI submitted as human-subjects research, or research submitted as QI. The board re-routes it.
The fix: run the determination honestly before you file, and claim the path the project is actually on.
The longest bounce of all.
Data security answered too thin
Where identifiers live, who holds the key, and when it's all destroyed — answered in a sentence.
The fix: name the storage, the access list, the de-identification step and the destruction date.
Revise and resubmit.
None of these are research problems. They're file problems — and file problems are entirely
preventable before submission. Which is why we build the whole file, not just read it.
What a complete file carries
An IRB application is never one form. It's a dossier, and the board reads it as one document —
every piece version-matched to every other.
IRB application formthe spine of the file
Approved research planSMR-stamped
Consent form(s)version-matched
Instruments & interview guides
Site permission letter(s)the one most often missing
CITI completion certificates
✓The application form — answers must quote the plan, not paraphrase it.
✓The SMR-approved research plan — the document the board reads yours against.
!Consent forms and recruitment materials — the most-revised documents in the file.
✓Instruments, surveys, interview guides — every question you'll ask, exactly as you'll ask it.
!Site permission letters — the slowest document to obtain and the most often absent.
✓CITI certificates — current, and in the right modules for your study.
How we handle it, start to finish
The whole process, in three moves — because the file, like the route, only works in sequence.
The determination and the plan
We read your project the way the board will, settle which review path it is on, and map every
document it needs — before a word is drafted. The same mismatch check the reviewers run, run first.
Every document, built and version-matched
The application, the consent forms, recruitment materials, instruments aligned to the approved plan,
the data-security plan, site permission letters drafted for signature — one file that says one thing,
everywhere.
Submitted, and every reply answered
We file it. When the board writes back, so do we — revision responses, amendments, continuing
review, point by point, document by document — until the approval letter is in your hands.
What stays yours: the research. The project, the data and the findings are yours.
Everything the board touches is ours to handle — and we handle it for Capella professionals every week, across DNP
quality-improvement projects, MSN capstones and doctoral research.
The desk
Three consultants, one file. Every Capella application that comes through the practice is read by a person
who has prepared hundreds of them, and the same three hands carry it from the determination to the approval letter.
Elise MarchettiDNP, APRN
Lead IRB consultant. Determinations and the plan.
Elise reads every new project the way Capella's board will, settles which review path it is on,
and maps the file before a word is drafted. She has carried Capella IRB applications from the first determination to
the approval letter for as long as the practice has taken them.
Harriet CrowleyPhD
Consent, instruments, data-security plans.
Harriet builds the documents the board reads most closely: the consent forms, the instruments and
interview guides, and the data-security plan, each version-matched to the stamped plan. When a return letter cites
consent language or data handling, her revision response is the reply.
Margaret OstrowskiMSN, RN
Site permission letters, submissions, board correspondence.
Margaret drafts the site permission letters for signature, follows up with the signatories, and files
the application when every piece is in. From then on the board's correspondence comes to her desk, and every reply
goes back point by point until approval.
Two more consultants staff the live chat on this page, so a question reaches a person who has read
a Capella file that week.
On the record
Four of the professionals whose Capella files we have handled, in their own words. Names shortened at their request.
My application had come back twice before I found the desk. Elise read the return letter line by line,
matched the consent to the protocol, and the next letter from the board was the approval. I wish I had sent it in
before the first submission.
Carmen D., DNP candidateQuality-improvement project, two returns before the review
I had a site permission letter signed by the wrong person and did not know it. They caught it in the free
review, drafted the replacement on the right letterhead, and told me exactly who had to sign. The board never had a
reason to write back about it.
Jerome K., PhD candidateDoctoral research, two clinical sites
I was certain my project was research. The determination read it as quality improvement, the file was
built for that path, and it went through without being re-routed. That one reading saved me a whole review cycle.
Megan T., MSN, RNCapstone project, single site
The board wrote back with seven points and I forwarded the letter. Margaret answered every one, document by
document, and I signed the revision response without rewriting a thing. Approval followed on the resubmission.
Alan W., DNP, APRNReturned once, approved on the revision
4.9 / 5 across the professionals we have served since 2006. The files described above were
all read, built and answered by the desk on this page.
What it costs
Every package is quoted after the free review, so the price follows the file rather than a menu.
Determination & Plan
For a project that is not yet filed and needs its path settled.
The review-path reading, argued and evidenced the way the board will test it
The document map for your file, piece by piece
A written plan you can carry yourself, or hand back to us
Quoted in writing once the free review is done.One fixed fee; nothing billed by the hour.
The Complete File
For a project ready to be filed, built so it says one thing everywhere.
The nine questions the desk is asked most, each answered in a sentence or two — the longer reading sits beneath.
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 in the ledger above: quality improvement filed as research, or the reverse, is re-routed and waits out another review pass.
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.
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.
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.
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.
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 above 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.
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.
A question that isn't here is exactly what the free review is for — put it in the form, or .
Bring your application before the board sees it.
A consultation costs you nothing and reads your file the way a reviewer will — where it
stands on the route, what it's missing, and what would come back. Then, if you want, we take the entire process
from there — every document, the submission, every reply — until approval.
Independent consultants · every week, Capella files · your research stays yours
This month
capellairb
Noted, and on your file.The offer is recorded against your project. A consultant will be in touch at the email and phone you gave to set up the free review.
One offer per project, applied to the fixed fee quoted after the review. Close this and nothing changes.