aspenirb

Your application will be inspected. The only question is who inspects it first.

Aspen University’s review board reads your capstone, MSN or DNP application the way an inspector reads a site: line against line, document against document. Every finding it could write is sitting in your documents right now, findable. An inspection you run first costs nothing; the one you leave to the board costs a review cycle. As independent consultants we handle the entire Aspen IRB process end to end — the determination and plan, every document, the submission itself, every reply to the board — every week.

The free application review

Tell us where the project stands. We read the file the way the board will and write the findings before it does.

Record of inspections

IRB application files prepared 1,200+
preparing Aspen files since 2015
average rating from the professionals we’ve served 4.8 / 5

— and files read every week

Exhibit — the same file, inspected twice

submission The inspection you run your file findings written here — in private, at no cost cured, quietly the board reads a clean file determination The inspection you leave to the board the same findings — written into the record your file the board reads the revision letter comes back — findings to cure, a response to draft one full review cycle resubmitted — the board reads it again determination
The findings in both lanes are identical — they were sitting in the documents all along. The variables are who writes them, whether they enter the record, and how much road follows. The blue road exists only in the lower lane.

Inspection report

Subject
One IRB application file — yours. The application, the plan it answers to, the consent, the letters, the certificates, the recruitment set.
Scope
The file, not the research. The report inspects what the board will read; the project, its data and its findings stay yours.
Inspecting party
Independent consultants, unaffiliated with Aspen University, who handle the entire Aspen IRB process — every document, the submission, every reply — every week.
Method
The board’s own cross-read, run early: application against plan, consent against application, letters against the data answers.
Severity marks
observation — noted now, cured cheapest minor — a query, a corrected page major — the file comes back
major finding

Finding 1 — The application paraphrases the plan it answers to

What the reviewer sees. The plan says 28 participants across two units; the application says “approximately 30 nurses.” The instrument has a validated name; the application describes it loosely, from memory. The reviewer reads the two documents side by side — that is the job — and every gap between them becomes a written query, because the reviewer cannot know which version is true.

Corrective action. Quote, don’t recall. Every number, instrument name, site count and procedure in the application is lifted verbatim from the approved plan — and where the plan itself is still unsettled, the plan is fixed first, then quoted.

major finding

Finding 2 — The consent is not the protocol’s consent

What the reviewer sees. The footer carries last term’s version date, or none at all. A required element — voluntariness, the right to withdraw without consequence, whom to contact with questions, what happens to the data — is missing or half-said. A consent that drifts from its protocol tells the reviewer the file was never read as one document.

Corrective action. Re-stamp the consent to the current protocol version, then walk its elements one by one against the consent requirements in Aspen’s current handbook — presence of each, not paraphrase.

major — the slowest to cure

Finding 3 — The site letter is absent, unsigned, or silent on the data

What the reviewer sees. No letter; a letter signed by a preceptor or unit manager without authority to grant access; or a warm letter of support that never says what data leaves the site or who may touch it. The reviewer cannot approve access that nobody with authority has granted.

Corrective action. A letter from an authorized signatory that names the site, the activities, and the data. This is the one document written on someone else’s clock — it is requested first, not last, because no other cure can start it retroactively.

minor finding

Finding 4 — The recruitment set is not what will actually run

What the reviewer sees. The flyer in the file is not the email that will be sent. The script mentions a thank-you the application never discloses. Whatever actually reaches a participant is an approved document or it is nothing — the reviewer treats an approximate version as an unapproved one.

Corrective action. Submit exactly what will run — the email as it will send, the flyer as it will hang, the script as it will be read aloud. If it changes later, that change is an amendment, not a liberty.

minor, becoming major

Finding 5 — “The data will be kept secure”

What the reviewer sees. One reassuring sentence where the reviewer needs four answers: where the data lives, who can open it, when identifiers come off, and when it is destroyed. Left vague, a minor query; left vague twice, a major finding — vagueness about data is the one thing a board is constituted to distrust.

Corrective action. Name all four, plainly: storage (where, and how protected), access (who, by name or role), de-identification (when, and by what method), destruction (when, and how). One named sentence each is enough.

observation, becoming major

Finding 6 — The CITI certificate is expired, or the wrong module

What the reviewer sees. A lapsed completion date, or coursework for the wrong kind of work entirely. On a clean file it is an observation; on a file already back for revisions it hardens into one more reason to doubt the whole.

Corrective action. Renew before submission, in the modules Aspen’s current portal actually requires for your kind of project. The cheapest line in the file to fix — and the worst one to be queried on.

major — the longest bounce

Finding 7 — The category claimed argues with the design

What the reviewer sees. The file says quality improvement while the design samples, generalizes and tests a hypothesis beyond the unit — or claims research review for a project built to improve one site’s own process. A wrong category is not a page-level correction: it bounces the file, because every later answer was written to the wrong question.

Corrective action. Let the design decide the category, then write the file to it. If the design and the intended category disagree, resolve that before a single form is filled in — everything else depends on it.

