What it costs: three packages, each a fixed fee, quoted in writing.
Packages are quoted after the free application review, so the price answers to your file, not a menu. The premium is Full Handover: the whole docket off your desk, submission and every reply to the board included.
The short answer
There are three packages. Determination & Plan is the reading and the document plan. The Complete File adds every document and exhibit, built and aligned, ready to file. Full Handover — the premium — adds the submission in GCU's current IRB portal and every reply to the board until the letter. Each is a single fixed fee quoted in writing after the free application review, with no hourly billing. Prices are not listed on the site because the quote answers to the file in front of us; and if the file is clean and the category exempt, the honest quote is that you do not need one.
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Determination & Plan
The reading, the review-path call, and the document plan against the AQR-approved proposal.
- The level-of-review reading on your approved proposal, in writing: not human-subjects research, exempt, expedited or full board — with the reasoning, so you can see how the board is likely to read the same facts.
- The document plan: every letter, certificate, consent document and exhibit the case will need, the order to build them in, and who at each site has to sign what.
- A drift read of anything you have already drafted against the approved text, marked line by line.
- Not included: the drafting of the documents themselves, the submission, or replies to the board. You build and file from the plan — or step up to one of the next two packages, quoted in writing.
Quoted in writing after the free review; a single fixed fee with no hourly billing.
Start with the free review -
The Complete File
Determination & Plan, plus every document and exhibit built and aligned, ready to file.
- Everything in Determination & Plan.
- The application itself, written against the approved proposal line by line.
- Consent and assent documents at the population's reading level; recruitment materials; instruments aligned to the approved proposal with permissions attached; the data-security plan.
- Site authorization letters drafted for each site's signature and matched to the procedures; CITI certificates checked and matched to every name on the protocol.
- Not included: the submission and replies to the board. You file the finished file in GCU's current IRB portal and answer the board yourself; if a return arrives and you would like us to take it from there, that is the step up to Full Handover, quoted in writing.
Quoted in writing after the free review; a single fixed fee with no hourly billing.
Start with the free review -
Full Handover most chosen
The premium: The Complete File, plus the submission in GCU's portal and every reply to the board until the letter. The whole docket off your desk.
- Everything in The Complete File.
- The submission handled in GCU's current IRB portal, with your sign-off.
- Every reply to the board: revision responses, clarifications, amendments and continuing review, until the determination or approval letter is in your hands — and amendments and continuing review after it, while the study runs.
- One holder for the file at every point, and a named consultant who writes first whenever the board writes back.
Quoted in writing after the free review; a single fixed fee with no hourly billing.
Start with the free review
What is in, and what is out
Every line the board reads, and which package builds it. Each package begins where the last one ends, so stepping up never pays twice for the same work.
| What the desk does | Determination & Plan | The Complete File | Full Handover |
|---|---|---|---|
| The level-of-review reading, in writing | Yes | Yes | Yes |
| The document plan: every letter, certificate, consent document and exhibit, in order | Yes | Yes | Yes |
| Drift read of anything already drafted | Yes | Yes | Yes |
| The IRB application, written against the approved proposal | No | Yes | Yes |
| Consent and assent documents | No | Yes | Yes |
| Recruitment materials | No | Yes | Yes |
| Instruments aligned, permissions attached | No | Yes | Yes |
| Data-security plan | No | Yes | Yes |
| Site authorization letters drafted for signature | No | Yes | Yes |
| CITI certificates checked against every name on the protocol | No | Yes | Yes |
| The submission handled in GCU's current IRB portal | No | No | Yes |
| Revision responses and clarifications to the board | No | No | Yes |
| Amendments and continuing review after approval | No | No | Yes |
| A single fixed fee, quoted in writing, no hourly billing | Yes | Yes | Yes |
Never in any package
- Conducting the research, collecting the data, running the analysis or authoring the findings. The study is yours.
- Predicting, promising or influencing the board's decision. The decision is the board's, on the file it reads.
- Filing anything in your name without your sign-off, or contacting GCU about you without your instruction.
- Hourly billing, or a fee that moves after it has been quoted for the scope agreed.
How the quote works
- The free application review. You send the form — where the manuscript stands, and whatever you already have: the AQR-approved proposal or current draft, any letters from the board, your instruments. A consultant reads what you send and replies by email, or by phone if you prefer.
- The reading. You get the level-of-review reading and an outline of the document plan. If the file is clean and the category exempt, the reading says so and recommends you file it yourself; there is no quote, because there is nothing to quote.
- The written quote. Otherwise you receive a quote for the package that fits the file — or for more than one, so you can choose — stating exactly what it covers, what it does not, and when payment is due. One fixed fee; no hourly billing; no fee that moves unless the scope does, and then only in writing.
- Acceptance. Work begins when you accept the quote in writing. The file moves to the first holder on the bench and you are told who that is.
Why no prices on the page: a quote that does not know whether your study is a single-site quality-improvement project with one consent form or a multi-site full-board file with four site letters and an assent document is not a quote, it is a guess, and guesses are how files earn return letters. The free review takes the guessing out; the quote follows it.
Pricing questions
Why are there no prices listed on the site?
Because the price answers to the file, not to a menu. Every package is quoted in writing after the free application review, as a single fixed fee with no hourly billing — so the number you receive is for your file, not for an average one.
The free review is what makes the quote honest: by the time we quote, we have read the approved proposal, settled the level of review and listed every document the case needs.
Is the free application review really free?
Yes — no obligation and no pitch. The review ends in a written finding, and sometimes the finding is that your file is clean and your category exempt, in which case we tell you to submit it yourself and there is nothing to quote.
It is the entry to the service, not a sample of it; everything after it is quoted.
If the board returns the file, do I pay again?
In Full Handover, no: every reply to the board until the letter is inside the package, and so are amendments and continuing review after it. In Determination & Plan or The Complete File, the submission and the replies are yours; if a return arrives and you would like us to take it from there, that is the step up to Full Handover, quoted in writing.
Either way the quote states exactly what it covers, so there is never a surprise line.
Can I move from one package to another?
Yes. Each package begins where the last one ends — the plan is the first part of the file, and the file is the first part of the handover — so a step up is quoted for the additional work only, in writing, and never pays twice for work already done.
Is there any hourly billing?
No. Every package is a single fixed fee for the scope quoted. If the scope changes — a new site appears, the committee changes the design after the plan is written — the change is quoted in writing before any work on it begins.
What if you tell me I should file it myself?
Then that is the finding, and it is free. If you would still like a second pair of eyes on the finished file before it goes in, ask; if the honest answer is that it does not need one, that is what we will say.