Fifteen questions the desk answers every week.

Yes. Any GCU doctoral study that collects data from or about living people — surveys, interviews, observations, or records that can be linked to a person — needs a determination from GCU's IRB before recruitment or data collection begins. Even a study that turns out to be exempt receives that status from the board, not from the researcher.

The order at GCU is committee, then academic quality review, then the IRB; the application is filed once the proposal clears AQR. The current sequence, forms and portal steps are set by GCU's current doctoral handbook or IRB portal, and part of our work is knowing what has changed in them.

After. At GCU the proposal clears academic quality review first, and the IRB application is then read line by line against that AQR-approved proposal. Filing before AQR gives the board nothing to read against.

The reading and the document plan can begin before AQR finishes, so the file goes in the moment the proposal clears — that is how the first move is built. Confirm the exact sequence in GCU's current doctoral handbook or IRB portal.

Yes. GCU expects current CITI human-subjects certificates for everyone named on the protocol, with names matching the application exactly. Which course track applies to your role and design is set by GCU's current doctoral handbook or IRB portal.

The classic slips are a certificate that quietly lapsed between proposal and application, and a committee or team change nobody re-papered. Both are checked before anything we build is filed.

If recruitment or data collection happens anywhere you do not control, yes: one letter per site, on letterhead, signed by someone with the authority to grant it, describing exactly what the site permits. The board reads the letter next to your procedures, so the two must match word for word.

A letter that authorizes less than the application describes is a return. We draft site letters for each site's signature, matched to the procedures, and tell you who at the site actually has the authority to sign.

Usually you still need a determination from the board, even if the answer is that the work is not human-subjects research or is exempt. Whether the data are identifiable — directly, or through a code that links back to a person — is what decides it, and that is the board's call, not the researcher's.

Public, de-identified datasets often read as not human-subjects research; records with identifiers or a linking key usually need review at some level, and a data-security plan. Describe the data source exactly in the form and the reading will say which way it leans.

They are the three levels of review the federal criteria assign. Exempt covers minimal-risk categories — still a board determination, not a self-declaration. Expedited covers minimal-risk work involving identifiable people, read by a designated reviewer rather than the convened board. Full board means the convened board meets on the file, usually because a protected population or more than minimal risk is involved.

Five questions reach most of the answer — living people, identifiers, protected populations, intent, interaction — and the level-of-review reading on the homepage runs them. The determination itself is always the board's.

Often, but not automatically. Many DNP projects are single-site quality improvement and may be determined not human-subjects research or exempt; PhD and EdD dissertations that generate generalizable knowledge usually go through the full application at whatever level the criteria assign. Either way the determination is the board's to make, and the current DNP route is set by GCU's current doctoral handbook or IRB portal.

The file's job is to say clearly what the project is and is not — intent, site, population — so the board makes the determination on the right facts. That is most of what Meredith's desk does on a DNP file.

Run the five questions — does the study involve living people, will identifiers exist, is anyone in the population one the regulations protect, is the intent single-site quality improvement or generalizable knowledge, and is there interaction or records only — and the likely level falls out. The free application review gives you that reading in writing, with the reasoning; the board makes the actual determination.

The questions you cannot answer are the finding: guessing on a federal application is how files earn their first return. Settle the open questions first and the level usually settles itself.

Drift — daylight between the application and the proposal AQR approved. A renamed instrument, a resized sample, a consent promise the procedures do not keep. The classic return is about alignment, not ethics.

Because the board reads the application against an already-approved text, every section of the file is a comparison. We build every document against the approved proposal so the board finds no daylight, and if a return comes anyway, the response is drafted the same way — answering each point without introducing new drift.

No. Not recruiting, not piloting with real participants, not "just collecting while the board reads." Data collected before the approval or determination letter exists cannot be used, and the board treats it as a serious matter.

The letter is the switch. Everything on this desk is aimed at building the file so the switch flips once.

The board's letter lists what it wants changed, clarified or added; the response must answer every point, in the board's order, without changing anything the board did not ask about. In Full Handover we draft and file that response and every reply after it until the letter; if you came to us after a return, the first move is the same reading, now with the board's letter as evidence of where the drift is.

The how-it-works page walks through a return step by step.

Not without an amendment. Any change to approved procedures — an instrument, the sample, a site, a recruitment window, a consent form — goes to the board as an amendment before it is used. A change made mid-study without one is one of the quickest ways to put an approval at risk.

Amendments and continuing review stay on our desk in Full Handover for as long as the study needs the board.

No — the study, the data and the findings stay yours, and the board's decision stays its own. What we handle is the entire IRB process: the determination and plan, every document, the submission and every reply to the board until the letter. The price is quoted in writing after the free application review, as one of three fixed-fee packages — Determination & Plan, The Complete File, and Full Handover, the premium — with no hourly billing.

Prices are not listed because the quote answers to the file in front of us; the pricing page sets out what each package includes and how the quote works.

A consultant reads what you send — the AQR-approved proposal or current draft, any letters from the board, where the manuscript stands — and replies with the level-of-review reading in writing and an outline of the document plan. It is free, with no obligation and no pitch; if the file is clean and the category exempt, the finding is that you should file it yourself.

It is the entry to the service, not a sample of it. Everything after it is quoted. Request it here.

No. gcuirb.com is an independent consulting practice. It is not affiliated with, endorsed by, or operated by Grand Canyon University, the College of Doctoral Studies, or the university's institutional review board, and it does not speak for any of them.

Grand Canyon University, GCU and related marks are trademarks of their respective owners, used here only to identify the institution whose review process is discussed. Where anything on this site and GCU's own materials differ, GCU's current doctoral handbook or IRB portal governs.