Corrective actions — how we handle the whole process

The report above is written from universal findings — the ones boards write most and cure slowest. Yours is written from your file. And everything after the report — the whole IRB process, end to end — is ours to carry when you want it.

  1. The determination and the plan. Quality improvement or human-subjects research; not human subjects, exempt, expedited or full board — the category is settled from the design first, with you, before a single form is filled (Finding 7 is cured here, because everything else depends on it). Then the plan is fixed, so every later answer has something to quote.
  2. Every document built, every finding cured. The application in the board’s own register; the consent stamped to its protocol with every required element; the recruitment set exactly as it will run; the instruments; the data-security plan naming storage, access, de-identification and destruction; the site permission letter drafted for an authorized signature — sent first, because it runs on someone else’s clock (Finding 3). Every document built by us, every finding in the report above cured before the file leaves.
  3. Submitted, and every reply answered until approval. The submission itself is ours to prepare and file. When the board writes back — revision letters, requested amendments, continuing review — the response memo and the revised pages are ours to draft, item by item, until the board is satisfied. The project, its data and its findings are yours; the decision is the board’s; carrying the file to it is ours.

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

Request the free application review

The free application review reads the full file and writes the findings. From there every cure, every document, the filing and every reply to the board can be ours to carry — and when the honest report is “submit it as it stands,” you hear that too.

The self-inspection

Six questions, answered from the file as it stands — not as you intend it to be. Each mirrors a finding above. A not-sure is drawn dashed, because a not-sure is itself a finding: the board settles whatever you leave unsettled, in the record.

0 of 6 answered

  1. Does every number in the application — sample, sites, sessions, instruments — quote the approved plan word for word?

  2. Is the consent stamped to the current protocol version, with every required element present?

  3. Do you hold a site permission letter, signed by an authorized signatory, that names the data?

  4. Are your CITI certificates current — and for the modules your kind of project requires?

  5. Do your data-security answers name storage, access, de-identification and destruction?

  6. Does the category you claim — quality improvement or research — match what the design actually does?

The inspecting party

Three consultants read every file. Each owns a part of the process and signs the findings she writes.

Miriam Kessler, DNP, APRN

Lead consultant · determinations and the plan

Miriam settles the category before anyone fills in a form: quality improvement or research, exempt, expedited or full board, read from the design rather than the hope. She has read Aspen files since 2015 and writes Finding 7 before the board can.

Charlotte Devereux, MSN, RN

Consent, instruments, data-security

Charlotte builds the consent to its protocol version and walks every required element against Aspen’s current handbook. Her data-security pages name storage, access, de-identification and destruction in one plain sentence each, because that is what the board is reading for.

Isabel Rourke, PhD

Site letters, submissions, board replies

Isabel drafts the site permission letter for signature before anything else, because it is the one document on someone else’s clock. She prepares the submission itself and answers every reply from the board, item by item, until the file is clean.

Findings, closed

Four files, four findings their owners did not see, and what happened at the board.

Renata S.

DNP candidate

“My application said ‘about 30 participants’ and my plan said 28. I had read it ten times and never saw it. Miriam’s report had it as Finding 1, and the file went to the board quoting the plan word for word. Approved on the first pass.”

Dominique A.

MSN candidate

“The site letter was the thing I kept putting off. Isabel drafted it for my director’s signature before we touched anything else, and it named the data and who could touch it. When the board read it there was nothing to ask.”

Helena W.

DNP, nurse educator

“I came to them after the board returned my file with six findings. The response memo answered each one in the board’s own words and the revised consent was stamped to the right version. Second read, approved. I only wish I had started with them before the first submission.”

Aaron T.

DNP candidate

“I had claimed quality improvement and my design was testing a hypothesis across three units. They caught it in the free review and we rewrote the file to the right category before anything was filed. The whole process was handled end to end, and the board’s letter was a determination, not a revision list.”

What it costs

We quote after the free review, so the price fits the findings in your file, not a menu. Three named packages; each is a fixed fee, put in writing before any work starts.

  1. Determination & Plan

    Included. The category settled from the design, with a written rationale; the plan fixed so every later document has something to quote; the list of documents the file will need and who signs each; a repair list for anything already drafted.

    A written quote follows the free application review. Fixed fee, no hourly billing.

  2. The Complete File

    Included. Everything in Determination & Plan, plus every document built in the board’s own register: the application, the consent stamped to its protocol, the recruitment set as it will run, the instruments, the data-security plan, the site permission letter drafted for signature; the CITI roster read against the requirements; the full cross-read before anything leaves.

    A written quote follows the free application review. Fixed fee, no hourly billing.

  3. Full Handover the premium package, and the most chosen

    Included. Everything in The Complete File, plus the submission itself, prepared and filed, and every reply to the board answered until approval: revision responses, amendments, then continuing review. The project, its data and its findings stay yours; the decision is the board’s; carrying the file to it is ours.

    A written quote follows the free application review. Fixed fee, no hourly billing.

Every package begins the same way: the free application review.

Request the free application review

The file is read first, then quoted. If the honest report is “submit it as it stands,” there is nothing to quote.

