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Your Aspen IRB application came back — reading the letter before you answer it

A returned file is a disposition with reasons attached, and Aspen’s IRB Handbook names four of them. The first work is not rewriting; it is sorting what the board actually wrote, because a deferred file, a conditioned file and a disapproved file each ask for a different answer.

Miriam Kessler, DNP, APRN · 2026-08-23

In short. Aspen’s handbook names four dispositions: approved, modifications required to secure approval, disapproved, deferred. Read which one you received before you write a word. Deferred means the file was incomplete; modifications required means the board named its conditions. Nothing may run until approval.

What did the board actually decide?

Aspen’s IRB Handbook sets out the possible outcomes plainly, and they are not gradations of a single verdict. They are four different findings about your file, and only one of them speaks to the merits of the project.

The four dispositions, and what each one is telling you
DispositionWhat the handbook says it meansWhat your answer has to carry
Approved“The study/project may commence.”Nothing. The terms of the approval now govern the work.
Modifications required to secure approvalChanges are required so that the project will meet the criteria for approval.An item-by-item answer and the corrected pages the items point at.
DisapprovedThe board has everything it needs to decide, and the project does not meet the criteria for approval.A response — the handbook says you may give it in writing, or in person by phone or video call.
DeferredUsed only where an application is incomplete, or a quorum was not met for a full board review.Completeness, or nothing at all. A quorum is not your file’s fault.

Two of these are commonly misread. Deferred is no judgement on the design at all — it is the handbook’s word for a file that could not be reviewed, because something required was missing or because the meeting could not be convened. And disapproved is not the end of the conversation: the handbook states that all applicants receive written notification, that a disapproval names its reasons, and that you will have an opportunity to respond. The federal rule behind it leaves a board exactly three determinations — approval, a conditional yes that names its conditions, or refusal — with a duty to decide in writing and to let the investigator answer a refusal.

Why do complete-looking files come back?

Because the board reads for consistency across documents, not quality within one. Aspen’s handbook is unusually direct: applications that are incomplete, that carry errors or typos, or that give inconsistent information will be delayed. It then ties the point to you rather than the paperwork — your application tells the IRB a great deal about you, so give it confidence through an accurate, well-written submission.

Aspen’s own published piece on the IRB lists the pitfalls its reviewers meet most: items skipped or supporting documents missing, unsigned permissions, sections that contradict one another, promises of anonymity or of no risk that the design cannot keep, thin justification for a population that needs safeguards, incentives large enough to read as undue influence, and proposals that hit a university restriction the applicant never knew existed. That last one is real here: the handbook states Aspen does not allow projects requiring a participant to take a substance into the body by any route.

Notice what unites the list. Almost none of it concerns whether the question is worth asking. It is about whether the file answers itself the same way twice.

How do I read the letter line by line?

Give every item in the letter four columns before you touch a document. This sort decides the shape of the whole reply.

  1. The board’s exact words. Copy them; never summarise. The reply gets read against the letter item for item, and a paraphrased item is one the reviewer must hunt for.
  2. The document it lives in. Application form, consent, recruitment set, instrument, site permission letter, training certificates, approved proposal. Some items live in two, and those are the ones that get half-cured.
  3. Whose signature it needs. Yours alone, your chair’s, or a signatory at the site. The handbook requires the application to reach the IRB already read and approved by your chair, with the chair’s signature and date — and a site permission letter has to come back on letterhead from someone who attests they have authority to grant it.
  4. Page or design. Whether the cure is a corrected sentence or a decision about how the project runs.

The items that are pages

Missing certificates, an unsigned form, a consent pitched above the reading level Aspen asks for, a flyer naming something the application never disclosed, an instrument attached in a version other than the one you will administer, or a field left at “the data will be kept secure” where the board asked where the data lives, who may open it and when it is destroyed. Each is cured in the document and closed with a sentence.

The items that are the design

An item that asks who is being recruited, what makes the selection equitable, why a population that needs safeguards is included at all, or what protects a participant who cannot freely decline — that item is not asking for better wording. It is asking you to change something about how the project runs, and then to write the file to the changed version. The same is true of anything touching the review path: the handbook is explicit that neither you nor your chair nor your committee members have the authority to determine the level of review, because that determination belongs to the IRB Chair or designee.

What was missing, if the file was deferred?

Aspen’s application checklist — Appendix E of the handbook — is the shortest route to the answer. Required with every application: the chair-approved application form carrying the chair’s signature and date, the university-approved proposal chapters in Word, and your CITI training certificates of completion. Then everything that applies to your project: a signed site permission letter on official letterhead, the informed consent form, an assent form, a HIPAA authorization form where medical records are involved at any point, the recruitment materials as they will actually be used, approvals from any other board with oversight of your site, and a copy of the instrumentation — with proof of purchase where an instrument was bought, and a signed permission letter where the author requires permission to use or modify it.

The handbook adds a mechanical trap worth checking before you blame the design: the application is signed digitally, which means Adobe Acrobat Reader and a configured digital ID. A file that arrives unsigned because the signature box never took is an incomplete submission, and the handbook says plainly what an incomplete submission does to a project. Our Aspen IRB application checklist walks the same list document by document, and what Aspen’s consent form has to contain covers the document that draws the most items on the letters we read.

What has to stop while the file sits with the board?

The work. Aspen’s handbook repeats it twice on facing pages, in the largest type it uses: absolutely no recruitment of participants, data access, data collection, or project implementation may occur prior to IRB approval. It states the consequence in the same breath — failure to secure appropriate approval from Aspen’s IRB may result in serious actions, including dismissal.

This catches honest people, because a returned letter feels like a conversation in progress rather than a closed door. It is a closed door. A pilot begun while the reply is being drafted, an invitation sent “so people are ready,” a chart pulled to check whether the sample is even there — each is activity before approval, and each turns a paperwork problem into a compliance one.

The other thing that must not happen is a silent rewrite. Answer what the board wrote; do not quietly improve four other things beside it. Unannounced changes read as a different project, and the reviewer who spots one starts checking everything you did not mention.

What does a good reply look like from here?

Item by item, in the board’s order, with the corrected page attached to the item that asked for it, and a sentence for each that says what changed and where. Nothing argued, nothing bundled, nothing improved in the margins. The mechanics of that memo — the ordering, the version stamps, the difference between an answer and a defence — are their own discipline, and we have written them up in answering the board’s findings so the next pass is the last. If the letter arrived after approval rather than before it, the form is different: see changing an approved Aspen project.

What to do next

Send us the letter and the file it came back to. We read both against Aspen’s current handbook and portal, sort every item into page or design, and write you the findings — free, and with no obligation attached. Request the free application review. If you want the reply carried rather than advised on, we draft the response memo and every revised page, and answer each further round the board writes: how it works sets out what that covers, and the FAQ answers the questions people ask before they send a letter to strangers. Throughout it the project, its data and its conclusions belong to you; only the determination belongs to the board.

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