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Aspen’s revision letter, answered — the memo that closes every item

A file that travels a third time usually did one thing wrong on its second: it answered the letter in continuous prose instead of item by item. A response memo is a document with a shape — the board’s findings in the board’s order, what changed under each, and the corrected page attached to the finding that asked for it.

Charlotte Devereux, MSN, RN · 2026-08-23

In short. Answer every finding separately, in the board’s order, quoting its words as the heading. Under each: what changed, which document and section holds it, and the attachment. Nothing argued, nothing bundled, nothing altered that the letter did not raise.

What is the board actually asking you to produce?

Conditions, met. When Aspen’s IRB returns a file marked modifications required to secure approval, it has already decided the project can be approved — on terms. The federal frame leaves a board three ways to end a review, and this is the middle one — a yes that names what has to change first. The conditions are the numbered items in your letter, and nothing else.

That reframing changes what you write. You are not defending the application; you are closing a list. The reviewer’s task on the second pass is to run down the letter and satisfy herself that each item is now answered. Everything that helps her do that quickly helps you. Everything that makes her hunt costs you a pass.

What shape does the memo take?

One block per finding, keeping the board’s own numbers, none of them combined and none moved out of sequence. Each block carries four things.

The four parts of a single response block
PartWhat goes in itThe failure it prevents
The findingThe board’s own sentence, copied exactly, as the heading of the block.The reviewer cannot match your answer to her item.
The changeOne or two sentences saying what is now different — not why the original was defensible.An answer that reads as a defence.
The locationThe document by name and the section or page where the change now lives.A cure the reviewer has to go looking for.
The attachmentThe revised document itself, labelled clearly, stamped to one version.A promise of a change instead of the change.

Where one finding touches two documents — a changed inclusion rule that appears in both the application and the consent — say so in the block and attach both. Half-cured items are the most common reason a file makes a third trip: the application was corrected, the consent still carries last version’s wording, and the reviewer now has a fresh inconsistency to write up.

What separates an answer from an argument?

Three habits turn a compliant reply into an argument, and reviewers recognise all three on sight.

  • Explaining that the original was fine. If the item was raised, the file did not say what you thought it said. Change the file rather than the reader.
  • Answering an adjacent question. An item asking who has access to the identifier log is not answered by describing your encryption. Aspen’s handbook wants the whole chain named — the data itself, its route in, its resting place, the people admitted to it, the protection around it, and its destruction.
  • Handing the item to somebody else. “My chair advised this approach” does not close a finding. Your chair reads and approves the application before it reaches the IRB — the handbook requires the chair’s signature and date on it — so the chair’s view is already in the file the board queried.

There is one legitimate disagreement: where the board has read the design as something it is not. Even then, the reply is not a rebuttal. State the reading plainly, point to the document and line that already says otherwise, and then make the clarifying change anyway. A board that misread your file has told you something true about the file — that this sentence can be read two ways, and a second reviewer will read it the same way.

One boundary is worth naming, because people spend replies on it: the level of review is not negotiable in a response memo. Aspen’s handbook states that neither the applicant nor the chair nor committee members determine the review level; the IRB Chair or designee does. What you can do is make the design’s own features unmistakable so the determination rests on an accurate reading.

Which findings need a document rather than a sentence?

Some items cannot be closed by writing anything at all. They close when a piece of paper arrives, and the signature on it is somebody else’s — which is why these get identified and started first, while the rest of the memo is still being drafted.

Findings that are only cured by an attachment
The findingWhat closes it, per Aspen’s handbook
Site permission missing, unsigned, or vagueA letter on official letterhead — the handbook says email will not suffice — naming you, the project title, a short purpose, a statement that the protocol has been reviewed, exactly what is permitted at the site, any restrictions, and the signatory’s title, email and phone, signed by someone attesting to their authority to grant it.
Instrument attached without permissionA signed permission letter where the author requires one, proof of purchase where the instrument was bought, and the author’s permission where you intend to modify the instrument at all.
Training certificates absent or lapsedCITI certificates of completion, saved and uploaded with the file; the handbook requires the training to be complete before the application is submitted.
Medical records in the designA HIPAA authorization form, which the handbook ties to any use of medical records — electronic, archival or paper — at any point in the project.
Participants who cannot consent for themselvesParental or guardian permission plus an assent document, with an assent script where assent is spoken rather than signed.
Participants who do not read the consent languageA translated consent and materials, approved before use, produced by a certified service with its stamp or by translation with an independent back-translation and a note confirming it — plus a fluent witness to the consent process who is independent of the project and is not the person obtaining consent.
A site with its own review boardThat board’s approval, submitted with the Aspen file; the handbook says you typically seek it before submitting to Aspen.

The site letter is the one to start on the day the finding arrives, because it runs on a signatory’s calendar rather than yours. Everything else in the memo can be drafted while that one travels.

What should the revised documents look like when they arrive?

Like finished documents, not like drafts caught mid-edit. Aspen’s own templates carry instructions in coloured type — the consent template tells you to type your project’s details where the blue font sits, then change every font to black and delete the instruction page before use. Files arrive at the IRB with the blue still in them more often than anyone would guess, and a template that still looks like a template invites the reviewer to check whether the content was tailored either.

The handbook is equally plain about surface quality, and for a reason that is not fussiness: typos and errors in recruitment materials, consent forms or instruments may steer participants away or make them question your credibility, so the board may require materials seen by participants to be revised for accuracy and clarity. For the consent specifically, Aspen asks for lay language below the ninth-grade reading level and points to the Flesch readability formula to check it.

The final pass, before the file leaves again

  • Every finding in the letter has its own block, in the board’s order, with the board’s words on it.
  • Every block names a document and a location, and attaches what it names.
  • One version of every document, stamped the same everywhere, with no earlier copy still in the folder.
  • Numbers, instrument names and site counts read identically in the application, the proposal, the consent and the recruitment set.
  • Nothing changed that the letter did not raise — and if something had to change anyway, it is disclosed in its own block rather than discovered.
  • Documents labelled clearly, signed where signatures belong, and complete: the handbook warns that an incomplete submission delays the project.

If the letter you are answering arrived before approval, reading a returned Aspen application covers the sorting that comes first. If it arrived after approval, the vehicle is different — see changing an approved Aspen project.

What to do next

Post us the letter together with the file it answers. Both get read, the findings come back in writing at no charge, and you are told plainly which items are corrections and which are decisions about how the project runs. Ask for the free application review. Should you prefer the reply carried rather than advised on, the memo is drafted item by item here, with every revised page it attaches, the resubmission prepared, and each subsequent round the board writes answered in turn. Terms are on the how it works page; the FAQ takes the questions that usually come first. Your work remains your own, and every determination is the board’s.

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