How it works — the whole Aspen IRB process, handled end to end

From the free application review to the board’s determination: what we do, what you do, and what Aspen’s review board does. The file is ours to carry; the project and its findings are yours; the decision is the board’s.

In short. You send the file as it stands and we read it the way Aspen’s board will, then write the findings — free, no obligation. From there the entire IRB process is ours if you want it: the category settled from the design, every document built, the submission prepared and filed, every reply to the board answered until it decides. The project, its data and its findings stay yours. The board’s decision is always its own.

The route, drawn

One file travels the same road whether we carry it or you do. The difference is where the findings get written — before the submission line, in private, or after it, in the board’s record.

Exhibit — the file’s road from first read to determination

Everything left of the submission line is ours to carry. The tributary is the one document on someone else’s clock, so it is requested first. The dashed loop is the part most people discover only after filing — and it is ours too, for as many replies as the board writes.

Stage one — the free application review

The entry to everything. You send whatever exists; we read it the way the board will and write the findings before it can.

What you send

The file as it stands, however unfinished — the project proposal or plan, the draft application if there is one, the consent, any recruitment drafts, the instruments, the site permission letter or simply the name of who would sign it, and your training certificates. A project that is still only a plan is a fine thing to send; a file the board has already returned is an even better one, because the letter tells us exactly what it read.

What we do with it

The board’s own cross-read, run early: application against plan, consent against application, letters against the data answers, category against design. Three consultants read the file — the inspecting party — each for the part of the process she owns, then each once more for the others’ pages.

What comes back

A written inspection report in the form you see on the homepage, written from your documents rather than universal ones: each finding with the evidence the reviewer would see, its severity, and the corrective action. Severity is marked the way the board weighs it:

observation — noted now, cured cheapest minor — a query, a corrected page major — the file comes back

With the report comes a reading of the review path the design earns — not human subjects research, exempt, expedited or full board — and a written, fixed-fee quote for whichever of the three packages fits the findings. When the honest report is “submit it as it stands,” you hear that, and there is nothing to quote.

What it costs

Nothing, and no obligation follows it. A clean file is told it is clean. Prefer to inspect before you send? The six-question self-inspection on the homepage runs the same cross-read from memory and tells you honestly when you do not need us.

Stage two — the determination and the plan

The category is a claim the file makes, and the board reads the claim against the design. So the category is settled first, from the design, with you — before a single form is filled in.

Quality improvement or human-subjects research; not human subjects, exempt, expedited or full board. A project that samples, generalizes beyond the unit or tests a hypothesis is behaving like research whatever it is called, and a file that claims the wrong category bounces, because every later answer was written to the wrong question. Aspen’s current handbook or IRB portal sets out the categories and forms in force for your program; our work is to read your design against them and write down why the claim holds.

Then the plan is fixed. Every number, instrument name, site count and procedure that the application will later quote has to exist somewhere first, settled — otherwise the application paraphrases, and paraphrase is the finding boards write most.

What you receive

A written determination rationale — the category claimed, and the features of the design that earn it.
The plan, fixed, so every later document has something to quote word for word.
The document list the file will need for that path, and who signs each.
A repair list for anything already drafted, keyed to the findings in your report.

This is the Determination & Plan package on its own, and the first stage of the other two.

Stage three — every document, built and cross-read

Each document in the file answers to another document. The board reads them against each other; so do we, before anything leaves.

The file, document by document
Document	What the board reads it against	The finding it prevents
The IRB application	The approved plan, line for line — quoted, never recalled.	Paraphrase of the plan
The consent	The current protocol version, and every required element present — voluntariness, withdrawal, contacts, what happens to the data.	Consent drift
The site permission letter	The data answers — an authorized signatory naming the site, the activities and the data that leaves. Drafted by us for signature, sent first.	Letter absent or silent
The recruitment set	What will actually run — the email as it will send, the flyer as it will hang, the script as it will be read aloud.	An approximate version
The instruments	The plan’s named, validated instruments — attached as they will be administered, with permission to use them where one is needed.	Instrument mismatch
The data-security plan	Four named answers: storage, access, de-identification, destruction.	“Kept secure”
The training certificates	The modules Aspen’s current portal requires for your kind of project, current through the study.	Expired or wrong module
The category claimed	The design itself — what it samples, what it generalizes, what it tests.	Category argues with design

Every document in the table is built by us, in the board’s own register, from the plan fixed in stage two. Then the full cross-read runs once more on the finished file — every finding in your report cured, every page stamped to the same version — before anything leaves. This is The Complete File package: stage two plus everything on this page.

Stage four — the submission, and every reply until approval

The part most people discover only after filing: the board writes back. With Full Handover, the premium package, the filing and every reply after it are ours.

The submission

We prepare the submission itself — every form completed, every attachment stamped and in the order the portal asks for — and file it with you through Aspen’s current IRB process. You remain the investigator of record: the board hears from you, under your name. We make sure what it hears is complete, consistent and answers what it asks.

When the board writes back

A returned file is not a rejected one; it is a letter listing findings. For each item we draft the written response in the board’s own terms and the revised page it points to, stamped and consistent with every other document, and the file goes back. Requested amendments — a second site, a changed instrument, a longer window — are drafted the same way. Continuing review and closure, when the board’s process asks for them, are ours too. The loop runs for as many replies as the board writes.

What we never promise

A decision, or a date. The board’s calendar is its own and so is its determination; nothing on this site predicts either, and nothing we do influences the board beyond the quality of the file it reads. What governs the clock is in the file’s control — the site letter requested first, the category settled first, a response that answers rather than argues — and that is where we spend the effort.

Whose work is whose

Yours: The project — its question, its design, its data, its findings. The signature of the investigator of record. The decision to file, and when.
Ours: The IRB process, end to end: the determination rationale, the plan fixed, every document built, the cross-read, the submission prepared and filed with you, and every reply to the board until approval.
The board’s: The reading, the questions, the calendar, and the decision. Its own, every time.

When the honest answer is “file it yourself”

Some files are clean. An application that quotes its plan, matches its consent, holds its letter, names its data answers, keeps its certificates current and claims the category its design earns is exactly what a clean determination reads like — and when that is what we find, the report says so and stops. The free review exists to tell you which kind of file you have. Independent consultants, unaffiliated with Aspen University, reading 1,200+ Aspen files since 2015, rated 4.8 / 5 by the professionals served — and files read every week.

Hand us the whole process — the determination, every document, the submission, every reply. The first read is free.

Request the free application review

Send the file as it stands, from the contact page. The findings come back in writing; from there every cure, the filing and every reply can be ours to carry — or the report says “submit it as it stands,” and that is the end of it.