Common questions, answered first

Nine questions the board gets asked before it is asked anything else — each answered in its first sentence, then explained. The full FAQ answers fifteen the same way.

Does my Aspen MSN or DNP project need IRB review?

If the project involves people or their data in any form — interviews, surveys, observation, chart review, an intervention on a unit — assume it needs a written determination from Aspen’s IRB before any data is touched, even when the likely answer is exempt or not human subjects research. A project does not self-certify; the determination is the board’s. Aspen’s current handbook or IRB portal states the form and the route for your program.

The question boards actually decide is not “is this a big study” but “does the design involve human subjects, and at what risk.” A capstone that surveys ten colleagues is small and still needs the determination; a project that only re-analyses de-identified public data may be ruled not human subjects research — but that ruling is still the board’s to write, not yours to assume.

Which findings do boards write most?

Five, in roughly this order: an application that paraphrases the plan it answers to; a consent that has drifted from its protocol version or is missing a required element; a site permission letter that is absent, unsigned or silent on the data; a data-security answer that is one sentence where four are needed; and a category claimed that the design does not support. All five are visible in the file before submission — which is the whole argument for reading it first.

Each is written up in the inspection report above, with the evidence the reviewer sees and the corrective action. The cheapest moment to cure any of them is before the board writes it into the record.

Can I start collecting data before the IRB approves?

No. Data collected before the board’s written determination cannot be made approvable after the fact — not by an amendment, not by a consent signed later. Recruiting, screening and “just asking around” count as data collection. Wait for the letter; if you are unsure whether an activity counts, that uncertainty is itself a question for the board.

The one thing you may do before approval is prepare: build the file, request the site letter, complete training, fix the plan. All of that is ours to carry if you want it — none of it touches a participant.

Do I need CITI training?

Expect to. Documented human-subjects training is part of nearly every IRB file, and the CITI Program is what boards most commonly accept; Aspen’s current IRB portal names the modules your kind of project requires. Keep the certificate current through the life of the study — an expired certificate or the wrong module is an observation on a clean file and one more reason to doubt the whole on a returned one.

It is the cheapest line in the file to fix and the worst one to be queried on. We read the certificates against the requirement before anything is filed.

What is a site permission letter, and why is it the slowest to cure?

It is a letter from someone with authority at the site — not a preceptor, not a unit manager without that authority — naming the site, the activities, and what data leaves with you and who may touch it. It is the slowest finding to cure because it is written on someone else’s clock: no cure you make can start it retroactively, so it is requested first, not last.

A warm letter of support that never mentions data is the most common version of this finding. We draft the letter for the authorized signature so that it says what the board reads for, and we send it before any other document is touched.

Exempt, expedited, full board — what is the difference?

They are three levels of review for human-subjects research, set by risk and design: exempt for minimal-risk work in defined categories, expedited for minimal-risk work read by a designated reviewer, full board for anything with more than minimal risk or a vulnerable population. You do not choose the level — you claim it on the form, and the board decides. The claim has to match the design.

Aspen’s current handbook or IRB portal sets out the categories and forms in force for your program. The determination and plan is where we settle the claim from the design, with a written rationale, before any form is filled in.

Is a quality-improvement project “research”?

Sometimes — and the word on the form does not settle it. Quality improvement is a claim the file makes, and the board reads the claim against the design: a project that samples, generalizes beyond the unit or tests a hypothesis is behaving like research whatever it is called. A file that claims the wrong category bounces, because every later answer was written to the wrong question. Let the design decide the category, then write the file to it.

This is Finding 7 in the report above — the longest bounce. It is also the first thing settled in every file we carry.

What happens when the board returns my file?

The board writes a letter listing its findings; the file is not rejected, it is returned for revision. Each item needs a written response in the board’s own terms plus the revised page it points to — stamped, and consistent with every other document in the file. A return costs a review cycle; a response that argues with the board costs two.

If you are already holding the letter, bring it. The response memo and the revised pages are part of what we carry, item by item, until the board is satisfied.

Do you conduct my research — and what does it cost?

No — the project, its data and its findings are yours, and the board’s decision is its own. We handle the IRB process end to end: the determination and plan, every document, the submission, every reply to the board. Pricing is quoted in writing after the free application review, as a fixed fee for one of three packages — Determination & Plan, The Complete File, or Full Handover, the premium package that takes the whole process off your desk. There are no hourly rates and no prices listed on this site.

The free review is the entry, not the service: it reads the full file and writes the findings. If the honest report is “submit it as it stands,” there is nothing to quote.

Fifteen Aspen IRB questions, answered first — the full FAQ

The board reads your file once with fresh eyes. Spend that read on a determination.

Not on findings that were curable a week before submission. Hand us the whole process — the determination and plan, every document built, the submission itself, every reply to the board answered — and the file goes in clean and stays carried until the board has decided. The project, its data and its findings stay yours; the decision is the board’s. It starts with the free application review — the full file, every finding, the exact cure for each.

Request the free application review

No obligation follows the review — a clean file is told it is clean.