Aspen IRB questions, answered first

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. Settling which route the design earns is the first stage of how we work.

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.

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, and the report tells you exactly which module to renew.

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.

A fourth outcome sits beside them: not human subjects research, for work that does not meet the definition at all — some quality-improvement and some secondary-data projects land there. 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.

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.

The reverse error exists too — a project built to improve one site’s own process, filed as research, with consent machinery and risk language the design never needed. Either way the cure is the same: the category is read from what the project actually does, and the file is written to that. It is Finding 7 on the homepage report, the longest bounce, and the first thing settled in every file we carry.

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. If the site has its own review board, its letter and its approval are two different documents; the board will want to see both.

Yes — the reading is the same for any Aspen capstone, project or doctoral study that touches human participants or their data, whatever the program. The forms, categories and route are set per program by Aspen’s current handbook or IRB portal, and the file is written to those; the findings boards write are the same findings everywhere.

Tell us the program and the project type in the note on the contact page, and the review is read against that program’s stated process.

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 on the homepage, with the evidence the reviewer sees and the corrective action, alongside two more that harden between submission and review: a recruitment set that is not what will actually run, and a training certificate that has lapsed. The cheapest moment to cure any of them is before the board writes it into the record.

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.

The discipline is to answer the question asked, cite the page changed, and change nothing the board did not ask about without saying so. A revised consent with a new version date, a data-security paragraph now naming all four answers, a letter that finally mentions the data — each goes back with a line in the memo that points to it.

Yes, and a returned file is in one way the best kind to send: the board’s letter tells us exactly what it read and what it wants. The free review reads the letter against the file, and the response memo and the revised pages are part of what we carry — item by item, for as many replies as the board writes, until it has decided.

Choose “Returned by the IRB” on the contact page and attach the letter. One of the ten accounts on the testimonials page is a file that came to us with six findings already in the record.

Nobody can honestly tell you, and we do not try: the board’s calendar is its own, and any figure on a consultant’s website is a guess dressed as a promise. What you control is everything that happens before the board’s clock starts and how many times it has to start — the site letter requested first, the category settled first, a file clean enough to earn one read instead of two, and a response that answers rather than argues.

Aspen’s current handbook or IRB portal is the only place to look for the board’s own stated process and meeting pattern. Our part is to make sure the file arrives complete and stays carried until the board has decided, so that whatever the calendar is, it runs once.

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.

What each package carries, and how the quote is made, is on the pricing page. 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.

The full file, read the way the board will read it, with every finding written up — the evidence the reviewer would see, its severity, the corrective action — plus a reading of the review path the design earns and, where the file needs work, a written fixed-fee quote for the package that fits. There is no catch: no obligation follows, nothing is charged, and a clean file is told it is clean.

The review is the entry to everything the practice does, which is the honest reason it is free: a file we have read is a file we can quote accurately. Send whatever exists from the contact page; a plan alone is enough to begin.

You, always. The board hears from you, under your name; we carry the file to it. With Full Handover we prepare the submission and file it with you through Aspen’s current IRB process, and we draft every reply — but the project is yours, the signature is yours, and the board’s decision is its own.

That is also why the inspecting party signs the findings it writes: you should always know which person wrote what, and be able to argue with her. We do not represent any university and we are not the board.

Yes. The file you send is read by the inspecting party and nobody else; it is never shared with Aspen University, any board, any site, or any third party, and it is deleted on your request. The intake form and chat reach the practice’s own lead-handling system and the practice’s email — no advertising networks, no trackers on this site.

The privacy page sets out what is collected, where it goes and for how long, in plain terms.